Lower the risk of biocontamination without compromising material integrity

By Tracey Whitehouse, Aegis Environments

Repeating the word “microbe” in a cleanroom facility can be much like yelling “fire” in a crowded theater. Regardless of the industry the facility ultimately serves, the control of microorganisms is of critical importance in virtually any cleanroom due to the particulate nature of microorganisms. Manufacturers of cleanroom construction materials and facility managers themselves realize this importance as they are challenged and tasked daily to meet the high standards of asepsis set for their cleanroom facility. Deterioration, defacement, and cross-contamination are all real effects that occur from the microbial “corruption” of cleanroom surfaces (e.g., soft and hard walls, ceilings, flooring, and air duct systems). Most significantly for the clean environment, these surfaces can give refuge to microorganisms and ultimately act as a transfer site (vector), offering ideal environments for the proliferation and spread of microorganisms, which is detrimental to maintaining sterility.

The ability to make microbial-resistant surfaces in a cleanroom environment has advantages in many applications. Besides following the current protocols for controlling airborne particles, steps can be taken to protect the surfaces in a cleanroom. And, because every material introduced into a cleanroom is a potential source of contamination, cleanroom designers and specifiers must seek materials that can lower that risk without compromising material integrity. This discussion relates to how antimicrobials added to plastics used in cleanroom surfaces can help to mitigate this source of biocontamination.

The antimicrobial feature

Antimicrobials, by definition, kill, suppress, or inhibit the multiplication of microorganisms. On earth, there are hundreds and maybe thousands of chemistries that kill microorganisms. Many of these-such as arsenic, lead, tin, mercury, silver, plant extracts, and animal extracts-may be “natural,” but they can be highly toxic to people and the environment in most uses. An effective antimicrobial for the cleanroom industry can’t just kill or repel microorganisms; it must do so safely, over the life of the treated surface, and without negatively affecting the other important characteristics of the surface on which it is applied.

The vast majority of antimicrobials, like the ones found in nature, work by migrating or moving from the surface to which they are applied. This is the mechanism by which these migrating (leaching) antimicrobials poison a microbe. A leaching antimicrobial is strongest at the source and weakest as it travels away from that source. The outermost edge of that migration is called the “zone of inhibition.” This zone of inhibition is where resistant microbes are born because, like any living organism, microbes will take extreme measures to survive. As a result of the exposure to sub-lethal doses of antimicrobials, microbes can genetically and enzymatically reinvent themselves as “super-strains.” The very nature of these types of antimicrobials to migrate creates long-term antimicrobial durability challenges because eventually the microbes will no longer be affected by the antimicrobial that was tasked to control their proliferation.

An antimicrobial with a different mode of action incorporates a non-leaching bound antimicrobial organofunctional silane molecule (SiQuat). The mode of action relies on the agent remaining affixed to the substrate, killing microorganisms as they contact the surface to which it is applied. When applied, the agent actually polymerizes with the substrate, making the surface itself antimicrobial. When a microbe contacts the polymer matrix on the treated surface of the fabric or fiber, the cell is physically ruptured by the 18 carbon polymer chain of the primary molecule. Drawn downward toward the positively charged nitrogen atom in the molecule, the microbe cell is literally electrocuted and its cell wall physically disrupted. There is no defense, no non-lethal dose, and no survivors that could build immunity to this physical mode of action. No microbial adaptation occurs, and this mode of action achieves broad-spectrum effectiveness against bacteria, mold, and algae (see Fig. 1).

Figure 1. Rendering of silane wall. Image courtesy of Aegis Environments.Click here to enlarge image

Once polymerized, the bound SiQuat does not migrate or create a zone of inhibition, so it does not set up conditions that allow for adapted organisms. Because it becomes part of the surface, it also does not cross the skin barrier, affect normal skin bacteria, or cause rashes or skin irritations.

Antimicrobial plastics used in cleanroom facilities

Achieving stability requires control of biocontamination in the design, specification, operation, and control of cleanrooms and associated critical environments. For many cleanroom facility managers in the microelectronics, pharmaceutical, and other industries, polyurethane (PU) based materials have proved to be a valuable asset to the cleanroom industry. Their durability, versatility, and ability to be easily cleaned have proved useful on hard surfaces such as furniture, insulation panels, sealants, and soft wall strips, panels, and framing. PU is also bonded to nylon knit for use in gloves and cleanroom suiting.

Biosafe Inc. (Pittsburgh, PA) has developed and patented a process that enables the inclusion of the SiQuat agent in a polymeric powder (HM 4100) compounded into plastics to impart durable antimicrobial properties throughout the component, inside and out. In testing with HM 4100 treated PU coated glass, a 6.82 log reduction against the test organism Escherichia coli with 1-hour contact time-at the 0.2 percent actives rate (ASTM E2149-01)-was demonstrated (see Table 1).

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Further testing was conducted to compare and determine the antibacterial efficacy of polyurethane plaques treated with 0.3 percent Biosafe HM 4100 against a 1 percent silver treatment. The samples were tested using the JIS Z 2801-200 test method with testing done at two separate 2-hour contact times against gram-negative Escherichia coli. Figure 2 demonstrates the efficacy of the bound HM 4100 on the treated PU as it relates to the silver sample.

Materials used in cleanrooms, particularly those used in panels and strips, rely on optically clear plastics to maintain a safe, blur-free work zone. New developments are underway to bring to market an antimicrobial plastic that not only imparts a biostatic surface but can also maintain the optical requirements needed for cleanroom window/panel specifications. Initial testing with an HM 4100 treated resin used in optically clear plastic manufacturing passed tests for yellowness, hazing, transmittance, and diffusion, among other properties, as compared to non-treated optically clear plastic. Virtually no optical differentiation was demonstrated (see Table 2).

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Specifying an antimicrobial in your cleanroom materials
To a cleanroom professional, nothing is more paramount than effective contamination control-not only for the safety of the staff, but also for the integrity of the product being manufactured. It is critical that these professionals review all materials that go into their cleanroom design. When researching antimicrobial plastics, the following points should be considered:

• Durability: Cleanroom materials require durable features. Plastics engineered for use in cleanroom and other aseptic facilities must have antimicrobial treatments that can survive the many abuses, namely abrasion from cleaning and product processing.
• Waste control/toxicity: Antimicrobials control a range of microbial pests, but their use must be managed so that they do not affect good and helpful microbes. Although heavy metals have long been rejected where they come into contact with the environment or human skin contact, silver-based products have unexpectedly made a resurgence.
• Spectrum of activity: Many materials are antimicrobial at the right concentration, but in cleanroom and medical applications, it is very important to strike a balance with broad range antimicrobial activity that is safe and economical. When integrating antimicrobial treatments into goods, this is even more important. A broad-spectrum antimicrobial will have activity at the deliverable concentration or contact concentration that kills or inhibits gram-positive bacteria, gram-negative bacteria, yeast, and mycelial fungi. Added spectra could include algae, virus, or other microbial pests.
• Adaptation: Any agent that affects a microorganism’s life has the potential to set up conditions where the microbial cells adapt or mutate into resistant types. This is undesirable in almost all settings but clearly should not be tolerated in a cleanroom facility. Consider the modes of actions of the antimicrobials you are considering before you make a final decision.

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Tracey Whitehouse is a technical writer based in Midland, MI. Aegis Environments provides antimicrobial technologies and services to the building, construction, and textile industries (www.aegismicrobeshield.com).

Standard’s key objective is to give industry-wide flexibility regarding implementation

By Steve Wisniewski and Chuck Stock, Integrated Project Services

Regulations have long required pharmaceutical and biopharmaceutical manufacturers to validate manufacturing processes, demonstrate control of manufacturing environments, and control contamination. In the United States, this mandate falls under the Code of Federal Regulations (21 CFR Parts 210 and 211). In 1998, the International Society for Pharmaceutical Engineering (ISPE) initiated an effort to develop its Commissioning and Qualification Baseline Guide to help manufacturers focus and prioritize their qualification efforts using the risk assessment tool of impact assessment. More recently, a task team formed through ISPE worked with the American Society of Testing and Materials (ASTM) committee E55.03 on a new consensus-based standard, Standard Guide for the Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. The standard (ASTM E2500) was voted upon and approved at the end of May.

Although participation by the U.S. Food and Drug Administration (FDA) in ASTM Committee E55 and FDA’s affirmative vote of the standard do not constitute adoption, it points toward the agency’s support for the new standard, which aligns with FDA’s published cGMPs. Furthermore, the National Technology Transfer and Advancement Act (NTTAA) and OMB Circular A-119 on Federal Participation in the Development of Voluntary Consensus Standards and in Conformity Assessment Activities both direct agencies such as the FDA to use voluntary consensus standards in lieu of government-unique standards whenever possible.

The standard provides high-level guidance-it explains what needs to be done but not how. The specifics of that will be addressed in an updated ISPE baseline guide. A task team is in place, and its goal is to have a revised draft of the guide available for ISPE membership review in time for ISPE’s annual meeting in November. Although the process is generally the same for everyone, how organizations choose to implement the standard will vary depending on their quality goals, time and cost requirements, and even internal roles and responsibilities. Navigating the process can be complex from the perspective of both engineering and project management. It requires a bit of a paradigm shift in management philosophy. Most companies will have to expand their project teams in order to leverage the product knowledge obtained by applying ICH Q8 and implementing a science- and risk-based approach by applying ICH Q9. The additional effort and resources, however, can not only facilitate regulatory compliance but can deliver additional benefits for the facility owner.

Balancing cost, efficiency, quality, and safety

ISPE initially developed its C&Q baseline guide to lay out engineering approaches and practices that would help owners design and validate cost-effective manufacturing facilities that meet their intended purposes in a timely manner. Its goals are to bring common terminology and methodology to all involved in the C&Q process, to provide a system impact assessment process, foster an interdisciplinary team approach, and establish a basis for planning and execution. It aims to eliminate such costly practices as repeating verification steps during qualification, qualifying systems that only require commissioning, and optimizing documentation levels. The guidelines also are designed to help minimize the project schedule and eliminate costly delays.

Built on the key concepts of good engineering practice (GEP), impact assessment, and qualification practices, the baseline guide addresses the process of designing, constructing, commissioning, and qualifying facilities, utilities, and equipment regulated by the FDA or other health authorities. The document positions commissioning and qualification activities as the foundation for process validation. In fact, a well conceived and executed commissioning and qualification plan greatly facilitates a timely, cost-effective validation effort. The document also recognizes that taking a comprehensive approach to commissioning and qualification plays a critical role in delivering effective, safe, and efficient facilities, utilities, and equipment.

A comprehensive approach requires assessing each system for its potential impact on the product quality and patient safety. At one end of the spectrum, parking facilities have no impact; at the other, the water for injection (WFI) or U.S. Pharmacopeia (USP) water system clearly has a direct impact. The gray areas are systems such as air conditioning, chilled water, or building management, which may have an indirect impact, depending on how they are designed and used. If the systems have no impact or only indirect impact, following GEPs should be sufficient. For systems with direct impact, it is necessary to make impact assessments at the component level to determine which components are critical. For example, if the HVAC system will have a direct impact, a component assessment might determine that only specific elements-the main and terminal HEPA filters and the sensors for temperature, differential pressure, and humidity-are likely to have an impact and are therefore critical. Components identified as critical will require qualification. The quality assurance unit must endorse the rationales to support these assessments.

ASTM verification: A risk- and science-based approach

The ASTM verification standard takes the ISPE baseline to the next level. The standard describes a risk- and science-based based approach to specifying, designing, and verifying elements of a manufacturing capability to ensure that those systems and equipment are fit for intended use, and that product quality risks related to those manufacturing elements are managed effectively. Ultimately, the manufacturing capability should be able to support defined and controlled processes that consistently produce a product that meets defined quality requirements. The standard applies a number of key concepts including a risk-based approach as provided by ICH Q9, Quality Risk Management; and a science-based approach and quality by design, as provided by ICH Q8. It applies the concept of critical quality attributes and calls for the use of subject matter experts (SMEs) to make critical determinations. Like the ISPE guidance, it acknowledges that GEPs may be sufficient for certain systems. It also seeks to minimize the paperwork burden by allowing for the use of vendor documentation.

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The standard applies to all elements of pharmaceutical and biopharmaceutical manufacturing capability, from the actual manufacturing systems, equipment, and automation systems; it can also be applied to laboratory and information systems. It applies to new manufacturing systems and may be used when implementing changes and improvements to existing systems and equipment. Finally, the standard is applicable throughout the product life cycle, from concept to retirement.

In effect, this is the same basic scope of activities that compliance professionals in the industry have addressed for the past 30 years but in a new, more flexible package that allows the pharmaceutical company to determine the methodology. The standard uses new terminology and better defines current terminology, reflecting the science- and risk-based approach, and it puts the quality team and technical experts in new roles.

One of the major differences is the concept of verification. Under the ASTM standard, the company should define a systematic approach to verify that the manufacturing elements-individually and in combination-are fit for intended use, have been properly installed, and operate correctly. The company must document the verification approaches used, providing a level of detail appropriate to the level of risk to product quality and patient safety, as well as the complexity and novelty of the approach. Traditional installation and operational qualification protocols can be set aside in favor of documented confirmation by SMEs that all acceptance criteria have been met. This documentation should include a review or overview of results, as well as a review of any non-conformance to acceptance criteria and corrective actions taken. The documentation should clearly state whether the manufacturing system or equipment is fit for intended use.

In contrast to the traditional qualification process, the verification approach requires that the quality unit shift its emphasis from quality control to quality assurance. Where previously the quality unit was involved in every protocol test case, every minor discrepancy, and endless wordsmithing to justify minor departures from engineering specifications, under the ASTM standard, the responsibility for engineering quality control falls on the technical experts with appropriate oversight by quality assurance. Non-critical discrepancies are addressed through GEPs. Instead of an obsessive focus on documenting every minor detail, the team can now focus its documentation practices on technical content-a far more efficient approach.

A new process paradigm

The move to the ASTM verification standard requires a new approach to the specification, design, and verification process, moving away from the “V Model” of commissioning and qualification. The new paradigm demands that the principles of good engineering practice, risk management, design review, and change management are applied at each stage of the process, from compiling design requirements to acceptance and release and beyond.

The keys to success under the ASTM standard are in upfront planning and interdisciplinary communication. Goals and objectives must be clearly defined, because they will drive the process and impact everything downstream. Accurate, well thought-out input into the requirements is critical. The requirements should be based on knowledge of the product and its manufacturing process, as well as regulatory requirements and the company’s own quality requirements. Available product and process knowledge can be determined by reviewing the scientific data gathered during experimental and development work. This information can provide the basis for specific product/process requirements relevant to product quality and patient safety. Specification and design activities should focus on those aspects that have been identified as critical to product quality and patient safety. Subject matter experts should be the ones to identify and document these critical quality attributes-functions, features, abilities, and performance or quality characteristics-that are necessary to consistently produce products of the required quality. The company should have a systematic means of conveying these specifications to those responsible for design so that manufacturing systems and equipment are properly designed to meet relevant requirements.

Subject matter experts also should define the acceptance criteria that must be satisfied in order to demonstrate that manufacturing systems and equipment meet the critical quality attributes. The quality unit should approve the acceptance criteria. The SMEs also should develop and approve the verification plan and specifications, including the method of verification and test strategy. Finally, the SMEs should perform the verification activities as defined, document the results, and document that verification activities have been completed. The ASTM standard allows for the use of vendor verification documentation.

An independent technical reviewer with the appropriate background, knowledge, and familiarity with the technical aspects of the manufacturing elements should review all completed verification documentation, ensuring that all tests have been completed and appropriately documented. The technical reviewer and SMEs should work together to address and resolve any departures from the verification plans and specifications.

From impact assessment to risk assessment

Another paradigm shift that the ASTM standard brings about is the approach to risk assessment. Since the ISPE baseline guide was introduced, companies have relied primarily on impact assessment-that is, evaluating the impact of the operating, controlling, alarming, and failure conditions of a system on the quality of the product. Impact assessment is a labor-intensive process that focuses on systems and components and usually is conducted after design development. Under the ASTM standard, impact assessment is just one of many tools, including hazard operability analysis (HAZOP), failure mode effects analysis (FMEA), and fault tree analysis (FTA) that can be applied to the process.

Risk assessment is performed throughout the design development to ensure that the systems and other facets of the design and operating philosophy can effectively monitor and control risks to the manufacturing process, such as process variability and contamination. Each selected process is assessed against a set of product and process user requirements. The risk management requirements include all components, functions, and features that serve, collectively or individually, to control risk. These are designated as critical elements. The risk assessment should determine the probability that any specific risk could impact process variation and the degree to which that impact could affect product quality and safety. Risks that are deemed unacceptable are to be eliminated by design, automated control, or procedural controls. Companies will find more specific details on risk management in ICH Q9.

When verifying manufacturing systems and equipment, the procedure should be documented in sufficient detail that trained individuals can repeat the test in the same manner and obtain the same results. Similarly, the observed results should be documented adequately, so that a technically competent person can verify that the inspection or test was performed properly and that the acceptance criteria were met. An independent SME should review the results to ensure that all tests were completed, acceptance criteria met, and all appropriately documented. Documentation should also include confirmation that any departures from specification have been addressed through GEPs or change control for nonconformance. Depending on the circumstances, the process of verification may or may not include performance testing. At the conclusion of verification, the subject matter expert will document the results of the verification effort in a verification report. The quality unit, and possibly other technical experts, will approve the verification summary report.

Conclusion

Pharmaceutical and biopharmaceutical companies are challenged to develop manufacturing capability quickly and cost effectively while safeguarding product quality and patient safety. To date, approaches to meeting that challenge have run the gamut from equating commissioning with qualification-a costly, laborious, and time-consuming tactic-to eliminating any commissioning and going right to validation-a course of action that is often fraught with failure.

To determine the best approach for implementing the ASTM verification standard, the company will need to explore its goals for the process. Does the system need to improve compliance? Enhance product quality? Provide greater contamination control? Minimize capital costs? Initially, it may be helpful to find an expert who is experienced with this verification process to create an approach plan and preliminary schedule and then develop a detailed list of activities to determine the project scope. Once that detailed foundation has been laid, the request for proposal can include a list of expected deliverables to ensure that potential vendors are bidding “apples to apples.” This phased approach can help save time and money and help the company obtain the desired outcomes from its chosen approach to verification/qualification under the ASTM standard.

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Steve Wisniewski is senior associate and director of compliance for Integrated Project Services (IPS), a full-service engineering firm specializing in the delivery of technical complex projects. He has more than 30 years’ experience in the pharmaceutical, biotechnology, and device industries, including senior management roles at Sterling Winthrop and Bausch & Lomb. He currently serves as chairman of the ISPE Community of Practice for Commissioning and Qualification, and serves on the ISPE Task Teams for developing the ASTM verification standard and the revised C&Q baseline guide.

Chuck Stock is senior vice president and principal in charge-compliance for IPS. He has more than 25 years of management-level experience in process, operations, and compliance in the pharmaceutical, biotechnology, and device industries. Stock has successfully started up, commissioned, and validated cell culture facilities, vaccine facilities, oral solids and liquids facilities, and bulk chemical and device facilities. He has developed and presented training programs and seminars for cGMPs, validation, project management, and master planning to U.S. and international industry groups and individual companies. He currently is team leader for Expert Consultants in a Consent Decree for quality system elements.

References

1. ASTM International, New Standard Guide to a Science and Risk-Based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems, 2007.
2. . International Society for Pharmaceutical Engineering, ISPE Baseline® Guide: Commissioning and Qualification, March 1, 2001.

Compatibility between wiper materials and chemical disinfectants affects stability and concentration

By Kimberly Dennis MacDougall and Valerie Williamson, Kimberly-Clark Professional

Cleaning environmental surfaces is critical to reducing health-care acquired infections and is the necessary first step in any sterilization or disinfection process, according to the Guidelines for Environmental Infection Control in Health Care Facilities from the U.S. Centers for Disease Control and Prevention (CDC).

Cleaning renders surfaces safe to handle or use by removing organic matter, salts, and visible soils, all of which interfere with microbial inactivation. The physical action of scrubbing with detergents and surfactants and rinsing with water removes a large number of microorganisms from surfaces.

In addition to physical cleaning, disinfecting or sanitizing surfaces is also critical to reducing health-care-acquired infections. However, not all surface sanitation efforts are equal. In fact, according to two recent studies, some common systems-such as using a cotton rag or cellulose-based wiper to apply bleach or quaternary amines to surfaces-deliver less-than-ideal concentrations of disinfectants/sanitizers to surfaces.

Disinfectant selection

An important step in the disinfection/sanitization process is mixing and application of the disinfectant. To be effective, the disinfectant should be mixed and applied to the surface uniformly, according to the directions, and the surface should remain wet for the length of time recommended by the manufacturer.

The selection and use of chemical germicides is another important step. A number of disinfectants are currently used in health-care facilities including alcohols, hypochlorites, chlorohexidine, iodophors, hydrogen peroxide, phenolics, and quaternary amine compounds.

Methods for applying surface disinfectants

There are various methods for applying surface disinfectants in health-care environments. In the studies described here, two common systems were evaluated:

• Open bucket system: This system employs an open bucket in which cotton rags or disposable cellulose-based wipers are submerged into the disinfecting solution and then taken out to wipe down various surfaces.
• closed bucket system with disposable non-woven wiper: These disposable cleaning wipers have a fiber preparation that is compatible with the disinfecting chemicals bleach and quaternary amines. A dry roll of wipers is placed into the bucket and the disinfecting chemical is added to saturate the wipers. The bucket is closed and the saturated wipers are dispensed via a port on the top of the bucket.

To ensure that the chemical concentration of the disinfectant solution is adequate, a simple paper indicator strip is typically used to check the parts per million of disinfectant (bleach or quaternary amines) present in the bucket. However, this practice does not monitor the amount of disinfectant in the liquid deposited from the wiper to the surface. And, in fact, it is the ability to deliver the correct concentration of germicidal ingredients to surfaces-to render microbes non-functional-that is the primary operative assumption underlining the principle of surface disinfection, and the focus of the two studies.

Study #1 and results

Two studies were conducted to examine the effects of commonly used wiping material substrates on the amount of quaternary amines and bleach being released to surfaces for the purpose of disinfection. It is important to emphasize that the systems used for the purpose of these studies are different and that each wiper type is used under conditions representative of its common use. Obviously, the length of time the wipers are exposed to the chemical and the number of wipers placed in the chemical at one time are significant factors. Therefore, the closed bucket system creates a significantly more challenging environment with regard to the exposure of the wipers to the disinfectant compared with the open bucket system because the wipers remain in contact with the chemical solution for a significantly longer period.

In the first study, the different wiping systems were compared over an 8-hour period, comparable to a single work shift in a hospital setting. The study was then extended out to three days to investigate the compatibility of the disposable non-woven wiper in the closed bucket over time, as this system provided 90 wipers per roll and lasted much longer than the open bucket of disinfectant fluid with dipped wipers. A conservative rate of using six wipers in the bucket per hour over the course of an 8-hour shift was investigated. Fluid samples were collected from the wipers and tested at predetermined time points to detect active quaternary amines available from the wiper for surface disinfection.

In conducting the study, a quaternary amine solution was prepared based on chemical manufacturer specifications, and duplicate buckets without wipers were used as controls. Fluid from the controls was collected and analyzed over an 8-hour period. Fluid was also removed from the open bucket and tested prior to the removal/dipping of the wipers to establish the effect of the correct concentration of the disinfectant solution at designated time points.

For the closed bucket system with the disposable non-woven wipers, quat samples were taken from three wipers at 10-minute time points to obtain solution for three titration measurements of disinfectant for each extraction. The fluid was extracted from the wipers and immediately collected in a plastic bag for quat release measurements, which were taken instantaneously.

For the cellulose-based wipers in the open bucket system, wipers were submerged in the quaternary solution for 5 seconds, every 10 minutes. Three wipers were removed at designated time points and the solution extracted for quat release measurements. Steps were taken to ensure that the wiper maintained adequate fluid and was not wrung dry. Measurements were taken instantaneously. There were three titrations completed for each extraction.

The study results showed a significant decline in the concentration of basic quaternary amines released when cotton rags or cellulose-based wipers were used in the open bucket system compared to the disposable non-woven wipers in the closed bucket system. In fact, an immediate drop-off of quat release at the time point of zero was noted for both cotton and cellulose-based wipers even though neither material was in continuous contact with the disinfectants in the open bucket. This observation suggests an instantaneous negative interaction between these materials and the disinfectant chemicals tested.

The study findings showed that the initial quat release from cotton was 53 percent lower than the original chemical disinfectant A solution, as shown in Fig. 1. Over 8 hours, representative of a standard work shift, the quat release from cotton continued to decline rapidly. Prior to the solution being depleted in the bucket, the quat release from the last cotton rag passed through the bucket was 0.83 percent of the original disinfectant concentration. By comparison, the cellulose-based wipers also displayed a sharp reduction in active quat release for chemical disinfectant A. At the conclusion of the 8-hour shift, the average quat release from the cellulose-based wipers was 21.5 percent of the original concentration.

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In contrast, the disposable non-woven wipers maintained at least 83.6 percent of the chemical disinfectant A solution concentration for the first 8 hours of the study. In extended three-day testing, the non-woven wipers retained an average of 88.6 percent of the original active concentration.

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The results for the chemical disinfectant B are shown in Fig. 2. According to study findings, the initial drop in active quat concentration for cotton wipers was 29.3 percent. This is a significant loss that may be of concern to health-care facilities using this type of disinfectant and wiping substrate to disinfect critical surfaces. Conversely, the study found that the initial disposable non-woven wiper taken from the enclosed bucket of chemical disinfectant B maintained 99.6 percent of the original chemical concentration. In extended three-day testing, the disposable non-woven wipers retained an average of 90 percent of the original chemical concentration.

These results suggest that the disposable non-woven wipers with a fiber preparation intended to yield quat compatibility would better maintain target disinfectant concentration as compared to cotton rags and cellulose-based wipers, even over a relatively prolonged period of time.

Study #2 and results

A second study was conducted to evaluate the effects of the same commonly used wiping substrates on the amount of bleach being released to surfaces for the purpose of disinfection.

The variables tested in the study-including the type of delivery system, the length of time the wipers were exposed to the chemical, and the number of wipers placed in the chemical at one time-mirror practices commonly used in health-care disinfection applications. The bleach solution tested was diluted to the chemical manufacturers’ recommended level for disinfection. Because bleach tends to be less stable over time, the testing period was limited to 72 hours.

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The study results showed that cotton rags and cellulose wipers in an open-bucket system rapidly depleted the active chloride ion present in bleach (see Fig. 3). However, the disposable non-woven wiper used in the closed-bucket system kept it stable for a full 72-hour period.

In the study, the chloride ion release from the first cotton rag from the open bucket was 11 percent lower than the original bleach concentration. The chloride ion release from the first cellulose-based wiper was 13 percent lower than the original bleach disinfectant solution and dropped to 28 percent lower after 24 hours of use.

In contrast, the initial chloride ion release for the disposable non-woven wipers was only 3 to 5 percent lower than the original bleach concentration even after 72 hours of use.

The significant decline in the release of bleach disinfectant when cotton rags and cellulose-based wipers were used in an open-bucket system implies that active disinfecting agents are not always applied to the surface in the ideal concentration to support optimum environmental disinfection.

Conclusion

It is interesting to note that the Association for Professionals in Infection Control and Epidemiology (APIC) calls for the use of disposable cloths during environmental (surface) cleaning as a way to prevent and/or control multiple drug-resistant bacteria and notes that, for all environmental surface cleaning, cloths should be thoroughly moistened with disinfectant. APIC further cautions against returning a cloth to the bucket of disinfectant once it has been used to wipe surfaces as this may “promote increased environmental contamination and microbial spread.”

The enclosed system described in these studies helps to avoid contamination of the wipers and the cleaning solution because it eliminates any opportunity to re-dip the wipers into an open bucket. In addition, the use of the closed-bucket system reduces the need for mixing new solution batches because the system is stable for an extended period of time. Factors such as changes in pH and exposure to air and light, which can affect the stability of bleach, are not a problem because the closed-bucket system allows for minimal bleach and wiper exposure to air and light.

In conclusion, infection control practices can be optimized through the selection of wiping material systems that are compatible with the chemicals (quaternary amines and bleach) used in the surface disinfection protocol. Likewise, some materials currently in use are far from optimal in their ability to provide disinfectant actives to surfaces in the intended concentrations. These findings are important considerations in the design of today’s infection control practices.

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Kimberly Dennis MacDougall is a research scientist and Valerie Williamson is category manager at Kimberly-Clark Professional (www.kcprofessional.com).

Half the battle in maintaining necessary cleanliness levels is reducing the amount of microorganisms and particulates that are tracked into the critical environment in the first place. The following is a selection of flooring mats that provide protection against foot- and wheel-borne contamination.

Compiled by Carrie Meadows

Antimicrobial-coated adhesive contamination control mat

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The new IdealMat™ from ITW ALMA is an adhesive-coated contamination control mat that captures particulates from foot traffic and equipment wheels, providing the most effective dirt and dust removal method available. The new mat offers a consistent adhesive coating on each layer, is available in 30 and 60 layers, and has an antimicrobial agent in the coating to reduce the potential for spreading germs and bacteria in the controlled area. ITW ALMA’s technical expertise and exact formulations ensure a consistent adhesive coating on each layer of the mat.

ITW ALMA
Kennesaw, GA
www.almainc.com

Mats custom manufactured to order

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Connecticut Clean Room Corporation (CCRC) provides cleanroom PolyTack Entrance and Message Mats. CCRC developed the first seamless one-piece PolyTack Entrance mat in 1979. Made-to-order mats allow CCRC the flexibility to produce a variety of sizes and messages depending on customer needs. The company also has an assortment of mat frames for those applications where mats cannot be adhered to the floor. Industries using these mats include pharmaceutical, high-tech, industrial, and others. Ask about BEE SMART information for customizing mats and many other products. To receive a catalog or for information on BEE SMART, call (860) 589-0049.

Connecticut Clean Room Corporation Bristol, CT
www.ctcleanroom.com

Polyester compound offers high coefficient of friction

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The Dycem Protectamat has been independently tested, showing greater ability to remove and hold particulate and bacterial contamination from foot and cart traffic prior to entering the critical environment. Made from a polyester compound with an exceptional coefficient of friction, Protectamat removes even the finest of contaminating particles from shoes and wheels. Its optically smooth, natural high-tack surface conforms to the shape of the shoe sole or wheel. The mat has no adhesive carryover, will not damage or pull off shoe covers, and requires no frame. It is easy to maintain within the established cleaning SOPs using the customer’s facility approved disinfectants and detergents. Protectamats are available in a standard 4-ft width and various lengths up to 13 ft. For samples and more information on Dycem’s contamination control mat and flooring products, e-mail [email protected] or call (800) 458-0060.

Dycem Warwick, RI
www.dycemusa.com

Adhesive mats feature antimicrobial protection

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High-Tech Conversions Inc., a manufacturer of wiping products and a supplier of consumable items used in cleanrooms, assembly lines, laboratories, and manufacturing, announces Tackified Entrance Mats that are made with an incinerable polyethylene film to remove both wheel-borne and foot-borne particulates before entering the cleanroom area. The mats feature seamless, one-piece construction that allows for full surface coverage and easy mobility for carts and wheeled machinery. Numbered tabs provide easy identification and sheet separation; the mats also contain an antimicrobial agent to provide long-lasting protection against bacterial growth. The mats come standard with full adhesive backing; 1 1/2-inch adhesive strips can be substituted upon request. Four mats come in each case (clear, white, blue, and gray), with 30 sheets per mat. Mats are available in sizes ranging from 18×36 inches to 36×60 inches.

High-Tech Conversions Inc. East Windsor, CT
www.high-techconversions.com

Reusable, washable flooring and disposable mats available

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Innotech Products offers two types of quality contamination control flooring systems: reusable, washable flooring systems by Dycem and disposable flooring such as sticky peel-off mats. Both systems effectively capture dirt and dust from foot traffic and equipment wheels before they enter the controlled environment. Reusable, washable sticky flooring systems will collect and retain more than 99 percent of particles, ranging from larger than 100 μm to smaller than 0.2 μm. Sticky peel-off mats will remove up to 95 percent of particles at the 0.3-μm range. Innotech also offers a line of ESD, anti-fatigue, and standard mats available for use with or without perforated flooring.

Innotech Products Minneapolis, MN
www.innotechprod.com

Framed and frameless adhesive mat offerings

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Liberty Industries introduces the Model #1021 All-In-One Tacky Mat®, a portable entrance mat, 24×30 inches, designed to remove small dirt particles and dust from feet. Frames are manufactured in either white or black high-impact polystyrene. Each individual sheet contains a microbial agent providing protection against growth of organisms such as mold, mildew, and bacteria. When the top sheet is soiled, simply peel away. Refills are easy to install and consist of a 60-sheet layer. Model #800030 series of Tacky Mat® offer maximum protection for foot-borne contamination. Each sheet has a strong adhesive coating that removes dirt on contact and protects sanitary conditions in cleanroom areas. Each mat consists of 30 disposable sheets. The mats install in seconds and can last weeks depending on the amount of traffic. No frame is required; the mat adheres to the floor.

Liberty Industries East Berlin, CT
www.liberty-ind.com

Adhesive-coated contamination control mat

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The PIP Technical Cleanteam® adhesive-coated contamination control mat is specifically designed to reduce foot-borne dust and particulates from entering the cleanroom. The mat is recommended for all controlled environments and offers multi-layer protection in 30 and 60 layers, four- and eight-pack configurations, and three colors (white, blue, and gray). For additional information, visit the company’s web site, call (800) 262-5755, or e-mail [email protected].

PIP Technical Uniontown, OH
www.pipusa.com

Low-density polyethylene layered mats

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Purus Mat is an advanced cleanroom mat with multi-layered adhesive that removes dirt and dust from foot traffic and wheels prior to their entry into a critical manufacturing environment in the electronics, medical device, and pharmaceutical industries. Purus mats are produced in an ISO 9000 factory; the completely integrated manufacturing process with extrusion, coating, laminating, and converting ensures consistent and superior quality. Quality control data and reports are available for each shipment or case of product. The mats are available in 30 or 60 layer versions. Each layer of the mat is fully coated with a particle-grabbing adhesive and constructed of 1.8 mil (50 μm) low-density polyethylene film. A low-profile numbered tab indicates the number of remaining layers and ensures removal of one layer at a time.

Purus International Inc. Indio, CA
www.purusint.com

Sticky mats provide high performance in clean zones

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Value-Tek offers mats that feature high-performance attributes such as tack level, adhesive softness, and adhesive thickness to trap and contain particles successfully. The tack level determines the amount of force required to remove particles from a surface and works in conjunction with the adhesive softness to embed particles into the mat. This will ensure that they are not later released onto another surface, while the adhesive thickness ensures that the adhesive has adequate depth to embed the particle. Value-Tek mats offer the most economical and effective particle reducing system by significantly reducing traffic-borne contaminants, and removing up to 95 percent of particles 0.3 μm and larger. The company offers a variety of sizes ranging from 18×36 inches to 36×72 inches in 30- and 60-layer configurations in white, blue, and grey. Mat frames are sold separately.

Value-Tek Phoenix, AZ
www.valutek.com

Selecting the right packaging solution for your product requires close collaboration with your package provider

By Michael D. Fisher, Fisher Container Corp.

What is your use and application? This is the first question a prospective customer should be prepared to answer when trying to determine the type of packaging material best suited for a current or new application/packaging project.

It sounds simple, but be careful, because “use and application” are loaded terms. Don’t forget that from a packaging perspective use and application encompass everything from the fill process all the way to final disposal of the packaging.

Also consider the old packaging adage, “A package is only as good as its shipping container.” There exist hundreds if not thousands of combinations of film types, co-extrusions, laminations, and compounds to enhance a material’s capabilities as well as whole families of adhesives used to customize the proper material for a specific product’s use and application. So be prepared to answer even more questions (see “Considerations for cleanroom packaging”).

There are quite a few other potential concerns as well, but let’s stop here and discuss some of these factors in more detail.

Material film type and density

Material density selection is based on each customer’s needs and specifications. For example, customers may specify a particular film type or gauge to best suit their own internal packaging and handling requirements prior to shipment. As a result, while one customer may specify a particular density because they have semiautomatic packaging machinery applications that need a film type with a low coefficient of friction for stackability, another may require just the opposite for speed and handling.

Film and gauge choices can be very confusing, and customers, especially those in the cleanroom industry, should be sure that their source has a wide range of knowledge concerning film performance capabilities at all levels. For example, a provider should be able to cite the film’s machinability; packing speeds that can be obtained by utilizing manual, automatic, and semiautomatic equipment; stackability; particle generation; outgassing, leachables, and extractables; clarity; MVTR; OTR; gloss; haze; puncture strength; elongation; seal integrity; dart impact, and so on. Everything is customized to address the needs and concerns of each individual customer even though two products may be exactly the same.

As an example, consider the cleanroom laundry industry. In the U.S., there are five major players in this industry and all five use one of the following three film types for a variety of reasons: low density, high density, and, on occasion, medium density polyethylene. Some use a combination of these materials while others strictly adhere to one type.

Ultra-pure polyethylene films and Tyvek® provide excellent protection for packaging products from sterile medical devices and pharmaceuticals to semiconductor and electronic devices, among others. Left and front: Low density PE film bag. Right: Tyvek® pouch, available in peelable and non-peelable formats. Photo courtesy of Fisher Container Corp.Click here to enlarge image

Since the cleanroom laundry industry’s products are generally soft in nature, the film choice can be one that doesn’t require a great deal of strength in comparison to packaging a medical device or a rigid product. The need to avoid pin-holing is an important requirement that can be achieved by simply choosing the proper gauge along with the proper material and sealing equipment. Clarity issues are important to some and not so to others. Sometimes this is determined by the customer’s clients or it’s just a matter of personal preference and aesthetics. Reading UPC codes through a cleanroom package can be the sole reason for high-clarity requirements.

Sterile presentation

Packaging that allows sterile presentation or peel can also be complicated and requires a great deal of expertise to properly choose and recommend the appropriate materials.

For example, prior to prescribing packaging materials for sterile products, it is essential to know what type of sterilization method will be applied to the package. Those most commonly used today are autoclaving/steam, dry heat, gamma/electron beam, ethylene oxide (ETO), and atomized peroxide/vapor. Whatever package type is prescribed must exceed the aggressive demands of the sterilization method.

Ease of opening is another essential film performance. One common material with a wide range of uses is DuPont’s Tyvek®. Tyvek® to Tyvek®, as well as Tyvek® sealed to other support films, allows it to be peeled back for sterile presentation.

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Tyvek® comes in several grades; prescribing the proper grade is essential. Tyvek sealed to polypropylene is a standard for many of the more aggressive sterilization methods. For the less aggressive, Tyvek® sealed to high density polyethylene can be used as well.

Film variations are geared toward end use and application, as well as the protection requirements of the product. Since this is largely determined by how the product is going to be shipped and then handled by the end user, it is often advisable for a customer to obtain a variety of sample packages from the provider for their own in-house and/or field testing.

Pouches

Pouch packages come in a vast variety of shapes and film combinations. These include four-wall, bottom-gusset, side-gusset, chevron, zippered pouches, K-pouches, flat pouches, header, shaped, and stand-up, to name just a few. Customers should take into consideration the variety of types that their sources are capable of providing to be sure that they are being offered the best possible solution for their product.

High density film bags are ideal for packaging clean garments such as gloves, hoods, boots, and masks. Photo courtesy of Fisher Container Corp.Click here to enlarge image

Pouches are generally used for applications that require a more aggressive seal and containment. The variety of monolayer, co-extruded, and laminated films are endless. Some types commonly used for cleanroom applications include foil polyethylene, polypropylene, PET, EVOH, nylon, metalocene enhanced structures, opaque films, and Tyvek®. Some applications even use eight-layered, co-extruded structures laminated to various support films. Suppliers need to have extensive expertise about how each film type will perform in conjunction with adhesives and other film types in order to successfully combine them.

Tyvek®-to-polyester combination peelable pouches are recommended for sterile presentations (such as medical devices and glass ampoules, etc.). They are suitable for gamma, steam, or ETO sterilization . Photos courtesy of Fisher Container Corp.Click here to enlarge image

Customers have a number of barrier requirements for their pouch packages. For example, a product that is light sensitive must naturally use a film that contains a UV inhibitor. Alternatively, a structure can be laminated to the film to prohibit any UV contamination.

Pharmaceutical manufacturers, in particular, are one group of customers that requires very aggressive oxygen and moisture protection to ensure their products will achieve the required shelf life. There are a number of laminated structures suitable for holding in moisture or to keep it out. Alternatively, customers can go straight to the “flexible-can” material-foil.

Oxygen can be the ultimate killer of a product, and there are a number of monolayer structures that can inhibit it. Again, there are also usually other considerations; it’s a matter of making an educated choice. Quite often, package clarity issues also come into play; if so, this eliminates the use of foil laminates or metallized structures. In these cases, EVOH co-extruded material is often the best choice since it inhibits oxygen but still allows you to see the product. In other cases, it may be easier to add pigment to obtain a translucent or opaque structure rather than going into laminations or co-extruded material to successfully meet a customer’s need.

Information is key

As always, the best source of information for prescribing the optimum solution for a particular product is the customer. The more information the customer can provide the package provider about the unique characteristics and requirements of the product, the better.

As easy as this may sound, it can sometimes be difficult depending upon what stage of development the product is in. For example, when a product or application is in an early developmental stage, it may be difficult to provide as much detail as the supplier needs about the possible use and requirements of the product in order to prescribe the best material or materials the first time out of the box. In these cases, as a minimum requirement, customers should expect their suppliers to insist on comprehensive and aggressive field and shelf-life testing using proven testing methodologies. In the end, the critical information this testing provides will save the customer valuable product, time, and money.

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Michael D. Fisher is president of Fisher Container Corp., based in Buffalo Grove, IL (www.fishercontainer.com).

Environmental control sensor with added barometric pressure capability

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The T7511 Ethernet sensor from Comet Systems has barometric pressure measurement capability in addition to temperature, humidity, dew point temperature, mixing ratio, and specific enthalpy. The sensor has been installed in applications for pharmaceutical and food processing. The large, dual-line LCD simultaneously displays selected measurements. The state-of-the-art capacitive sensor features excellent calibration, long-term stability, and inertia against water and condensation. Communication modes include Modbus TCP, Telnet, World Wide Web pages, SNMP, and SOAP.

Comet Systems, s.r.o. Roznov pod Radhostem, Czech Republic
www.cometsystem.cz

Bioprocess control platform

Bioreactor system manufacturer and supplier Applikon Biotechnology B.V. has launched i-ControlXL for the bioprocessing market. Specifically designed for the bioprocess industry, the easy-to-use platform offers industrial power, reliability, and expandability using standard controllers (PLC) and distributed control systems (DCS). Benefits of the system include intuitive navigation; a color touch-screen; options for bioreactor controls, pumps, and sensors; the ability to use the same system to control autoclavable vessels, single-use bioreactors, or SIP/CIP systems; and the power to meet today’s needs but with sufficient expandability to meet future process control needs.

Applikon Biotechnology B.V. Schiedam, the Netherlands
www.applikon.com

High-shear fluid processors

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Microfluidics has introduced six standardized offerings of the M-700 series Microfluidizer® high-shear fluid processors. The M-7125 and M-7250 machines can now be purchased in any of six configurations designed to cost-effectively meet the needs of the biopharmaceutical industry. Configurations begin with the standardized Basic package, which includes a skid-mounted pharma-grade feed pump, a sanitary flush diaphragm pressure transducer with digital readout, and certified product contact surfaces, and range to an advanced Constant Pressure system, with facilities for aseptic processing, data acquisition and recording, closed-loop temperature controlled product heat exchangers, and real-time product flow measurement. In keeping with cGMP guidelines, all packages come with IQ/OQ documentation, a document turnover package, on-site startup and training, and CE compliance. Options such as pharma-grade heat exchangers, PLC control, temperature sensing with digital readouts, ultra-clean in place (UCIP), and motor starter panels are available.

Microfluidics Newton, MA
www.microfluidicscorp.com

Fiber-reinforced coating

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Valspar Flooring, a division of Valspar Corporation, helps facilities and contractors achieve smooth, seamless environments with its new Descoglas® RF reinforced wall and ceiling coating system. Field proven for connecting unlike substrates without the use of joints or sealants, this high-build surfacing system wraps walls and ceilings into the floor, eliminating corners, cracks, and crevices that harbor dirt and bacteria. Suited for a variety of substrates, Descoglas RF features built-in fiber reinforcement for dimensional stability and long-term resistance to impact and abrasions, thermal shock resulting from high-pressure steam cleaning, and exposure to aggressive chemicals. The coating creates a static-resistant surface that inhibits particle buildup, making it suitable for pharmaceutical and cosmetic manufacturing plants, cleanroom environments, food and beverage processing facilities, and health care operations.

Valspar Flooring Wheeling, IL
www.valspar.com

Mass spectrometer

The Hiden HPR-60 molecular beam mass spectrometer (MBMS) is specifically designed for investigative research of quantitative analysis of reactive and neutral gaseous species sampled directly from processes as diverse as plasma and combustion/flame chemistry, catalytic reactions, chemical vapor deposition, semiconductor gas abatement, and environmental chemistry. The compact, low-footprint system is supplied in both two- and three-stage differentially pumped versions for applications operating up to atmospheric pressure. The close-coupled multi-stage pumping and precision-aligned skimmer cones rapidly reduce pressure to the UHV regime, forming a well-defined molecular beam and minimizing intermolecular collisions of both reactive and condensable species for optimum analysis integrity.

Hiden Analytical Warrington, U.K.
www.hidenanalytical.com

Anaerobic system for clinical labs

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Advanced Instruments’ subsidiary, Spiral Biotech, now offers the Anoxomat™ Mark II anaerobic system for the cultivation of anaerobic, microaerophilic, and capnophilic bacteria in laboratories. The system’s automatic jar evacuation/replacement technology is an alternative to anaerobic chambers and gas bags currently used in clinical laboratories. Users have reported that the Anoxomat delivers significant savings in terms of consumables, time, effort, and money vs. anaerobic jars, anaerobic glove cabinets, or CO₂ incubators. Each Anoxomat cycle involves an evacuation phase, followed by replacement using an oxygen-free gas mixture. One cycle achieves 70 to 80 percent removal of the original atmosphere and gives a microaerophilic environment in one minute. Three cycles achieve an anaerobic atmosphere in less than 3 minutes. A built-in quality assurance system checks for leaks before incubation. The system also checks whether the catalyst is capable of achieving the desired conditions and warns the user of a threat of gas failure.

Spiral Biotech Norwood, MA
www.spiralbiotech.com

Contamination risk assessment kit

HardyVal™ kits include all the products needed to easily assess the risk of microbial contamination of compounded sterile preparations (CSPs) according to USP <797> requirements for media-fill challenge testing. The kits are available in three versions: low-, medium-, and high-risk levels. Each ready-to-use kit contains what is needed to test the proficiency of one technician or pharmacist. Clear instructions and diagrams, as well as a result logsheet, are included in each set.

Hardy DiagnosticsSanta Maria, CA
www.hardydiagnostics.com

Industrial terminal with touch-screen

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MGR Industries announces the new APC Technology™ ET41150 sealed industrial terminal with 10.4-inch touch-screen. Designed for use in harsh environments, the ET41150 is impervious to dust, airborne particulates, and liquids with a face sealed to IP65. The touch-screen can be used with and without a glove. The terminal was designed as a drop-in replacement for the 3M Dynapro™ ET3170. It provides operators with a user-friendly, highly accurate touch-screen for interface with host computers using ANSI-based control code protocols. The terminal comes with a 1-year limited warranty.

MGR Industries Fort Collins, CO
www.mgrind.com

Chemically inert sapphire tubes and rods

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A line of optical quality sapphire tubes and rods for demanding optical, medical, laboratory instrumentation, and research applications has been introduced by Meller Optics, Inc. The tubes and rods feature Moh 9 hardness, are chemically inert, and optically clear, targeting them for critical applications where glass or other materials are not acceptable. Available with a clear or frosted finish, the tubes permit visual monitoring of fluid transfer and the rods are ideally suited for use as light guides, plungers, and spacers. Featuring an 80-50 scratch-dig I.D. finish and a 60-40 scratch-dig O.D., the sapphire tubes come in 1/8 to 2 inch diameter sizes up to 500 mm long, with walls as thin as 0.020 inch and can be provided with one end sealed. Rods are offered in sizes from 0.080 inch to 1 inch diameter up to 800 mm long.

Meller Optics, Inc. Providence, RI
www.melleroptics.com

Particle-free dry wipe board and accessories

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Cleanroomshop.com, a web-based cleanroom consumables supplier, has recently expanded its product line by securing exclusive distribution of a new range of chalkless boards from Pilot for the European health and cleanroom market. The innovative, antibacterially coated chalkless boards offer a contamination-free alternative to drywipe and flip charts. The CleanWriter panel is made up of micro-magnetic particles, which respond to a magnetic stylus and eraser, allowing the board to be used like a conventional white or black board. The use of magnetic stimuli negates the need for dry wipe markers, cleaning fluid, and tissues, eliminating the generation of particles altogether. A range of accessories are available to complement, maintain, and facilitate the use of the chalkless boards.

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Ta Cleanroomshop.com, Connect 2Cleanrooms Ltd.Cumbria, United Kingdom
www.cleanroomshop.com

Class 100 cleanroom cabinet oven

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No. 962 is a 500°F (257°C) electrically heated, Class 100 cleanroom cabinet oven from Grieve, currently used for pass-through depyrogenation of glassware. Workspace dimensions measure 24x36x27 inches. The oven features 4-inch insulated walls; a Type 304, 2B finish stainless-steel exterior with 1/2-inch inside radiused corners; and welded, ground, and polished interior seams. The unit has single access doors, front and rear. It also includes a red pilot light to indicate when the oven’s opposite side door is open, solenoid-operated door locks, and 650 CFM intake pressurizing blower. The oven features a HEPA fresh air filter with 2-inch pre-filter; a stainless-steel, high temperature HEPA recirculating filter; a minihelic pressure gauge; and DOP validation port across each set of filters.

The Grieve Corporation Round Lake, IL
www.grievecorp.com

Stainless-steel tube insulation for clean environments

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UFP Technologies, Inc. has launched T-Tubes®, its stainless-steel tube insulation for clean processing environments. Molded to fit industry standard tubes and fittings, T-Tubes are thin, easy to install, chemically resistant up to pH12, require no jacketing, withstand temperatures of -55° to +311°F, and achieve better than industry performance for ASTM E84 with a flame spread index of 5 and a smoke developed index of 5. The insulating products are made from ZOTEK® F, a family of closed cell foams from Zotefoams, plc based on Kynar® PVDF. T-Tubes will not wick or absorb moisture, are entirely washable, and are crush resistant. They provide critical protection for personnel working around hot processing lines in the biotechnology, semiconductor, pharmaceutical, chemical, cosmetics, and food and beverage industries.

UFP Technologies, Inc. Georgetown, MA
www.ufptech.com

Clinical water purification system

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The RiOS-DI from Millipore Corporation is a water purification system that provides consistent and reliable purified water for low-volume clinical analyzers requiring between 10 and 30 L/day. It provides users with a reliable alternative to buying, storing, and handling bottled water. RiOS-DI efficiently combines reverse osmosis (RO) technology with deionization (DI) resins to produce CLSI® Special Reagent Water (SRW). With high resistivity and low TOC (typically >10 MΩ·cm at 25°C and <50 ppb before storage), this product water is of higher quality than either water produced by stills or service DI water. A built-in, 254-nm UV lamp ensures low bacterial levels (typically <10 cfu/mL after UV).

Millipore Corporation Billerica, MA
www.millipore.com

Acrylic flowmeters for process systems

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KOBOLD’s KFR line of flowmeters provides low-cost, accuracy, and range availability, bridging the microflow and large flow ranges. The KFR has a one-piece acrylic body with PVC or metal fittings for durability. Large lettering and extra hash marks make the scale clearly visible. The low-flow meters offer an inherently stable float design, while the larger meters feature a float stabilization mechanism. In the larger flow ranges, the stabilization mechanism allows a smaller installation footprint and a correspondingly lower price. The low volume flowmeters (models KFR-1000 through KFR-4000) are available with integral needle valves.

KOBOLD Instruments Inc. Pittsburgh, PA
www.koboldusa.com

Pulsed UV light decontamination system

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Xenon Corporation offers a modular, non-toxic, in-line sanitization system that employs pulsed UV light to kill DNA and prevent microorganisms from replicating on virtually any surface or package. The SteriPulse-XL® Surface Sanitization System employs pulsed UV light to achieve up to 6 log kill, which kills DNA and prevents replication. Featuring modular construction with high peak energy lamps to destroy DNA, this non-contact system typically generates less than 100°F heat to prevent damage to plastic surfaces. Providing a low-temperature, non-toxic, non-chemical, and mercury-free way to fully sanitize surfaces, the system consists of one or two lamps, a power supply, and controller that can be easily integrated into process systems. Typical applications include sanitizing materials, filling and sealing processes, and packages.

Xenon Corporation Wilmington, MA
www.xenoncorp.com

Vented balance enclosures

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Air Science USA has introduced a new line of balance enclosures designed for precision containment/operator protection when compounding and powder weighing. The units exceed OSHA, ANSI, and all relevant international standards for vented enclosures designed to handle potent compounds with toxicity levels of Class 1, 2, and 3. The enclosures incorporate the Air Science turbulence-free design that provides a smooth transition of airflow into the enclosure. In addition to balances, these enclosures are suitable for microscopes and robotic equipment. They are constructed of PVC and acrylic with epoxy resin work surfaces. Six models are available from 24×23 inches to 48×23 inches, with a choice of 19.5 or 30 inches in height.

Air Science USAFort Myers, FL
www.air-science.com

Stainless-steel connection system for sensors and control devices

Woodhead Industries, a division of Molex Incorporated, now offers a stainless-steel version of the BradConnectivity™ Ultra-Lock™ Connection System, which is designed and engineered to meet the stringent sanitary requirements, including high-pressure washdown, for manufacturers in the food, beverage, and pharmaceutical industries. The threadless, M12-compatible system comprises a series of integrated cordsets, distribution boxes, and receptacles built on a patented “push-to-lock” technology that enables fast, easy installation without turning the coupler. This positive locking feature, combined with a unique radial seal, assists in reducing downtime related to failed sensors and other control devices subjected to severe washdown. Ultra-Lock connectors stay fully mated, even under the stresses of machine vibration and cable pulls, reducing the risk of intermittent connections.

Woodhead Industries Lisle, IL
www.woodhead.com

Modular aluminum framing for contamination-sensitive environments

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Bosch Rexroth offers modular aluminum framing components specifically designed for cleanroom applications and other contaminant-sensitive environments. As an alternative to welded steel components, the system uses easy-to-assemble, bolt-together construction for maximum configurability using only simple hand tools. Independently cleanroom-tested by the Fraunhofer Institute for Production Technology and Automation in Germany, this series includes smooth-surfaced aluminum extrusions and aluminum cover strips that eliminate particle traps and minimize outgassing in cleanroom structures. A range of accessories designed to ensure maximum airflow with minimum turbulence lets users build tables, carts, enclosures, and more for reasonable start-up and operating costs. The modularity of the Rexroth aluminum structural framing system lets manufacturers reconfigure cleanroom structures as needed.

Bosch Rexroth Buchanan, MI
www.boschrexroth-us.com

Deep-drawn sinks with corrosion-free construction

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The new Euro-style sinks from Eagle MHC combine advances in highly functional design with corrosion-free construction to optimize sanitation and efficiency in the industrial workplace or lab settings. Euro-style edging on these sinks makes it easier to keep the surrounding work and floor areas clean, while a new bowl design provides more space and maneuverability for washing compared to competitor’s sink models. Offered with a choice from one to four bowl compartments, the sinks feature heavy gauge stainless-steel construction, including the bowls, drainboards, and backsplash components. Custom sink configurations are available to meet special layout requirements, including drop-in bowl configurations. Sound deadening is also available. All models are approved by the National Sanitation Foundation (NSF).

Eagle MHC Clayton, DE
www.eaglegrp.com

Airflow modeling software

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ANSYS, Inc. has released version 3.0 of its ANSYS® Airpak® airflow modeling software, which introduces key enhancements that increase productivity, improve the meshing technology, and enhance the realism of displayed results. The tool introduces a new and intuitive user environment, which features a model manager, advanced object wizards, alignment tools, and four-window simultaneous views. Version 3.0 also offers a mixed meshing capability in which the user can utilize mixed tetrahedral and hexahedral meshes. The new automatic hex-dominant mesher can be used to mesh geometries quickly and efficiently. It uses advanced meshing algorithms to allow the most appropriate cell type to be used to generate body-fitted meshes for the most general geometries.

ANSYS, Inc. Southpointe, PA
www.ansys.com

Peel-packaged sterile gloves

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Sempermed offers SemperCare® CR Sterile exam gloves. The non-latex examination gloves provide a quality solution for professionals who are at risk of becoming sensitive to natural rubber latex. Manufactured using an advanced synthetic formula, SemperCare® CR Sterile imparts physical characteristics more closely approximating those of natural rubber latex. The gloves have a textured surface that offers a secure grip, wet or dry. The beaded cuff increases its strength and protection. Single ambidextrous gloves are packaged within sterile peel pouches.

Sempermed Clearwater, FL
www.SempermedUSA.com

Hydrogen peroxide gas disinfection technology

Global Ecotek’s CIMR™ infection and mold control technology creates 0.02 ppm of hydrogen peroxide (HP) gas from the oxygen and humidity already in the air. The HP gas is then supplied to the protected area where it diffuses everywhere air goes, disinfecting microbes in places unreachable with other technologies. The HP molecules have both localized positive and negative charges; they are drawn to viruses and bacteria by electrostatic attraction. The gas is odorless and safe to use in occupied areas. According to OSHA, 1 ppm of HP gas is safe throughout the workday. Ozone-free CIMR™ Infection Control Technology only uses one-fiftieth of that amount. A duct-mounted unit designed to protect up to 40,000 cubic feet draws less than half an amp of electricity and requires maintenance only once every 33 months.

Global Ecotek Glen Mills, PA

VOC analyzer

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ETG Risorse e Tecnologia’s uVOC-CAM is a gas chromatography (GC)-based system that continuously detects volatile organic compounds (VOC) at up to 16 sampling points with a detection limit of 0.1 ppb. The system has been successfully used in semiconductor cleanrooms to detect VOC contamination. The GC technology is most suitable for identification of complex molecules, providing a direct reading of the detected compound as well as its concentration. Examples include 2-Butanone, acetone, ethanol, isopropanol, N-hexane, ethyl benzene, and many others. The system features an H₂ generator, on-board calibrator, and a PC and software based on an HMI interface.

ETG Risorse e Tecnologia Montiglio, Italy
www.etgrisorse.com

HEPA mobile storage carts

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Vectech Pharmaceutical Consultants, Inc. has announced its stainless-steel HEPA mobile storage carts, with patented horizontal laminar flow design, that meet Class 100 (ISO 5) conditions. The HEPA carts are equipped with large modular storage compartments divided into multiple shelf areas that are easy to load, use, and clean. The carts come in standard sizes to allow safe movement of products through 3×7-ft door openings without expensive facility modifications. Vectech can also custom-design a HEPA cart to meet size, application, or specific product requirements. Units can be operated continuously by standard 120‑V power by using an integrated cord and reel system or stand-alone for up to 4 hours of operation by onboard batteries. The carts are factory tested to high performance standards, require low maintenance, and allow easy access to all serviceable components. Carts include magnahelic monitoring across the filter and integrated ports for challenging the integrity of the filter.

Vectech Pharmaceutical Consultants, Inc. Farmington Hills, MI
www.vectech.com

Rationale for non-compliance with voluntary environmental control standards requires understanding ‘best practice’ recommendations by industry experts

By Gregg Mosley, Communications Vice President, IEST

In reviewing the current standards and recommended practices for cleanrooms and controlled environments it is difficult to imagine the simple beginnings for the concept. Although many professionals worked on test methods and controlling microbial bioburden and particulate contamination, the original idea of a modern cleanroom was quite different. In the late 1950s, engineer Willis Whitfield, on staff at Sandia National Laboratories in Livermore, CA, conceived a simple idea: “To keep a room very clean, let air be the janitor.” His first tested design-using cleansed, monotemperature, laminar airflow-produced room contamination levels 1,000 times cleaner that any previously obtained. Patents for the cleanroom idea were issued to Whitfield in 1962.

Timing for Whitfield’s concept appears perfect as immediate applications were made in three separate areas. Electronics manufacturers saw the application as a tremendous cost savings to reduce product failures. Health care facilities implemented the design to reduce infections in operating room theaters. And the U.S. government operations at NASA applied the cleanroom concept to control particulate and microbial bioburden contamination of extraterrestrial vehicles in the space program. The latter application was combined with sterilization of materials and components to minimize the prospect of accidental contamination of space and other extraterrestrial bodies in the solar system by projectiles from earth.

Manufacturing sterilized medical products

The combination of controlled environmental and sterilization practices developed at NASA has had a primary impact on manufacturing of sterile medical products. The outcome of the NASA projects demonstrated that sterilization was a function of the pre-existing product bioburden. Therefore, control of the environments for manufacturing and packaging of medical products has a direct impact on one’s ability to produce these sterile products. Many of the scientists involved in the NASA systems moved on to careers in government or industry directly related to production of sterile medical products. Recent ISO sterilization standards 17665-1 (2006) for moist heat; 11137-1, -2, and -3 (2006) for radiation; and 11135-1 for ethylene oxide (2007) identify the importance of quantifying and characterizing product bioburden as part of sterilization validation. For aseptically manufactured sterile products, components must be sterilized first, then the product should be final packaged in a controlled environment to ensure aseptic conditions are maintained for processing of the lot. These sterilization standards are not required by the U.S. Food and Drug Administration (FDA), though they are often considered best practice. However, for products marketed in the European Union (EU), the standards are required in the Medical Device Directives (MDD).

Current recommended practices and ISO standards for cleanrooms are developed under the leadership of the Institute for Environmental Science and Technology (IEST). Status of these standards and recommended practices was reviewed in the July issue of CleanRooms. IEST is the secretariat for ISO Technical Committee 209 (ISO/TC 209), Cleanrooms and associated controlled environments, and represents the United States as administrator of the U.S. Technical Advisory Group (TAG) to ISO/TC 209.

Industry perspectives on critical environments

A corporate determination of whether to comply with the ISO 14644 and 14698 series of standards for cleanrooms often appears to depend on whether the effects imparted by the critical environment are direct and immediate or not. For instance, manufacturers of electronic components verify the performance of components immediately and generally at a 100 percent inspection level. These quality control inspections may be repeated when multiples of components are assembled as subsystems. An increase in the number of rejects is detected immediately and correlates directly to the financial bottom line. Numerous quality inspections, set up early in the production sequence, minimize the potential loss of materials and employee time compared to inspections that are less frequent and further downstream.

In health care facilities, applying best practice for operating rooms and other potential sources of nosocomial infections minimizes both the probability of patient lawsuits and successful prosecution. In addition, best control practices as well as lawsuit history affect insurance premiums at health care locations.

Similarly, manufacturers of pharma-ceutical products that are aseptically filled see direct correlation. When such products fail required tests for sterility, the finished products lots may be rejected. In these situations, product cannot be reworked and the financial impact is immediate. Rework is not possible because tests are destructive; hence, statistically based sampling plans rather than 100 percent inspections are used. However, for these manufacturers, loss of the product is only the beginning of the financial loss. Medical product manufacturers operate as a regulated industry under the auspices of the FDA, similar national regulatory agencies, and/or the ISO notified bodies. Therefore, quality system problems often require internal investigations where effort is expended by staff at higher administrative levels to investigate and review all related data, training, and system controls. This is necessary to determine whether a general degradation of control can be identified somewhere in the quality system as the root cause. An identified root cause must be resolved, a corrective action implemented, and the effects monitored over time to determine whether the correction was successful. Requirements for these activities are covered in 21 CFR Part 820, Subpart J or ISO 13485: 2003, 8.5.2.

For products that are terminally sterilized, the effects of the critical environment used for manufacturing are not as clear as the examples given. Environmental particulates and microbes may have no impact on the ultimate quality of manufactured medical products. If products are cleaned, decontaminated, passivated, or rinsed prior to final packaging, most contaminating microbes may be removed or inactivated. For some products, the contribution of microbes by the manufacturing environment may be relatively insignificant compared to the levels on incoming components.

Sterilization validation

Terminally sterilized products may use an approach to sterilization based on bioburden, which is the microbial load naturally occurring on the product. Another approach referred to as “overkill” uses substitute microbes (biological indicators) with a known very high resistance to the sterilization method. Finally, a combination approach using information from both microbial groups is referred to as the “bioburden/BI approach.” Validation methods using radiation sterilization are bioburden based, so the impact of bioburden numbers and resistance is critical. Manufacturers using radiation take more notice of product bioburden changes and the manufacturing environment that may be a contributor. However, moist heat and ethylene oxide sterilization most often employ the overkill method. In this approach, bioburden has a lesser significance so long as the numbers remain below some maximum defined level and the types of microbes have a known low resistance to the sterilization method. Some manufacturers using these sterilization methods appear less concerned with the manufacturing environment and potential impact on the product. Often their rationale is that the overkill approach to sterilization will compensate for excursions in product bioburden, possibly imparted by the controlled manufacturing environment.

As it relates to reliance on an overkill sterilization method, bioburden must still be monitored and known so far as numbers and resistance to the process. Objective evidence must be available comparing bioburden levels for product and the manufacturing environment to show whether or not a correlation exists. Without historical data maintained in a baseline monitoring program, one cannot determine what levels of environmental contamination do or do not create a problem for the finished product. If the environment could have an impact on the product quality attributes, then a defensible monitoring program is a requirement. A scientifically based, pragmatic approach to controlled environmental monitoring should ensure consumer safety and reduce manufacturer cost and risk.

Regulatory perspectives

The regulatory requirements are not so forgiving, though. The same investigations and corrective actions apply for terminally sterilized products as for aseptic pharmaceuticals. In addition, FDA and ISO regulations cite the need for monitoring and control of the manufacturing environment. The FDA Quality System regulation addresses issues related to manufacturing environmental controls in sections 21 CFR §820.3, §820.70, and §820.75 discussing processes, process controls, and validations. Sections §820.181 and §820.184 cover documentation requirements for process and device records. ISO 13485: 2003 cites similar needs in clauses: 4.2.4 control of records, 6.3 infrastructure, 6.4 work environment, 7.5 production controls and validation, and 8.2.3 monitoring and measurement of processes.

In addition, changes in quality system regulations such as those specified in ISO 13485: 2003 require that risk assessment (including the impact of environmental controls) must be performed. The risk assessment task can be reduced by comparing devices typically manufactured in similarly controlled environments. When a company chooses not to follow voluntary ISO standards guidelines, the supporting rationale should be documented and re-evaluated when risk assessment changes.

The desire by manufacturers to comply with voluntary cleanroom standards often directly correlates to finances. However, it is important to understand how regulatory agencies perceive compliance to quality systems regulations and these voluntary cleanroom standards because they have been developed by a consensus of experts. Rationale for why they do not or need not comply is essential if they choose another testing series and compliance is often easier to accomplish.

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Gregg A. Mosley is founder and president of Biotest Laboratories, Inc. (Minneapolis, MN). Mosley serves IEST as chair of the editorial board for the peer-reviewed Journal of the IEST and as the executive committee communications vice president. He has more than 30 years of experience as a microbiologist, chemist, and biochemist in various academic and industry positions. He is co-chair of both the AAMI Biological Indicators and the Industrial Moist Heat Sterilization Committees. Email: [email protected].

By Winn Hardin

Two recent announcements serve to illustrate the point that radio frequency identification (RFID) technology is beginning to prove a useful and valuable technology in cleanroom applications and sensor-embedded pharmaceutical manufacturing equipment.

One announcement by Billerica, MA-based Millipore Corporation describes that company’s plan to embed RFID tags in precision filters used to manufacture pharmaceuticals in controlled environments, while AdvantaPure (Southampton, PA) announces a new RFID patent on its “HoseTRACK” technology for monitoring tubing used in pharmaceutical cleanroom manufacturing.

“RFID’s strength is in what bar codes cannot do,” explains ABI Research’s (Oyster Bay, NY) research director, Michael Liard. “There’s no ability to attach sensors to bar codes for tracking environmental or performance changes. With RFID embedded sensors, you have the convenience of sending, receiving, and monitoring advanced features and functionality. If you look at the [return on investment] in RFID, it’s in high-value, high-risk items that help justify the additional cost.”

The RFID tags in Millipore’s filters store information about where the filter was manufactured, as well as providing real-time information about product performance, including what fluids are present during the manufacturing process. According to the company, this information will help customers to ensure regulatory compliance and make recording and conveying manufacturing data faster and more reliable.

Radio frequency identification (RFID) technology is making its way into clean processing equipment, such as Millipore’s Viresolve® filters (inset) and AdvantaPure’s HoseTRACK tubing monitoring system. Photos courtesy of Millipore Corporation and AdvantaPure.Click here to enlarge image

Similarly, AdvantaPure’s HoseTRACK hose identification and life-cycle analysis system also takes advantage of integrated sensors that add cleaning logs and operational histories to the memory block in the RFID tag fixed to the outside of the medical tubing. The company also embeds sensors and tags into other bio/pharmaceutical process equipment, including mixing vessels, plastic pouches, and filters. When paired with an RFID reader, the system can help generate the data needed to meet FDA’s 21CFR Part 11 reporting requirements; the company says that the data tracking system reduces time spent gathering information for audits, and helps maintain clear and secure documentation compared to conventional log books.

Ultraviolet-C (UVC) technology for air purification has recently been endorsed or specified by numerous federal, state, and local government agencies such as the Government Services Administration (GSA), CDC, EPA, and FEMA, as well as industry organizations including the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) and the Illumination Engineering Society of North America.

Other endorsements and specifications of UVC as an acceptable means for air purification have been documented by agencies such as the New York State and New York City Departments of Health, the Kansas Department of Health and Environment, and the National Institute for Occupational Safety and Health (NIOSH).

ASHRAE also recently created a formal technical committee to promote and assist in the use of UVC in HVAC systems (TC 2.9 UV for Air & Surfaces). In addition, two Standards Projects Committees (SPC 185.1 and SPC 185.2) have been formed and are in the process of establishing standards for the application of UV in HVAC systems.

Driving these trends is an increased level of attention from end users regarding indoor air quality (IAQ) and its impacts on home and building occupants. There is also an increasing recognition of UVC as viable technology for energy savings, cost avoidance, and improving IAQ. Based on energy efficiency and maintenance savings alone, many UVC installations have return on investment of less than 1 year, according to Ultra Violet Devices, Inc., a manufacturer of UV and molecular filtration products.

September 20, 2007 — HOUSTON, TX — Hardide-T, the new tungsten carbide-based component coating developed by Hardide Coatings, has received U.S. Food and Drug Administration (FDA) go-ahead for use on food processing equipment.

This opens up significant opportunities for Houston-based Hardide Coatings, Inc. to enter the U.S. food manufacturing sector and to build on its European position where the coating is already being used successfully in food processing applications. As a result of the FDA go-ahead, the company has already entered tests with one of the world’s leading manufacturers of high-pressure homogenizers and homogenization systems, which has global distribution to the food, dairy, and beverage industries.

The opportunities for Hardide-T in food manufacturing are primarily in valve, pump, and actuator applications where the company has proven success in other industries.

Hardide-T offers an unprecedented combination of ultra-hardness, toughness, low friction, and chemical resistance when applied to components made from a wide variety of metals. Unlike most ceramics and carbides, Hardide-T is not prone to chipping or flaking, as it will flex with the substrate under severe impact.

Dan Wilson, Hardide Coatings, Inc.’s U.S. business development manager, says, “This is a major development and opens up a vast range of new opportunities for us. Not only are wear, corrosion, and galling major issues for many food manufacturing and fluid handling applications, but we have also seen that we can increase the life of critical seal components that run in contact with Hardide.

“We are already working very successfully in this sector in the U.K. An example is one of the world’s largest food and beverage companies, which was having repeated failures with a hard chrome coating that was puncturing and flaking under abrasive conditions, causing the galling of critical ball valves and seats. The life of the parts was increases in excess of 20-fold after being coated with Hardide-T.”

Hardide-T is widely used around the world in aggressive wear or chemical environments in industries including oil and gas, aerospace, valves, and pumps. Its unique combination of properties include:

• Up to 3,500 Hv.
• Accurately controlled thickness ranging from 5 to 100 microns.
• Resists 3,000 microstrain deformation without damage to the coating.
• Binder-free.
• Nano-pore, dense, homogeneous structure.
• Superior bond strength due to chemical bond.
• Low coefficient of friction (Hardide-against-Hardide is approximately half of steel-on-steel).
• Excellent anti-galling properties. In repeated customer tests, Hardide-against-Hardide performs better than any metal combination.
• Satin-like “as-coated” surface finish, but can easily be polished to a mirror finish if required.

Hardide Coatings, Inc. is a Hardide plc company. The company has manufacturing facilities in Bicester, Oxfordshire in the U.K., as well as Houston, Texas, USA.

The Hardide Technology
The Hardide coating process is performed in a chemical vapor deposition (CVD) furnace and is applied to customer supplied components, which are heated to 500 degrees depending on the substrate and the application. Once at the desired temperature, a controlled mixture of gases is pumped into the furnace. In the furnace chamber, a chemical reaction takes place between the gases, which crystallizes on the surface of the components, producing a smooth layer of binder-free tungsten carbide coating with abrasion-, erosion-, and chemical-resistant characteristics. This process enables all parts of the component including internal surfaces to be coated.

Web site: www.hardide.com