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With the health and wellbeing of end customers on the line, pharmaceutical manufacturers put ultra-pure water systems to the test.

By Sarah Fister Gale

Bacteria love water. In the water systems of pharmaceutical manufacturers, controlling bacteria requires vigilance and careful planning, from design through daily operation.

Pharmaceutical-grade water systems are some of the most carefully designed and monitored water systems in any industry. This water is used in the cleaning of delicate pharmaceutical manufacturing equipment, as well as being the most frequently used ingredient in drug manufacturing for ingestible and injectable medical products used by the weakest and most vulnerable consumers. As a result, it is highly regulated and operators are required to rigorously test and monitor water quality constantly to ensure standards are being met.

Pharmaceutical water quality standards are dictated by the U.S. Pharmacopoeia (USP), the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other health care products manufactured and sold in the United States. All pharmaceutical water systems must be validated to demonstrate that they meet, and will continue to meet, their quality specification as defined by USP, which lays out the guidelines for testing and establishes minimum purity requirements for water quality used in these products.

Unlike electronics industries, which focus on managing particulate contaminants in their ultra-pure water systems, pharmaceutical facilities are more concerned about microbiological contaminants that can threaten the health and safety of consumers. This calls for a different type of testing and control system to guarantee quality and effectiveness. While contaminants in the microelectronics industry can weaken yields, bacteria in pharmaceutical water can cause illness and potentially death if left unchecked.

Multiple steps

A typical pharmaceutical-grade water system will include a pretreatment step to condition the water; initial filtration; a softening step; dechlorinization using activated carbon or bisulfite; a reverse osmosis step; and an ion exchange resin or electro-ionization to further purify the water, says Chris Fournier, vice president of marketing for Mar Cor Purification, a provider of filtration, water, and disinfection technologies in Lowell, MA. If there are additional requirements for the final product, further processing steps may be added, such as a 0.1-μm or 0.2-μm filter, or ultraviolet lights for bacteria control. “It can go on and on depending on the client,” he says.

The first steps, in which raw or municipal water is initially filtered, are important because this creates a level playing field for the additional water treatment efforts. “Raw water supply varies in quality,” says Chris Mach, biopharmaceutical marketing manager for Pall Corporation, a global filtration, separations, and purifications company based in East Hills, NY. The pretreatment step may include several filters to remove impurities, which can include particulates, inorganics, microorganisms, dissolved gases, and organic compounds.

These pretreatment steps reduce the effect of potential variations in feed water quality, minimizing the operating and maintenance requirements in the final treatment stages. The pretreatment step has little effect on contaminants such as anions, total bacteria count, TOC, and volatile components, but pretreatment must be effective to minimize plant operating costs and reduce the burden on later filtration steps. Pall’s clients typically use cross-flow microfiltration to remove small suspended solids, large colloids, and microorganisms from large volumes of feed water. These systems use backwash and air scrubbing techniques to minimize requirements for chemical regeneration.

Ultra-filtration membranes, typically made using hollow fiber or ceramic materials, are also incorporated downstream in the water system to further filter particles, bacteria, viruses, pyrogens (endotoxins), colloids, and large organic molecules.

The softening step replaces the hard ions with sodium to make the downstream processing run more smoothly and prevents minerals from forming a hard scale in the pipes.

Reverse osmosis is used in many pharmaceutical-grade water systems to further filter contaminants. Reverse osmosis is a separation process that uses pressure to force a solvent through a membrane that retains the solute on one side and allows the pure solvent to pass to the other side. The membranes used for reverse osmosis have a dense barrier layer in the polymer matrix where most separation occurs. In most cases the membrane is designed to allow only water to pass through this dense layer while preventing the passage of other materials. This process requires that a high pressure be exerted on the high concentration side of the membrane, usually 30-250 psi. Reverse osmosis offers many benefits to operators. It does not require the addition of chemicals, it has excellent throughput capabilities, and it delivers highly purified water.

“The membrane acts as an efficient barrier to all dissolved salts and inorganic molecules as well as most organic compounds,” says Mach of Pall Corp.

The dechlorinization step, in which chlorine is removed from water before it is used in processing, is one of the most delicate points in a water treatment system, Mar Cor’s Fournier points out, because the chlorine in the water kills the bacteria. “Once the chlorine is gone, your protection is gone.”

He notes that there are two common choices for dechlorinization. Activated carbon removes the chlorine without additional chemicals;, however, the carbon bed at the bottom of the carbon filter can act as a breeding ground for bacteria. “If you use carbon, you have to be extremely diligent about monitoring the filter,” he says.

With chemical dechlorinization, the bacteria are destroyed and there is no remaining harborage for bacteria to grow, but it is an additional chemical reaction in the water system that needs to be carefully handled. “Carbon versus chemical is a big decision for pharmaceutical facilities,” Fournier says. “Many times we consult closely with the client on their preference and design the final system around that choice.”

Tracking biological contaminants

Once a system is up and running, operators wage a constant battle against biological contamination. “Probably the most difficult to control and thus important contaminants to monitor closely in water systems are microorganisms,” says Pat Whalen, vice president of operations for LuminUltra Technologies, an ISO 9001:2000-certified dealer of second-generation adenosine triphosphate (ATP) monitoring products in Fredericton, New Brunswick, Canada. Those contaminants of concern include any form of bacteria, as well as algae, yeasts, molds, and other microbiological elements. Most bacteria in pharmaceutical water systems exist as biofilm that adhere to equipment surfaces. They may be found on virtually any surface in contact with water and, as a result, are not uniformly distributed.

“As soon as you sanitize a system the bacteria will start to build up again,” Fournier says. “Manufacturers are always looking for ways to design water systems that create less of a risk for bacteria. That’s the most difficult part of the design. It’s easy to remove inorganic and organic contaminants during construction of the system, but once you turn it over to the operator, keeping it in compliance is a lot more difficult.”

Even in robust systems, the most common source of bacteria in any treated water comes from the source or city water supply and seasonal issues can cause the biggest upsets, says Nissan Cohen, owner of Start-Up Business Development, an independent consultancy in Louisville, CO. For example, in summer months, the city water department will often increase levels of chlorine to deal with rising algae problems. Pharmaceutical companies using that water source need to be aware of the impact these seasonal concerns can have on their own water supply. “Municipalities are not obligated to report what they are doing to the water, so you can’t control it,” Cohen says.

Ineffective water treatment, a break or breakdown in the system, and dead legs where water sits and stagnates also can cause bacteria and biofilm build-up in the water system; poorly managed control systems, inadequate testing programs, or insufficient operator training can exacerbate the problem.

Figure 1. Ozone generators such as this device from Absolute Ozone are commonly used to disinfect water distribution systems because ozone sanitization can be conducted in much less time than chemical sanitization and ozone is easier to remove after sanitization is complete. Photo courtesy of Absolute Ozone.Click here to enlarge image

Sanitization strategies
Bacteria collection is inevitable, so a rigorous sanitization schedule is necessary to keep the system in compliance. “The biggest issue for pharmaceutical manufacturing facilities centers on the frequency of sanitization,” says Fran McAteer, vice president of quality at Microbiology Research Associates, a microbiology consulting, research, and testing services firm in Acton, MA. “All water systems need to be sanitized. The problem is that people don’t adhere to their sanitization schedule,” he notes.

A typical sanitization process using chemicals creates significant downtime, knocking out a system for 6 to 24 hours. “A lot of companies don’t like to have their systems down that long so they delay sanitization,” McAteer says. The result can be a build-up of biofilms and unpredictable contamination events.

Fournier notes that Tier 1 facilities tend to be very strict about sanitization schedules, whereas smaller operations may increase testing and monitoring to delay the cleaning step. “Every owner has their own validation protocol,” he says. “Some have more latitude than others.”

There are a variety of strategies for sanitization of a pharmaceutical-grade water system. For chemical sanitization processes, operators flush the water system with highly biocidal chemicals, such as hydrogen peroxide or bleach, and leave the chemicals in the system for an established hold time before flushing them out. This is followed by chemical testing of drain water to ensure that residual chemicals have dissipated and are not left in ports or pipes, McAteer explains. He points out that chlorine will break down on its own after a small amount of time, and hydrogen peroxide can be broken down using ultraviolet lights.

“Still,” he says, “some people feel that using harsh chemicals in a pharmaceutical-grade water system is too big a risk.”

Hot water is another alternative now being used by some facilities, Fournier says. As a sanitization step, facility operators bring the temperature of the water to 80°C and maintain it there for roughly an hour. “In pharmaceutical operations, 80°C is considered an acceptable sanitization technique,” he says. One of the benefits of hot water sanitization is the speed to completion because there is no rinse-out step.

“Hot water is a newer technique, so fewer processing operations use it now,” Fournier adds. “Chemicals are still considered very effective. It’s what most operations use because it’s effective, predictable, and the biodegradable chemicals are not hazardous.”

Ozone sanitization is another commonly used microbial disinfectant in water distribution systems. Ozone acts faster than chlorine to kill bacteria and is easier to remove once the sanitization process is completed, says Mischa Shifrin, president of Absolute Ozone, an ozone generator manufacturer in Canada. It can be conducted in much less time than chemical sanitization, enabling pharmaceutical manufacturers to reduce their downtime. “Ozone is an extremely aggressive oxidant and will destroy any bacteria that have survived the pretreatment and filtering,” Shifrin asserts.

The other benefit to ozone is that it has a very short half life. “In moderately warm water it will die in 10 to 12 minutes,” he says, noting that some users will heat the water or apply ultraviolet lights to guarantee its destruction, although he feels these are unnecessary steps. There are also monitors available on the market that will continuously measure levels of dissolved ozone in the water stream.

“Before implementing ozone, one should explore the amount of ozone required, and select a proper ozone concentration and type and size of ozone generator required,” Shifrin says, noting that quality systems as well as health and safety issues come into play around these decisions.

HPC vs. ATP

Along with effective treatment, testing plays a critical role in the management of any water system. Each site must have established standard operating procedures (SOPs), which can include daily or weekly tests at water supply and use points. In some facilities, tests correspond with batch production cycles.

“The effectiveness in managing a system can only be measured by having measurable results. In this case, an accurate indicator of total microorganisms is the best tool to provide confirmation of effective system operation and maintenance,” says LuminUltra’s Whalen. To prove compliance, operators must test bacteria and contamination levels in the water system frequently enough and in a variety of areas to verify water quality. The tests should be conducted at all drops in the system, which include dead end pipes, ports, and faucets leading off the system. “If you do not measure contamination, you cannot control contamination,” he concludes.

Depending on the pharmaceutical products being made, testing may be as frequent as every day for manufacturers of parenteral drug systems, or injectables; or less frequently for water systems used primarily for clean-in-place systems or Class One medical devices in which water is not a primary ingredient.

For decades, pharmaceutical facilities have relied on heterotrophic plate count (HPC) tests as the method for enumerating heterotrophic organisms in treated water. A heterotrophic organism is any organism that obtains nutrients by feeding off of organic compounds in the water. These tests use a low nutrient medium, such as R2A agar, in combination with a lower incubation temperature and longer incubation time to stimulate the growth of stressed and chlorine-tolerant bacteria. This is particularly important because in treated water, fast growing bacteria tend to be eliminated or injured by sanitization procedures, leaving slower-growing bacteria behind, McAteer says. Nutritionally rich media, such as plate count agar, support the growth of fast-growing bacteria but may suppress slow-growing or stressed bacteria found in treated water.

Figure 2. The Pallchek Rapid Microbiology system identifies the presence or absence of biological contamination by assessing the existence of ATP in test organisms. Photo courtesy of Pall Corporation.Click here to enlarge image

To test water samples for their heterotrophic microbial load, a water sample is filtered through a filter membrane, then the filter is rinsed to remove any existing bacteriostatic/fungistatic contaminants. The filter is then aseptically transferred to plated heterotrophic agar media and incubated at 37°C. The visible colonies that are present in the sample, grown from clusters, chains, and single cells of the heterotrophic bacteria, show up on the media and are quantified as total colony forming units.

This is a very effective testing method, giving facilities a reliable “present or absent” result of bacteria in the water; unfortunately, test results can take two to five days to fully bloom. That creates a number of obstacles for facilities operators. The most obvious shortcoming of these tests is that they force facilities to quarantine or hold finished product for days until test results can be verified, which extends the production cycle, requires additional storage area, and reduces the shelf life of a product.

A positive result can also leave operators without a lot of direction in identifying or eliminating the source of the contamination because the test results are so old. The contamination event could have been temporary, localized, or a result of a water-borne incident that happened that day.

For example, an operator may take a measure at a dead leg-or closed valve in the system-and find a high bacteria count that is the result of water stagnating in that dead-end pipe. “Once you flush the pipe, the bacteria may quickly pass out of the system, but you wouldn’t know that if you were waiting five days for test results,” Whalen says.

“The chief issue in controlling water system biological contamination is time,” he adds. “Current practices using culture tests drags down productivity and can be very expensive.”

Figure 3. Osmotron unit for the production of purified water, highly purified water, and water for injection (USP). All quality relevant parameters such as conductivity and temperature are monitored continuously with online measuring devices. Photo courtesy of Christ Technology Group.Click here to enlarge image

A recent development in pharmaceutical-grade water system testing is changing that time problem through the slow but steady replacement of HPC tests with use of rapid techniques, such as the measurement of ATP. ATP is a molecule found only in and around living cells; as such, it gives an interference-free indication of total biological concentration. Applications of ATP tests are based on capturing the microorganisms, releasing the ATP from within the cell, and measuring the amount of bioluminescence generated when the released ATP is mixed with a solution containing the firefly enzyme luciferase. Light is produced within seconds and can be measured with a luminometer. The amount of light emitted from this reaction is directly proportional to the amount of ATP present. A high reading of relative light units (RLUs) indicates that a sample contains a high number of microorganisms, provided the background ATP level is low. Unlike traditional HPC testing methods, results from a bioluminescent reaction can be obtained quickly.

Because the results are available immediately, facilities operators can get on-the-spot information about their contamination status, instead of having to wait days for cultures to bloom.

“Rapid testing is certainly a trend that has been evolving in this industry and many others over the years,” Whalen says. LuminUltra manufactures a second-generation ATP test kit for ultra-pure water applications, which measures ATP at very low concentrations with no incubation requirement in minutes and at dollars per test. “As manufacturers become more efficient, they need to have access to information faster, and rapid testing plays a critical role in this regard.”

He notes that although rapid ATP testing for microorganisms has been successfully used for nearly 30 years in the food and beverage industry, the pharmaceutical industry is slower to embrace these test methods, largely, he feels, because of a lack of education about their availability and applicability. “The industry just doesn’t know there is a better way.”

Online monitoring

Along with bacteria testing, online monitoring of TOC and conductivity can be used to bring facilities real-time information about their contamination content so they know exactly when an event happens. “You can do that all online,” says independent consultant Cohen, noting that many facility operators are still hesitant to implement online monitoring due to a lack of knowledge or an inability to interpret the software results. “The pharmaceutical industry tends to take a conservative approach, but the FDA is advocating a more risk-based approach to contamination management. Online monitoring helps achieve that. It lets you control contamination before it becomes an issue.”

He also notes that continuous monitoring eliminates validation issues because you can prove the water system was always in compliance with quality standards.

Whalen agrees. “What is needed to control contamination is a single measurement that can be easily applied at any point in the process on a routine basis, with instant feedback that can allow operators to adjust treatment requirements as needed to maintain high product quality,” he says. “If quality and operation managers were able to gain accurate information in real time, issues could be resolved on the spot and raw materials-in this case, water-could be released faster, which would dramatically increase productivity, reduce risks, and improve product quality.”

Online TOC and conductivity analyzers designed for continuous monitoring of waters can deliver ongoing analysis developed to USP requirements, notes Christian Stark, head of marketing for Christ Water Technology Group, headquartered in Aesch, Switzerland. “They offer real-time information for conductivity and temperature so that operators can limit the impact of events and avoid errors due to sampling, handling, and transport.”

Figure 4. With a human machine interface (HMI), such as the Christ Liprocontrol software, the process of a water system can be visualized easily. Photo courtesy of Christ Technology Group.Click here to enlarge image

However, online monitoring has valuable but limited applications for these water systems. “Real-time monitoring is already in use for most of the quality relevant parameters such as TOC, conductivity, and temperature,” Stark says. For the microbiological issues acknowledged, though, no online monitoring devices are known so far.

In combination, however, real-time monitoring and timely bacteria testing can help keep any water system safe and in compliance, eliminating downtime and reducing contamination events, Whalen says. “We believe that access to better monitoring tools will lead to better management and preventive maintenance of water systems, ultimately resulting in greater efficiency, reduced production costs, and improved product quality for pharmaceutical manufacturers.”

Resources and contacts

Absolute Ozone Edmonton, Alberta, Canada www.absoluteozone.com

Christ Water Technology Group Aesch, Switzerland www.christwater.com

LuminUltra Technologies Ltd. Fredericton, New Brunswick, Canada www.luminultra.com

Mar Cor Purification USA Lowell, MA www.mcpur.com

Microbiology Research Associates, Inc. Acton, MA www.mra-bact.com

Pall Corporation East Hills, NY www.pall.com

Start-Up Business Development Louisville, CO 303-926-1866

A new silver-based disinfectant could rise to challenges presented by resistant bacteria in health care environments

By Michael L. Krall, PURE Bioscience

Two million patients in the U.S. become infected each year while hospitalized, and more than 70% of the bacteria causing these infections are resistant to antibiotics, with approximately 90,000 patients a year dying as a result of their infections.¹ Three of the most common hospital acquired infections (HAIs) are Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli.

Hospitals becoming risky business

The growing bias toward outpatient care has made hospitals the repository of acutely ill and vulnerable patients, and performance of more aggressive operative techniques on an ever-aging population increases the age/acuity target mix for infections. Antimicrobial resistance continues to develop in those treatment environments demonstrating the highest patient risk, with intensive care units at the center of antibiotic resistance generation.²

Cost estimates of HAIs range from $5 billion to $30 billion in the United States each year.^3-5 The economic impact of these infections will be felt even more dramatically within the next 12 months as hospitals will be forced to completely absorb the cost of the majority of HAIs. The Centers for Medicare and Medicaid Services (CMS) has recently published regulations that indicate that beginning in 2008, Medicare will not compensate hospitals for HAI-related claims because CMS considers such infections preventable. Approximately 57% of patients contracting HAIs are Medicare patients.⁶

Increasing governmental and consumer pressure will drive hospitals to seek improved infection control technologies. One impetus is that HAI reporting will soon become mandatory in all states. The Healthy Hospitals Act of 2007 amends title XVIII of the Social Security Act to require public reporting of health care-associated infections data by hospitals and ambulatory surgical centers; it also permits the Secretary of Health and Human Services to establish a pilot program to provide incentives to hospitals and ambulatory surgical centers to eliminate the rate of occurrence of such infections.

Deficiencies of widely used products

Procedure and routine form the backbone of hospital infrastructure; however, even a perfectly executed maintenance schedule cannot overcome the constant introduction of microorganisms to the hospital environment. Hospital visitors, accidental cross-contamination by staff, quick room turnovers, and growing resistance to antimicrobials remain constant challenges to a well run hospital. Assuming that precautionary procedures are universally and accurately applied, yet observing that HAI rates are still rising, another variable in the hospital setting must be examined: the products employed during implementation of the maintenance routines.

Hospitals rely on sodium hypochlorite (bleach) or quaternary ammonia-based products for disinfection of environmental surfaces in all areas of the facility-from procedure, critical, and ambulatory care areas to common and administrative spaces. Dependence on these “traditional” disinfectants has become increasingly problematic as awareness of their dangers has risen. Bleach and quaternary ammonia products are not ideal for many areas of the hospital because they are toxic and produce harsh fumes. Dermal, ocular, and inhalation exposure to quaternary ammonia fumes can result in a variety of reactions, ranging in intensity from skin irritation/burning, redness, and blistering; eye irritation/burning, pain, and swelling; to respiratory irritation/burning, irritation to mouth, throat, and nose, flu-like symptoms, and headache, among others.⁷ In addition, allergic-type reactions including hives and contact dermatitis have been reported.

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Bleach-based products pose similar challenges in that they are corrosive and can cause severe chemical burn damage to eyes and skin and may release harmful vapors. Inadvertent, yet unfortunately common, mixing of bleach with acids or ammonia releases dangerous chlorine or chloramine gas, which can cause acute respiratory irritation and, in extreme cases, asphyxiation.^8,9 Quaternary ammonia and bleach-based products are obviously problematic for use near health-compromised-especially respiratory-compromised-patients. Restrictions related to toxicity of and exposure to traditional disinfectants often require hospitals to displace patients in order to properly disinfect facilities, resulting in increased turnover time (and lost revenue) for procedure areas and patient rooms.

Hospitals must frequently re-apply these traditional disinfectants because the products require long contact times and do not provide residual protection against re-contamination of surfaces. Also, more strains of organisms are developing resistance to quaternary ammonias as well as other common disinfectants and sanitizing agents. Researchers have observed strains of methicillin-resistant Staphylococcus aureus (MRSA) and other resistant bacteria that have shown an increasing tolerance to common biocides including quaternary ammonias.^10,11 In spite of the use limitations and innate health risks posed by these products, when used under strict protocols, bleach and quaternary ammonias have adequately controlled the transmission of disease-causing organisms in closed population environments like hospitals. Until now.

A new solution to HAIs must be implemented to prevent further human and economic losses.

‘Silver bullet’ solution?

Silver has been recognized for thousands of years as an effective anti-infective agent.¹² Hippocrates, the father of modern medicine, wrote that silver had beneficial healing and anti-disease properties, and ancient cultures stored food, water, and other liquids in silver vessels to prevent spoilage. U.S. pioneers at the turn of the 20th century placed silver dollars in milk bottles to prolong freshness. Silver compounds were even used successfully to prevent infection in World War I before the advent of modern antibiotics.

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Although the widespread use of silver went out of fashion with the development of modern antibiotics, recently there has been renewed interest in silver as a broad-spectrum antimicrobial. Many silver technologies have been successfully commercialized after achieving the appropriate regulatory registrations and approvals for niche uses. In medicine, silver sulfadiazine cream, often used in combination with silver-coated dressings, is the “standard of care” for the antibacterial/antibiotic treatment of serious burns. Additionally, silver-coated catheters and other medical devices are gaining market share, with over-the-counter silver impregnated bandages now available to consumers. Several industries have embraced silver as a natural and effective antimicrobial solution, with silver technologies now prevalent in food processing and packaging materials, water treatment equipment, textiles, construction products, and HVAC systems. Increasing consumer awareness and use of silver as an antimicrobial continues to rise as more and more domestic and international companies are integrating silver technologies into plastics for various products.

The safety of silver and silver compounds has been extensively reviewed in the public literature and summarized and interpreted in U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) decisions, by other federal agencies, and by international organizations. For example, the EPA has evaluated silver on multiple occasions and has concluded that there are no adverse health effects associated with ingestion of silver. In animal studies, as reported by the Agency for Toxic Substances and Disease Registry (ATSDR) in 1990 and EPA in 1993, silver is of low acute toxicity (no toxic effects reported at the doses tested). Furthermore, there is no evidence of acute or chronic toxicity, mutagenicity, carcinogenicity, neurotoxicity, or reproductive or developmental effects due to silver.^13,14 In addition, the EPA Office of Water set a Secondary Maximum Contaminant Level for silver in drinking water of 0.1 mg/L based solely on cosmetic effects; although this is a nonenforceable level offered for guidance purposes, the decision determined that there are no health effects associated with 0.1 mg/L in water.¹⁵ Identical conclusions to those reached by EPA and ATSDR were reported by the World Health Organization (2003) and by the National Research Council (NRC, 2004).^16,17 Neither WHO nor NRC identified any new data beyond that considered by ATSDR and EPA.

Silver’s multiple modes of action are believed responsible for its quick and broad-spectrum efficacy (which depends upon its ionization level) as well as for the low probability of inducing bacterial resistance. Creating a stabilized ionic silver formulation opens the door for its use in a wide array of products and treatments-including hard surface disinfection. Perhaps the most differentiating and salient characteristic of silver is the fact that no clinical evidence exists of the development of ionic silver-resistant microbial strains.¹⁸

One ionic silver disinfectant registered with the EPA (EPA registration number 72977‑3) carries claims of broad-spectrum efficacy superior to those of traditional disinfectants (see tables). In addition to antiviral and antifungal claims, the 30-ppm silver dihydrogen citrate (SDC) disinfectant carries a 30-second kill against Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella choleraesuis, and Listeria monocytogenes. The first new disinfectant active to be registered by the EPA in more than 30 years, the SDC-based product also provides 24-hour residual protection against standard indicator bacteria and a two-minute kill claim on MRSA and vancomycin-resistant Enterococcus faecium (VRE). Moreover, SDC-based disinfectants pose little if any health hazard because they are odorless, colorless, non-corrosive, non-flammable, and compatible with other disinfecting cleaners.¹⁹

Bacteria are actually attracted to SDC as opposed to being repelled as they are by traditional disinfectants.²⁰ Bacteria utilize carbon, including organic compounds like citrate, as a nutritional source.^21,22 Because of the citric acid component of the SDC molecule, bacteria recognize and take in the SDC as a food source (see Fig. 1). After easily entering the microorganism through membrane transport proteins, the ionic silver binds to DNA and intracellular proteins and causes irreversible damage to the DNA and protein structure (see Fig. 2). Metabolic and reproductive functions halt, and the organism dies.²³ This unique “Trojan horse” mode of action is in addition to the expected affinity between silver ions and sulfur-containing thiol groups in metabolic and structural proteins bound to the membrane surface.²⁴ In this extracellular attack, SDC targets these critical proteins and destroys their structure (see Fig. 3). Disruption of the organism’s membrane function and integrity lyses the membrane and the organism dies.

Figure 1. Silver dihydrogen citrate’s (SDC’s) rapid and broad spectrum efficacy is largely attributed to its dual mechanisms of action and unique characteristics. These two mechanisms, alone or in combination, make SDC a powerful antimicrobial while mitigating microbial resistance. Image courtesy of PURE Bioscience.Click here to enlarge image

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Figure 2. Bacteria are actually attracted to SDC because they recognize citric acid as a food source. SDC easily enters the microorganism like a “Trojan horse” through membrane transport proteins, binds to DNA and intracellular proteins, and causes irreversible damage to the DNA and protein structure. Metabolic and reproductive functions halt and the organism dies. Image courtesy of PURE Bioscience.Click here to enlarge image

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Figure 3. Silver ions are attracted to sulfur-containing thiol groups in metabolic and structural proteins bound to the membrane surface. SDC targets these critical proteins and destroys their structure in an extracellular attack. Disruption of the organism’s membrane function and integrity lyses the membrane and the organism dies. Images courtesy of PURE Bioscience.Click here to enlarge image

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In this time of rapidly growing human and economic costs of HAIs, including resistant strains of bacteria, solutions must be developed and implemented to prevent such infections. The burden of loss will continue to grow for patients who suffer from HAIs, families who feel the impact of fatalities from the infections, and the economy that has been absorbing up to $30 billion annually (and growing) for a largely preventable epidemic in our hospitals.

Michael L. Krall is CEO of PURE Bioscience, which develops and markets technology-based bioscience products (www.purebio.com).

References

1. U.S. CDC, “Campaign to Prevent Antimicrobial Resistance in Healthcare Settings: Why a Campaign?”, www.cdc.gov/drugresistance/healthcare/problem.htm, 2001.
2. J.D. Siegel, MD, et al., Healthcare Infection Control Practices Advisory Committee, “Management of Multidrug-Resistant Organisms in Healthcare Settings,” pp. 8-10, 2006.
3. U.S. CDC Office of Enterprise Communication, “Hospital Infections Cost U.S. Billions of Dollars Annually,” Mar. 2006.
4. R.W. Haley, “Incidence and Nature of Endemic and Epidemic Nosocomial Infections,” Hospital Infections, Boston: Little, Brown, pp. 359-74, 1985.
5. R.R. Roberts et al., “The Use of Economic Modeling to Determine the Hospital Costs Associated with Nosocomial Infections,” Clinical Infectious Diseases (36:11), pp. 1424-1432, 2003.
6. D. Murphy, RN, BSN, MPH, CIC, et al, “Dispelling the Myths: The True Cost of Healthcare-Associated Infections,” An APIC Briefing, Feb. 2007.
7. U.S. EPA Office of Pesticide Programs Antimicrobials Division, “Incident Reports Associated with Quaternary Ammonium Compounds (Quats),” http://pi.ace.orst.edu/search/getDocketDocument.s?document=EPA-HQ-OPP-2006-0339-0009, Feb. 15, 2006.
8. U.S. EPA Pesticides and Toxic Substances (7508W), “Sodium and Calcium Hypochlorite Salts,” R.E.D Facts 738-F-91-108, www.epa.gov/oppsrrd1/REDs/Factsheets/0029fact.pdf, Sept. 1991.
9. U.S. Dept. of Health and Human Services Agency for Toxic Substances & Disease Registry, “Calcium Hypochlorite (CaCl₂O₂)/Sodium Hypochlorite (NaOCl) CAS 7778-54-3/7681-52-9;UN 1748/1791,” Medical Management Guidelines, www.atsdr.cdc.gov/MHML/mmg184.html.
10. A.P. Fraise, “Susceptibility of Antibiotic-Resistant Cocci to Biocides,” J. Appl. Microbiology Symp. Suppl. (92), 185X-162S, 2002.
11. G. Sundheim et al., “Bacterial Resistance to Disinfectants Containing Quaternary Ammonium Compounds,” International Biodeterioration & Biodegradation (41:3-4), pp. 235-239, 1998.
12. J.L. Clement, P.S. Jarrett, “Antimicrobial Silver,” Metal-Based Drugs (1), pp. 467-482, 1994.
13. National Toxicology Prog., NIEHS, Research Triangle Park, NC, NTIS #PB2002-109208, 2002.
14. U.S. EPA, Office of Pesticide Prog., Re-registration Eligibility Decision for Silver, case 4082, 1993.
15. U.S. EPA, Silver, Integrated Risk Information Systems, last rev. Oct. 28, 2003 (1996).
16. . WHO, “Silver in Drinking Water,” Geneva (WHO/SDE/WSH/03.04/14).
17. NRC, Spacecraft Water Exposure Guidelines for Selected Contaminants (1:9), The National Academies Press, 2004.
18. A.B. Lansdown, “Silver I: Its Antibacterial Properties and Mechanism of Action,” J. Wound Care (11:4), pp. 125-30, Apr. 2002.
19. PURE Bioscience web site, www.purebio.com/technolo gies/silver_dihydrogen_citrate.
20. L. Benov, I. Fridovich, “Escherichia coli Exhibits Negative Chemotaxis in Gradients of Hydrogen Peroxide, Hypochlorite, and N-chlorotaurine: Products of the Respiratory Burst of Phagocytic Cells,” Proc. Natl. Academy of Sci. of the United States of America (93:10), pp. 4999-5002, May 1996.
21. K. Todar, “Nutrition and Growth of Bacteria,” Todar’s Online Textbook of Bacteriology, University of Wisconsin-Madison Dept. of Bacteriology, 2004.
22. G. Molin, “Mixed Carbon Source Utilization of Meat-Spoiling Pseudomonas fragi 72 in Relations to Oxygen limitation and Carbon dioxide Inhibition,” Appl. and Environ. Microbiology (49:6), pp. 1442-1447, 1985.
23. Q.L. Feng et al., “A Mechanistic Study of the Antibacterial Effect of Silver Ions on Escherichia coli and Staphylococcus aureus,” J. Biomedical Mat. Research (52:4), pp. 662-668, 2000.
24. A.D. Russell, W.B. Hugo, “Antimicrobial Activity and Action of Silver,” Progress in Medicinal Chemistry (31), pp. 351-70, 1994.

gloves

Critical environments differ from one application to the next, but one aspect they all share is the need for adequate hand protection. Glove products can vary widely in sterility, weight, length, resistance to contaminants, and the materials from which they are made, affecting how you choose one hand-protection product over another for your application.

Compiled by Carrie Meadows

Secure grip in chemical environments

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Ansell offers AlphaTEC™ gloves, the first chemical-resistant gloves to incorporate Ansell Grip Technology™. Designed as a liquid-proof product requiring less force to grip oily or wet objects, AlphaTEC gloves have been successfully tested at the production sites of 25 major industrial companies throughout Europe. More than 83 percent of workers claimed they could perform tasks better with AlphaTEC gloves. The gloves integrate microscopic channels in a patented, ultra-thin nitrile layer to direct fluids away from the grip surface, leaving a significant dry contact area that provides almost the same grip that is possible under fluid-free conditions. This improved adherence promotes greater worker comfort and minimizes stress and fatigue. The production process ensures an exceptionally safe chemical barrier. The gloves’ polymer coating does not penetrate into the liner during the manufacturing process, which results in consistent protection for the skin. AlphaTEC’s nitrile coating is also designed for greater flexibility. For more information, visit the company’s web site or contact Customer Service at 800-800-0444.

Ansell Red Bank, NJ www.ansellpro.com

Suitable for strict industrial environments

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The CleaN-DEX® glove from Best Glove, Inc. is the answer to protecting technicians and products in clean environments. This Class 100 cleanroom specialist delivers ultra-low ESD and particulate counts, protecting high-end semiconductors and other clean manufactured products. The CleaN-DEX glove’s “clean” white color is ideal for environments where exacting standards of industrial hygiene are required. Its textured fingertips deliver enhanced grip and tactile discrimination. The glove’s 12-inch length and beaded cuff design ensure compatibility with cleanroom garments and apparel. Best Glove also offers a number of other glove choices, such as the N-DEX® S9905 (sterile) and two bagged N-DEX gloves, the N-DEX® B9905 and the N‑DEX® original B6005 that are ideal for many clean environments.

Best Glove, Inc. Menlo, GA www.bestglove.com

Range of glove offerings for various cleanroom classes

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Connecticut Clean Room Corporation (CCRC) offers a complete line of gloves including a wide selection of vinyl, latex, nitrile, and specialty gloves. The company’s gloves meet or exceed the stringent requirements needed in critical environments ranging from Class 100,000 to Class 1 (U.S. Fed. Std. 209E). Glove sizes vary depending on style and manufacturer. With more than 25 years of experience with cleanroom products, CCRC can assist in selecting the right glove for each application. The proper fit provides comfort and enhances wearability, dexterity, and safety. CCRC offers a new catalog that features an assortment of special products that meet all critical manufacturing, industrial, and sanitary standards. To receive a catalog or for information, call 860-589-0049 and ask the Customer Care Team for more details.

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

New polymer alternative that withstands deterioration

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Harada USA Corporation is developing and manufacturing a new glove product developed for high-tech customers who require a higher level of cleanliness, especially for expanding 32 nm technologies. The company has succeeded in manufacturing a LYCRA® polymer that does not require additives, catalysts, emulsifiers, stabilizers, powders, or chlorination, which other cleanroom glove products depend upon. The ability for CE gloves to withstand physical abuse and remain intact without degradation, shedding or peeling is a prerequisite for reducing contamination. Although many CE gloves present positive data at the start-of-use when removed from the bag, performance during use deteriorates quickly. DuraCLEAN® with LYCRA® is the first and only CE glove that delivers leading performance in the areas of airborne molecular contamination, particle contamination, ionic contamination, and electrostatic discharge without compromise, according to Harada USA.

Harada USA Corporation San Diego, CA www.haradausa.com

Wide range of cleanroom gloves compatible up to Class 10

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High-Tech Conversions Inc. offers a wide range of cleanroom gloves. Available for most applications, the gloves are available in six main varieties and feature comfortable, high-quality construction. Additionally, they are Class 10 compatible and sterile. Powder-free, non-sterile nitrile and latex gloves are available in various sizes and in quantities of 100/double bag, 10 bags/case. They are Class 100 cleanroom compatible and come in 9 1/2 and 12 inch lengths. A Class 100 cleanroom compatible anti-static vinyl glove is also offered. Powder-free, non-medical gloves and lightly powdered non-medical gloves come in nitrile, latex, and vinyl versions. Vinyl gloves are translucent white and ESD safe. Both lightweight and heavyweight cotton gloves in both men’s and women’s sizes are overcast hemmed and unhemmed and come in quantities of one dozen per bag. Static dissipative (ESD) nylon cloth gloves are cleanroom quality gloves that are breathable, with conductive fibers running throughout the glove.

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

Hand protection offers reduced contamination, static removal

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Innotech Products offers a complete selection of gloves that will meet or exceed the requirements of each customer’s application. A diverse selection of bagged or boxed nitrile, latex, and vinyl disposable gloves, as well as nylon, vinyl coated, cotton, and chemical/acid-resistant gloves and glove dispensers are offered. The product line includes attributes such as powder-free, anti-static, ESD safe, sterile, and temperature resistant. Cleanroom gloves undergo special washing and cleaning processes to remove particulates, reducing contamination. Anti-static gloves are made from fibers that will control static generation and prevent static charges while handling objects. ESD safe gloves will remove static buildup while technicians handle sensitive components. Chemical gloves provide varying degrees of protection against harmful elements and resist abrasion or cutting. Finger cots offer added protection and are more cost-effective than double gloving; they are available in conductive, nitrile, and pink anti-static versions. To speak to a cleanroom specialist regarding these and other critical environment needs, call 888-270-0458.

Innotech Products Minneapolis, MN www.InnotechProducts.com

Aseptically packaged gloves for cleanroom environments

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KIMTECH PURE* G3 Sterile Latex Gloves from Kimberly-Clark Professional are designed for use in sterile cleanroom environments. The gloves are made from natural rubber latex with low proteins and low endotoxins. They are non-hemolytic and non-cytotoxic. The 12-inch long gloves are hand-specific and are packaged in polyethylene for aseptic donning. The gloves are available in hand sizes 6 through 10.

Kimberly-Clark Professional Roswell, GA www.kcprofessional.com

Additive-free polyethylene construction

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KNF Clean Room Products manufactures the Ultraglove™ using pure additive-free polyethylene film in a cleanroom environment according to the stringent Ultraclean™ cleanliness level, as with all of KNF’s products. A final test of the glove is performed to determine ash content and any presence of additives, such as slip, antiblock, AHTs, and BHTs. The Ultraglove™ is widely used in the polysilicon and wafer production industry due to its low cation and anion content. The sterilized, chemical-resistant gloves are suited to applications in the medical, biomedical, medical device, and veterinary medicine fields.

KNF Clean Room Products Ronkonkoma, NY www.knfcorporation.com

Cleanroom-fabricated and pre- laundered hand protection

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Magid Glove & Safety offers the Fiberlock® 132NYA cleanroom glove, which provides great dexterity and touch sensitivity and is low-linting. This glove is seamless and 100% nylon, with a high-density construction and double-hemmed edge, making it suitable for particulate restrictive areas in the electronic, semiconductor, and automotive paint industries. The 132NYA is manufactured entirely in a cleanroom with an ISO 6 rating by using heat-treated, texturized, stretched, cleaned, and packaged yarn. Once produced, the gloves are taken to an on-site laundering facility and pre-laundered to retain their size after multiple launderings and then packaged in heat-sealed BHT-free polybags. Online purchasing is available 24/7. Browse the online catalog of more than 30,000 safety items for virtually every industry. In addition to signature Magid products, the company offers brands such as Aearo, Ansell, Best, 3M, Uvex, MSA, and more.

Magid Glove & Safety Chicago, IL www.magidglove.com

Glove products meet critical environment standards

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PIP Technical offers many styles of gloves used in the critical environment industry. PIP Technical products range from disposable nitrile and latex to pure vinyl and co-polymer vinyl, as well as a wide variety of glove liners. These products are designed and manufactured to meet strict standards for critical environments. PIP Technical’s Cleanteam® products can provide assurance of documented performance. Contact the company at 800-262-5755, by e-mail at [email protected], or visit the web site.

PIP Technical Uniontown, OH www.pipusa.com

Drybox and isolator gloves

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Renco has added a full range of sterile, Hypalon®, and nitrile drybox gloves to its product line. Renco’s Hypalon® drybox gloves are leak-tested and powder-free. The company will sterilize to customer specifications. Products are available to fit hand sizes 7-10.5, left/right and ambidextrous, and port sizes of 6, 8, 10, and 12 inches. Nuclear, chemical, pharmaceutical, and biotech companies around the world have chosen Renco products for more than 40 years. Renco also holds two GSA (Government Services Administration) schedules. The company’s product line includes a wide range of drybox and isolator gloves, sleeves, and the patented Titeline Glove System. In addition to Hypalon® and nitrile, butyl, polyurethane/Hypalon®, latex, neoprene, Viton®, and butadyl protection solutions are offered. Renco also supplies stainless steel, polypropylene, and PVC glove ports, cleanroom/ESD safety shoes, and supplies. For product questions, estimates, and to place an order, call 800-257-8284, or e-mail [email protected].

Renco Corporation Manchester, MA www.rencogloves.com

Customized options, reconditioned gloves available

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More than 80% of Riverstone Holdings’ cleanroom gloves are made from nitrile and ~20% from natural rubber. The gloves are ambidextrous, ranging from 9 to 14 inches, and come in sizes from extra small to 3X large. For better gripping, gloves with textured fingertips or tacky gloves are also available. Riverstone currently produces Class 10 gloves, Class 100 gloves, Class 100 chemical-resistant gloves, and Class 100 gloves with enhanced ESD protection. The company is able to customize individual product batches to meet customers’ varying requirements. Currently available in the Asian market, used Riverstone gloves in good condition can be sent back for reconditioning instead of disposal, spearheading sustainable development. Riverstone’s proprietary program ensures that there will not be any cross-contamination involved. The company’s manufacturing plants in Malaysia, Thailand, and China are ISO 9001:2000 and ISO 14001:2004 certified. Riverstone also distributes finger cots, cleanroom packaging materials, and other cleanroom consumables including swabs, face masks, wipers, and coveralls.

Riverstone Holdings Ltd. Selangor, Malaysia www.riverstone.com.my

Puncture-resistant gloves in PVC dispenser

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Techni-Cleaned Class 10 nitrile gloves are manufactured in three colors-white, blue, and green-which allows coding by size, coding by product, coded double gloving, and many other opportunities. Techniglove products contain no natural rubber or silicone and meet the most stringent requirements for particles and extractables. The proprietary Microtexture Formers offer an exceptional fit and a soft, supple feel. Exclusive on-line batch testing is available for this product. According to the company, the Technipak is the world’s only plastic (PVC) dispenser box with 5-mil thick powder-free nitrile gloves for controlled environments. The clean PVC dispenser reduces the particulate found on paper boxes and can be wiped clean in wet applications. The gloves are puncture-resistant and are 100% nitrile, reducing the potential for allergic reactions to natural rubber latex proteins.

Techniglove International Corona, CA www.techniglove.com

Tri-blend chemical glove

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Valutek offers a variety of latex, PVC, and nitrile gloves to fit any customer’s cleanroom and controlled environment needs. The latest addition to the company’s product line is a tri-blend chemical glove, made from a unique polymer blend of latex, nitrile, and neoprene, which provides complete protection against all chemicals in an immersion application. The combination of protection against acids and solvents makes the chemical gloves ideal in microelectronics environments for a number of critical functions: chemical mixing and transporting; acid etching; handling Quartzware instruments and equipment; and handling silicon wafers in acid baths. It comes in a natural color, 15-inch cuff length, and 20-mil thickness, and each pair is carefully inspected and packaged in individual poly bags. The gloves will debut on December 1 and are able to be pre-ordered.

Valutek Phoenix, AZ www.valutek.com

Compiled by Carrie Meadows

Food scale designed to prevent contamination

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The Combics Food Scale series from Sartorius has been designed to withstand rigorous and complete disinfection while maintaining precision and accuracy. Manufactured in accordance with European Hygienic Equipment Design Group (EHEDG) guidelines, all standard models are made entirely of high-alloy AISI type 304 stainless steel, which is ideal for food industry applications as well as chemical and pharmaceutical markets where product contact is of concern. An open design prevents contamination from inaccessible areas, and detailed cleaning instructions simplify the analysis and control of potential hazards in strict accordance with Hazard Analysis and Critical Control Points (HACCP) regulations. The complete food scale series has reliable and accurate weighing capacities from 6-150 kg; mechanical overload protection keeps the weighing system safe from both horizontal and vertical impact.

Sartorius Corporation Edgewood, NY www.sartorius-usa.com

Multi-use pump for high vacuum systems

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Pfeiffer Vacuum offers the XtraDry™ dry vacuum pump for all medium vacuum applications down to 10^-1 mbar where there is a need to pump dry, inert, and non-reactive gases. Operated as either a stand-alone or backing pump, XtraDry™ operates free of hydrocarbons and particulate matter, which prevents contamination of the process or the environment. The pump is well suited for use in semiconductor applications such as load locks and differential seals, as well as a backing pump for turbo pumps in high vacuum systems. A unique seal design prevents gas backstreaming within the pumping system, enabling gases to be pumped regardless of their molecular weight. Automatic standby mode reduces the speed of the pump by more than 30% during operation near ultimate pressure, saving energy and increasing service life.

Pfeiffer Vacuum, Inc. Nashua, NH www.pfeiffer-vacuum.com

Filter module provides leak-free protection for pharma, biotech

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Camfil Farr has introduced a new “RFM22” ducted terminal filter module that delivers leak-free protection for ISO 5-8 applications in the pharmaceutical and biotech industries. The all-welded module incorporates a gel seal HEPA or ULPA filter and is designed specifically for use where hoods must be regularly validated for performance and leak-free operation. The filter module is easily serviced from the room side for filter changeout, airflow adjustment, and filter scan testing. The RFM22 filter module is suitable for standard t-bar ceilings, gel-grid systems, and hardboard or plaster systems, and may be adapted to horizontal or reverse flow applications. It may be used in new installations or as a direct replacement for competitive modules.

Camfil Farr Riverdale, NJ www.camfilfarr.com

Ionizer controls ESD in process tool applications

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MKS Instruments, Inc. has introduced the Ion Systems Critical Environment In-tool Ionizing Blower Model 5822i. Designed for extremely tight ion balance, the small size of the Model 5822i ionizer makes it ideal for ESD control in process tools used in the hard disk drive, backend semiconductor, and other automated manufacturing environments. The ionizer maintains a balance of <±1 V or better with an external monitor and <±3 V without. The internal automatic balance correction system ensures accurate ionization of the target. The patent-pending collimator is installed over the fan and directs ionized air to the target, improving ion delivery and shortening decay times, as well as increasing the range of the 5822i ionizer. The separate control box allows the blower to be installed in small, hard-to-reach spaces without fitting additional connections or wiring. The ionizer is cleanroom compatible and RoHS compliant.

MKS Ion Systems Wilmington, MA www.mksinst.com

Spiral-tip swabs for a range of cleaning tasks

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Qosina presents a new, black, dual-tip cotton swab (Part # 10219). Qosina’s spiral/spiral swabs are suitable for cleaning many surfaces. The tightly wound black spiral tips grab more dust and debris and clearly show removed residue. The 3-inch biodegradable cotton and paper swabs are packaged 10 per easy-open perforated sleeve, with two sleeves per sheet. These are a sanitary and economical choice for chores requiring multiple swabs. Qosina has more than 5,000 SKUs in its inventory including swabs, brushes, connectors, tubing, valves, clamps, caps, syringes, and adapters. Call the company’s customer service specialists to obtain the latest 2007 catalog, request a sample, or place an order at 631-242-3000, fax 631-242-3230, or e-mail [email protected].

Qosina Edgewood, NY www.qosina.com

Biological safety cabinet

The “Blu Space” microbiology safety cabinet is a Class II biohazard safety cabinet with an automatic control system according to the European Standard EN 12469. It ensures the protection of the operator, product, and environment against risks from contaminated aerosol-involved applications during the manipulation of biological active or infectious substances. The cabinet is designed for use in microbiology, virology, hematology, cell culture laboratory, and recombinant DNA research applications. A front barrier prevents aerosols from passing through the inside of the cabinet to the outside. The cabinet also features ISO 5 unidirectional airflow and absolute filtration of the exhaust according to EN 1822-1.

International PBI S.p.a. Milan, Italy www.internationalpbi.it

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

Fusion-bonded latex and synthetic polymer gloves

Sempermed is now offering the Polymed® exam glove, which features a unique “fusion” bonding of latex and synthetic polymers. This creates a multi-layer glove that combines the elasticity of latex and the strength of copolymers, which protects against cracking and/or peeling in normal usage. Polymed® contains 50 μg or less of total water extractable proteins per gram, which significantly reduces the potential for allergic reactions. This glove also offers powder-free protection that eliminates the aerosolization of glove powder as well as the powder transfer of latex proteins. The multi-layer coating provides added comfort against the skin and ease of donning for both wet and dry hands, and the micro-rough surface on the fingers and palm offers excellent sensing and a safe grip. The glove’s neutral pH balance also provides additional skin-friendliness.

Sempermed USA, Inc. Clearwater, FL www.sempermedusa.com

Instrument-quality shaft collars

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A new line of instrument-quality shaft collars for designers of medical, pharmaceutical, and scientific instruments or precision equipment is being introduced by Stafford Manufacturing Corp. Stafford IQ Shaft Collars feature one-piece construction with radiused outside edges, a 32 RMS finish on all surfaces, and a self-locking clamping screw. Precision balanced for use on high-speed rotating equipment, these instrument quality shaft collars are offered in electropolished stainless steel, steel with a hot black oxide finish, and anodized aluminum. Available in standard sizes from 1/4 to 6 inches I.D., Stafford IQ Shaft Collars were developed to provide alternatives to conventional shaft collars that are more precise, attractive, and application-specific. Special treatments such as tapped holes and mounting flats can be provided.

Stafford Manufacturing Corporation North Reading, MA www.staffordmfg.com

Hard-mount vibration cancellation system

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Technical Manufacturing Corporation (TMC) has introduced the FloorPlatform PZT™ active inertial vibration cancellation system designed for use with scanning electron microscopes (SEMs). The FloorPlatform PZT features sub-hertz vibration cancellation in an active hard-mount floor platform that fits most commercial SEMs. The system is compatible with all internal vibration isolation systems. The company says it incorporates proprietary Stacis technology in a much smaller footprint, requiring minimal tuning during installation. With vibration cancellation starting below 1 Hz, FloorPlatform PZT features extended stroke piezoelectric actuators and damped, powder-coated steel plates that sandwich four isolators and TMC’s DC 2000 digital controller. The system can support 900 to 1,600 lb and has no soft air suspension. It is available with three or six degrees of freedom.

Technical Manufacturing Corporation Peabody, MA www.techmfg.com

Closed-loop gas chiller

Brooks Automation’s Polycold® PGCL system has been tested and qualified on a PVD process for copper/tantalum barrier-seed deposition. By providing a lower chuck temperature (as low as -70°C), higher process thermal loads can be managed while maintaining the wafer at the required temperature, enabling better film uniformity, higher process yields, and wafer throughput. The closed-loop gas chiller provides cooling of wafers and chucks using an inert gas coolant. It also eliminates problems associated with liquid chillers such as leaks into the chamber that lead to significant system down time, cost of replacement fluid, safety concerns, and process contamination. PGCL also eliminates the cost of a continuous high-purity gas supply.

Brooks Automation Chelmsford, MA www.brooks.com

FT-IR metrology tool for minienvironments

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Thermo Fisher Scientific Inc. has revealed its latest FT-IR metrology system, the Thermo Scientific ECO 3500. Incorporating an ISO 1 rated Spartan® equipment front-end module (EFEM) from Asyst Technologies Inc., the ECO 3500 benefits from the highest industry standards of cleanliness in microenvironments. Also featuring a proven spectrometer and enhanced analytical software, the system is designed for seamless integration into automated wafer handling facilities. The dual end-effector configuration with two 300 mm in-line load ports speeds up the wafer transfer process between the front-opening unified pod (FOUP) and the wafer stage and optimizes sample throughput. Installation is much improved with an air-cooled infrared source in place of the conventional use of cooling water. The ECO 3500 is capable of various chemical analyses and dimensional measurements such as epitaxial film thickness and SOI or MEMS thickness.

Thermo Fisher Scientific Inc. Madison, WI www.thermo.com/spectroscopy

Control unit for particle monitoring systems

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The Series DPM Particulate Monitor combines with the PMS Particulate Sensor to provide a basic baghouse and cartridge filter leak detector designed for general maintenance planning and process protection. It is easy to use and reliable. Leakage is gauged in real time, on the spot, without prior baseline data and without signal tuning. An alarm point is set by simply moving an indicator up and down the gauge with the convenient, lockable key pad. The digital readout in absolute units ensures correct interpretation of the readings and provides accurate historical comparisons. The DPM control unit is housed in a rugged cast aluminum enclosure, while an LCD displays particulate levels in bar-graph and digital forms.

Dwyer Instruments, Inc Michigan City, IN www.dwyer-inst.com

Vertical lift for storage and retrieval

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The MegaLift™ FSE Vertical Lift Module (VLM) from MegaStar Systems meets OSHA standards for quiet operation, allowing it to be installed in a variety of non-warehouse type automated storage and retrieval applications. The lift uses a no-lubrication cable drive system, rather than traditional chain drive or rack and pinion systems, that provides clean, smooth, fast, and quiet operation rated at 65 dB. This “silent” operation makes the MegaLift FSE VLM suitable for installation in laboratories, offices, and other areas where noise reduction is necessary. It consists of an enclosed system of vertically arranged trays that automatically locates and retrieves stored items and delivers them to an ergonomically positioned workstation. The unit’s Flexi‑Space™ feature automatically scans the height of each tray and stores it in the smallest space possible, in as little as one inch increments, to significantly improve storage density. Its vertical design takes advantage of unused overhead space to save up to 85 percent of the floor space required by rack and shelving systems.

MegaStar Systems Marietta, OH www.megastarsystems.com

Shatter-resistant UV germicidal lamps

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Shat-R-Shield’s line of ultraviolet (UV)/germicidal lamps are safety-coated fluorescent lamps that emit specific high-output UV radiation that destroys bacteria, viruses, spores, and molds. By using a physical process-rather than chemical-to inactivate pathogens, the lamps are versatile and appropriate for applications such as food packaging and product sterilization; air and water purification for HVAC areas, such as intensive care units; and use in water treatment centers instead of adding chemicals to the water supply. The lamps’ clear and tough coating will safely contain virtually all glass and lamp elements in the event of accidental breakage. Shat-R-Shield UV germicidal lamps are available as T5 and T8 fluorescents through the company’s network of electrical distributors. For more information, call 800-223-0853 or visit the company’s web site.

Shat-R-Shield Salisbury, NC www.shatrshield.com

Single-use peristaltic pumps

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Single-use DAFPA™ peristaltic pumps from Flexicon America, Inc. have become an attractive alternative to replace piston pumps in production filling applications for production biologics and bio-based pharmaceuticals utilized in the treatment of specific diseases. The Flexicon Multi Filling System addresses limited-run production requirements, with gentler handling and built-in flexibility via a customized system of trolley-mounted pumpheads. In contrast to a piston pump filling system that often requires extensive and time-consuming equipment washdown and validation procedures, the trolley-mounted Flexicon Multi Filling System requires only the replacement of the fully disposable single-use tubing and filling needle. The trolley-mounted peristaltic systems are offered in configurations of 4 to 16 pump heads mounted to a stainless-steel cabinet with easy rolling casters to permit convenient access to the main filling machine.

Flexicon America, Inc. Burlington, VT www.flexiconamerica.com

Horizontal laminar flow station

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Terra Universal’s TerraFlo™ horizontal laminar flow station provides an economical work environment that exceeds the most stringent contamination requirements for the pharmaceutical, biotech, electronics, and semiconductor industries. Powerful filter/blower and filter/fan modules provide a back-to-front laminar flow of filtered air across the work surface. The adjustable multi-speed, direct-drive blower lets the user control air speed to meet custom requirements. It also provides an industry-best low noise level of 50 dBA. Select the filters to meet specific requirements: HEPA filters are rated 99.99 percent efficient at removing particles 0.3 μm or larger, and ULPA filters are rated 99.999 percent efficient at 0.12 μm particles.

Terra Universal Fullerton, CA www.terrauniversal.com

Versatile depth filter capsule for small-scale operations

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The SupraCap™ 100 depth filter capsule for Pall Corp. is the only intermediate-scale depth filter to be offered in a range of sizes, styles, and configurations, the company says. The filter capsule’s versatility and performance simplify scale-up and speed processing of 5-100 L applications typical of clinical batches, personalized medicines, and pilot-scale operations. The new disposable depth filter format eliminates the need for cleaning and cleaning validation of traditional stainless-steel filter housings, minimizes cross-contamination risks, and reduces capital costs, all of which are critical to smaller-scale clarification and pre-filtration applications. The capsule design also provides a lower hold-up volume than standard module housings for greater product recovery. The capsule is completely enclosed to eliminate direct operator handling of fragile filter discs. It also protects operators from high potency or biologically toxic compounds. SupraCap 100 depth filter capsules can be manifolded together or connected upstream of Kleenpak™ Nova filters as a fully integrated disposable system.

Pall Corporation East Hills, NY www.pall.com

Drying chamber for LED manufacturers

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Interlab now offers a special version of its critically clean, HEPA-filtered drying console, adapted for LED manufacturing processes. The model MDS/250/LED is the result of the company’s work with a major LED manufacturer in addressing the processing and performance standards specific to that industry. It is the most recent version of Interlab’s critical evaporative drying systems. The touch-panel controlled MDS/250/LED design goes beyond the company’s patented technique of incorporating HEPA or ULPA filtration within the actual recirculating air path. It also features a laminar flow-guide that prevents formation of particle-retaining turbulent pockets in the corners of the drying chamber. The result is a miniature high-performance “inverted cleanroom” in which freedom from contamination can be assured throughout the rapid drying cycle.

Interlab Inc. Danbury, CT www.interlab-inc.com

Chemically resistant macro volume pipettor

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Biohit, Inc., has expanded its mLINE family of pipettors with the addition of the new 1-10 ml volume range. The macro volume pipettor, along with the new 10-ml tip, provides a convenient way to handle large volumes of liquid accurately and safely. The 10-ml instrument is a suitable working tool for water, food, and environmental labs, as well as in biotech and chemical industries. The Pipettor features excellent chemical resistance and is compatible with most liquids including chloroform. Biohit Safe Cone filters installed into the tip cone can minimize the risk of contamination. The mLINE pipettor is fully autoclavable and is adjustable in 20-μl increments. It operates with a light touch for both pipetting and tip ejection. All Biohit products are CE/IVD marked following ISO standards for quality and environment standards.

Biohit, Inc. Neptune, NJ www.biohit.com

Fume hood product line designed to meet various challenging requirements

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Duralab Corporation offers a broad line of fume hoods designed to meet all size and application requirements. Hoods are available with bypass, variable air volume, and add air designs. Special hoods designed to meet the unique needs of wheelchair operators can be supplied. Radioisotopes, perchloric acid, low bench height walk-in, demonstration, and portable models are also available. A complete line of accessories can be provided, including service and electrical fixtures, airflow monitors, sinks, exhaust blowers, and more. The Duralab engineering department is staffed to provide assistance in project planning, design, and cost estimating. Engineering drawings for approval can be provided prior to fabrication of the furniture. A factory trained labor force is available for non-mechanical installation.

Duralab Corporation Parlin, NJ www.duralabcorp.com

Web-based remote surveillance monitor

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The NEWPORT® iSE environmental monitor provides web-based remote surveillance of environmental conditions in critical HVAC applications such as computer server rooms, cleanrooms, and laboratories, as well as critical refrigeration and cold chain applications. Users can view virtual charts and record temperature, relative humidity, and dew point over an Ethernet network or the Internet with no special software-just a web browser. Up to four years of data can be recorded on the removable flash memory. The device can trigger an alarm if temperature or humidity goes above or below a set point that the user determines. The alarms can be sent by e-mail to a single user or to a group distribution list, including text messages to Internet enabled cell phones and PDAs.

NEWPORT Electronics, Inc. Dallas, TX www.newportUS.com

Cleanroom vacuum with HEPA filtered collection container

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Nilfisk-Advance America has developed the compact IVT 1000 CR cleanroom vacuum, available with optional Safe-Pak™ technology-the first disposable, HEPA-filtered vacuum cleaner collection container designed for potent compound and hazardous material applications. The IVT 1000 CR addresses the cleanliness and hygiene standards required in cleanrooms in a compact machine, without sacrificing ease-of-use or worker comfort. Equipped with an ULPA exhaust filter as standard, the innovative IVT 1000 CR is also quiet, compact, and easy to maneuver and, like the trolley and all accessories, is autoclavable for simple and convenient cleaning. The system was designed to collect sub-micron particles and retain them in a HEPA-filtered container, protecting the vacuum from contamination as well as providing a safe and easy means for disposing of the collected waste. The Safe-Pak is also available with Nilfisk’s CFM 3156 and 3306 industrial vacuum cleaners.

Nilfisk-Advance America Malvern, PA www.pa.nilfisk-advance.com

High-volume microglass HEPA filter

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Advanced Filtration Concepts introduces the new HV (High Volume) HEPA filter manufactured by Engineered Filtration Systems (EFS). The EFS HV HEPA filter is designed specifically for critical applications that require high-efficiency particulate air filtration. The mini-pleated wet laid microglass of the HEPA filter optimizes airflow; high-efficiency V-bank style media packs result in low pressure drop and energy conservation. The EFS HV has an extended media area (431 sq. ft.) that results in a longer service life and fewer replacements. The filters are rated at ASHRAE 99.99 percent. Typical applications for the EFS HV HEPA filter include cleanroom environments, semiconductor and electronics manufacturers, medical and pharmaceutical facilities, laboratories, testing facilities, and other critical applications.

Advanced Filtration Concepts Vernon, CA www.advfiltration.com

Upgradeable syringe pumps

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Both the features and the syringe capacity of the PHD22/2000 syringe pumps can be upgraded without purchasing a new pump. The PHD 22/2000 Series is available in several models: infusion only, infusion/withdrawal, or programmable. These pumps can accommodate 4, 6, or 10 plastic, glass, or stainless-steel syringes with the addition of a multi-rack. The standard rack accommodates two syringes. Feature upgrades are performed at the Harvard Apparatus factory, but syringe rack upgrades can be performed by the user with the purchase of an upgrade kit. The PHD 22/2000 Series is accurate to ±0.35 percent and offers a broad flow rate range from 0.0001 μl/hr to 220 ml/min. These units accommodate syringes ranging from 0.5 μl to 140 ml.

Harvard Apparatus Holliston, MA www.harvardapparatus.com

Wireless medical and lab temperature monitoring

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Accsense’s fast and easy wireless monitoring system allows medical, pharmaceutical, and laboratory applications a complete management option for keeping temperatures, CO₂ levels, humidity, and any other measurements in check with constant monitoring. Receive alarm notifications via e-mail, phone, or pager if problems arise, anywhere, anytime. The out-of-the-box system is up and running in five minutes, allowing users to start recording data and receiving information immediately through web-based software. Print out reports for JCAHO and other industry compliance and prove that samples are under constant control. A complete Accsense wireless system automatically forms a secure, self-healing wireless mesh network. Sensor pods are compatible with a range of standard external plug-in sensors and probes, including thermocouples, resistance temperature detectors, and thermistors.

Accsense, Inc. Santa Barbara, CA www.accsense.com

500° cleanroom cabinet oven

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No. 923 is an electrically heated, 500°F Class 100 cleanroom cabinet oven from Grieve, currently used for drying precision parts in baskets. Workspace dimensions measure 36x36x51 inches. The oven features an aluminized steel exterior construction, stainless-steel door cover and control panel face, and stainless-steel interior with continuously backwelded seams and 4-inch thick insulated walls. Double front doors with positive latching door hardware are also included. No. 923 has two 30x24x6-inch thick, stainless-steel, high-temperature HEPA recirculating filters and easily removable ductwork to expose the filters for inspection and replacement. Controls on the cabinet oven include a digital indicating temperature controller, manual reset excess temperature controller with separate contactors, recirculating blower airflow safety switch, and solid-state contactors.

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

Dust-free vertical storage

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Enclosed vertical storage cabinets from Eagle MHC are designed for critical manufacturing, assembly, and storage areas where products and components need to be securely stored in a dust- and dirt-free environment. Eagle’s NSF-approved vertical storage cabinets feature a chemically resistant, easy-to-clean stainless-steel exterior. The cabinet body is made of 18-gauge stainless steel, with interior stainless-steel shelves adjustable on 4-inch vertical increments. Double-pan, 20-gauge stainless-steel hinged key-locking doors provide long-life durability, along with secure, dust-free protection of all cabinet contents. Enclosed vertical storage shelves are available with a flat top or an alternative sloped top providing laminar flow to meet stricter cleanroom requirements. Eagle offers both stationary models and a mobile version featuring 5-inch plate casters and brakes, so the shelving unit can be moved easily from one location to another without removing the load during transport. The cabinets are 72 inches high and are offered in 36- and 48-inch lengths. Custom sizes are also available upon request.

Eagle MHC Clayton, DE www.eaglegrp.com

Total organic carbon analyzers and validation support

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The Sievers 500 RL On-Line and the Sievers 900 Series TOC Analyzers from GE Analytical Instruments are the most sensitive TOC instruments on the market and ideal for cleaning validation applications. With the patented selective CO₂ conductometric membrane detection, an autoreagent feature for complete oxidation, 21 CFR Part 11 compliance readiness, and operating ranges of 0.03 ppb to 50 ppm, the analyzers can be used for clean-in-place (CIP) rinse samples, swab recovery surface samples, and USP water releases without daily recalibration before running different levels of sample concentrations. GE Analytical Instruments also offers a comprehensive guide on using TOC methodology in lab and on-line cleaning validation applications. The Sievers Cleaning Validation Support Package (CVSP) contains examples, worksheets, templates, and sample protocols to significantly reduce the time and effort required to develop and complete cleaning validation protocols and procedures. Sievers TOC Cleaning Validation Kits, which include 72 certified (<10 ppb) TOC vials and 100 cleanroom-laundered sampling swabs.

GE Analytical Instruments, a division of GE Water & Process Technologies Boulder, CO www.geinstruments.com

Cleanroom Class 1 robots

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Adept Technology, Inc. has announced Adept Python cleanroom Class 1 ESD modular Cartesian robots. They are the latest addition to the cleanroom and ESD product line that includes SCARA, six-axis, and Cartesian robots. The new robots are targeted at precision assembly and handling applications in the solar, disk drive, LCD, semiconductor, and life sciences markets. The Python robots provide high speed and precision motion while maintaining very clean operation. The modules run on SmartController™ CX controls and software platform and can be configured to fit a wide range of ESD-sensitive product applications that require speed, precision, and flexibility.

Adept Technology, Inc. Livermore, CA www.adept.com

Portable cartridge collector shows 99+ percent efficiency

The SPC-1000 from AER Control Systems is a portable cartridge-based filtration unit that complies with OSHA for multiple operations and meets the hexavalent chromium standard. Smoke, gases, fumes, exhaust vapors, and dust from industrial processes are collected and filtered up to 99+ percent efficiency at 0.5 μm. Typically used for control of low to moderate concentrations of dry contaminants, the SPC unit offers manual push-button pulsejet filter cleaning. The unit features nominal 1,000 CFM @ 5.5 inches of static pressure powered by a 115 V, single-phase 1.5 HP TEFC motor. The HEPA filter has a 177-sq.-ft. filter area and can be changed without tools.

AER Control Systems LLC New Haven, CT www.aercontrolsystems.com