The development of a comprehensive PHSS monograph will enhance the recognition of RABS as an alternative to isolators and provide a framework for regulatory compliance

By James Drinkwater, Bioquell UK

As aseptic processing and related activities follow risk-based approach initiatives, separation of the process from the most potentially contaminating source–operators and associated process personnel–becomes a key consideration. Conventional cleanroom “open” aseptic processing, including filling and related processes where “operator-to-process” separation relies on gowning and simple barriers, is starting to be challenged as current Good Manufacturing Practice (cGMP).¹

The basis of cGMPs requires that pharmaceutical facilities take reasonable advantage of available technology to improve quality assurance. With a clear need for separative barrier systems, the development of restricted access barrier systems (RABS) has provided an alternative to traditional isolators. Not every process is suited to isolation barrier technology; this is a step change from conventional cleanroom operations and can impose design challenges that restrict production operations.

The contamination control performance of isolators in meeting regulatory requirements is well established. To be a viable alternative, RABS must combine a number of contamination control measures using a system approach to achieve quality by design for risk-assessed operations.

Separation between operators and an aseptic process or related procedure is considered essential for reducing the risk of potential biocontamination. With a system approach this must be complemented by controls for the environment, operator access, and all aseptic and sterile process transfers.

RABS have been available for some time, but a clear definition, a framework of RABS types, and RABS operating methods have not been the subject of an international monograph or standard.

RABS definition and monograph development

The U.S. Food and Drug Administration (FDA) prompted initiatives for clearer definitions of RABS. The International Society of Pharmaceutical Engineers’ (ISPE) Joint USA and European working group formed to provide a definition document.² This was recognized as a key step toward establishing RABS technology as a significant contamination control measure for aseptic manufacturing.

Since publication of the ISPE definition, RABS development has continued in the areas of specification, application, and operating principles. The ISPE baseline definition includes key requirements of RABS situated in a minimum ISO Class 7 background environment and RABS barrier manual disinfection in association with sterilization of direct and indirect product-contacting parts. For example, direct product-contacting parts are the product delivery system and product closures/containers. Indirect product-contacting parts would be feeder bowls, trackways, stopper delivery chutes, and any gloves likely to make contact with contacting parts during processing or related activities.

Since the ISPE initiative, the European-based Pharmaceutical and Healthcare Sciences Society (PHSS) formed a RABS special interest group to develop a technical monograph³ that provides information regarding RABS developments and advances.

PHSS completed a comprehensive review of current industrial RABS that meet international regulatory authority requirements. During the review process it also became clear that there were some simple restrictive screen barriers that could not be considered RABS and did not offer adequate contamination control for more challenging aseptic processes. By more clearly specifying RABS, such inadequate contamination control measures would be unable to claim the control attributes and risk reduction provided by RABS.

The RABS concept

The RABS barrier concept differs from an isolator in that the contamination control attributes of RABS include a combination of a physical personnel access barrier (rigid screens) and aerodynamic barrier (HEPA-filtered) downflow air, typically with overspill air to the surrounding environment. This combination of physical and airflow barrier surrounding the ISO Class 5 critical process zone is one of the key specifications that differentiates RABS from isolators. Another discerning factor is that the minimum background environment for RABS is ISO Class 7 in variance to isolators that can be installed in a minimum ISO Class 8 environment.

ISPE set out the principle of “active” and “passive” RABS relating to associated air handling (HVAC) systems. Active RABS have dedicated, onboard, downflow air handling systems. Passive RABS share the downflow air handling system with the cleanroom. PHSS has continued to use this classification within the new technical monograph.

Considerations for RABS selection

Operational principles of barrier function, sterilization processes, barrier/equipment disinfection, and process operations/procedures all have to be integrated for RABS to be an effective contamination control measure. With the separation concept established⁴–operator-to-process separation–operator intervention under barrier-aseptic conditions becomes a significant event. Avoidance of such interventions should be the starting point for any defined aseptic process. Unavoidable interventions (open-door operator access to the ISO Class 5 process zone during aseptic operations) would need justification supported by risk assessments and adequate risk reduction measures. Such deviations are likely to be subject to more intense scrutiny.

The combination of contamination control methods becomes a key consideration in RABS selection. There are different processes, different levels of biocontamination risk, and varying operational requirements. The PHSS RABS monograph considers the operational challenges and variance in user requirements, together with providing a framework for RABS types and practices to meet current and future challenges.

How sterilization and disinfection technologies interact in the aseptic process are critical components in the RABS selection process.

There is a key separation in RABS operating principles based on the type of disinfection process (manual disinfection or automatic sporicidal gassing) and how the necessary sterilization processes are applied to product-contact parts.

With isolators, it has become an accepted practice that indirect product-contacting parts can be disinfected in place (without need for pre-sterilization), provided the high-level disinfection process can be validated with sporicidal challenge biological indicators and achieves robust and repeatable 6-log reduction. Such disinfection performance is typically only achieved by automated sporicidal gassing processes.

RABS may also be specified with sporicidal gassing, thus adopting the same technique used for disinfecting isolators.

Alternatively, with manual disinfection of the RABS, indirect product-contacting parts would be subject to a sterilization process.

Figure 1. Left: An “active” RABs has a dedicated, onboard downflow air handling system. Right: A “passive” RABS shares the downflow air handling system with the clean environment. Photos courtesy of Franz Ziel Germany and Boehringer Ingelheim Pharma, respectively.Click here to enlarge image

In all cases, sterilization is required for all direct product-contact parts (e.g., product delivery path, delivery pumps, associated filling needles, and product closures). This process can be completed via a validated clean-in-place and sterilize-in-place (CIP/SIP) process or sterilization out-of-place with subsequent aseptic transfer and assembly into place.

Manual vs. automated disinfection

It is recommended to base RABS disinfection validation on disinfectant standards published by the European Committee for Standardization (CEN).⁵

A manual “wet and wipe” disinfection process may be used for the RABS barrier and enclosed process equipment (non-critical surfaces) if the disinfection process is capable of validation with repeatable efficacy. There is an important distinction between validation of a disinfectant (under standard conditions) and a disinfection process (under operational conditions). The process of disinfection is completed with the RABS airflow systems fully operational, so it is subject to process variables including drying effects that reduce contact time.

If a manual disinfection process is used for the RABS barrier and non-critical surfaces of the enclosed process equipment, then it will be necessary to use sterilization processes for all indirect product-contact parts. Sterilization would normally be out-of-place–with aseptic transfer and assembly of all indirect product-contacting parts, including feeder bowls, trackways, chutes, and glovesleeves that are specified as potentially making contact with sterilized surfaces during aseptic processing or related procedures.

RABS may also be integrated with an automated sporicidal vapor disinfection system for high-level disinfection achieving 6-log sporicidal reduction on specified RABS barrier and associated process equipment surfaces.

The most widely used sporicidal vapor gassing process for isolators–which may also be applied to RABS–is hydrogen peroxide vapor.⁶

The sporicidal gassing process for RABS should be low temperature (guidance figure: within ~10

By Hank Hogan

After the shaking stopped in China on May 12, officials at Intel (Santa Clara, CA) began a familiar drill. The company has a microprocessor test facility in Chengdu, some 50 miles from the epicenter of the powerful quake. According to spokesperson Agnes Kwan, company officials first checked on employees, making sure everyone was all right. They then turned their attention to the buildings and the equipment inside them.

As part of this effort, Intel took immediate action. “As a precaution, we removed the facility from local power and water service until we could do a full assessment,” says Kwan.

In the end, the manufacturing areas at the site turned out not to have sustained damage. The facility was back on line in less than 10 days, notes Kwan.

Sanyo (Osaka, Japan) wasn’t so lucky back in 2004. During that year’s Chuetsu earthquake, the company’s Niigata semiconductor fabrication cleanroom facility suffered extensive damage. Of the five manufacturing lines, one was rendered inoperable and it was months before the buildings were inspected and utilities restored. In the end, says company spokesperson Aaron Fowles, the five lines that had existed at the site prior to the quake were reorganized into two and manufacturing resumed. “In a period of five months, the production levels were back at 70 percent of their original capacity,” he says.

Because of its experience, Sanyo has implemented changes that should help diminish the impact of future earthquakes. These innovations were tested in a 2007 quake in the same region. Fowles says these improvements fall into two categories: one equipment/facilities related and the other involving procedures.

With regard to hardware, changes included fitting gas and chemical dispensing systems to withstand all but the most severe earthquakes. That reduces the chance of hazardous leaks and cuts the time needed to assess damage, since personnel likely won’t have to wait for containment efforts to be complete. Other changes fortified wiring to absorb serious shaking without damage. A third modification added wheels to line machines, mobile shelves, and desks. This allowed them to slide back and forth across the floor without tipping over.

Procedural changes involved reviewing and updating manuals, along with the associated employee training. One result was that the handling of the 2007 earthquake was much smoother than had been the case in 2004. “This aided us in confirming the whereabouts and conditions of all employees within one day, when last time it took up to three days to confirm,” says Fowles.

In some ways what Sanyo did is representative of the industry as a whole. Pat McCluskey, a senior structural engineer with engineering and construction firm CH2M HILL (Denver, CO), notes that the semiconductor industry came of age in earthquake-prone California and is now located in Japan, Taiwan, and China, all of which have their own quake issues. As a result, the industry has had to contend with shaky situations many times and a bit more is learned with each event.

McCluskey notes, for example, that decades ago there was little interest in anchoring things within a building. Today it is standard practice. Also, other improvements are being implemented, ones that avoid the rigidity that can allow more damage to take place. “We’re starting to see the application of systems that don’t just rely on strength. They rely on displacement. They rely on damping. We’ve gone from building a concrete box to trying to build a willow tree,” he says, referring to the flexibility that can save a facility and its internal components and structures.

The reason for this shift is a recognition that movement can’t be stopped and the more rigid something is the stronger it has to be. One idea is to convert movement into heat by, for example, bronze slide plates. These let some slip occur but also transform kinetic energy from movement into heat that is dissipated. Active damping that counteracts incoming disturbances is also becoming more prevalent in vibration-sensitive tools, reports McCluskey.

However, all such efforts fly somewhat in the face of good business continuity planning. What some companies do is have an alternate location they can operate from, explains Gartner research vice president Roberta J. Witty. But fabs are very expensive, so it’s not really feasible to have a spare sitting around ready to take over in the case of a disaster.

“If you’re not going to build out a second site, you really have to pay attention to mitigating as much risk in the existing site as you possibly can,” says Witty.

One way to do so is to have multiple utility feeds and access routes. But the best solution may be the most obvious one, she notes: to avoid the problem entirely by not building in an earthquake zone at all.

Choosing the wrong vacuum can put your facility, processes, and personnel at risk

By Paul Miller, Nilfisk CFM

In the past several years, plants across the United States have seen an increase in dust-related explosions. From sugar dust to phenolic resin, blasts in the workplace are becoming all too common. Although critically controlled environments–like those found in food, pharmaceutical, and electronics manufacturing–may not contain an explosive concentration of combustible dust as seen in the plants that did fall victim to dust-related catastrophes, these facilities are not immune from similar disasters that can destroy more than just infrastructure, especially those that handle hazardous materials.

In response to the recent blasts, the Occupational Safety and Health Administration (OSHA) is embarking on a journey to develop industry standards of prevention. The agency’s preliminary research includes random audits of any facility that handles powder and bulk solids. And in the meantime, officials have made suggestions that include incorporating an industrial HEPA-filtered vacuum into maintenance plans, but for facilities that are handling materials classified hazardous by the National Fire Protection Agency (NFPA), incorporating the wrong vacuum can actually add to the risk. For this reason, cleaning with a certified explosion-proof vacuum (EXP) that surpasses industry standards is critical.

Certifiable explosion-proof: Beware of ‘dress up’

Operators and managers cannot afford to take chances when it comes to protecting the facility. Look for EXPs that are explosion-proof to the core. This means that everything from the outer shell to the internal mechanics including the motor, switches, filters, and inner chambers should be grounded and constructed of non-sparking materials such as stainless steel. Some companies offer basic models dressed up with a few anti-static accessories and describe them as suitable for explosive material. These imposters may still create arcs, sparks, or heat that can cause ignition of the exterior atmosphere and overheating that can ignite dust blanketing the vacuum.

Figure 1. An explosion-proof vacuum should be certified by a nationally or internationally recognized testing agency. Shown here: Nilfisk CFM’s 118EXP. Photo courtesy of Nilfisk CFM.Click here to enlarge image

Approval by a nationally or internationally recognized testing agency such as CSA is imperative and will protect the buyer from purchasing a “poser.” Users should look for models that state they are certified for use in their specific NFPA classified environments. This provides legal certification and ensures that every component in the vacuum from the ground up meets strict standards for preventing shock and fire hazards.

Explosion-proof vs. intrinsically safe

In environments where electricity is unavailable or undesirable, pneumatic vacuums for hazardous locations are excellent alternatives. It is important to note that only electric vacuums can be certified and deemed “explosion-proof,” but properly outfitted pneumatic vacuums, referred to as “intrinsically safe,” often pack the same punch as their electric counterparts while still meeting the requirements for use in an NFPA classified environment. Again, beware of companies that refer to their pneumatic models as certified explosion-proof. Testing agencies for air-operated machines simply do not exist.

Filtration

As with any critical environment vacuum, superior filtration should not be sacrificed on an explosion-proof model. For peak operating efficiency, the vacuum should have a multi-stage, graduated filtration system, which uses a series of progressively finer anti-static filters to trap and retain particles as they move through the vacuum. For companies of all shapes and sizes, the use of HEPA filters is not just critical but mandatory. Quality HEPA filters offer an efficient, effective way to trap and retain the smallest dust particles, down to and including 0.3 μm, helping to preserve air quality and protect workers. Manufacturers also have the option for an ULPA filter, which captures particles down to and including 0.12 μm. In order to prevent combustible dust from being exhausted back into the ambient air, the HEPA or ULPA filter should be positioned after the motor to properly filter the exhaust stream. The motor’s commutator and carbon brushes generate dust, and if the exhaust stream is not filtered that dust will simply be released back into the environment.

Spill response

Spill response should also be taken into account when purchasing an EXP. Although OSHA’s current audits are specifically looking at companies that handle dry solids, manufacturers’ maintenance plans are also under the microscope. If the user plans to collect flammable or explosive chemicals, a wet-model EXP is a viable option; these are also available in both electric and pneumatic versions.

Figure 2. Facilities should develop and implement hazardous dust inspection, testing, housekeeping, and control procedures in order to prevent dust-related explosions. Photo courtesy of Nilfisk CFM.Click here to enlarge image

null

Conclusion

Picking the right vacuum often raises a lot of questions, especially when it comes to disaster prevention. Ask the vacuum manufacturer to do an on-site analysis of each operation’s vacuum needs in order to recommend the appropriate types of vacuum, hose, and accessories.

As displayed in one too many plants all across the U.S., the term “maintenance” oversimplifies the role an industrial vacuum system plays in today’s manufacturing processes. The right vacuum can save money, protect the integrity of the product, increase productivity, and most importantly, protect your most valuable asset, your employees.

Paul Miller is vice president and general manager at Nilfisk CFM in Malvern, PA (www.nilfiskcfm.com).

---

Guidance on dust explosion prevention

An ignitable material, an ignition source, and oxygen are all it takes for a potential explosion at a facility. Most manufacturing plants have all three. In 2006, fatalities involving explosions and fires increased by 26 percent in the manufacturing sector, according to the Bureau of Labor Statistics Census of Fatal Occupational Injuries. In addition to injuries, explosions cost companies millions of dollars. Between 1992 and 2002, FM Global’s pharmaceutical and chemical clients experienced dust explosions resulting in $32 million in losses. And OSHA has estimated that there are approximately 30,000 U.S. facilities at risk for combustible dust explosions. Simply put, there’s a lot at stake.

NFPA 654, Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing, and Handling of Combustible Particulate Solids, contains comprehensive guidance on the control of dusts to prevent explosions. The following are some of its recommendations:

• Minimize the escape of dust from process equipment or ventilation systems.
• Use dust collection systems and filters.
• Utilize surfaces that minimize dust accumulation and facilitate cleaning.
• Provide access to all hidden areas to permit inspection.
• Inspect for dust residues in open and hidden areas at regular intervals.
• Clean dust residues at regular intervals.
• Use cleaning methods that do not generate dust clouds if ignition sources are present.
• Only use vacuum cleaners approved for dust collection.
• Locate relief valves away from dust hazard areas.
• Develop and implement a hazardous dust inspection, testing, housekeeping, and control program (preferably in writing with established frequency and methods).

JUNE 12, 2008 — CROWN POINT, IN — MicroWorks Inc., a microbiology consulting and training firm, has announced it will expand its laboratory, manufacturing, and distribution center in Crown Point, IN, creating up to 19 new jobs by 2011.

The firm, which provides its training and consulting services to pharmaceutical manufacturers and suppliers across the country, will invest $1.6 million to purchase an existing 10,000 sq. ft. facility at 2200 W. 97th Place to house its expanded operations.

“MicroWorks is a home-grown Indiana company and a prime example of an entrepreneurial life sciences business that is investing in Indiana and creating jobs for hard-working Hoosiers,” says Governor Mitch Daniels.

MicroWorks, which currently employs six associates, plans to begin hiring lab technicians and clerical staff immediately to coincide with the new facility’s opening later this summer. The company also plans to hire microbiologists and warehouse positions by the end of 2009.

The expansion comes less than three months after the company launched its MicroWorks Swab Sampling System, a system that replaces traditional swab methods and contact plates typically used in recovering microorganisms from environmentally controlled cleanrooms.

“Northwest Indiana was the right place for our growing business due to the close proximity to major markets such as Indianapolis and Chicago and our central location in the country,” says Dawn McIver, founder and chief executive of MicroWorks. “The timing for this expansion was coordinated with the launch of our new product and the current regulatory atmosphere towards upcoming rapid microbiological methods, which we plan to offer to our clients.”

Founded in 1996, the company has built its business around providing training and performing projects for companies across the pharmaceutical industry, including environmental monitoring programs, disinfectant qualification, and contamination control.

The Indiana Economic Development Corp. offered MicroWorks Inc. up to $32,500 in training grants based on the company’s job creation plans. The City of Crown Point will consider property tax abatement.

“This development is reducing blight and creating quality career opportunities for our local workforce,” says Crown Point Mayor David Uran. “We celebrate this as a community and are proud that MicroWorks is calling Crown Point home.”

About MicroWorks
MicroWorks, Inc. is a microbiological consulting and training firm that was established to assist pharmaceutical manufacturers in the completion of their studies. The company, which operates out of 10,000 sq. ft. of laboratory and office space in Crown Point, IN, provides a full range of microbiological services including, consulting, training, monitoring, and equipment validation.

Visit Microworks

JUNE 10, 2008 — /PRNewswire/ — PASADENA, CA — Jacobs Engineering Group Inc. has received a contract from Estelux to provide engineering, procurement, and construction management (EPCM) services for a new polysilicon manufacturing facility at the existing petrochemical site in Ferrara, Italy.

Estelux is an Italian startup company with a mission to provide first-class polysilicon, strategic to the entire photovoltaic supply chain. SOLON Group, one of the largest European solar module and photovoltaic systems manufacturers, owns shares in Estelux.

Officials did not disclose contract details.

Polysilicon is purified silicon, which is the base of all crystalline silicon photovoltaic cell panels. Estelux’s plant production will cover a fundamental step in an integrated complete photovoltaic supply chain that starts with solar-grade polysilicon production and ends with the installation of photovoltaic systems.

Jacobs will execute the work from its Milan, Italy, office with support from specialist offices in Greenville, SC, and Mumbai, India. Jacobs’ Milan office previously completed the preliminary design of the plant.

The new plant will consist of two production buildings, where the polysilicon production process starts with trichlorosilane decomposition to form silicon rods, with a special closed process system, and a finishing building, with laboratories and control rooms, where the rods are crushed, transformed, and packed in a contamination controlled environment. The facility will have top-class off-gas treatment plants; a high-voltage electrical substation (with transformation and distribution stations for medium and low voltage); a wastewater treatment plant; distillation and fractionation columns; associated utilities; and other infrastructure.

The original and traditional production process called “Siemens process” has been optimized by Estelux Team to achieve a top-class product quality. The plant will reach its full operating capacity in 2010, with a polysilicon production of 4,000 tons per year. The total investment will amount to approximately 360 million euros.

The facility will be built on an area inside the Ferrara petrochemical site. Environmental impacts will be minimized during the demolition and enabling works prior to construction. Design and construction will maximize energy saving through solar panel utilities usage and recycling technologies, as well as sustainable water and rail transportation solutions and logistics issues. The plant’s proximity to the raw material for production limits hazardous materials handling to directly controlled adjacent areas inside the petrochemical site.

Estelux’s CEO Domenico Sartore notes, “Estelux is a pioneer in the photovoltaic and sustainability industry and we are glad to have Jacobs as a partner in this investment because we share the same vision and approach of developing innovative solutions.”

In making the announcement, Jacobs group vice president Robert Matha says, “We are proud to be selected by Estelux for this strategic project. Jacobs is committed to deliver the highest value of service to help them establish a strong market-leader position and satisfy the growing demand for polysilicon-based renewable energy sources.”

About Jacobs Engineering Group
Jacobs, with more than 55,000 employees and revenues exceeding $9.0 billion, provides technical, professional, and construction services globally.

Visit Jacobs

JUNE 9, 2008 — /FDA Digest/ — U.S. Department of Health and Human Services (HHS) Secretary Mike Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

Today’s action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.

“Last year we outlined important changes in how this nation deals with imports. We are moving from an intervention strategy — where we stand at the border and try to catch things that are unsafe — to an integrated strategy of prevention with verification. We are rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers,” Secretary Leavitt says.

The Secretary continues, “Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace. I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products.”

Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:

• FDA will significantly expand its reach beyond American borders by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with FDA standards.
• Another initiative will offer expedited entry for goods bearing certification by trusted parties.
• FDA will modernize its information technology
  infrastructure.
• Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections with funds in the budget amendment.

The increase brings the Administration’s total proposed increase in the FDA’s budget for FY 2009 to $404.7 million — a 17.8 percent boost in funding from FY 2008.

Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:

• Authorizing FDA to accredit highly qualified third parties to evaluate compliance with FDA requirements.
• Authorizing FDA to require certification of designated high-risk products as an additional condition of importation.
• Authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities.
• Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

“FDA’s mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan,” says Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “FDA has already embarked on an ambitious program to transform the agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly.”

Consistent with the Administration’s emphasis on fiscal discipline, the budget amendment is fully paid for within budgetary totals.

The budget amendment proposes the following increases for core FDA programs:

• Protecting America’s Food Supply (+$125 million) — The increase allows FDA to intensify actions to implement FDA’s Food Protection Plan. Announced on Nov. 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.

The increase in food protection activities will allow FDA to reduce threats to the food supply, expand FDA’s international presence, and increase technical assistance to help ensure that foreign and domestic food facilities comply with food safety standards. FDA will also be able to improve the risk-based approach it uses to conduct more targeted import exams and foreign and domestic inspections of food manufacturing, processing, and packaging facilities. FDA will pursue additional research on ways to prevent intentional and unintentional contamination, deploy screening technologies to identify microbial and chemical contamination, and respond more quickly to contain outbreaks of food-borne illness.

• Safer Drugs, Devices, and Biologics (+$100 million) — The increase of $100 million for the FDA’s medical product programs will strengthen FDA’s ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing through approval and post-approval safety surveillance. FDA faces growing challenges from the globalization of medical product development and manufacturing. The increase for medical product programs will allow the FDA to respond to this trend.

FDA will more aggressively conduct active safety surveillance to identify early signs of adverse events linked to medical products. FDA will also implement new requirements under the FDA Amendments Act of 2007 related to clinical trials, pediatric drugs and devices, postmarket study commitments, and the labeling and safe use of drugs. FDA will also establish unique device identifiers to track devices, facilitate device recalls, and support inventory management during disasters and the response to terrorism events. Finally, FDA will conduct more import exams and foreign and domestic inspections of medical product manufacturers.

• Modernizing FDA Science and Workforce (+$50 million) — The budget amendment also proposes increases to strengthen FDA’s capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the critical path initiative. FDA will also improve laboratories and other facilities that are essential to carrying out FDA’s mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.

The program increases listed above include $65 million to modernize FDA’s information technology infrastructure. Additional information is available online at www.importsafety.gov; www.fda.gov; and www.fda.gov/oc/initiatives/advance/food.html.

Visit HHS

JUNE 3, 2008 — /PRNewswire/ AGAWAM, MA — Microtest Laboratories has doubled its microbial identification and analytical services with the purchase of an additional MicroSeq(R) microbial identification system from Applera Corp.

The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

“With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” states Dr. Steven Richter, Microtest president and CSO. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.”

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate and require up to a one-week turnaround time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” says Richter. “Our ability to provide rapid identification helps our customers minimize downtime, which directly affects their bottom line. When manufacturing is halted or a cleanroom is shut down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.”

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

• Contract manufacturing
• Pharmaceutical testing and validation
• Medical device testing and validation
• Environmental control and testing
• Water validation
• Mold identification
• Biologics/virology

The MicroSeq system is 99 percent reliable with repeatable results and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, MA, the company’s expertise and flexible processes enhance product safety and security, accelerate time-to-market, and minimize supply chain disruption.

Visit Microtest