New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

AGAWAM, MASS. – June 9, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In a new white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)

Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts:
• #1: Evaluate the Process, Determine the Potential Contaminants
• #2: Determine the Limits
• #3: Identify the Analytical Test
• #4: Validate the Method for Use
• #5: Validate the Cleaning Process

For a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” visit Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Or, download a free copy from http://www.microtestlabs.com/cleaning-validation-paper.

At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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New White Paper: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers

AGAWAM, MASS. – June 8, 2010 – Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?

Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.

But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at www.microtestlabs.com/environmentpaper, may help.

The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.

The white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass.

Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http:/www.microtestlabs.com/environmentpaper.

Or, obtain a free copy of the white paper from Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest, a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries, is based in Agawam, Massachusetts, USA. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Microtest Labs Offers Expanded Clean Room, Contamination Testing Services for Medical Device Manufacturers

AGAWAM, MASS. – June 8, 2010 – Microtest Laboratories (www.microtestlabs.com) features new technology and professional staffing as part of its expanded offering of proven, one-stop provider of contamination and clean room testing services for manufacturers of medical devices.

Microtest Labs will highlight its MLT testing services and expertise at the Medical Design & Manufacturing East / MD&M East Exposition, booth #1251, June 8-10, 2010 in New York City.

Microtest helps manufacturers maintain control of their controlled environment to ensure regulatory compliance as well as to achieve greater productivity. Microtest assists manufacturers to identify, assess and resolve a wide range of clean room and environmental contamination problems while ensuring little or no process disruption or downtime.

Microtest’s environmental services group is comprised of highly trained microbiologists with extensive experience applying modern testing technologies in all varieties of clean room and other controlled environments. Their work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO), the European Union (EU) Annex, and the U.S. Food and Drug Administration (FDA).

Microtest offers the following testing and support services:

• ISO certification and clean room validation, to any ISO Class required, for all controlled environments, including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods.

• HEPA filter repair, replacement, and installation for all controlled environments including clean rooms, laminar flow hoods, biological safety cabinets , compounding aseptic isolators, and fume hoods.

• Viable sampling, including evaluating for contamination of aerobic and anaerobic microorganisms, surface testing and analysis, active air sampling, and collecting passive air samples. In-house MicroSeq® DNA-sequence-based analyzers provide results as fast as 24 hours to speed isolation and elimination of the source.

• Nonviable air particulate sampling and testing to ISO 14644 guidelines, the EU Annex, or both.

• Disinfection validation, including dilution testing, phenol coefficient testing, sporicidal testing, and germicidal testing.

• Gowning validation as well as assistance with developing and demonstrating proper gowning procedures.

• DNA-sequence-based microbial identification utilizing in-house MicroSeq® Microbial Identification Systems for fast, precise and reliable bacteria, mycoplasma, and mold identification.

• Compressed air/gas testing, including nonviable air particulate testing; compressed air testing for aerobic, anaerobic, and fungal organisms; and testing for hydrocarbons and water vapors.

For more information about Microtest Laboratories’ complete offering of contamination and clean room testing services for manufacturers of medical devices, visit Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Or, visit Microtest website at: http://www.microtestlabs.com/cleanroom-testing-services or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Microtest Labs Highlights 20 Years’ Experience as Leader in Cleaning Validation Studies for Medical Devices Designed for Reuse

AGAWAM, MASS. – June 8, 2010 – Microtest Laboratories will highlight its 20 years of experience in providing cleaning validation studies of medical devices designed and labeled for reuse at the Medical Design & Manufacturing East /MD&M East Exposition, booth #1251, June 8-10, 2010 in New York City.

Microtest bases its cleaning validation studies on the recommendations of the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), and the American Society for Testing and Materials (ASTM).

In doing so, Microtest can document, with a high level of assurance, that a given cleaning process used on a given device will clean it effectively — to parameters predetermined by the manufacturer — after each use.

Services include AAMI TIR12 and AAMI TIR30 cleaning validation.

At Microtest, the studies are conducted according to a thorough, multi-step process. The device is first inoculated with a biological challenge organism — a spore strip or liquid spore inoculum — used as an indicator. Recommendations of the United States Pharmacopeia (USP) and Association for the Advancement of Medical Instrumentation (AAMI) suggest organisms with high resistance to the given sterilization process. The device is then cleaned, and tested for recovery of the indicator.

If the indicator hasn’t been reduced by at least a factor of 3 logs, the cleaning cycle fails the test. Valid devices must pass three consecutive cleaning cycles to be considered validated.

Testing uses spore strips with 106 spores per strip, or liquid suspensions. Inoculated devices are cultured under an ISO Class 5 (Class 100) laminar airflow hood, using aseptic technique, determination of recovery factors, and traditional culture/enrichment techniques to optimize indicator recovery.

Test controls include the following:
• All culture media undergo USP Growth Promotion Testing (GPT) and sterility assurance to ensure optimal recovery and sterility
• Incubators are calibrated and monitored 24/7 via an advanced SCADA system
• Bacterial spore populations used in biological challenges are controlled and verified per USP prior to use
• Each sample is tested with positive and negative controls

Microtest possesses the knowledge, experience, specialized equipment and techniques, and strict adherence to protocols required to provide the highest level assurance of required for cleaning validation studies of medical devices designed and labeled for reuse.

For more information, visit Microtest Laboratories at MD&M East, booth #1251, June 8-10, 2010 in New York City.

Or, visit the Microtest website at http://www.microtestlabs.com/medical-device-testing/reusable-device-testing/cleaning-validation.html or call 1-800-631-1680.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

AGAWAM, MASS. – June 2, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In a new white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)

Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts:
• #1: Evaluate the Process, Determine the Potential Contaminants
• #2: Determine the Limits
• #3: Identify the Analytical Test
• #4: Validate the Method for Use
• #5: Validate the Cleaning Process

Download a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” from http://www.microtestlabs.com/cleaning-validation-paper.

At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations