White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

AGAWAM, MASS. – April 20, 2010 – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. The typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical are discussed in a new, free, white paper.

The new white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” will be available from Microtest Labs at Interphex 2010, booth #147, April 20-22, 2010, in New York City.

The new white paper is also available for free download at: http://www.microtestlabs.com/control-environment.

The white paper focuses on what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”).

Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

The white paper is authored by Alex Mello, Director of Project Management, Manufacturing, of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services. In the white paper, he:

• Warns to test only when necessary to reduce interventions.
• Explains to test using methods that give data as quick as fittingly possible to condense processing times.
• Discusses how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

For a copy of the free white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit Microtest Laboratories at Interphex 2010, booth #147, April 20-22, 2010 in New York City.

Or, visit the Microtest website at: http://www.microtestlabs.com/control-environment. 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.

Microtest Labs is a Leader in Cleaning Validation Studies for Medical Devices Designed for Reuse

AGAWAM, MASS. – April 21, 2010 – Microtest Laboratories is a leader with 20 years of industry experience in providing cleaning validation studies of medical devices designed and labeled for reuse.

Microtest Labs will highlight its expertise in providing cleaning validation studies at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

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 BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

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.

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

AGAWAM, MASS. – April 21, 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 BIOMEDevice, booth #1025, April 21-22, 2010 in Boston. 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 BIOMEDevice, booth #1025, April 21-22, 2010 in Boston. 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.

Microtest Labs Provides Experienced USP Microbial Limits Testing of Raw Materials, Other Nonsterile Products for Pharma Manufacturers

GAWAM, MASS. – April 21, 2010 – Microtest Laboratories, a leader in pharmaceutical testing services, is an experienced resource of USP Microbial Limits Testing (MLT) of raw materials and other nonsterile products in pharmaceutical manufacturing.

Microtest Labs will highlight its MLT testing services and expertise at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

The quantitative phase of MLT testing determines the bioburden of given pharmaceutical manufacturing samples, determining the number of total aerobic organisms as well as the total number of yeasts, and molds. The qualitative phase of testing examines samples per U.S. FDA criteria for “objectionable organisms.”

For minimum coverage, these criteria require testing for the following:

• The bacteria Escherichia coli (E. coli)
• The bacteria Staphylococcus auseus (S. auseus)
• The yeast Candida albicans (C. albicans)
• The bacteria Pseudomonas aeruginosa (Ps. aeruginosa)
• The fungus Aspergillus niger (A. niger)

The first step in microbial limits testing is the preparatory testing which validates the product with the method used. This ensures the product has no inhibitory effect on the recovery of organisms from the product. Once the product has passed the preparatory test, the product is validated for routine screening. The routine microbial limits screening test consists of the total aerobic and total yeast and mold counts as well as the test for objectionable microorganisms. If the total aerobic and total yeast and mold counts are acceptable and no objectionable organisms are found, then Microtest microbiologists okay the swift release of the product or raw material.

Full microbial limits testing then inoculates specific organisms into general nutrient media. After allowing time for any growth, Microtest microbiologists transfer the results to specific media that show differential reactions to the presence of a given organism.

While the preparatory and the routine microbial limits screening test can be particularly problematic for inexperienced laboratory personnel at other facilities, Microtest brings the industry’s highest levels of expertise to MTL testing.

This expertise enables Microtest to deliver its clients a competitive advantage – in the form of faster regulatory approvals and time to revenue, high-quality customized testing, the elimination of schedule disruptions and reduction of risks, accelerated reliable turnarounds, and enhanced costs savings.

For more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Or, visit Microtest website at: http://www.microtestlabs.com/pharmaceutical-testing-services/usp-assays/usp-microbial-limits.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.

New, Free White Paper: “Environmental Monitoring and Certification in Controlled Environments

AGAWAM, MASS. – April 21, 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 www.microtestlabs.com/environmentpaper. Or, for more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston. 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.

New White Paper for Dietary Supplement Manufacturers Provides How-to for New Compliance Paradigm

AGAWAM, MASS. – April 5, 2010 -- Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is presented in a free white paper, available now for download from http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:
• Developing the Necessary Quality System
• Management “Buy In”
• Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
• Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. 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.

# # #

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