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White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
AGAWAM, MASS. – Contamination by an unknown organism often calls for total shutdown of a cleanroom’s operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike. A new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties. The white paper is available, free, for download at: http://www.microtestlabs.com/microseq. “Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves –as well as on the equipment and materials they bring into the environment,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories. With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist. “Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified,” Champagne said. The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times. As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements. Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production. Download the new white paper, “The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” at http://www.microtestlabs.com/microseq/ 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. # # #  Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations
Labels: analytical laboratory, analytical services, medical device, Microseq, Microtest, release testing, sterility validation
Microtest Labs Offers Free Microbial Identification Testing, Free Shipping on Other Tests, to MD&M West Attendees
AGAWAM, MASS. – January 29, 2009 – To highlight its 20 years of experience as a leader in medical device testing services, Microtest Laboratories (http://www.microtestlabs.com/) is offering free microbial identification testing, along with free shipping on other lab tests, to eligible attendees visiting the Microtest exhibit, #828, at MD&M West 2009 in February.
The free offers highlight Microtest’s wide range of laboratory testing and validation services – and problem solving approach – that combine to assist medical device manufacturers to gain a competitive marketplace advantage.  “We work with our clients throughout the testing and validation process to help reduce down-time, lower costs and risk, speed regulatory approvals and time to market, and minimize schedule disruptions,” said Dr. Steven Richter, Microtest President and Chief Scientific Officer.
The free microbial identification offer demonstrates the fast, precise and reliable bacteria, mycoplasma, and mold identification services that Microtest provides by utilizing its two in-house MicroSeq® Microbial Identification Systems.
With two MicroSeq systems, Microtest delivers precise and reliable test results in a 24-hour time period – rather than traditional testing that’s often less accurate and requires a week or more turn around. Microtest is one of only a few labs in its area with such technology.
Microtest is also offering one year of free standard ground shipping to spotlight the dozens of other medical device testing services it offers, including Gamma/ethylene oxide (EO) sterilization validation, and Reusables, Endotoxin, and Sterility testing and related services.
To receive any of the free offers, companies must register at the Microtest exhibit (booth #828) during the MD&M West 2009 Expo. Current Microtest clients are not eligible.
Microtest’s medical device testing facilities are ISO 9001 and ISO 17025:2005 certified, and U.S. FDA-regulated, meeting all GLP/GMP standards. For more information, visit Microtest at MD&M West 2009 in booth #828, on the Web at http://www.microtestlabs.com/medical-device-testing, or call 1-800-631-1680.
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.
# # # Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations Labels: analytical laboratory, analytical services, medical device, medical device manufacturing, Microseq, Microtest, release testing, sterility validation
White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
AGAWAM, MASS. – September 15, 2008 – 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. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services. The white paper, “ Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product” focuses 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”). It is available for download at: http://www.microtestlabs.com/control-environment. 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. In the white paper, the authors: Warn to test only when necessary to reduce interventions. Explain to test using methods that give data as quick as fittingly possible to condense processing times. Discuss 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.
The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services.
To download the white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit: http://www.microtestlabs.com/control-environment.
About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and 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.
# # # Labels: analytical laboratory, analytical services, medical device, Microseq, Microtest, release testing, sterility validation, white paper, whitepaper
Microtest Labs Doubles Microbial Identification, Analytical Services
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,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “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 turn around time. “In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, 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 & Validation
· Medical Device Testing & Validation
· Environmental Control and Testing
· Water Validation
· Mold Identification
· Biologics/Virology The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today. About Microtest Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical and 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 http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. Labels: Aseptic, Contract Manufacturer, drug, Fill/Finish, laboratory, manufacturing, Microseq, Microtest, pharmaceutical, Sterility Testing, virology
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