Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of New White Paper

AGAWAM, Mass. — Jan. 23, 2012 — A new white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is now available from Microtest Laboratories at http://www.microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from Microtest Laboratories website at http://www.microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical manufacturing, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that 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. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

Microtest Laboratories Will Manufacture ImmusanT’s Nexvax2 Immunotherapeutic Vaccine for Expected Clinical Trial

AGAWAM, MASS. – January 10, 2012 – Microtest Laboratories has announced that the company will manufacture and provide supporting pharmaceutical testing services for ImmusanT, Inc.’s Nexvax2^® immunotherapeutic vaccine for its expected upcoming clinical trial.

In addition to manufacturing Nexvax2, Microtest will provide a full range of testing services to ImmusanT supporting its drug product manufacture, including method transfer activities, complete final product release testing, storage and stability.

ImmusanT recently raised $20 million in financing to advance the development of their technology, Nexvax2, for the treatment of celiac disease. Celiac disease is an inherited autoimmune disorder that is triggered by the consumption of foods containing gluten causing an immune response resulting in inflammation of the small intestine. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study.

“As a one-stop source of on-site pharmaceutical testing and manufacturing services, Microtest provides a fast, efficient, cost-effective — and risk-minimizing — alternative to subcontracting with a variety of providers at multiple locations,” said Alex Mello, Director of Project Management, Microtest Laboratories. “We deliver the flexibility, solutions, and problem-solving experience manufacturers must have to ensure the most expeditious release of their product.”

Microtest Laboratories provides flexible, customizable aseptic processing and fill/finish services – and a full-range of pharmaceutical testing services – for biotechnology and pharmaceutical companies of all sizes conducting Phase 1, 2, or 3 clinical trials. Microtest fill/finish operations comply with U.S. FDA and European EMA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.

For more information, visit the Microtest website at: http://www.microtestlabs.com/aseptic-processing/fill-finish/ or contact Alex Mello, Director of Project Management, at 1-800-631-1680, extension 121. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest Laboratories

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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Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com