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Disinfectant Qualification Questions are Answered for Sterile Drug Manufacturers in New White Paper

AGAWAM, Mass., March 20, 2013 /PRNewswire/ -- Manufacturers of sterile drug products are required by the FDA to undertake disinfectant qualification studies to determine the effectiveness of their disinfecting agents. A new white paper, "Disinfectant Qualifications: Insight and Perspective," answers the most frequently asked questions about conducting a successful study. Download the paper from Microtest Laboratories at

Disinfectant qualification studies provide aseptic manufacturers with detailed information on their use of disinfectants, the level of their effectiveness, and the appropriateness of their use. With variables such as surfaces, disinfectants used, and organisms, it is imperative that disinfectant studies be carried out correctly and thoroughly.

The white paper, in a question and answer format, reviews the methodology involved in a disinfectant qualification study and explains what is to be expected when one is initiated. Answers are provided to such FAQs as:

  • What companies should perform such studies?
  • Why should the studies be undertaken?
  • How are the studies executed?
  • What should be included?
  • How long is the study process?
  • How much does a study cost?

The white paper is authored by three Microtest Laboratory regulatory microbiology and contract laboratory experts with a combined 41 years of experience: Deborah Ensign , Shawn Sherry , and Kate Bloomrose .

With FDA regulations requiring clean rooms to meet prescribed standards, a thorough, well conducted disinfectant study will not only help manufacturers of sterile drug products meet FDA regulations, but also protect product integrity and safety.

Download a copy of the new white paper, "Disinfectant Qualifications: Insight and Perspective," from the Microtest Laboratories website at Or, request a copy by calling 1-413-786-1680 or toll-free 1-800-631-1680.

About Microtest Laboratories
Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

Based in Agawam, Massachusetts, USA, 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, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at

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Steve Richter , Ph.D. |

SOURCE Microtest Laboratories
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