Navigation Links
Disinfectant Qualification Questions are Answered for Sterile Drug Manufacturers in New White Paper
Date:3/20/2013

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 http://microtestlabs.com/disinfectant-qualifications.

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 http://microtestlabs.com/disinfectant-qualifications. 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 http://www.microtestlabs.com, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.
Steve Richter , Ph.D. | http://www.profnetconnect.com/steve_richter_ph.d


'/>"/>
SOURCE Microtest Laboratories
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. United States Hospital Supplies Market Outlook to 2018 - Disposable Hospital Supplies, Mobility Aids and Transportation Equipment, Operating Room Equipment, Sterilization and Disinfectant Equipment and Others
2. Europe Hospital Supplies Market Outlook to 2018 - Disposable Hospital Supplies, Mobility Aids and Transportation Equipment, Operating Room Equipment, Sterilization and Disinfectant Equipment and Others
3. Asia Pacific Hospital Supplies Market Outlook to 2018 - Disposable Hospital Supplies, Mobility Aids and Transportation Equipment, Operating Room Equipment, Sterilization and Disinfectant Equipment and Others
4. iMD Companies responds to shareholder questions
5. Submit Questions to Nobel Laureates and Other Experts about Genetics and Society
6. US Peptides Increases Inventory on Sterile Bacteriostatic Water
7. Clean Room Environmental Best Practices for Medical Device & Pharmaceutical Manufacturers are Focus of Boston Seminar on June 6
8. Pharmaceutical Manufacturers Attempt to Safeguard Business Continuity from Potential Threats and Disasters to Production
9. Pharma Leader Series: Top 20 Antibacterial Drug Manufacturers 2012-2022
10. SafeCode Drug Technologies Corp. in Negotiations With Manufacturers to Develop Prototype
11. Frost & Sullivan: Respirator Manufacturers to Develop Innovative Solutions to Overcome Economic Challenges in North America
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/4/2016)... , Dec. 3, 2016  Findings from a ... of CTL019, an investigational chimeric antigen receptor T ... and young adult patients with B-cell acute lymphoblastic ... oral session at the 58th American Society of ... 4:00-5:30 p.m.). The global Phase II study found ...
(Date:12/2/2016)... -- Persistence Market Research (PMR) delivers key ... titled, "Global Market Study on Cardiac Pacemaker: North America Regional ... 2016 and 2024". The global cardiac pacemaker market was valued ... likely to decline to US$ 3923.8 Mn by 2024. ... is anticipated to exhibit a declining CAGR of -0.5% ...
(Date:12/2/2016)... 2016 According to a ... by Product (Instruments, Reagents, Software), Technology (Immunoassay, Clinical ... Nephrology, Infectious Diseases) - Forecast to 2021" published ... USD 60.22 Billion in 2016. This market is ... during the forecast period (2016-2021) to reach USD ...
Breaking Medicine Technology:
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... ... in Beverly Hills, California, will be included in the 2016 “Guide to America’s ... exceptional professionals based on the amalgamation of their education, experience, and professional associations. ...
(Date:12/2/2016)... Wilmington, Delaware (PRWEB) , ... December 02, 2016 ... ... has released a new version of its SaaS LIMS, CloudLIMS Lite. CloudLIMS Lite ... from sample entry through labeling, storing, shipping and disposal. The new version is ...
(Date:12/2/2016)... ... December 02, 2016 , ... Sourced from the Isbre Springs beneath the ... its unmatched natural purity of just 6 ppm TDS (Total Dissolved Solids) in addition ... has been available in several ShopRite and FoodTown stores in NJ and received rave ...
(Date:12/2/2016)... ... , ... "Pro3rd Accents Volume 2 is a set of 30 accented lower ... just a few clicks of the mouse," said Christina Austin - CEO of Pixel ... from various styles with accented animations, rigid boxes, simplistic lines, and more. In Addition, ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... to build intelligent, connected applications, was named the best Sales Team of 2016 ... winner announcement was made today by the Software & Information Industry Association (SIIA), ...
Breaking Medicine News(10 mins):