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Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief
AGAWAM,
MASS. — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance
criteria —are detailed in new technical brief available from Microtest
Laboratories.
Bacterial
endotoxins cause fever, septic shock, and other disease symptoms — and thus
attract considerable regulatory scrutiny from such organizations as the U.S.
Food & Drug Administration (FDA) and the United States Pharmacopeial
Convention. Regulations require that devices that contact circulating blood or
cerebrospinal fluid, or are used with intraocular products or in vitro
fertilization procedures, are required to be endotoxin-free.
- Definition of endotoxins;
- Various tests used for their detection;
- Use of depyrogenation and other ways to remove
endotoxins;
- Types of devices that should be tested;
- Preparation and testing of samples;
- Options for sampling containers;
- Acceptance criteria for each of the assays; and
- Sources of official information, reference, and
guidance.
“The
Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D.,
said Steven Richter, Ph.D., president and scientific director of Microtest
Laboratories — and a former FDA official.
The
paper is one in a series about testing, manufacturing, and regulatory issues of
concern for medical device manufacturers from Microtest Laboratories, a leader
in testing services and contract manufacturing for medical devices,
pharmaceuticals, and biotechnology.
About Microtest Laboratories
Microtest Laboratories is a leader in testing
services and contract manufacturing for medical devices, pharmaceuticals, and
biotechnology. It was founded in 1984. The company’s expertise and flexible
processes enhance product safety and security, speed time to market, and
minimize supply chain disruption. Microtest’s unique single-source capability
to provide testing and manufacturing solutions allows the firm to support a
full pharmaceutical or medical device product release. The company’s facilities
in Agawam, Massachusetts, USA include state-of-the-art aseptic manufacturing
areas; analytical chemistry, microbiological, and virological laboratories;
Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus
depyrogenation capabilities; purified water systems; and voice/data systems. 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 on Facebook at http://goo.gl/TndoBg.
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Labels: assay acceptance, definition, endotoxin testing, endotoxin-free, endotoxins, medical device manufacturers, Medical Devices
Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of White Paper
AGAWAM, MASS. – May 12, 2014 – A white paper outlining the six steps
that pharmaceutical and medical device manufacturers must employ to qualify
disinfectants used in their environmental cleaning processes is available from
Microtest Laboratories. It is available for download from http://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.
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>.62>61>51>
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.
Labels: disinfectant qualifications, environmental cleaning, manufacturing environment, medical device manufacturing, Medical Devices, pharmaceutical manufacturing, pharmaceuticals
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