AGAWAM, Mass., Aug. 10, 2011 /PRNewswire/ — Environmental
testing and monitoring programs are essential elements in
pharmaceutical and medical device manufacturing. Companies must
understand industrial sterilization and contamination control
procedures to bring products to market on time and on budget.
In attempting to meet regulatory demands from sources such as
the U.S. FDA and the European Pharmacopoeia, the greatest challenge
for medical device and pharmaceutical manufacturers may be
determining what exactly is required for compliance. How must
manufacturers design, implement, certify, and maintain correct
sterilization and environmental
monitoring programs?
Unfortunately, there is no single reference document that U.S.
manufacturers may rely upon to help them design, validate, and
demonstrate room class compliance. Nor, given the monumental scope
of the task, is it likely that one will be drafted anytime
soon.
But a new, free white paper titled “Environmental
Monitoring and Certification in Controlled Environments: Meeting
Regulations and Achieving Effective Microbial Control for
Pharmaceutical and Medical Device Manufacturers,”
available for free download at http://www.microtestlabs.com/environmentpaper,
may help.
The white paper reviews the key elements of a best-practice
environmental testing program, including sterilization standards,
FDA requirements, and the critical factors in maintaining
controlled environments. Topics include: What Is Required; Viable
vs. Nonviable Particulates; Sampling Plans; Validation Management;
Sterilization Programs; Cost/Product Savings; Critical Factors; and
The Benefits of Experience. The paper also discusses how these
challenges may be met w
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