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October 31st 2018
The article discusses specific challenges we face when preventing microbial growth, considering the regulations & validations of drug products and why efficacy is the main concern in active ingredients.
An excerpt of this article is as follows:
When considering the regulation and validation of drug products, the efficacy of the active pharmaceutical ingredient (API) is often a concern; ensuring the compound elicits the appropriate effect at the correct target site is crucial. Another regulatory requirement of drug development and manufacturing is guaranteeing that no inappropriate organisms can sustain themselves within the product or its packaging.
Antimicrobial preservatives are added to pharmaceuticals, medical devices, personal care products, cosmetics and food products to inhibit the growth of microorganisms inadvertently introduced during the manufacturing process or during the use of products with multiple-dose containers. Preservative efficacy testing (PET) (also known as antimicrobial effectiveness testing) is undertaken to ensure that the preservative maintains its ability to inhibit microorganisms, and is required by British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) standards.
If you are interested in reading the digital article in full, please visit the Cleanroom Technology website. The article will also be available in Manufacturing Chemist’s November issue, or a copy can be requested directly from Wickham Laboratories.
As a GMP/GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of our laboratory technicians and managers enables us to be fully conversant with global regulatory expectations.
We are committed to providing a quality testing service, combining high levels of client satisfaction together with the maintenance of appropriate accreditation. This and the continual pursuit of delivering excellence remain central to our business.
We are routinely inspected by the MHRA, FDA and Home Office, and offer the opportunity for clients to conduct audits on a regular basis.
For more information about Wickham Laboratories Limited and our services, please contact us at +44 (0)1329 226600 or firstname.lastname@example.org. To directly request a company brochure, please visit the Resource Centre section of our company website.