Sterility Testing Environments And The Vital Role Of Isolators

This article discusses the steps which must be taken to ensure an aseptic environment under the strict regulatory requirements for sterility testing, including effective sanitisation and cleaning procedures.

An excerpt of this article is as follows:

Sterility testing is a regulatory requirement for pharmaceutical products and medical devices to assess if goods are free from contaminating microorganisms.

The test is carried out after it has been subjected to a sterilisation procedure (irradiation, chemical sterilisation or heat sterilisation). It is not possible to test an entire manufactured batch, thus the sterility test is classified as a statistical result; only a portion of the batch is tested to provide assurance that the rest of the batch is sterile.

The United States Pharmacopoeia (USP <71>), the European Pharmacopoeia (EP 2.6.1) and Japanese Pharmacopoeia (JP 4.06), provide guidelines for the minimum number of containers that must be tested depending on the product type, fill size and batch size that must be taken into consideration when performing the sterility test.

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Company Overview

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.