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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