Pharmaceutical Sterility Testing

Sterility testing in a pharmaceutical context largely refers to a test performed on a finished and packaged product. The item tested should be clear of bacteria, fungi and viruses. Sterility tests can also be performed on laboratory materials that have been treated to be sterile before using them in analysis.

Product Sterility Tests

• Sterility tests on a product are performed to ensure that the final product is free of any contamination. Sterility tests on products apply only to items that need to be sterile and have been packaged specifically to be sterile, such as injected medicines.

Method

• To ensure the item does not get contaminated while being tested, sterile products can be analyzed in specially designed clean rooms. Laminar Airflow cabinets are also used to perform the tests in. The analysts wear clean suits and only put their hands into the cabinet for the test. These cabinets are completely sterile and have special air systems to blow air out of the cabinet, resisting any potential dirty air flowing into the test area.

Reason

• The reason sterility tests are performed is to ensure the manufacturing line is making and packaging the product safely. Sterility tests are performed on a certain percentage of each batch of product, and failures result in the entire batch being held back for checks or refused for release.