Sterility can be defined as the freedom from the presence of viable microorganisms. The sterility test of sterile pharmaceuticals tests to determine the presence or absence of extraneous viable contaminating microorganisms in a sterilized pharmaceutical. The test for sterility is carried out under aseptic conditions.

Sterility test is an important part of GMP microbiology. USP <71> prescribes the sterility testing method used for pharmaceuticals and biologics.

How SIG can help

SIG laboratory provides sterility testing for pharmaceuticals with a method referring to USP 42 NF 37, 2019 <71>.

The types of samples that can be tested are:

• Liquid infusion
• Injection drug
• Liquid injection antibiotics
• Solid injection antibiotics
• Antibiotic cream
• Sterile aerosol products (asthma medication)
• Liquid medicine

Method of Analysis

The sterility test at SIG laboratory is carried out using a Clean Room, including classes D, C, B, and A. Class B (room) and A (BSC) are the places for testing.