Bioburden Testing vs. Microbial Aerosol Challenge Testing

Bioburden testing is an important quality control step that detects the level of contamination of a product at any stage, from initial product manufacture to final distribution. As microorganisms exist on every surface (including our body), bioburden can be accidentally introduced during the manufacturing or packaging process in many ways. Some of the most common examples are contamination through the raw materials used, technicians, tubing/piping used to transfer product between development stages in a process, or the manufacturing environment itself. With such abundant sources of contamination, regular bioburden testing supports the long-term control of manufacturing sites.

Microbial aerosol challenge tests evaluate if external bacterial contaminants can enter a medical product’s sterile packaging system. Microbial aerosol challenge testing is essential for verifying multi-use vial enclosure systems (such as those used for vaccines and other parenteral products).  All microbial aerosol challenge methods are performed in an ISO Class 5 laminar flow hood to maintain sterility during the assessment. Microbial aerosol challenge testing ensures that the sterile or aseptic vials act as an effective microbial barrier and preserves the sterility of the product even when the outside is exposed to high concentrations of bacteria. Vials with robust microbial barriers will not have bacterial growth within the vial after aerosol challenge testing.