By James Drinkwater, Bioquell UK Process & Compliance Director. Chairman PHSS – Pharmaceutical & Healthcare Sciences Society
There is a trend in sterility testing towards barrier separation technology e.g. isolators and closed barrier workstations. These ‘closed systems’ provide a physical separation of operators to the sterility test process and this is a major step towards more effective biological decontamination risk management. Closed barriers also provide a chance to apply automated hydrogen peroxide vapour (HPV) biological contamination, which has validated 6-log sporicidal efficacy.
Providing biological contamination control with effective biodecontamination of the sterility test work zone is just one part of risk management. The major challenge is entering test materials and product samples into an aseptic environment without compromise of the aseptic conditions or sterile products.
Sterility test processes also have to be flexible to cope with different sample types, closure types and batch sizes. Some samples taken from a sterility test process may have other chemical, toxic or biological (virus) contamination on the outside of test containers or within the agar monitoring plate. In this instance, cross-contamination control may also be required.