BI Resistance Testing, Sterilant Intrusion & Residue Effects Testing (SIRE)

BI resistance testing and sterilant intrusion and reside effects testing with a specialization in hydrogen peroxide decontamination.


What We Did for Our Clients


Amgen is a biopharmaceutical company headquartered in Thousand Oaks, California. We provided them with a variety of services at their headquarters, as well as at their Rhode Island and Puerto Rico locations.
  • Validation master plan and User Requirements Specifications development
  • H2O2 Generator User Requirements Specifications development
  • Process equipment and isolator User Requirements Specifications development


Genentech is a leader in the biotechnology industry, pioneering the development of groundbreaking therapies for a variety of medical needs in the oncology, immunology, and neuroscience spaces. We provided them with cycle development and performance qualification services at their Hillsboro, OR location. Services included CD/PQ protocol development and execution for the two SKAN ARIS sterility testing isolator systems and two SKAN aseptic processing isolator systems.


Ology Bioservices is a CDMO that specializes in biopharmaceuticals, vaccines, and other pharmaceutical products. We provided them with BI resistance testing and sterilant intrusion and residue effects protocol generation and execution services at their Alachua, FL location to support the validation of a 4-glove turbulent airflow Getinge Isoflex sterility testing isolator system.

BI Resistance Testing

Advanced Barrier Concepts specializes in the hydrogen peroxide decontamination process and provides biological indicator resistance testing (D-value) for Geobacillus stearothermophilus spores to establish a baseline resistance for the annual revalidation of a decontamination cycle. Biological indicators are used to demonstrate thorough dispersion of the sterilant vapor around the surfaces of operational equipment and supplies and on all other exposed surfaces inside an enclosure. Multiple challenge BIs are used for cycle development and performance qualification testing with the acceptable result being zero positive BIs when using one BI at each location to determine an efficacious cycle.

Sterilant Intrusion & Reside Effects Testing (SIRE)

We also provide sterilant intrusion and residue effects (SIRE) protocol development and execution. This protocol is designed to determine if hydrogen peroxide can penetrate into product containers and environmental monitoring supplies at levels that could lead to false negatives. The SIRE testing focuses on assessing any ingress of the sterilant after back-to-back decontamination cycles have been completed.
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