B-Lactam Pharmaceutical Facility Decommissioning & Decontamination

Sterile Science supported a pharmaceutical manufacturer operating two connected buildings in California that needed to fully decommission a facility previously used for B-Lactam antibiotic compounding. The site was being transitioned to non-pharmaceutical use, and the property owner required documented proof that all B-Lactam residues had been chemically neutralized and the facility was safe for general re-occupancy, including by individuals with penicillin allergies.

Challenges

• Facility: The project covered 42,500 ft² and 924,500 ft³ volume across cleanrooms, warehouses, offices, mezzanines, and HVAC systems.

• Contamination: B-Lactam compounds are potent allergens even at trace levels, requiring chemical denaturation rather than physical removal alone.

• Dust: Prior partial demolition redistributed dust and potentially spread residual contaminants.

• Odor: A lingering odor in certain areas needed to be assessed and explained to satisfy client concerns.

Solution

After assessing the facility requirements, Sterile Science designed a two-phase decontamination protocol combining targeted manual chemistry with facility-wide dry fog deployment.

• Manual Denaturation: Known B-Lactam production and handling zones were wiped down using 1% sodium hypochlorite solution with a minimum 10-minute contact time, followed by a DI water rinse.

• Lower-Risk Areas: Offices and warehouses were HEPA-vacuumed and wiped with 70% IPA.

• Dry Fog Treatment: The entire facility, including offices, warehouses, restrooms, mezzanines, and HVAC supply and return ducts, was treated with Minncare Cold Sterilant using Sterile Science’s validated dry fog system.

• Validation Conditions: Each room was calculated for chemical volume based on temperature, humidity, and cubic footage, with ≥70% RH maintained for a minimum 1-hour contact time in every treated zone.

Results

The facility was successfully decontaminated and validated to a 6-log sterility assurance level, with all 19 biological indicators returning negative results—confirming complete elimination of even highly resistant organisms. All work was performed under Sterile Science’s ISO-certified Quality Management System and in compliance with US FDA GMP regulations (21 CFR Parts 210, 211, and 820). This provided the documented proof required to confidently certify the space as safe for re-occupancy, removing uncertainty around residual contamination and ensuring no further remediation or regulatory oversight was needed.

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