Pharmaceutical, biopharmaceutical, supplement, chemical, food, and beverage manufacturing all rely on knowing that equipment is clean and decontaminated before going into production. Not sure where that equipment has been? Or do you need to demonstrate an equipment decontamination process and procedure? Allow Federal Equipment Company to help with our Decontamination Services.
Common equipment contaminates include:
- Bacterial spores
- Fungi, mold and biofilms
- Gram-positive bacteria
- Enveloped viruses
- Myco bacteria
- Non-enveloped viruses
- Gram-negative bacteria
- β-lactam (beta-lactam)
This three step-process will show that equipment is free from beta-lactam antibiotics as well as destroy up to 99.9999% of harmful pathogens and contaminates.
1. β-lactam (beta-lactam) antibiotic testing.
Beta-lactams are broad spectrum antibiotics including penicillin, cephalosporins and many others. The first step is to confirm that critical beta-lactam compounds (specifically, Penicillin G and Ampicilin) are absent from the product contact surfaces of the equipment. This test is performed by swabbing the equipment in several hard to reach areas and then analyzing the swabs using mass spectrometry equipment. You will want a full, written report confirming the absence of these beta-lactam compounds.
2. Equipment Decontamination exceeding bioburden standards set in the United States Pharmacopeial Convention (USP) Chapter <1072> "Disinfectants and Antiseptics"
There are several options that provide bioburden reduction ranging from Log3 (99.9%) to Log6 (99.9999%). Standard treatment, which is appropriate for most situations, is to perform dry vapor fogging with pharmaceutical grade equipment and EPA registered peracetic acid/hydrogen peroxide cold sterilant. An advanced treatment can be used for challenging or high-risk applications. This advanced treatment uses chlorine dioxide gas sterilization using ClorDisSys equipment with an EPA registered chemical steriliant and treatment protocol. These treatments must be performed in a controlled environment by an NIH credentialed biodecontamination company.
3. Validation - Document Performance Compliance
Upon completion of the equipment decontamination process and after receipt of the beta-lactam lab analysis, get a report of the validation for the mechanical, chemical and biological performance. Validate biological performance using biological indicators inoculated with Log6 Geobacillus stearothermaphilus bacterial spores (ATCC 12980). All equipment decontamination processes and swabbing procedures should be performed using the associated manufacturers / lab operating protocols.