Pharmaceutical, biopharmaceutical, nutritional supplement, chemical, food, and beverage manufacturing all rely on fully decontaminated equipment before production can begin. Decontamination of used manufacturing equipment for these important industries is always recommended, or maybe your team needs help establishing decontamination processes and procedures. Federal Equipment Company’s equipment decontamination services are here to help.Request Consultation
The following contaminants frequently plague improperly cleaned pharmaceutical, biopharmaceutical, nutritional supplement, chemical, food, and beverage manufacturing equipment.
Our three-step decontamination of equipment process will demonstrate that equipment is free from beta-lactam antibiotics, destroy up to 99.9999% of harmful pathogens and contaminants, and document validation procedures.
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 ampicillin) 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. We produce a full, written report confirming the absence of beta-lactam compounds
Equipment decontamination requirements are established 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, appropriate for most situations, is a dry vapor fogging procedure with pharmaceutical-grade equipment and EPA-registered peracetic acid/hydrogen peroxide cold sterilant.
Advanced treatment can be used for challenging or high-risk applications. This advanced treatment uses chlorine dioxide gas sterilization using ClorDisSys equipment with EPA-registered chemical sterilants and treatment protocol. These treatments must be performed in a controlled environment by an NIH-credentialed biodecontamination company.
Upon completion of the equipment decontamination process and receipt of the beta-lactam lab analysis, we’ll provide validation documentation. The report will 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
When buying used equipment known to be contaminated, you can save time and money and avoid quality and compliance issues with our three-step equipment decontamination process. The process can also be applied to existing contaminated equipment and even entire facilities.Request Consultation
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