Achieving Annex 1 Compliance with DuPont Tyvek IsoClean
Manufacturers of sterile medicinal products need to establish a Contamination Control Strategy (CCS) to proactively identify, monitor, measure, scientifically evaluate, and mitigate potential risks of microbial and particulate contamination to product safety, quality, and efficacy.
The Contamination Control Strategy includes early detection, prevention, remediation and verification of all critical control points (design, personnel, equipment, operations, supplies, raw materials, containers, cleaning/disinfection, procedures) throughout facilities to manage and maintain the highest standards of safety, quality and compliance.
Tyvek IsoClean Cleanroom Garments
All white suits may look the same, but DuPont Tyvek makes a difference where it’s needed most on the job. Tyvek offers unmatched protection, improved breathability, and better garment durability. It’s lighter than many spunbonded-meltblown-spunbonded (SMS) and microporous film (MPF) alternatives, and its durability delivers a consistently better barrier, even with wear and abrasion.
Choose from a complete line of clean-processed and sterile single-use clothing designed to support your controlled environment gowning needs. Tyvek IsoClean provides a barrier against dry particles, microorganisms, and nonhazardous liquids, while also helping to reduce the risk of introducing particles into the cleanroom environment due to the garment’s inherently low-linting properties.
How to Remain Compliant
If you are operating in GMP Grade A/B cleanrooms, consider these questions related to your cleanroom garment systems to help ensure that you remain compliant.
Are my cleanroom garments sterilized according to a validated sterilization process?
First, understand if your cleanroom garments come with a Certificate of Sterility or a Certificate of Irradiation. A Certificate of Irradiation communicates that the garments were exposed to a specific radiation dose but does not guarantee sterility. While both certificates are essential for validating the safety of sterilized products, a Certificate of Sterility addresses the end result of being free from viable microorganisms, whereas a Certificate of Irradiation highlights the method used to achieve that sterility through irradiation.
Sterility of Tyvek IsoClean garments is achieved by gamma irradiation. Radiation dosage is validated in accordance with ISO 11137 for an SAL of 10-6 for a five-year shelf life. A Certificate of Sterility comes with every shipment of Tyvek IsoClean sterile garments.
How do I evaluate the cleanliness of my garments?
Second, understand the life of your cleanroom garments. Washing and sterilizing garments multiple times leads to damaged fabric and larger pores, thereby increasing the release of particles and fibers into the environment.
Tyvek IsoClean garments are inherently low-linting. Clean-processed Tyvek IsoClean garments are specially processed to help minimize particle shedding and are tested for particle shedding using the Helmke Drum (IEST-RP-CC003.5) test.
What is the filtration efficiency of my garments?
Next, understand the bacterial and particle filtration efficiency of the garments. Fabrics with larger pore sizes, such as woven polyester and SMS are not effective at retaining particles shed by the operator.
Tyvek IsoClean garments provide a consistent barrier against dry particles and microorganisms and because Tyvek IsoClean garments are only used once, particle filtration efficiency (PFE) and bacterial filtration efficiency (BFE) performances are constant. The average bacterial filtration efficiency of Tyvek IsoClean single-use clean and sterile garments is 98.4% with a standard deviation of 0.9% for 3.0 micron particles.
Do I have the necessary documentation to check if my cleanroom garments meet Annex 1 requirements?
Finally, understand if you have traceability of the garment manufacturing process and documentation to support your CCS.
For Tyvek IsoClean, the production of raw materials is well controlled by DuPont as the sole manufacturer. Tyvek IsoClean sterile garments have lot traceability, from fabric manufacturing to garment conversion and sterilization. Product quality documents are readily available via Fisher Scientific SureTRACE to quickly help meet customer requirements and provide product quality traceability.
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