Seal Integrity Testing Systems For Tyvek Medical And Pharmaceutical Packaging
Tyvek® gives the premium microbial barrier protection for sterilized medical instruments and pharmaceuticals. Apart from protecting the medical devices and pharmaceutical products from physical damages, medical and pharmaceutical packages also should provide an effective microbial barrier and help to maintain the sterility of the products. Bacteria and viruses with sizes varying from 0.002 to 100 microns are a constant threat to pharmaceuticals and medical devices which in turn can be hazardous to the patients.
Tyvek® has been known to provide superior microbial barrier under the most rigorous, highly contaminated conditions. Tyvek® is made of continuous, randomly oriented high-density polyethylene (HDFE) filaments. This unique structure gives Tyvek® greater resistance to microbial penetration than other packaging materials.
Extensive research work has been done on the microbial barrier performance of porous medical packaging materials. Conventionally, water bath/bubble leak testing method were used where the packaging is placed into a water bath. Bubbles will be seen coming from the pack in case of any leakage, which is a destructive, subjective test method. PTI’s VeriPac package integrity testing method is a non-destructive alternative to the conventional water bath leak test or bubble leak testing method. VeriPac leak test systems can be utilized for non-destructive package integrity testing for Tyvek and porous packaging.
VeriPac inspection systems are based on the ASTM approved vacuum decay test method F2338. It is listed in ISO 11607 USP <1207> and is an FDA recognized consensus standard for package integrity testing. This technology has been proven under the GMP regulatory guidelines. The ASTM F2338 method was developed using VeriPac leak test instruments. VeriPac Series have been used in the leak detection of high-risk applications that require the highest level of reliability and accuracy.