Unfortunately, shipping issues can occur with sterilized products. There are not special carriers that ship sterilized products. According to ISO 11607-1:2006 section 6.3 Packaging-system performance testing: “The packaging system shall provide adequate protection to the product through the hazards of handling, distribution and storage.” and “Performance testing shall be conducted on the worst-case sterile barrier… Read More »
A validation typically takes two weeks for bioburden determination and an additional two weeks for sterility testing from a laboratory. After about a month your company can have a sterilization validation and be able to begin treating product.
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Gamma Sterilization is a proven, accepted method for sterilizing medical products and devices. FTSI is experienced in working with small or specialized manufacturers of medical products to provide them the same sterilization capabilities of larger producers. In addition, we can accommodate rapid turn-around times and small lots which are often a requirement of smaller companies.… Read More »