Blog
11 Dec: Prince Sterilization Services is proud to announce its recognition as the Contract Sterilization Service Company of the Year 2024 by Medtech Business Review
Prince Sterilization Services is proud to announce its recognition as the Contract Sterilization Service Company of the Year 2024 by…
5 Nov: Prince Sterilization Services Partners with Vance Street Capital
November 4, 2024 Prince Sterilization Services, LLC (“Prince”) is pleased to announce a partnership with Vance Street Capital (“Vance Street”),…
1 Mar: FDA Encourages Vaporized Hydrogen Peroxide Medical Device Sterilization: Reducing Reliance on Ethylene Oxide (EtO)
FDA Encourages Vaporized Hydrogen Peroxide Medical Device Sterilization: Reducing Reliance on Ethylene Oxide (EtO) The path towards utilizing vaporized hydrogen…
12 Oct: 2022 New Jersey Manufacturer of the Year
Prince Sterilization Services wins 2022 Manufacturer of the Year! Prince Sterilization Services, LLC October 12, 2022 On Friday, October 7,…
14 Jul: Releasing Sterile Product from a Validated Sterilization Process
Releasing sterile product from a validated terminal sterilization process does not require the performance of a compendial sterility test such as that outlined in USP <71> Sterility Tests or EP 2.6.1. Sterility. The only way to achieve a proper sterility assurance level (SAL) on a pharmaceutical product or medical device is through exposure to a validated sterilization process that is designed to deliver the appropriate lethal conditions to the specific product. The compendial sterility tests are not designed nor intended to make the determination of whether or not the entirety of a sterilized batch of products/devices is sterile. While not the intention of this article, the limitations of the sterility test are well defined and accepted [1]. Below is an excerpt taken directly from USP <71> Sterility Tests.