Since 1984, Parter Sterilization Services (PSS) has been providing contract sterilization services to medical device manufacturers for their routine EO sterilization requirements as well as their engineering and validation studies.
PSS is registered with the State of California in addition to the Federal Food & Drug Administration (FDA). The PSS Quality System and sterilization operations are also ISO and EN certified.
The plant operates 24 hours a day, 7 days a week, without interruption, resulting in rapid turn-around time for processing of customers’ products.
The PSS staff offers assistance in designing appropriate sterilization cycle parameters specific to each type of product and packaging. Support is also provided for selection and design of adequate packaging compatible with EO sterilization process.
Assistance is also provided for developing validation protocols, chamber loading patterns, temperature and percent relative humidity (RH) mapping, etc.
PSS sterilizers are fully operated and controlled by state of the art microprocessors, with capacities ranging from 21 to 483 cubic feet of usable space (¼ Pallet to 6 Pallets of product) thus accommodating small to large volumes of products.
PSS utilizes different blends of EO and CO2 as sterilant gas mixture with an EO gas concentration ranging from as low as 200 to as high as 550mg/Liter, specifically developed for processing a wide range of products and packaging. These blends are non-explosive and in full compliance with Federal and State regulatory requirements.
During Validation and Engineering runs, the temperature and %RH are monitored throughout the product packaging by the use of highly reliable, wireless electronic devices that allow for accurate analysis of the collected data.