SteriTek understands that irradiation is only part of a sterilization process. Both the product geometry in the shipper box and the shipper box count are just as important for a validated sterilization process.
At SteriTek all production boxes are weighed, measured, and labeled as a check of conformance to the original dose map and to ensure lot traceability. Boxes off-weight, or suspect in any way, are followed up by a call to the responsible party at the customer’s site for disposition prior to processing.
Scalable Lot Sizes
From one box to a truckload. Process validations are applied to single shipped boxes and then are irradiated sequentially.
Processing of Controlled Substances
SteriTek is DEA registered and approved for the processing of controlled substances (Schedule II and higher) with restricted access and continuously monitored secured storage cages for pre and post-processed products.
Validated Temperature-Controlled Rooms
Validated Cold (2C to 8C) and Freezer (-16C to -26C) temperature-controlled rooms with separate doors and areas for pre- and post-processing. Both are validated to pharmaceutical standards and maintained with remote sensors/alarms.
Turnkey Sterilization Validation
SteriTek provides turnkey Sterilization Validation packages (per ISO 11137 VDmax, Method 1, Methods 2a and 2b) for companies that wish to outsource their sterilization validation work.
Managed Validation services provide all irradiation services routinely performed for production validation, generation of original validation protocols for your approval, handling and management of needed microbiological laboratory services, completion of the validation protocol, and a final comprehensive report appropriate for the level of regulatory review associated with your product.
Of your finished products guarantees compliance to ISO 13485 and ISO 11137. SteriTek is able to sterilize medical shipper box configurations up to 76 inches long, 15 inches wide and stacked up to 48 inches tall at the highest service level.