Services

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.

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.

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.

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.

Validated Processing

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.

 

DualBeam

DualBeam™ is our innovative process for sterilizing customer product. This process combines the use of two independent, horizontally opposed LINACs with our unique product carrying 'totes'. This allows us to provide simultaneous beam processing, facilitating high-volume production that provides uniform dose to the product without having to flip the customer’s boxes.

This DualBeam™ configuration provides SteriTek with some unique advantages over other e-beam sterilizers:

Flexibility and Expanded Product Options

SteriTek's totes allow for a huge amount of flexibility when dose-mapping and processing a variety of different products - no matter the size. This effectively guarantees that SteriTek will be able to find a sterilization solution for your product.

True Redundancy

Other facilities offering e-beam sterilization that feature two LINACs oriented vertically require the use of a product 'flipper' when using only one LINAC.

This requires extensive and costly dose mapping to ensure the product is uniformly sterilized after the flip - which cannot always be guaranteed.

At SteriTek, the tote is simply rotated and sent back along the conveyor facing the opposite direction, this does not disturb the product on the tote and so allows for validated sterilization with either LINAC without compromise.

This allows SteriTek to offer true LINAC redundancy, giving us excellent up-time which helps us maintain our industry-fastest turnaround time - come rain or shine!