Steri-Tek Services | E-Beam & X-ray Sterilization Services
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Services

 

Routine Sterilization Processing (48 hr. standard)

Processing for Accuracy and Accountability

Steri-Tek 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 Steri-Tek 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.

steri-tek xray facility for electronic sterilization.

Scalable Lot Sizes

From one box to a truckload. Process validations are applied to single shipped boxes and then are irradiated sequentially

Non-Validated Processing

To address the non-production irradiation efforts that are required both for initial testing and for maintenance testing during the life cycle of a medical device. Whether for evaluation of a new lot of plastic polymer or for evaluation of a new lot of plastic polymer or for decontamination of returned goods prior to examination, Steri-Tek will provide the same control and service level of irradiation as for your finished goods.

Validated Processing

Of your finished products guarantees compliance to ISO 13485 and ISO 11137. Steri-Tek is able to sterilize medical device shipper box configuration up to 76 inches long, 15 inches wide and stacked up to 48 inches tall at the highest service level.

Managed Validation

Services provide turnkey packages for companies that wish to outsource their sterilization validation work. It may include technical consultation services, protocol development, management of the irradiation and microbiological testing plus final reporting.

Other Services We Offer

Consulting

Consulting Services are FREE to all our customers • Consulting and turnkey sterilization validation programs for each client’s special need • We work with all major microbiological testing laboratories • We help you choose the best validation program to meet your requirements • From on-site seminars and turnkey validation programs to friendly technical advice, our technical services team provides an extraordinarily broad array of service for each client

Turnkey Sterilization Validation

Steri-Tek provides turnkey Sterilization Validation packages (per ISO 11137 VDmax) for companies that wish to outsource their sterilization validation work. It may include technical consultation services, protocol development, management of the irradiation and microbiological testing plus final reporting.

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.

This level of verification service is provided for the client that wishes to outsource their sterilization validation work and concentrate on their core business of product development and manufacture. We provide the supplier assessments for subcontracted laboratory services, maintain current standards information to support the validation work, and design economical and sound continuing audit programs to maintain the validation that are appropriate to your regulatory requirements.

With its tailored validation services, Steri-Tek is committed to supplying validation information with exceptional responsiveness to your needs. We want to provide a partnership with you that provides processing and superior business, technical and regulatory support.

Other Services We Offer

Validated Temperature-Controlled Rooms

Validated temperature control room for sterilization productOur validated cold (2C to 8C)  and freezer (-16C to -26C)  temperature-controlled rooms has separate doors and areas for pre- and post-processing. Both are validated to pharmaceutical standards and maintained with remote sensors/alarms over telephone lines.

Split Dose Processing

Some sensitive materials cannot tolerate the small heat rise with normal sterilization doses, 10-15 C above ambient for 24 kGy. Steri-Tek minimizes the effect by either:

  • Biasing the temperature lower by cold storage or
  • Splitting the target dose into two or more passes with a cool down between each irradiation event.
  • Steri-Tek routinely incorporates both these approaches singularly and in combination within our sterilization procedures.

Crosslinking & Scissioning

  • Crosslinking services to strengthen and/or enhance material qualities including, polymer modification for wire, cable and tubing products, and polyethylene and polyvinyl chloride products.

Semiconductor Enhancement

Composite Material Curing

Radiation Tolerance Series Study

Steri-Tek sets up and delivers up to five specified doses to the specified sets of samples of your packaged devices to determine the effect of irradiation on the materials and packaging at various dose levels. The resultant samples are analyzed by the client or test laboratories to determine the physical effects of radiation. This test is frequently paired with a Depth-Dose Penetration study to determine if there are adverse physical effects at the highest dose expected in routine irradiation. It may also be used to determine the effect of re-sterilization on a returned device, or to establish the upper limit for dose in a radiation-sensitive device.

Precise Dose Delivery – Internal

Steri-Tek will target a specific area of your device within a box at a narrow dose range. This experiment will enable you to examine the effects of a precise dose delivered to a particular part of your device.

Product Dose Mapping Per ISO 11137

This testing provides a three-dimensional map of the dose received throughout the product/package during irradiation. Not less than 12 dosimeters are located in areas where the lowest and highest doses are likely to occur. Additional surface dosimeters are attached to provide the reference for production runs. Three test runs are made to determine the reproducibility and uniformity of the dose delivery. Part of the process is to work with the customer to determine the optimum packaging to minimize variability and processing costs. A report includes raw data with the internal dose levels referenced to the external target data. The report also recommends a target surface dose and process limits. Steri-Tek documentation is created to assure that the intended dose is delivered in routine production. Product dose mapping is requirement for irradiation validation in ISO 11137.

Verification Dose Audit per ISO 11137

Good quality practices (and ISO 11137) dictate that the response of a medical device’s existing bioburden be checked during both initial process validation and periodically thereafter. Samples are irradiated at a dose that is a fraction of the production dose and the samples are then checked for sterility. A successful verification dose experiment therefore assures a safety factor in routine sterilization. Steri-Tek will deliver a dose within 10% of the target or within 0.5 kGy, whichever is larger, to comply with the current regulatory requirements.

DEPTH-DOSE PENETRATION STUDY

  • Uses multiple dosimeters to monitor high-low density areas of a specific product/package configuration for routine irradiation
  • Allows a surface dose specification in order to deliver the minimum dose throughout the product/package PRODUCT DOSE MAPPING (Validation Process)
  • Determines optimum packaging to minimize variability and processing costs
  • Recommends a target surface dose and process limits
  • Provides a three-dimensional map of the dose received throughout the product/package during irradiation

VERIFICATION DOSE AUDIT (Validation)

  • Verifies existing bioburden
  • Provides an additional safety factor

VERIFICATION DOSE DISTRIBUTION STUDY

  • Maps the maximum and minimum doses delivered to the product in a single layer • Optimizes the verification dose

PRE-QUALIFIED PACKAGING PROGRAM

  • Pre-qualified packaging options for Steri-Tek’s E-beam irradiation processing • Allows you to know your materials are sterile, but time is the limiting factor

MICROBIOLOGICAL TESTING (Validation)

  • Verifies that the resident bioburden meets the requirements of the standard • Includes: bioburden determination; verification dose calculation and irradiation; sterility testing to verify that the resident bioburden meets the requirements of the standard.
Medicine sterilization at Steri-Tek's facility

R&D Verification includes a relatively simple dose distribution study to set a dose specification that provides good assurance that a minimum dose is delivered throughout the product. A radiation tolerance series study provides doses delivered at up to five data points. From this study, you are able to test your products for material compatibility to determine the maximum dose that will not degrade the product. We tailor the experiments to your specific needs and provide a written report of the findings with recommended process control limits for your product irradiation processing.

This level of verification service is provided for the client who is using the materials for Research and Development Studies and not for clinical trials. The typical user does not need full validation documentation for regulatory compliance and has a good idea the product is relatively clean microbiologically. It may be useful for returned goods processing verification to confirm that higher levels of contamination can be successfully treated and/or that additional irradiation does not degrade the functionality of the product. It is not intended for products destined for use in clinical trials, Class II or III Medical Devices, drug products or as support for ISO certification.

It includes Radiation Services Radiation Tolerance Series and Dose Distribution Study. A written report with interpretation of the results, plus the recommended dose process control limits for your product is provided.

Production Validation provides a package of irradiation services that, when combined with your validation protocols and microbiological testing work, will meet all regulatory requirements for ISO and FDA 3rd party requirements. The basic package assumes materials compatibility and preliminary R&D work is complete and adds Product Dose Mapping per ISO 11137, Verification Dose Delivery per Method 1 or AAMI TIR27, and recommends irradiation process controls tailored to your product or family of products. The final report includes information on the packaging configuration, tote configuration, and product weight limits for which the irradiation process is qualified. It also includes a product-specific Process Request Record for ordering routine processing that lists any processing requirements and specific processing controls you require to handle product routinely.

This level of validation services is for clients who are qualifying their product for sale under the EN Medical Device Directive, FDA CDRH, or CDER regulatory requirements, and have in-house regulatory personnel familiar with both sterilization validation and current microbiological testing requirements of the reviewing parties. We will provide supporting information as directed by your protocol design as required This service includes Radiation Service Product Dose Mapping per ISO 11137 and Verification Dose Audit plus required routine processing specification documents, required reports, a contract agreement to fulfill the requirements of 21 CFR Part 801.150 (e), and review of your protocols and reports by our qualified regulatory personnel if you wish.

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.

This level of verification service is provided for the client that wishes to outsource their sterilization validation work and concentrate on their core business of product development and manufacture. We provide the supplier assessments for subcontracted laboratory services, maintain current standards information to support the validation work, and design economical and sound continuing audit programs to maintain the validation that are appropriate to your regulatory requirements.

With its tailored validation services, Steri-Tek is committed to supplying validation information with exceptional responsiveness to your needs. We want to provide a partnership with you that provides processing and superior business, technical and regulatory support.