When completing this form, every field must be completed. If any field is not applicable, it shall be noted with “N/A”. Incomplete forms will result in potential delays in processing.
When selecting this option please download and email the attached form
This is the final section. Once you are ready hit the green submit button at the bottom of the form and your request will be sent for processing
RESPONSIBILITY
Assignment
Responsible for use of radiation sensitive labels (false negatives, false positives, placement)
Ensure that special instructions are provided for sample processing placement requirements, product temperature sensitivity requirements, and time sensitive requirements for product capable of supporting microbial growth.
CUSTOMER
Determine if 21CFR 801.150 for Device, or 21CFR 201.150 for Drugs are applicable to processing of the Products.
Ensure that Products may be processed without violating any governmental regulations.
Assure compliance with any and all federal, state and local labeling or "right to know" laws, Including but not limited to, California's Safe Drinking Water and Toxic Enforcement Act of 1986, if applicable.
Notification of intent to recall product processed at STERIS.
Medical Device Manufacturer provision of FDA product listing information to FDA and STERIS in accordance with 21 CFR, Part 807
Product listing with FDA in accordance with 21 CFR, Part 807
STERIS
Subject to STERIS's reasonable confidentiality obligations, allow customer access to the processing facility, upon reasonable notice, during normal business hours for the purpose of conducting Quality System audits, at customer’s expense, related to the processing of customer products.
Perform periodic internal audits according to Quality System. A record of the audit shall be maintained on file.
Allow the U.S. FDA to inspect its facilities as stated in section 704(a) of the Food, Drug and Cosmetic Act and 21 CFR Part 200.10, if applicable.
II. PROCESS CONTROL
Ensure that the CUSTOMER process specifications are achieved and that documentation for each load is reviewed by a Qualified STERIS Representative before release to CUSTOMER.
Notify CUSTOMER of equipment changes in accordance with STERIS’s established change control procedure.
Evaluate STERIS’s equipment change control notification and communicate action to STERIS, as needed.
III. MATERIAL HANDLING AND DOCUMENTATION REQUIREMENTS FOR INCOMING PRODUCT TO STERIS
Ensure proper shipment of Product to STERIS to include Labeling, Packing List, Purchase Order and Process Specifications (or completed Special Radiation Request).
Provide proper labeling and identification for all products / samples. Packing slip shall match product code on case label. All exceptions will be communicated in advance of shipment to STERIS.
Resolve damaged goods disposition.
Complete Non-Sterile Shipping Agreement, if applicable.
Confirm that documentation to satisfy 21CFR 801.150 for Device, or 21CFR 201.150 for Drugs is provided, if applicable.
Receive and record incoming product samples to STERIS.
Resolve count discrepancies with CUSTOMER.
IV. PROCESSING
Carry out processing parameters in accordance with CUSTOMER specifications.
Control the flow of Products to and from the processing area to prevent mixing of processed and non-processed Products.
Installation, qualification, operation and maintenance of equipment, calibration of process monitoring equipment and training of operating personnel.
Determine the compatibility of Products and packaging with the processing procedures and for determining the appropriate processing modality and parameters. All tests related to the processing of the Products. Ultimate and full responsibility for Products release into commercial distribution, including labeling of Products as sterile. All tests related to assessing the final sterility assurance of the products.
Ensure specifications are provided in writing to STERIS for all special instructions or special handling requirements prior to processing product.
Prior to product being processed, notify STERIS if products are flammable, corrosive, combustible, bio-hazardous, bio-active, or hazardous in any way. In addition, an MSDS will be provided for all products, prior to processing, if they are flammable, corrosive, combustible, bio-hazardous, bio-active, or hazardous in any way.
Assure that any changes to the manufacturing, packaging, and the product are evaluated for their impact on the continued validation of the processing parameters.
Prior to product being shipped to STERIS, notify STERIS when there is a change to product case size, weight, or any other change to the product that could in any way change processing parameters.
V. PROCESSING NONCONFORMITIES
Determine and notify CUSTOMER thereof.
Determine corrective action and notify CUSTOMER thereof.
Implement corrective action.
VI. SHIPMENT FROM STERIS
Document number and destination of samples sent for testing from STERIS on the STERIS Packing List. (If applicable)
Generate a Certificate of Processing and a Packing List for each shipment.
Document the quantity of Product from STERIS on the Certificate of Processing. Any discrepancies will be resolved with CUSTOMER prior to shipment.
Label all processed Product as “Processed” or similar, with no reference to the Product being sterile.
