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Quality Certificate - Lot No.909259

Quality Certificate - Lot No.909259

Product catalog summary
Quality Management System: The document confirms compliance with the ISO9001 standard, ensuring a robust quality management system is in place.
Sterilization and Sterility Assurance: The product has been sterilized according to ANSI/AAMI/ISO 11137 standards, achieving a Sterility Assurance Level (SAL) of 10-3. This indicates a high level of sterility assurance.
Product Details: The product is a 200mL container with a red screw cap, catalog number TP200-14. It is designed to maintain sterility for three years from the manufacturing date.
Lot Information: The document lists two lots, 809259 and 909259, with the latter having a manufacturing date of 2024/10/01 and an expiration date of 2027/10/01.
Quality Assurance: Performance testing is conducted based on a statistically significant number of samples to meet internal or agreed specifications, ensuring a high Assurance Quality Level (AQL).
Certification: The certificate of compliance was issued on 2024-11-25, confirming the product met Corning Incorporated - Life Sciences' quality standards at the time of batch release.
Contact Information: Sandra Bianchi, Plant Quality Manager, is the contact person for quality-related inquiries.
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Catalog excerpts

Quality Certificate - Lot No.909259-1

CORNING CORNING GOSSELIN SAS 123 Route de Caëstre 59190 - Borre FRANCE www.corning.com/lifesciences Refer to website for regional contact information Certificate of compliance Date of certificate : 2024 - 11 - 25 Page 1 Product description Container 200mL PS RedScrewCap Ioni sed 162/CS Catalogue number TP200-14 Lot number 909259 Quality Management System Complies with the current version of the ISO9001 standard. Sterility Assurance Level Product has been sterilized and dosimetrically released per the requirements of ANSI/AAMI/ISO 11137, "Sterilization of health care products - Radiation". Products meet a minimum Sterility Assurance Level (SAL) of 10-3. Expiration statement This product is designed to have an expiration date of 3 years from the date of manufacture regarding sterility. Performance testing (AQL) Inspection based on a statistically significant number of samples towards to internal or agreed specifications that determine Assurance Quality Level. This product met Corning Incorporated - Life Sciences' high standards of quality at the time of batch/lot release Sandra Bianchi Plant Quality Manager, Borre [email protected]

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