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Quality Certificate - Lot No.832974

Quality Certificate - Lot No.832974
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Quality Certificate - Lot No.832974

Product catalog summary
Product Description: The product is a 200mL container with a PS Red Screw Cap, catalog number TP200-14.
Sterility Assurance Level (SAL): The product achieves a SAL of 10-3 through an irradiation method compliant with ANSI/AAMI/ISO 11137 standards.
Quality Assurance: The product complies with ISO9001 standards and meets Corning Incorporated - Life Sciences' high quality standards at the time of batch/lot release.
Inspection and Testing: Performance testing is based on a statistically significant number of samples to ensure compliance with internal or agreed specifications.
Expiration Information: The product is designed to have a sterility expiration date of 3 years from the manufacturing date, which is 2022/10/01, leading to an expiration date of 2025/10/01.
Lot Information: Lot number 832974, with the certificate of compliance dated 2022-12-13.
Contact Information: For regional contact information, refer to www.corning.com/lifesciences. The plant quality manager is Hugues Vanderschelden, located in Borre, France.
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Catalog excerpts

Quality Certificate - Lot No.832974-1

CORNING CORNING GOSSELIN SAS 123 Rue de Caëstre - CS40019 59529 HAZEBROUCK CEDEX BORRE - FRANCE www.corning.com/lifesciences Refer to website for regional contact information Certificate of compliance Date of certificate : 2022 - 12 - 13 Page 1 Product description Container 200mL PS RedScrewCap Ioni sed 162/CS Catalogue number TP200-14 Lot number 832974 Quality Management System : Complies with the current version of the ISO9001 standard Sterility Assurance Level This product is sterilized using an irradiation method compliant with the requirements of ANSI/AAMI/ISO 11137 to achieve a 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 Hugues Vanderschelden Plant Quality Manager, Borre [email protected]

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