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Carolina Components Single use kit

Kits designed according to customer specifications on suitability requirements. Comprehensive component library with SAL 10-6 connection and sterility verification. Production capacity with the possibility of welding and overmouling as well as inserting the kits into systems with sterile Beta Bags.
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Description

Production and packaging are carried out in controlled environments in accordance with ISO 14644-1 ISO Class 7 standards.

Disposable kits are supplied with:

Certificate of conformity

Irradiation certificate

Shelf-Life Statement

Storage Conditions Statement

TSE/BSE Status Statement

USP Class VI Statement

Supply Chain Custody Statement

Melamine/Nitrosamine Statement

Elemental Impurities Risk Assessment

Batch Integrity and Release Testing (USP and ) available

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  4. Carolina Components Single use kit