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.

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