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Rubber Stoppers: Delivering Safe Sterile Components

Supplying ‘ready-to-use’ primary packaging components is the logical follow-up to supplying ‘ready-to-sterilise’ components. By transferring washing and sterilisation operations to the supplier, this concept gives greater flexibility to pharmaceutical laboratories. Delegating a key operation like sterilisation requires the highest degree of quality assurance, and it is the responsibility of the supplier to guarantee the sterility of the parts it supplies. Obtaining sterile components requires mastery of all the applicable pharmaceutical requirements, control over the process before irradiation, and a validation procedure to ensure effective sterilisation.

MASTERY OF THE PRODUCTION PROCESS BEFORE IRRADIATION

Sterile, ‘ready-to-use’ products, whether stoppers or plungers, undergo a specific manufacturing process before being sterilised by gamma radiation...

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