Brochure
Packaging and Sterilization
Validated RTU, RFS, and RTP packaging and sterilization solutions that eliminate in-house washing and sterilization burden and deliver sterile components ready for aseptic filling.
Status
Published
Format
Brochure
Language
English
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Registration Required
Resource Overview
About this Brochure
Datwyler's packaging and sterilization solutions allow pharmaceutical and biotech manufacturers to significantly reduce the operational burden of component preparation by shifting washing, siliconization, sterilization, and process validation responsibilities to Datwyler. The validated ready-to-use (RTU) platform delivers washed and sterile closures in PE/EVOH bags that are vacuum-packed for sterility verification at point of use and can be deployed directly in aseptic filling operations—eliminating capital investment in sterilization equipment, reducing manufacturing labor costs, and simplifying stock management. RTU components comply with EP, USP, and JP pharmacopeial requirements and the latest FDA regulatory guidelines, with controlled bioburden and endotoxin levels, validated washing programs conducted in Grade C cleanrooms, and compliance with ISO 11137-1 & 2 for gamma irradiation and ISO 17665 for steam sterilization. For the most stringent contamination control requirements, RTP bags minimize human intervention in the component transfer process. Datwyler also supports customers in sterilization method selection through a structured three-step consultative approach, and offers on-site validated steam sterilization in an ISO class 5 cleanroom at its FirstLine® Middletown facility.
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