Cleanroom assemblies

Challenge

Ready-to-use systems and components are of vast application in the modern biopharmaceutical manufacturing. Ensuring contamination-free production runs and user-friendly SOPs, is of particular focus when dealing with injectable products.

Assembled in cleanrooms, provided sterilized, in double or triple packaging, such devices maintain the cleanliness chain, while cutting the validation costs.

The complexity of the pharmaceutical production often requires on-demand customized devices and their clean packaging to optimize and secure the processes, reduce product loss and ensure smooth validation.

Expertise

For decades, Aseptic Technologies masters the key requirements for the most critical pharmaceutical ready-to-use devices, their clean production, packaging and sterilization :

Disposable fluid path AT-Filling Kit™
Disposable aseptic connector AT-Connector™and AT-Connect™
Re-packaging of AT-Closed Vial®in cryoboxes and nests, AT-Caps™
Ready-to-use assemblies and kits

Custom device manufacturing in cleanroom

We share our excellence with our customers, providing tailored sterilized assemblies in specified packaging :

Device and packaging design for cleanroom operation
ISO 7 cleanroom assembly and packaging
Validated radiation sterilization (gamma-irradiation)
Quality support and compliant documentation

Quality standards

ISO9001 :2015 Quality management systems

ISO 15378 : 2017, Primary packaging materials for medicinal products

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