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Ready-to-use assemblies
The challenge behind single-use assemblies
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.
With over 20 years of experience, we leverage our joined innovative expertise in aseptic processes and production of single-use assemblies to offer you custom cleanroom assemblies that meet your needs.
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-Cap™
- 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
Read more in Compliance
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