Menu
RTU Ready-to-use assemblies
The difficulty of single-use assemblies
Pre-made systems and components have a wide range of uses in today's biopharmaceutical manufacturing industry. Particular emphasis is placed on maintaining contamination-free production runs and creating user-friendly SOPs when working with injectable products.
Manufactured in sterile environments, packaged in double or triple layers, these devices help to uphold cleanliness standards and reduce validation expenses.
The pharmaceutical production's complexity often necessitates customized devices and clean packaging as needed to optimize processes, reduce product loss, and ensure smooth validation.
We use our combined knowledge in aseptic processes and single-use assembly production, accumulated over 20 years of experience, to provide personalized cleanroom assemblies that align with your requirements.
Skill and knowledge
Aseptic Technologies has been skilled at meeting the essential needs for the most important pharmaceutical ready-to-use devices, such as their clean manufacturing, packaging, and sterilization, for many years.
- Single-use fluid pathway AT-Filling Kit™
- Disposable sterile adaptor AT-Connector™ and AT-Connect™.
- AT-Closed Vial® are repackaged in cryoboxes and nests with AT-Cap™.
- Pre-made assemblies and packages ready for use
Manufacturing of custom devices takes place in a cleanroom setting.
We offer our outstanding quality to customers by supplying customized sterilized assemblies in designated packaging.
- Design of equipment and packaging suitable for use in cleanroom environments.
- Assembly and packaging in a cleanroom meeting ISO 7 standards.
- Authorized radiation sterilization (gamma-irradiation)
- Quality assistance and documentation that meets regulations
Standards of quality
- ISO9001:2015 is a set of standards for managing quality within an organization.
- ISO 15378 : 2017 pertains to primary packaging materials used for medicinal products.
Read more in Compliance
