Your Cart (0)
SIGN IN
Single Use
Description
Ready-to-Use Solutions for Critical Biopharmaceutical Applications
Advanced Couplings, Ltd. (ACL) delivers a wide range of solutions, and in this catalogue, we showcase our single-use assemblies built specifically for the biopharmaceutical industry. Engineered for critical applications in the production of therapeutic proteins, monoclonal antibodies, and vaccines, these gamma-irradiated products combine safety, reliability, and ease of integration. Manufactured and packaged in ISO Class 7 certified cleanrooms, they ensure the highest standards of quality while supporting efficient, contamination-free operations.
For further requests/bespoke requirements please contact sales.
Features
Manufacturing Process
Each single-use assembly is prepared in strictly controlled cleanroom environments meeting ISO Class 7 standards. Every unit undergoes a thorough quality inspection to ensure defect-free condition before being carefully labeled and packaged. Products are enclosed in primary and secondary protective polybags, marked with identification and gamma irradiation indicators, and then secured in doublebagged cartons for safe transport. This meticulous approach guarantees sterility, traceability, and reliable performance for demanding biopharmaceutical applications.
SterilizationOur single-use assemblies undergo gamma sterilization to achieve the highest sterility assurance level, with the procedure validated in line with international standards (ISO 11137-2). After careful packaging, the assemblies are processed at certified gamma irradiation facilities. Upon return, every package is thoroughly checked for integrity and proper irradiation indicators, ensuring the batch meets strict quality requirements before release. This process guarantees safe, sterile, and ready-to-use products for critical biopharmaceutical applications.
