Aseptic Filling Quality Standards and Cytiva SA25

2024/05/14

When it comes to the production of sterile products, EU GMP Annex 1 is the highest standard that pharmaceutical manufacturers must adhere to. To provide a Class A environment and ensure sterility, barrier technology (either isolators or RABS) is the best solution to address critical factors such as quality of air, material and ingredient transfer, decontamination, etc. mentioned in Annex 1.

To comply with Annex 1 and further eliminate operator intervention during the sterile filling process, Amaran Biotech’s sterile filling line adopts the Cytiva (formerly known as Vanrx) SA25 Aseptic Filling Workcell, a robotic-integrated gloveless isolator that utilizes advanced automation technology to handle all critical factors mentioned in Annex 1. By leveraging this advanced technology, Amaran Biotech has successfully manufactured dozens of GMP batches for our customers since 2022 with zero sterility issues. In addition, SA25 uses single-use materials to prevent cross-contamination between different products, further ensuring the delivery of high-quality products to customers.

2024-05-14T15:43:19+08:00