How the rise of low maintenance aseptic processing lines elevates contamination risks

With increased attention from regulatory agencies and drive towards compliance; contemporary procedures to ensure cleanliness of vials for use in aseptic processing environments are at the forefront of technology now more than ever.

Manually washing vials is both inefficient and inconsistent in that it poses risk of large variations in the level of cleanliness batch to batch and vial to vial. Proper and thorough vial washing (depyrogenation), is therefore vital in ensuring the safety of end users.

Whilst pre-sterilised containers could be the answer, its excessive cost makes it a non-viable long-term solution. However, with its many advantages, continuous aseptic processing has fast become the most popular and recommended practice within manufacturing facilities.

With its ability to complete a cycle in as little as 30 minutes and adhere to cGMP guidelines to satisfy the strictest of process and cleaning (CIP/SIP) protocols or software compliance (CFR 21 Part 11), aseptic processing is a clear solution. Its favourability however is extremely dependent on using the right equipment to achieve the best results.

The purpose of a vial washer is to remove particulate and every moving part generates particles. PennTech vial washers have no moving parts underneath the vial washer base plate, no gears, belts, chain, grease points, to name a few. With only two moving parts (central column and out-feed mechanism) this is a unique feature to Penntech, with other similar instruments incorporating a large number of moving parts inside the washing area, increasing the risk of recontamination of cleaned vials.

PennTech is a world leader in the field of complete aseptic vial production lines, offering a suitable and affordable solution for your application needs. As exclusive agent for the PennTech product range in UK, Ireland and France, Biopharma Group is able to assist in assessing the best aseptic processing machinery for your needs.

For more information, contact Richard Lewis at [email protected] or +44 (0)1962 841092