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 more than ever.
Manually washing vials is inefficient and inconsistent, posing a 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. Continuous aseptic processing with its many advantages, 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 winning solution. Its favourability however is dependent on using the right equipment to achieve the best results.
The purpose of a vial washer is to remove particulate and each moving part generates particles. PennTech vial washers have no moving parts underneath the vial washer baseplate, no gears, belts, chain, grease points, etc. With only two moving parts (central column and out-feed mechanism) this is a unique feature to Penntech; other similar instruments incorporating a large number of moving parts, increase 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 agents for the PennTech products in UK, Ireland and France, Biopharma Group is able to assist in assessing the best aseptic processing machinery for your needs.