In Neuhaus in the German state of Thuringia, we manufacture several millions containers for very special active ingredients every year. The final products are only a few centimeters long, but their production requires high manufacturing technology, ultra-clean conditions, extensive hygiene measures and strict controls.
Every morning when he comes to work, Ali Silay steps into another world. But stepping inside isn’t as easy as it sounds. When Silay arrives at the building on the Röchling site in Neuhaus, he first has to take off his shoes and put on a pair of black transfer shoes. Then he goes through a door into the first gowning room. There he has to strip down to his underpants, wash and disinfect his hands, put on a hood, beard protection, clean room underwear and socks and swing over a bench (called a sitover), changing his transfer shoes in the process. Next he must disinfect the safety shoes for the next area, put on a half-length lab coat and pants, take off his transfer shoes, put on the disinfected shoes and disinfect his hands again. And that’s just the beginning. Like a castle, the facility has several defensive walls in order to keep out all kinds of contaminants.
Once the plastic containers have successfully passed all quality inspections and been processed further, they fall into a sterile transport bag. When the bag is full, an employee seals it.
But a full and sealed bag doesn’t mean it's over. One side of the bag is processed so that it is permeable to gas. The contents – around 4,000 containers – are then fully sterilized once again.
Several million containers are produced in Neuhaus every year. After being sterilized, several hundred thousand containers are delivered in one batch to our customer for filling.
Some products must be manufactured under particularly clean conditions. This applies especially to the life sciences and semiconductor technology, but also to aerospace technology, certain foodstuffs and nanotechnology. There are different clean room classes, which are assigned in line the EU GMP Guidelines (GMP = good manufacturing practices) as follows:
Number of particles with a diameter equal to or greater than 5 micrometers
When it comes producing sterile drugs (pharmaceuticals), four clean room classes normally apply to the production areas according to Annex 1 of the EU GMP Guidelines. The following table shows the classification based on the particles contained in the air.
EU GMP class
|Max. number of particles permitted per m3 (equal to or greater than)|