Drainage systems in pharmaceutical industry must be 100% reliable
Hygiene standards are very high in pharmaceutical industry; in this sector, more than others, there’s no room for mistakes. To prevent drugs from being contaminated during the production phase, the entire environment, not just the machinery, is under strict sanitation protocols. Suffice it to say that no drug can be marketed before "cleaning validation", a process that provides documented evidence that an approved cleaning procedure will provide clean equipment, suitable for its intended use. When it comes to processing, storage and conservation of substances used in medicine or cosmetics, the sanitation operations of the environment follow strict health regulations, starting from an appropriate plant design. In this regard floors must be taken into consideration as well: indeed, drainage systems play a key role as their performance, especially in pharmaceutical industry, must be flawless.
Sterilization of clean rooms in the pharmaceutical industry
In pharmaceutical plants bacteria must absolutely be kept out. The "cleanrooms", in industrial laboratories as well as in hospitals, must be completely sterile. But what are "cleanrooms"? Sterilized and controlled atmosphere environments designed to maintain extremely low levels of particulates, such as dust, airborne organisms for pharmaceutical production. Air purity in a cleanroom is even higher than that of an operating room: indeed, air flow systems ensure forced recirculation of the air which is thus filtered. The standard that regulates clean rooms, and all associated controlled environments, is ISO 14644. The operation of a cleanroom is based on the sterilization process which is possible only if the room is completely sealed.
Drainage systems to protect cleanrooms from bacteria
In the cleanrooms of pharmaceutical facilities, floors play a key role and drainage systems as well, taking surface water away from floors and thus eliminating stagnant waste water, smells and, consequently, the risk of microbial growth. Drainage systems must also keep cleanrooms aseptic. In a nutshell: they must force the water out without letting dirt and bacteria coming back up. How to do that? Inoxsystem® boasts within its product range square top floor drains with blind cover and O-Ring gasket supplied insted of the standard drilled cover. You just have to remove the blind cover with a suction cup to let water be drained away when needed and then, once cleaning operations have been completed, replace the blind cover on the floor drain in order to keep the environment completely separated from waste water. This blind cover is equipped with an “O-ring” gasket, a resistant loop of elastomer which is compressed resulting in zero clearance, thus "sealing" the room and effectively prevent bacteria from contaminating the environment. And what about the flooring? All Inoxsystem® products can be equipped with a clamping flange for PVC flooring widely used in cleanrooms as they have no grout lines. Drainage systems will be provided with a frame and a screwdown flange that mechanically clamp the vinyl beneath ensuring a water tight seal between vinyl floor and clamp making it impossible for germs and bacteria to proliferate. Finally, for unrivalled hygienic performance, Inoxsystem® has developed the new Inoxsystem® Total Hygienic line, drainage systems especially suitable for the pharmaceutical sector. In addition to internal rounded corners, a feature that all Inoxsystem® product range have, this type of floor drains and channels are equipped with a removable odor trap & filter basket kit for a complete and thorough cleaning.
Pharmaceutical industry requires drainage systems made of grade 316 stainless steel.
The importance of choosing the right material for drainage systems is vital for their performance. In pharmaceutical industry drainage systems must be manufactured in stainless steel as it is the only alloy that meet the strict standards of hygiene of this sector. Its extreme resistance to corrosion, indeed, eliminates the risk of contamination due to volatile organic compounds. However, stainless steels are not all the same: all users shoud evaluate their suitability for each itended use. Unlike the food sector, where grade 304 stainless steel is widely used, the pharmaceutical sector requires grade 316. Both contain chromium and nickel, yet the key difference is molybdenum: 316 stainless steel contains molybdenum, 304 stainless steel does not. Molybdenum drastically enhances corrosion resistance, making 316 stainless steel the ideal solution especially for more saline or chloride-exposed environment, or where acids at a high concentration are used.