When lives are at risk, there is no room for compromise. Isolators play a vital role when humans need to handle pharmaceuticals or pathogens. Isolators are at the interface between an aseptic or aseptic/toxic zone and humans. This is where pathogens are analysed, trials are conducted and pharmaceuticals are produced or filled into containers. Isolators are small Grade A cleanrooms which comply with GMP/PIC guidelines. They provide an (aseptic) environment which has less than one particle with a diameter of 0.5micrometre in 28.3cubic feet of air. By way of comparison, normal unfiltered air has 25000 particles.
The material and functional characteristics of every part that is used in the production of isolators have to comply with very demanding quality criteria, namely the extremely stringent requirements of the pharmaceutical industry. These requirements are defined on regulatory basis in ISO standards US and EU Pharmacopeia and FDA guidelines, etc.
SKAN systems are FDA compliant. The US Food and Drug Administration is the toughest test agency in the world when it comes to pharmaceutical production. Even the FDA references on SKAN’s decontamination process with hydrogen peroxide1) and the effect of carrier material on bio indicators2).
The company has developed a (H2O2) hydrogen peroxide based decontamination system which is first fully embedded in the process and control flow and second effectively reduces micro organisms to the required level of a 10-6 contamination safety level. This decontamination method has now become a worldwide standard cited in the FDA guidelines.
Over- or negative- pressure is maintained in the isolators depending on the active ingredient which is being filled. Negative pressure is used for highly active, cytotoxic substance such as drugs used to combat cancer. This ensures that the active ingredients cannot be released to the outside even if the clean room area develops a leak. Overpressure is maintained in the isolator when aseptic and
non-toxic active ingredients are being handled to prevent microbial contamination.
SKAN is currently building a filling line for a customer. The line is designed for syringes which are pre-filled with flue vaccine. Pre-sterilsed syringes are transferred into the cleanroom area in sealed tubs, each with 100 pieces. Electron beams (E-Beam) decontaminate the surface of up to six tubs per minute transferred into the filling isolator. A small robot in the peeling zone of the isolator removes the cover foil. The vaccine is then filled into the syringes and sealed in a fraction of a second. When production is fully up and running, six tubs, 600 syringes will be filled every minute.
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André Bösiger is with Skan AG, Basel, Switzerland. www.skan.ch