Most pharmaceutical manufacturing is done with an aseptic process to ensure medical products are free of any contaminants. This means that sterilized liquids or powders are inserted into sterilized containers before shipping out to the market. Unfortunately, even aseptic processes aren’t entirely safe from contamination, and the culprit here is human handling of the products. There are two possible barrier systems for such situations, namely – RABS and Isolator Technologies. It is crucial to ensure that the chosen system meets your manufacturing facility’s needs before installing either. Let’s take a more in-depth look at both of these technologies to understand more about their importance.
Restricted Access Barrier Systems or RABS focus on flexible handling while providing a barrier between the operator and the production environment. The rigid machine enclosure on the protection area’s side is secured with airtight doors and safety locks. There are ports with gloves for the operator to use for performing actions in the production area.
RABS technologies come in two categories – active and passive. Active RABS have dedicated equipment for handling the air of the cleanroom. Passive RABS systems, on the other hand, seal the cleanroom till its sealing. Both of these are quite an attractive offer for facilities with existing cleanrooms since they can improve your filling quality without disrupting the existing systems in place. These can even be used in integration with isolators in case you have one. In such an integrated system, the RABS would help approach the microbiological scale and ensure that the isolator remains pure.
An isolator is a more robust barrier that entirely separates the operator and production area. The doors are always shut in this, which makes it possible to use them even in class C cleanrooms. Isolators come equipped with fully functional bio-decontamination systems along with units to maintain the cleanroom air. The air handling units also maintain the cleanroom temperature and pressure as per the requirements of the pharmaceuticals being produced.
These barrier systems come with the highest levels of sterilization and can be used for longer production times. They use hydrogen peroxide for decontamination, which performs sterilization without disrupting the pharmaceuticals’ chemical composition. There have been several leaps in the development of isolator machines in the past decade, significantly reducing the period required for decontamination.
Both barrier systems play an essential role in the pharmaceutical industry. The systems are essential to maintain sterilized environments for the production of pharmaceutical products in a safe manner. As for choosing the one which fits your industry, the RABS system will offer you an economic advantage. However, when you add in both machines’ running and cleaning costs, the advantage is almost nullified. Isolator technologies will give you the cleanest environment and the least probability of accidental contamination. Using them in an integrated approach is perhaps the most suitable method for most pharmaceuticals as it allows getting the best of both worlds.