Not every isolation system grants to have all of the mandatory features for quality control. Essential services require a targeted fitting. Hence our suggestions.
Isolator systems are allegedly the best and most cost-effective solution for sterility testing processes in the pharmaceutical field, and this concept has become more and more popoular. The ability and competence to prevent background related contaminations, thanks to the material and aerodinamic barrier they create to separate the working area from the installation area, is widely acknowledged. But not all the isolators are comparable, or offer the same performances. In other words, not all of the isolators are suitable to perform quality control processes.
Given that, which can be listed as essential characteristics to look after when choosing a sterility testing isolator?
We picked 7: this is what should not be overlooked in a quality control isolation system.
- Inflatable seals which allow a remarkably high air tight level – ISO 10648-2 compliant Class II is the preferred option;
- Seals made of silicone compound with silver ions for the inhibition of microbiological growth on the surface of the seal itself;
- Engineered filtration system made with High-Efficiency Particulate Air (HEPA H14) and/or Ultra Low Penetration Air (ULPA U15) filters;
- Unidirectional ventilation system on the working area, with a GMP-compliant air flow of 0.45 m/sec ± 20%;
- Integrated vapour phase high-concentration hydrogen peroxide bio-decontamination system, for fast bio-decontamination cycles;
- Means for the integration of environmental monitoring systems, both non-viable (particulate) and viable (microbiological)
- Means for an automated integrity check for both the isolation system and the gloves mounted on the system itself.