Application of isolation technology has gradually gained more prominence in the pharmaceutical industry, microelectronics, and health care.
In the pharmaceutical industry, the application of isolation techniques and solutions conveys distinguished significance for several reasons. On the one hand, guaranteed preventing of cross-contamination among medicaments is essential to ensure that the pharmaceutical company produces several product types in a plant so that compliance with the latest GMP and cGMP requirements is verified, and impeding that any active ingredients may contaminate different products. On the other hand protection of the operators is also of crucial significance. When cytostatic and hormone preparations with high-level active ingredients are being produced contact of the operators with any such ingredients must be hindered. As regards health, regular exposure, and contact with the active ingredients may have serious consequences in the long run.
Additionally, the use of isolators and cleanrooms is also important in health care, for instance, in operating theatres. The isolation techniques we offer are the following:
Glove isolators, the so-called gloveboxes. The English Company, the Extract Technology, is a market leader in this field and has innumerable references in Hungary and Central and Eastern Europe alike.
We supply both categories of the RABS systems (Restricted Access Barrier Systems), the cRABS (closed RABS), and the oRABS (Open RABS) systems. The RABS systems are typically integrated into fluid filling production lines. The Italian Steriline Company has RABS and isolator systems it produces for its own for the purpose of being integrated into its filling machines).
LAF booths (Laminar Air Flow Booths): Rooms typically used for the surveying and manipulation of powder products, where the operators’ health protection and preventing the cross-contamination of preparations is guaranteed by the vertical down-flow of laminar air current and the HEPA filters integrated into the wall. There are vertical laminar booths (“Downflow Booth”) and transversal laminar booths (“Crossflow booth”).
The Offloading Systems are applied in cases when powder products are to be unloaded from drying equipment (e.g. conical vacuum dryers, filter dryers, etc.) and dispensed into some sort of packaging (e.g. drums or bags). In such cases, a typical solution is, that transversal laminar boot is applied, combined with inflatable sealing positioned over the opening of the drum, or the additional use of an uninterrupted nylon hose may further prevent the dust escape. The Extract Technology Company takes a leading position in this field as well.
Another essential task is to solve the transfer of products in a closed system between different production equipment. The use of Split Butterfly Valves is one of the most effective and space-saving solutions for this purpose. In this case, the butterfly valve is composed of an active and a passive part that are docked together during operation. The active part can be fixed onto e.g. the discharge stub of a centrifuge, or onto the charging or feeding inlet of a reactor, while the passive part (from which even more than one can be used together with the same active part) is typically mounted on the discharge outlet of drums, tanks or flexible bags. Exposure of operators to hazards is mitigated by this to a minimum level. With the application of the foregoing techniques, the OEL (Operators’ Exposure Level) is maintained at a low level, even below 1 microgram. In this field, we represent the British market leader Company, the Chargepoint. This equipment is available in sterile or even in pressure-resistant designs (e.g. for the feeding of reactors).
Manufacturers associated with Isolation Technology:
- Extract Technology Ltd.: Dust escape free and aseptic solutions (LAF booths, isolators, downloading systems)
- Steriline: cRABS, oRABS, isolators
- Bioquell: VHP generators
Major References in Isolation Technology:
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