Research Support Room
The KPI bio clean room is not only separated by importance into 1A/2A areas but also consists of a Class 1A Zone that is used as a facility to manufacture materials for injection. Also, each area maintains an appropriate cleanliness by using sound, overpressure, and a return duct to block cross-contamination. Cross-contamination is mainly prevented by gradually lowering the overpressure that is pushing the air inside the clean room (manufacturing room, replenishment room) outside. Biological (microorganisms and viruses), chemical (detergents, and antiseptics), and physical (pebbles and glass) contamination is prevented by separating the movements of humans, raw materials, subsidiary materials, waste materials, and final products. Finally, dirt contamination is prevented by a curved surface and an inclined plane which are invisible.
The manufacturing room in the bio clean room has separate manufacturing and replenishment tanks for herbal medicines, animal medicines, oil ingredients, and toxic ingredients to prevent cross-contamination in manufacturing. All the machines are ready for use after disassembly, cleaning, sterilization and reassembly. Work tables and cables are cleaned every day, and walls, ceilings, and floors are cleaned with a fungicide using 70% ethanol once a week.
The KPI not only provides non-pyrogenic (endotoxins-free) water for injection as pharmacopuncture-manufacturing water through a precise process, but also uses purified water (PW) and water for injection (WFI) for medicines and material cleaning. The KPI only uses pure water for injection in the pharmacopuncture manufacturing process, thus preventing microorganisms and pyrogenic materials from being present in the manufactured pharmacopuncture.
We implements once-a-month examinations for microorganisms and mycetes, such as active microbial tests, passive microbial tests, and contact-surface microbial tests. Purified water and water for injection are tested for purity and pyrogenic materials biweekly, and Oriental medical doctors at the KPI supervise the process.
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Research Support Room
