Improvement of manufacturing environment through cleanroom implementation.
In the production facilities for pharmaceutical testing drugs, it was necessary to move equipment within the warehouse for business expansion. There was a need for cleanliness measures to prevent foreign substance contamination, and a comfortable air conditioning environment for about 20 workers was desired. Issues: 1. Production is taking place in a warehouse environment without air conditioning management. 2. Establishment of a validation process. 3. Air conditioning equipment is not in place.
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A clean room of class 100,000 with dimensions W14000×D9475×H2800 has been established, and through temperature control, we have simultaneously improved the working environment and production quality! 1. Constructing the room in the KAMATA clean room. 2. Achieving temperature control and cleanliness by using HEPA filters in ceiling-mounted multi air conditioners. 3. Newly establishing a changing room, handwashing area, and air shower at the worker entrance. By installing high-performance filters in the multi air conditioners and medium and high-performance filters for outdoor air processing, we have achieved a quasi-clean room environment, preventing foreign matter adhesion.
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