GMP-compliant clean booth
In order to manufacture biofilters consistently on one floor, you requested separate rooms for each process, with independent cleanliness management in clean booths. This consultation included the creation of validation documents for pharmaceutical manufacturing. Issues and Points: 1. We want to make effective use of the limited space. 2. We would like the internal work to be visible from the outside. 3. Considering work efficiency, we want to install pass boxes between each room. 4. Since there is a possibility of transferring production equipment to another factory in five years, we hope for a structure that is easy to dismantle and relocate. 5. Since this is for pharmaceuticals, we would like validation documents.
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basic information
We propose the KAMATA clean booth. By using a unique aluminum frame and making the upper half entirely transparent with resin panels, we have created an environment where internal operations can be visually monitored. Compared to clean room panels, it offers a significantly greater sense of openness. Thanks to its special structure, installing panels on both the outer and inner surfaces eliminates unnecessary steps and reduces dust accumulation. We provide validation reference materials for cleanliness management in each room, including cleanliness measurement, airflow measurement, and voltage measurement. Additionally, leveraging the advantage of being our own product, we propose a reduction in preparation and on-site construction time compared to conventional methods. Key Points: 1. Adoption of the KAMATA frame, which allows for easy disassembly, relocation, and expansion. 2. Submission of validation materials in accordance with our regulations, including measurement management and shipping certification starting from IQ and OQ. 3. Use of transparent resin panels on the entire front for visual monitoring. 4. As a proprietary product, preparation and construction periods can be shortened.
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