GMP-compliant clean booth
In order to manufacture biofilters consistently on one floor, they 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. They want to make effective use of limited space. 2. They would like the internal work to be visible from the outside. 3. Considering work efficiency, they want to install pass boxes between each room. 4. Since there is a possibility of transferring production equipment to another factory in five years, they prefer a structure that is easy to dismantle and relocate. 5. As this is for pharmaceuticals, they require 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 from transparent resin panels, we have created an environment where internal work 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 conduct cleanliness management for each room and provide validation reference materials that include cleanliness measurements, airflow measurements, and voltage measurements. Additionally, leveraging the advantage of our in-house products, we propose a reduction in preparation and on-site construction periods compared to conventional methods. Key Points: 1. Adoption of the KAMATA frame, which allows for easy dismantling, 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 visibility. 4. As an in-house product, preparation and construction periods can be shortened.
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Company information
In the current situation where advanced technological capabilities are required of Japanese companies as a whole, we aim to be a trading company that not only possesses "integrity" and "technology," but also explores our customers' needs and responds to their requests.