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  6. [Case Study] GMP-Compliant Clean Booth

[Case Study] GMP-Compliant Clean Booth

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last updated:Oct 22, 2020

蒲田工業
蒲田工業
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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.

    Clean Booth
KE-6_2P (09.7月 セパシグマCB_ページ_1.jpg

[Case Study] GMP-Compliant Clean Booth

KE-6_2P (09.7月 セパシグマCB_ページ_1.jpg
KE-6_2P (09.7月 セパシグマCB_ページ_1.jpg
  • Related Link - http://www.kamata.co.jp/html/solution/2009/07/gmpn…

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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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[Case Study] Validation-managed Production Environment - GMP-compliant Clean Booth

[Case Study] Validation-managed Production Environment - GMP-compliant Clean Booth

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蒲田工業

蒲田工業

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In today's world, where advanced technological capabilities are required of all Japanese companies, we aim to be a trading company that not only embodies "integrity" and "technology," but also explores our customers' needs and responds to their requests, rather than being just a simple trading company.

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