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Validation & Certification: Ensuring Regulatory Compliance at all times
Validation, or regulatory compliance, remains indispensable in industries like pharmaceuticals, medical implants, semiconductors, space, defence, biotechnology, and food manufacturing. It ensures that cleanrooms and HVAC systems meet the toughest design, installation, operational, and performance standards. As an organisation of repute in the line, we, Kaizen Airtech, know what it is to design and manufacture validated and certified cleanrooms, be it for new or existing set-ups.
Key Steps in Validation and Certification that we at Kaizen Airtreat follow:
Initial Qualification: It includes within itself Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). A collaborative effort, it contains the steps mentioned below.
Design Qualification: Undertaken mainly through manufacturers and developers, it is done to ensure that the design meets real-world specifications.
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ): These involve end-users and their qualified personnel verifying the installation for its functionality and performance.
Periodic Validation: Routine assessments at fixed intervals that assure the system adheres to established standards.
Comprehensive Reporting: Detailed documentation to provide transparency and support regulatory compliance.
How Kaizen Airtreat’s Validation Helps:
It guarantees (after detailed testing) that the end product of a cleanroom system is of the desired quality while the cleanroom itself is safe to operate under normal conditions.
Such a guarantee (as an outcome of rigorous testing) induces user confidence in the system’s ability to perform under actual working conditions.
Validation, in the long run, helps maintain a contamination-free environment that is as per existing laws and statutes.
Reasons to Choose Kaizen Airtreat for Project Validations:
• Our +13 years of experience and the expertise it has brought us- and more so, in a diverse range of industries.
• Tailored, customised solutions designed for specific client-industry needs.
• Compliance with Industry Best Practices in validating projects to ensure high efficiency in every project.
Mr. Yuvaraj Shelke (KAIZEN AIRTREAT PRIVATE LIMITED)
Phase 3, Navale IT Zone, S.No. 51/2A/2, Office No. 201, 2nd floor, Near, Navale Bridge, Narhe, Pune, Maharashtra - 411041, India
https://www.kaizenairtech.co.in
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