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Discover the Excellence of ChemPharm India’s Pharmaceutical Clean Rooms
At Chempharm India, we excel in crafting state-of-the-art clean rooms specifically customized for the pharmaceutical industry. With 40 years of experience, we were pioneers in this field in India and our expertise guarantees that these facilities meet the rigorous requirements essential for producing top-notch pharmaceutical products while upholding the safety and integrity of the manufacturing process.
Our expertise spans from concept to completion in the pharmaceutical and medical devices sector. We excel in providing turnkey solutions for setting up pharmaceutical plants. Our competitive edge lies in our advanced manufacturing setup, which is one of the largest in capacity, equipped with state-of-the-art German and Japanese fabrication machines, which results into successful implementation of over 1,000 projects and supplied more than 10,000 containment equipment, including tablets, capsules, syrups, ointments, injectables, anti-cancer medications, hormones, and steroids.
Characteristics of Our Clean Rooms for the Pharmaceutical Sector:
Regulatory Compliance: Our clean rooms are meticulously constructed to adhere to all required industry regulations and standards, including cGMP (current Good Manufacturing Practices). Every aspect of the design and construction process complies with the guidelines established by regulatory bodies, minimizing the risk of contamination and ensuring product safety.
Controlled Environment: We engineer environments that maintain accurate control over crucial parameters such as temperature, humidity, and airflow. These controls are indispensable for processes involving delicate compounds and formulations, ensuring unwavering product quality.
Advanced Filtration Systems: Our clean rooms are equipped with advanced high-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filters, capable of capturing airborne contaminants down to 0.3 microns with an impressive efficiency of 99.99%, as a result our filtration system guarantees that the air quality within the clean room surpasses the highest standards.
Customizable Designs: Recognizing that every pharmaceutical operation is unique, our clean rooms are customized and designed to be adaptable and modular, enabling effortless expansion and adaptation to meet your evolving needs.
Contamination Control: Our designs integrate features that minimize the risk of cross-contamination, including proper zoning, gowning procedures, and dedicated airlocks. These measures are paramount in safeguarding both personnel and product integrity.
Validation and Testing: We conduct rigorous validation and testing of all clean room systems to ensure they function as intended. Our comprehensive approach encompasses airflow studies, particle counting, and environmental monitoring, instilling confidence in the operational compliance of your cleanroom.
Technical requirements and relevant standards
- ISO Classification Compliance: Pharmaceutical cleanrooms must meet strict ISO 14644 standards for air cleanliness, such as ISO Class 8 (Class 100,000) or ISO Class 5 (Class 100), which control particulate levels and ensure a clean manufacturing environment.
- Insulated Cleanroom Panels: These cleanrooms often use PUF/EPS insulated wall panels for managing temperature and minimizing contamination risks, creating a stable, controlled environment.
- Turnkey Pharmaceutical Cleanrooms: Designed for pharmaceutical production, these cleanrooms adhere to cGMP standards. Turnkey solutions integrate advanced features such as HEPA filtration, positive pressure maintenance, and easy-to-sanitize surfaces to prevent contamination.
- Clean Rooms vs. Sterile Rooms: In pharmaceutical settings, clean rooms are distinct from sterile rooms, which demand even stricter microbial and particulate standards. Cleanrooms are essential for production, while sterile rooms focus on aseptic processing and packaging.
- Functional Characteristics: Key components of pharmaceutical cleanrooms include HEPA filters, controlled airflow, temperature/humidity regulation, and pressure differentials that help prevent cross-contamination, crucial for maintaining an ISO-compliant cleanroom environment.
Why Choose Chempharm India?
With extensive experience in the pharmaceutical sector, Chempharm India stands as your trusted partner for cleanroom solutions. Our unwavering commitment to quality, safety, and regulatory compliance guarantees the efficient operation of your cleanroom, allowing you to focus on your core strengths—developing and manufacturing life-saving products.
For further details on our pharmaceutical clean room solutions or to discuss your specific requirements, please reach out to us today!
Experience, expertise and assistance are the key components of our products and services. Our client portfolio is too extensive for us to name all the companies that we have supplied over the years. However, we hope this brief summary will serve to portray the diversity and scale of our clean room design, manufacture and supply program around the world, including stainless steel fabrication and HVAC/AHU.