Pharma and Biopharma
Cleanrooms for the pharma and biopharma industry
Bio-pharma and pharma industries research and develop life-saving medicines, including drugs, vaccines and antibodies. Contamination in this field can be hazardous, sometimes even to the patient. Hence, contamination control is non-negotiable.
FTCL manufactures modular cleanrooms that guarantee a contamination-free environment. To guarantee a highly regulated cleanroom, our team brings a thoughtful, detail-driven approach to every single aspect of cleanroom design and installation. For cleanrooms in India’s pharmaceutical manufacturing, we especially ensure that they adhere to FDA guidelines, GMP(Good Manufacturing Practice) and ISO 14644.
Modular HVAC in the Pharmaceutical and Bio-Pharma Industry
Turnkey Cleanroom & HVAC Solutions for Indian Pharma & Bio-Pharma Industries
When you choose Fabtech, you're investing in a custom-built cleanroom and HVAC system that is seamlessly integrated to suit your facility's exact needs. We handle everything in-house, from design and engineering to installation and validation. For your biopharma/pharma facility, it means a compliant and ready-to-use facility with the least hassle.
Technical requirements and relevant standards
While these requirements are mandatory for pharmaceutical and biopharma cleanrooms in India, certain parameters can be customised based on your specific process and operational needs.
- ISO 14644 Compliance (ISO 1 to ISO 9),
- Particle Count Limits
- Temperature
- Humidity
- Pressure Differentials:
- Air Changes per Hour (ACH)
- HEPA Filtration
- Federal Standard 209E (USA) and WHO-GMP (according to product)
Uses of Cleanrooms in Pharma
- Drug Manufacturing
- Sterilization
- Packaging
- Quality Control
- API Production
Uses of Cleanrooms in Biopharma
- Biologics Production
- Cell Culture
- Vaccine Manufacturing
- Gene Therapy and Stem Cell Production
- Clinical Trials
- Protein Purification
Our Pharma and Bio-pharma cleanrooms