Cipla Phase-III Formulation Clean Rooms
High-Specification Pharmaceutical Formulation Cleanrooms
To accommodate a major formulation line expansion, Cipla contracted Medxon Technologies to design, fabricate, and validate 2,500 square meters of high-grade Clean Room environments, meeting WHO-GMP and ISO 14644 Class 7 (Class 10,000) sterile standards.
The Engineering Challenge
A major struggle when managing bulk oral solid dosage (OSD) manufacturing is the high volume of loose powder dust generated during mechanical tableting. The air circulation path had to satisfy high-capacity air changes, prevent cross-contamination between adjacent formulation cabins, and maintain precise relative humidity levels to prevent active ingredients from absorbing ambient water vapor.
Medxon's Executed Solution
- Rigid Modular Ceilings and Walls: Installed double-skin polyurethane foam (PUF) sandwich panels with PPGI skin overlays. We sealed every vertical seam, window, and door frame lock to maintain a hermetic barrier.
- Cascaded Pressure Management: Engineered custom differential pressure loops. We maintained higher pressures inside the central corridor and negative pressures in the raw material tableting rooms, forcing loose powder dust directly toward dust collectors.
- Chilled Water Integration: Connected the cleanroom air loops with centralized chilled water plants, combining heavy-duty dehumidifiers to lock humidity levels at 40% (±3%) year-round.
Project Outcomes
The expansion successfully satisfied WHO-GMP validation audits. The client reported highly stable production conditions with zero powder cross-contamination.