Pharmaceutical & Biotech
Engineering Services

Complete clean room engineering for pharmaceutical and biotech manufacturing — classification, airflow design, HVAC, and contamination control strategy from concept to DQ documentation.

• Clean room classification — ISO Class 5–8, GMP Grade A/B/C/D
• Unidirectional (laminar) airflow design for Grade A critical zones
• Turbulent airflow and air change rate design for Grade B/C/D areas
• Differential pressure cascade — contamination control between zones
• HEPA H14 filtration system design and filter validation methodology
• Temperature (21±2°C) and humidity (45±10% RH) control design
• Airlock and personnel/material flow strategy
• Design Qualification (DQ) documentation for regulatory submission

Design of critical pharmaceutical utilities — WFI, Purified Water, Clean Steam, Nitrogen, and Instrument Air systems complying with pharmacopoeia and cGMP requirements.

• WFI (Water for Injection) generation and distribution loop design
• Purified Water (PW) system — RO, EDI, distribution loop
• Clean Steam generation and distribution for sterilisation applications
• Nitrogen generation and distribution for inerting applications
• Compressed air system design — oil-free, instrument quality (ISO 8573)
• Passivation and sanitisation system design for WFI and PW loops

Complete MEP design for pharmaceutical manufacturing buildings — including HVAC for production areas, support spaces, and utility areas.

• HVAC design for production blocks — clean room units and support area conditioning
• Chilled water system design for process and building cooling
• Exhaust and containment systems for potent compound handling (OEB categories)
• Electrical system design — HT/LT distribution, UPS for critical systems
• Fire protection — NFPA/NBC compliant systems for pharmaceutical manufacturing