HVAC Consulting
From design to commissioning and qualification.
Over 15 years of HVAC commissioning and qualification for biopharma facilities, with a track record across GSK, Novartis, Eli Lilly, MSD, Thermo Fisher, PharmaGend and AbbVie.
Services
How I can help
Commissioning & Qualification (C&Q)
- C&Q strategy: system boundaries, system classification assessment (direct/non-direct impact), C&Q strategy, leveraging, and Validation Master Plan (VMP)
- C&Q planning: detailed planning from Mechanical Completion (MC) through Performance Qualification (PQ)
- Qualification: System Risk Assessment (SRA), Design Review (DR), DQ, IQ, OQ and PQ
- Test protocols: writing, reviewing and approving commissioning and qualification protocols
- C&Q testing: air and pressure balancing; testing of AHUs, FCUs, UDAFs, pass boxes and fume hoods; temperature, humidity, air changes, room differential pressures, pressure recovery, particle counts, room recovery, and airflow pattern visualisation
- cGMP: current GMP regulatory requirements (EU, FDA, ISO); risk-based validation
Design
- User requirements: drafting, reviewing and approving detailed HVAC and cold room user requirements
- Concept design: cooling load calculations, concept P&IDs, AHU zone diagrams, pressure layouts and classification layouts
- Detailed design: duct and piping layouts; selection of AHUs, FCUs, dehumidifiers, LAF, CAVs/VAVs, fans, filters and diffusers
Warehouse and Cold Rooms
- Temperature and humidity mapping: warehouse temperature/RH mapping and cold room temperature mapping for GMP compliance
Project Management
- Leading C&Q teams and coordinating with users, automation, electrical, black utilities, contractors, designers and EHS
Track record
Selected projects
- Biologics and vaccine facilities: GSK, MSD
- Insulin fill-finish facility: Eli Lilly
- Large-scale biopharma filling facility: Thermo Fisher
- Cleanroom energy-saving pilot: AbbVie
- Requalification, reclassification and audit support: Thermo Fisher, Novartis
Enquiries
atul@atulmathur.com