Haeating, Ventilation, and Air Conditioning (HVAC) systems are critical systems that can affect the quality of pharmaceutical industry and can hamper the safety and efficacy of products. That’s why HVAC systems should be appropriately designed and managed throughout their life cycle and documentation such as schematic drawings should also be maintained to reflect the current situation.
Design of HVAC Systems
- The HVAC system capacity should be sufficient to ensure that the required performance is maintained during normal use by taking into consideration, for example, room leakage, duct leakage and filter conditions.
- Adequate ventilation shall be provided.
- Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.
- Conditions and limits for parameters such as temperature, relative humidity and air cleanliness should be specified and achieved, as needed, for the materials and products handled, as well as for process risk.
- Air filtration systems, including pre-filters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.
- Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.
- Where possible, ducting, piping, fittings, sensors and other components should be clearly marked or labelled for ease of identification, indicating location and direction of flow as appropriate.
- The performance of HVAC systems should be controlled and monitored to ensure continuous compliance with defined parameters, and records should be maintained. Limits defined should be justified.
- Appropriate alarm systems should be in place to alert personnel in case of failure of a critical component of the system, for example, a fan.
- Failure mode and effect of critical components should be analyzed. The analysis should include possible room pressure changes due to fan failure and possible impact of partial system shutdown on ease of opening doors for escape purposes.
- The effect of fan failure on building and HVAC components should be assessed. Where appropriate, provision should be made for a fan interlock failure matrix.
Components of HVAC systems
- Materials for constructing the components of an HVAC system should not become a source of contamination.
Maintenance of HVAC systems
Maintaining accurate and up-to-date schematic engineering and verification testing documentation is the single most important thing you can do to be “inspection ready”. Along these, maintenance is probably the second most important thing to have a handle on. Whether it’s preventive, predictive or true reliability centered maintenance, without a mechanism to assure that systems operate within acceptance criteria you just don’t have a state of control.
Qualification of HVAC systems
The quality of steam, water, air, other gases etc. should be confirmed following installation using the qualification steps as described below –
- User requirements specification (URS)
- Design qualification (DQ)
- Factory acceptance testing (FAT) /Site acceptance testing (SAT)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
Read Also:
Reference:
- USFDA 21 CFR 211.46
- PIC/S GMP Annex - 15
- WHO Annex - 8
- ISPE (HVAC FAQs)
