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Heating, Ventilation and Air- Conditioning (HVAC) Part 4:

Supplementary Training Modules on Good Manufacturing Practice. Heating, Ventilation and Air- Conditioning (HVAC) Part 4: Commissioning, qualification and maintenance. WHO Technical Report Series, No. 961, 2011. Annex 5. Section 8. HVAC. Objectives To understand key issues in

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Heating, Ventilation and Air- Conditioning (HVAC) Part 4:

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  1. Supplementary Training Modules on Good Manufacturing Practice Heating, Ventilation and Air- Conditioning (HVAC) Part 4: Commissioning, qualification and maintenance WHO Technical Report Series, No. 961, 2011. Annex 5 Section 8

  2. HVAC Objectives • To understand key issues in commissioning, qualification and maintenance of HVAC systems 8.

  3. HVAC Documentation requirements to assist in commissioning, qualification and maintenance • Description of design, installation and functions • Specifications, requirements • Manuals • Operating procedures • Instructions for performance control, monitoring and records • Maintenance instructions and records • Training of personnel • programme and records

  4. HVAC Commissioning Commissioning (is integrated in qualification) and includes: • Setting up, balancing, adjustment and testing of entire HVAC system • It helps to ensure it meets URS and capacity • Acceptable tolerances for parameters set before commissioning • Precursor to qualification 8.1.1, 8.1.4, 8.1.6

  5. HVAC Commissioning (2) Records and data include: • Installation records – documented evidence of measured capacities of the system • Acceptance criteria set for system parameters • Training of personnel (e.g. operation and maintenance) • O&M manuals, schematic drawings, protocols, reports 8.1.2, 8.1.3, 8.1.5

  6. HVAC Qualification • Validation is an extensive exercise • Qualification of the HVAC system is one component in the overall approach that covers premises, systems/utilities, equipment, processes, etc. • Risk-based approach for HVAC qualification • See also full guidelines on "Validation" in WHO TRS No 937, 2005, Annex 4. 8.2.1

  7. HVAC Qualification • Described in a Validation Master Plan (VMP) • Reflects the nature and extent, test procedures, and protocols • DQ, IQ, OQ, and PQ • Risk analysis to determine critical and non-critical parameters, components, subsystems and controls 8.2.2 - 8.2.5

  8. HVAC Qualification • Direct impact components and critical parameters should be included • Non-critical systems and components are subjected to Good Engineering Practices (GEP) • Acceptance criteria and limits defined in design stage • Design conditions, normal operating ranges, operating ranges, alert and action limits 8.2.6 - 8.2.11

  9. HVAC • Design conditions and normal operating ranges set to achievable limits • OOL results recorded and investigated 8.2.10 – 8.2.12

  10. HVAC Qualification – examples of aspects to consider • DQ – Design of the system, URS • (e.g. components, type of air treatment needed, materials of construction) • IQ – Verify installation • e.g. relevant components, ducting, filters, controls, monitors, sensors, etc. • includes calibration where relevant

  11. HVAC Qualification Typical parameters to be included in qualification (based on risk assessment): • Temperature • Relative humidity • Supply, return and exhaust air quantities • Room air change rates • Room pressures (pressure differentials) 8.2.13

  12. HVAC Qualification Typical parameters to be included in qualification (based on risk assessment) (2): • Room air flow patterns • Room clean-up rate • Particulate matter, microbial matter (viable and non-viable) • HEPA filter penetration tests • Containment system velocity • Warning/alarm systems 8.2.13.

  13. HVAC Conduct of the tests: • Time intervals and procedure to be defined by the manufacturer - based on risk assessment (influenced by the type of facility and level of protection) • See also ISO 14644 for procedures • Requalification, and change control • Documents: system airflow schematics, room pressure cascade drawings, zone concept drawings, air-handling system allocation drawings, particle count mapping drawings 8.2.14 – 8.2.18

  14. HVAC Qualification • Tests performed according to protocols and procedures for the tests • Results recorded and presented in report (source data kept) • Traceability, e.g. devices and standards used, calibration records; and conditions specified

  15. HVAC Schedule of tests to demonstrate continuing compliance *Test procedure as per ISO 14644 8. Table 3

  16. HVAC Recommended optional strategic tests *Test procedure as per ISO 14644 8. Table 3

  17. Cleanroom monitoring program (1) HVAC • Routine monitoring program as part of quality assurance • Additional monitoring and triggers, e.g. 1.Shutdown 2.Replacement of filter elements 3.Maintenance of air-handling systems 4. Exceeding of established limits

  18. Cleanroom monitoring programme (2)Particles and Microbiological contaminants HVAC • Number of points/locations for monitoring determined, specified, documented in procedure and or protocol • Sufficient time for exposure, and suitable sample size • Identification and marking of sampling points • Definition of transport, storage, and incubation conditions • Results to reflect the procedure/protocol followed • Define alert and action limits as a function ofcleanliness zone/class See also ISO 14644

  19. HVAC Cleanrooms should be monitored for microorganismsand particles Example of a sampling points

  20. Qualification – examples of aspects to consider in qualification (OQ, PQ) Test Uni-directional airflow / LAF Turbulent / mixed airflow Description Differential pressure on filters 2 2 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) Room differential pressure N/A 2, 3 Airflow velocity / uniformity 2, 3 Optional Airflow volume / rate 2 2 Parallelism 2 N/A Airflow pattern 2 3 HVAC

  21. HVAC Maintenance • Procedure, programme and records for planned, preventative maintenance • e.g. cleaning of filters, calibration of devices • Keep O&M manuals, drawings etc. • Appropriate training for personnel • Change of HEPA filters by suitably trained persons • Impact of maintenance on: • Product quality and Qualification 8.3.1 – 8.3.6

  22. HVAC Premises may influence HVAC design / performance. Therefore consider: • Adequate airlocks, change rooms, passages • Required pressure cascades • Detailed diagrams available with pressure cascades, air flow directions and flow routes for personnel and materials should be prepared and maintained; • Change room classification 9

  23. HVAC Inspecting the air-handling system • Verification of design documentation, including • description of installation and functions • specification of the requirements • Operating procedures • Maintenance instructions • Maintenance records • Training logs • Environmental records • Discussion on actions if OOS values • On site verification (walking around the site)

  24. HVAC Take home message. What is essential? • Appropriate design of AHUs and HVAC system • Correct components, and MOC • Ensuring appropriate cleanliness of air, environmental conditions (e.g. temperature and RH), and area classification to prevent contamination and cross-contamination • Qualification data to support claims • Regular calibration, maintenance and cleaning

  25. HVAC Conclusion Air-handling systems: • Play a major role in the quality of pharmaceuticals • Should be designed properly, by professionals • Should be treated as a critical system

  26. HVAC Group Session

  27. HVAC Group Session – modified layout MAL = Material Air Lock PAL = Personnel Air Lock

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