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Heating, Ventilation and Air-Conditioning (HVAC) Part 3: Commissioning, Qualification, and maintenance Good Manufacturing Practice 1.

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Presentation on theme: "Heating, Ventilation and Air-Conditioning (HVAC) Part 3: Commissioning, Qualification, and maintenance Good Manufacturing Practice 1."— Presentation transcript:

1 Heating, Ventilation and Air-Conditioning (HVAC) Part 3: Commissioning, Qualification, and maintenance Good Manufacturing Practice 1

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

3  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 Documentation requirements to assist in commissioning, qualification and maintenance HVAC 3

4 Commissioning Precursor to qualification Includes setting up, balancing, adjustment and testing of entire HVAC system to ensure it meets requirements in URS and capacity Acceptable tolerances for parameters Training of personnel 8.1.1, 8.1.4,

5 HVAC Commissioning (2) Records and data maintained include: Installation records – documented evidence of measure capacities of the system Data: Design and measurement for, e.g. airflow, system pressures O&M manuals, schematic drawings, protocols, reports 8.1.2, 8.1.3,

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. See also full guidelines on "Validation" in WHO TRS No 937, 2005, Annex 4. Risk-based approach for HVAC qualification

7 HVAC Qualification (2) Described in a Validation Master Plan (VMP) VMP to include the nature and extent of tests, and protocols DQ, IQ, OQ, and PQ Risk analysis to determine critical and non-critical parameters, components, subsystems and controls

8 DQ (Design Qualification) Documented evidence that the premises, supporting systems, utilities, equipments and processes have been designed in accordance with the requirements of GMP. IQ (Installation Qualification) The performance of test to ensure that the installation (such as machine, premises, manufacturing area, etc) used in manufacturing process are appropriately selected and correctly installed and operate in accordance with establish specification. OQ (Operational Qualification) Documented verification that the system or subsystem performs as intended over all anticipated operating ranges. PQ (Performance Qualification) Documented verification that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods. 8

9 HVAC Qualification (3) 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

10 HVAC Design conditions and normal operating ranges set to achievable limits OOS results recorded –

11 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

12 HVAC Qualification (4) 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)

13 HVAC Qualification (5) Typical parameters to be included in qualification (based on risk assessment) (2): Room clean-up rate Particulate matter, microbial matter (viable and non- viable) HEPA filter penetration tests Containment system velocity Warning/alarm systems

14 HVAC Qualification (6) Conduct of the tests: Time intervals and procedure to be defined by the manufacturer Influenced by the type of facility and level of protection See also ISO for methods of testing Requalification, and change control – ,

15 HVAC Qualification (7) 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

16 Test procedure* and key aspects Maximum time interval ObjectiveTest Parameter Particle counter. Readings and positions 6 months or 12 months depending on Class Verifies cleanlinessParticle count test Measure pressure difference 12 monthsAbsence of cross- contamination Air pressure difference Measure supply and return air, calculate air change rate 12 monthsVerify air change rates Airflow volume Velocity measurement 12 monthsVerify unidirectional airflow and or containment condition Airflow velocity HVAC Schedule of tests to demonstrate continuing compliance * 8. Table 3 *Test procedure as per ISO 14644

17 HVAC Recommended optional strategic tests *Test procedure as per ISO Test procedure* and key aspects Maximum time interval ObjectiveTest Parameter Filter media and filter seal integrity 12 monthsVerify filter integrityFilter leakage Airflow direction and pressure differential 12 monthsVerify absence of cross-contamination Containment leakage Time taken maximum 15 minutes 12 monthsVerify clean-up timeRecovery (time) Airflow direction, documented evidence 12 monthsVerify required airflow patterns Airflow visualization 8. Table 3 *Test procedure as per ISO 14644

18 C LEANROOM MONITORING PROGRAM (1) 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 HVAC 18

19 C LEANROOM MONITORING PROGRAMME (2) P ARTICLES AND M ICROBIOLOGICAL CONTAMINANTS 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 of cleanliness zone/class HVAC See also ISO

20 air Example of a sampling point Cleanroom monitoring program (3) Cleanrooms should be monitored for microorganisms and particles HVAC 20

21 D EFINITION OF C ONDITIONS air as built air at restin operation HVAC 21

22 Q UALIFICATION – EXAMPLES OF ASPECTS TO CONSIDER IN QUALIFICATION (OQ, PQ) Test Differential pressure on filters Turbulent / mixed airflow Description Uni-directional airflow / LAF Room differential pressure Airflow velocity / uniformity Airflow volume / rate Parallelism Airflow pattern 22 N/A2, 3 Optional 22 2N/A 23 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) HVAC 22

23 Test Turbulent / mixed airflow Description Uni-directional airflow / LAF Recovery time Room classification (airborne particle) Temperature, humidity N/A2 22,3 N/A2,3 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) HVAC Q UALIFICATION – EXAMPLES OF ASPECTS TO CONSIDER IN QUALIFICATION (OQ, PQ)

24 HVAC Maintenance Procedure, programme and records for planned, preventative maintenance e.g. cleaning of filters, calibration of devices Appropriate training for personnel Change of HEPA filters by suitably trained persons Impact of maintenance on: Product quality Qualification –

25  Verification of design documentation, including description of installation and functions specification of the requirements  Operating procedures  Maintenance instructions  Maintenance records  Training logs  Environmental records  On site verification (walking around the site) Inspecting the air-handling system HVAC 25

26 Air-handling systems:  Play a major role in the quality of pharmaceuticals and other biological products.  Should be designed properly, by professionals.  Should be treated as a critical system. Conclusion HVAC 26

27 T HANK YOU Any Question??? 27


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