Hvac Part3

(1)

Heating, Ventilation and

Air-Conditioning (HVAC)

Part 3:

Commissionin

g,

Qualification

,

and

maintenance

Supplementary T

raining Modules

on

Good Manufacturing Practice

(2)

HVAC

Objectives



To understand key issues in

commissioning,

qualification and

maintenance

of HVAC systems

8. 8.

(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

(4)

HVAC

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

(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, 8.1.6

(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)

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

(9)

HVAC

 Design conditions and normal operating ranges set to achievable limits  OOS results recorded 8.2.12 – 8.2.15 ACTION LIMIT ALERT LIMIT ALERT LIMIT ACTION LIMIT

Operating Range - Validated Acceptance Criteria Normal Operating Range

(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.

(11)

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)

(12)

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

(13)

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 14644 for methods of testing

 Requalification, and change control

(14)

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

(15)

HVAC

Schedule of tests to demonstrate continuing compliance

*Test procedure as per ISO 14644 _{8. Table 3}

Test p roc edure* a n d k e y a s p e c t s M ax i m u m t i m e interval Objective Test Parameter Particle counter. Readings and positions 6 months or 12 months depending on Class Verifies cleanliness Particle count test

Measure pressure difference 12 months Absence of cross-contamination Air pressure difference

Measure supply and return air, calculate air change rate 12 months

Verify air change rates Airflow volume Velocity measurement 12 months Verify unidirectional airflow and or containment condition Airflow velocity

(16)

HVAC

Recommended optional strategic tests

*Test procedure as per ISO 14644

8. Table 3 Test p roc edure* a n d k e y a s p e c t s M ax i m u m t i m e

interval Objective

Test Parameter

Filter media and filter seal integrity

12 months Verify filter integrity

Filter leakage

Airflow direction and pressure differential 12 months

Verify absence of cross-contamination Containment leakage

Time taken maximum 15 minutes

12 months Verify clean-up time

Recovery (time)

Airflow direction,

documented evidence 12 months

Verify required airflow patterns

(17)

Cleanroom 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

(18)

Cleanroom monitoring programme (2)

Particles and Microbiological

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

(19)

air

Example of a sampling point

Cleanroom monitoring program (3)

Cleanrooms should be monitored for microorganisms and

particles

(20)

Definition of Conditions

air

as built

air air

at rest

in operation

HVAC

(21)

Qualification

_–

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 2 2 N/A 2, 3 2, 3 Optional 2 2 2 N/A 2 3

1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ)

(22)

Test Turbulent /

mixed airflow Description Uni-directional

airflow / LAF Recovery time

Room classification (airborne particle)

Temperature, humidity

N/A 2 2 2,3 N/A 2,3

1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ)

HVAC

Qualification

_–

examples of aspects to consider in

qualification (OQ, PQ)

(23)

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

(24)

 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)

Inspecting the air-handling system

(25)

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

Conclusion

(26)

This series of explanations will now be followed by:



Group discussion, with a simple exercise



Short test

Further proceedings

(27)

Group Session

Service Room Warehouse A / L o c k 1 A i r L o c k 2 Air Sh ower Sampling

Rooom Service Corridor (contains Vacuum & RO water supply)

Weighing Tablet 1 Tablet 2 Liquids Mix Softgel Capsule Packing Emergency Exit Clean Corridor Equipment Wash Air Lo ck 3 Sterile eyedrops dispensing & aceptic filling

2 Stage personnel entry for eyedrops Male Change 2 Male Change 1 Female Change 1 Female Change 2 Packed Goods Quarantine Air Lo ck 4

Primary & Secondary Packing

(28)

Group Session

_–

modified layout Secondary Packing 30Pa 0Pa 20Pa 30Pa 0Pa 0Pa 10Pa 10Pa 10Pa 20Pa 20Pa 40Pa 50Pa 60Pa 50Pa 40Pa 15Pa 15Pa Primary Packing Change MAL 3 Air Lo ck 30Pa Post Staging 30Pa 30Pa 0Pa 15Pa 15Pa 20Pa 20Pa 30Pa 20Pa 0Pa 10Pa Service Room Air L ock 4 Packed Goods Quarantine Female Change 2 Female Change 1 Male Change 1 Male Change 2 PAL Sterile eyedrops dispensing & asceptic filling

MAL 4 Equipment Wash Clean Corridor Emergency Exit Softgel Capsule Packing Liquids Mix Tablet 2 Tablet 1 Weigh Booth

(contains Vacuum & RO water supply) Service Corridor Sampling Rooom Air Sh ower M A L 2 M A L 1 Warehouse

MAL = Material Air Lock