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Qualification of HVAC systems Tony Gould
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Qualification of HVAC systems
Tony Gould
2 |PQ Workshop, Abu Dhabi | October 2010
WHO referenceWHO reference
WHO Technical Report Series, No. 937, 2006 - Annex 2
"Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning
systems for non-sterile pharmaceutical dosage forms"
Comprehensive guide
May also be applied to other dosage forms
Not intended to be prescriptive – risk principles apply
3 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
Objectives
To understand key issues in
commissioning,
qualification and
maintenance of HVAC systems8.
4 |PQ Workshop, Abu Dhabi | October 2010
• 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
• program and records
Documentation requirements to assist in commissioning, qualification and maintenance
HVAC
5 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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
6 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
Commissioning (2)
Records and data maintained include:
Installation records – documented evidence of measure capacities of the system
Data: Design and measurement for e.g. air flow, system pressures
O&M manuals, schematic drawings, protocols, reports
7 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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, 2006, Annex 4.
Risk based approach for HVAC qualification
8 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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, sub-systems and
controls
9 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
A C TIO N LIM IT
A LERT LIM ITA LERT LIM IT
A C TIO N LIM IT
O perating Range - Validated Acceptance Criteria
Norm al O perating Range
Design Condition
11 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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
12 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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
13 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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
Re-qualification, and change control
14 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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)
15 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
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
16 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
Schedule of tests to demonstrate continuing compliance
*Test procedure as per ISO 14644
Test ParameterObjectiveMaximum time interval
Test procedure* and key aspects
Particle count testVerifies cleanliness6 months or 12 months depending on Class
Particle counter. Readings and positions
Air pressure difference
Absence of cross-contamination
12 monthsMeasure pressure difference
Airflow volumeVerify air change rates
12 monthsMeasure supply and return air, calculate air change rate
Airflow velocityVerify unidirectional airflow and or containment condition
12 monthsVelocity measurement
17 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
Recommended optional strategic tests
*Test procedure as per ISO 14644
Test ParameterObjectiveMaximum time interval
Test procedure* and key aspects
Filter leakageVerify filter integrity12 monthsFilter media and filter seal integrity
Containment leakageVerify absence of cross-contamination
12 monthsAirflow direction and pressure differential
Recovery (time)Verify clean-up time12 monthsTime taken maximum 15 minutes
Airflow visualizationVerify required airflow patterns
12 monthsAirflow direction, documented evidence
18 |PQ Workshop, Abu Dhabi | October 2010
Cleanroom monitoring program (1)
Routine monitoring program as part of quality assurance
Additional monitoring and triggers e.g.
Shutdown Replacement of filter elements Maintenance of air handling systems Exceeding of established limits
HVAC
19 |PQ Workshop, Abu Dhabi | October 2010
Cleanroom monitoring program (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
20 |PQ Workshop, Abu Dhabi | October 2010
air
Example of a sampling point
Cleanroom monitoring program (3)
Cleanrooms should be monitored for micro-organisms and particles
HVAC
21 |PQ Workshop, Abu Dhabi | October 2010
Definition of Conditions
air
as built
air air
at rest in operation
HVAC
22 |PQ Workshop, Abu Dhabi | October 2010
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
Air flow 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)
HVAC
23 |PQ Workshop, Abu Dhabi | October 2010
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)
24 |PQ Workshop, Abu Dhabi | October 2010
HVACHVAC
Maintenance
Procedure, program 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 |PQ Workshop, Abu Dhabi | October 2010
• 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
HVAC
26 |PQ Workshop, Abu Dhabi | October 2010
HVAC and Quality Risk ManagementHVAC and Quality Risk Management
What about risk assessment/risk management in HAVC systems?
Recommended risk assessment prior to qualification
Design requirements
Qualification (GMP) vs GEP
Ongoing performance
Ongoing maintenance
27 |PQ Workshop, Abu Dhabi | October 2010
HVAC and Quality Risk ManagementHVAC and Quality Risk Management
Type of products and materials
Product range
Campaign
Cleaning
Design, age, changes
Monitoring results (OOLs)
28 |PQ Workshop, Abu Dhabi | October 2010
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
HVAC
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