Validation and Qualification of HVAC
Transcript of Validation and Qualification of HVAC
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MCC PRESENTATION - GMPMANUFACTURING ENVIRONMENTS
Presented by :
Deryck Smith ConsultingEngineers
Module 5
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GMP Manufacturing Environments
Air Handling Systems
HVAC Systems
Heating
Ventilation
Air Conditioning
Module 5: Validation, Qualification
& Maintenance
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Validation / Qualification of HVACSystems
Topics for this Module:
1. The definition and need for validation of HVACSystems
2. A qualification approach for HVAC Systems
3. Retrospective qualification
4. Inspection of HVAC Systems5. Maintenance of HVAC Systems
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Validation / Qualification of HVACSystems
The documented act of proving that any
procedure, process, equipment, material, activity
or system, actually leads to the expected results.
Defini tion of Validation :
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Validation / Qualification of HVACSystems
PIC/S Defini tion of Validation :
Action of proving, in accordance with the principles of
Good Manufacturing Practice, that any procedure,
process, equipment, material, activity or system
actually leads to the expected results.
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Validation or Qualificationof a HVAC System ?
Qualification :
The action of proving that any equipmentworks correctly and actually leads to the
expected results.
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Validation or Qualificationof a HVAC System ?
A system must be qualified to operate in a validated process
Equipment and systems are qualified
A process is validated
A number of systems make up a process
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Qualification / Validation Issues
A good design is essential, but it has to becomplemented by:
Qualification of air handling systems
Process validation
Maintenance and periodic re-qualification
Adequate documentation
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A Qualification approach for HVAC systems
Key Definitions :
DQ - Design Qualification
IQ - Installation Qualification
OQ - Operational Qualification
PQ - Performance Qualification
VMP - Validation Master Plan
GEP - Good Engineering Practice
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A Qualification approach for HVAC Systems
A Validation Master Plan
Design Qualification
User requirement document
Installation Qualification
Operational Qualification
Performance Qualification
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A Qualification approach for HVAC systems
Qualification requires :
1. Collaboration of experts
2. Budget
3. Planning
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A Qualification approach for HVAC systems
Planning :
Which systems are critical / non-critical ? (Risk assessment)
Direct or indirect impact (ISPE)
Which aspects of the system will be qualified ?
Which aspects of the system will be handled under GEP ?
These decisions have implications on the extent, cost and time
of the qualification process.
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A Qualification approach for HVAC Systems
Critical vs non-critical systems :
(Risk or Impact assessment)
Impact assessment
Critical component
Non-critical component
ISPE Definition: Impact assessment is the processby which the impact of a system on product quality
is evaluated and the critical components within
those systems are identified.
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Critical Components
A critical component within a systemwhere the operation, contact, data,
control, alarm or failure will have a directimpact on the quality of the product.
Eg. Supply air fan in an AHU, HEPA filters,
HVAC control system.
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Non-critical Components
A non-critical component within a systemwhere the operation, contact, data,
control, alarm or failure will have an in-direct, or no impact on the quality of theproduct.
Eg. Main facility chiller, Eskom hightension transformer on site.
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A Qualification approach for HVAC Systems
User Requirement
(ie. What)
Functional Design
(ie. How as schematic)
Detail Design(ie. How to make)
Implementation
InstallationQualification
Operational
Qualification
Performance
Qualification
PQ Test Plan
OQ Test Plan
(inc.FAT)
IQ Test Plan(inc.PDI)
Design
Development
Impact
Assessment
Model for Direct Impact systems
ISPE Baseline Guide Vol.5
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A Qualification approach for HVAC Systems
User Requirement
(ie. What)
Functional Design
(ie. How as schematic)
Detail Design(ie. How to make)
Implementation
Physical Completion& Inspection
Setting-to-work & Testing
Regulation & Adjustment
Performance
Testing
Commissioning Plan
(inc.FAT)
(inc.PDI)
Design
Development
Impact
Assessment
Model for Indirect Impact systems
ISPE Baseline Guide Vol.5
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A Qualification approach for HVAC Systems
Validation policy Organizational structure of validation activities Summary of facilities, systems, equipment and
processes to be validated
Documentation format to be used for protocols andreports
Planning and scheduling Change control References to existing documents
The Validation Master PlanThis document should contain :
Ref : PIC/S Annex.15
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A Qualification approach for HVAC Systems
User requirement specification (URS)
What operational requirements are there ?
Required room temperatures and relative humidities
Cleanroom classifications for the areas
Single pass or re-circulated HVAC systems ?
Room pressures / Air flow directions
GMP requirements
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A Qualification approach for HVAC Systems
DESIGN QUALIFICATION (DQ)
First step in the qualification of new HVAC
systems.
It documents the design of the system and
will include :
a) Functional Specification.
b) Technical / Performance specification for equipment.
c) Detailed Air Flow Schematics.
d) Detailed layout drawing of the system.
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A Qualification approach for HVAC Systems
A thoroughly executed DQ process ensures the following :
Compliance with GMPs and other regulatory requirements.
Design meets the user requirements.
Design details facility airflow and pressure cascade philosophy.
Design takes into account process and personnel flow (cross-contamination issues)
Design details materials of construction.
Design details safety requirements.
Full details of the intended construction prior to implementation.
Details all equipment that must be ordered.
ISPE Baseline Guide Vol.5
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A Qualification approach for HVAC Systems
Installation Qualification (IQ)
The goal of IQ is to verify and document the
quality, installation and integrity of the HVAC system.
Execution of IQ protocols provides assurance that
a HVAC system is installed in accordance with the
qualified design.
IQ should highlight discrepancies between designlayouts detailed in the DQ and what has been
constructed (As-built status)
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A Qualification approach for HVAC Systems
IQ should include, but not be limited to the following :
a) Installation of equipment, piping, services and
instrumentation checked against current engineering
drawings and specificationsb) Collection and collation of supplier operating and
working instructions and maintenance requirements
c) Calibration of measuring instruments requirements
d) Verification of materials of construction
Ref : PIC/S Annex.15
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A Qualification approach for HVAC Systems
Practical aspects of IQ :
Design drawings can be marked up and deviations highlighted.
DQ to be complete and signed off before IQ begins.
IQ protocols to be written and approved prior to implementation.
Check lists for components to be installed can be used. Items such as fans, fan
motors, cooling and heating coils, filters, temperature and relative humidity
sensors and differential pressure gauges can be included in check lists.
Duct and pipe pressure test reports.
Filter integrity tests.
Functionality Loop checks and alarm tests for HVAC control systems.
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A Qualification approach for HVAC Systems
Practical aspects of IQ (cont.) :
Calibration of measuring instruments.
Calibration of additionally used instruments.
Initial cleaning records.
Basic commissioning checks.
Maintenance requirements.
IQ process checks that the correct components are installed in the correct
location.
Materials of construction
Spare parts
Change controls
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A thoroughly executed IQ processensures the following :
A fully verified installation that complies withthe documented design. (all deviations will havebeen recorded and assessed.)
All equipment documentation and maintenancerequirements would be documented.
Completed calibration of measuring
instruments. Materials of construction would have been
verified.
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Operational Qualification (OQ)
The purpose of OQ is to verify anddocument that an HVAC system providesacceptable operational control under at-
rest conditions. ISPE definition : The purpose of OQ is to
establish, through documented testing,
that all critical components are capable ofoperating within established limits andtolerances.
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Operational control / operation within established limits andtolerances can be demonstrated by any of the following :
Ability to maintain temperature, relativehumidity and pressure set points.
Ability to provide air of sufficient quality andquantity to ensure achievement of specifiedcleanroom conditions.
Ability to maintain any critical parametersstated in the DQ consistently.
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Operational Qualification should include, butnot be limited to the following :
Tests that have been developed from knowledgeof processes, systems and equipment.
Tests to include a condition or a set ofconditions encompassing upper and loweroperating limits, sometimes referred to as worst
case conditions.
Ref : PIC/S Annex.15
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Practical aspects of OQ :
IQ reports must be completed and signed off. OQ protocols to be written and approved prior to completion.
Measurement reports are required to demonstrateachievement of critical parameters as detailed in DQ.
Eg: * Temperature measurement report
* Humidity measurement report
* Differential pressure measurement report
* Air flow direction measurement report
* Room particle count measurement report
* All drawings etc.done in as-built status* All maintenance/ cleaning instructions available
* All O & M staff to be trained to use and maintain the HVAC system.
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A Qualification approach for HVAC Systems
The purpose of PQ is to verify and documentthat an HVAC system provides acceptableoperational control under full operational conditions.
PQ verifies that over time, the criticalparameters , as defined in the DQ are being
achieved. PQ should follow successful completion of IQ
and OQ.
PERFORMANCE QUALIFICATION ( PQ)
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A Qualification approach for HVAC Systems
Tests, using production materials,qualified substitutes or simulated
product, that have been developedfrom knowledge of the process andfacilities, systems or equipment.
Test to include a condition or set ofconditions encompassing upper andlower operating limits.
PQ should include , but not be limited to the following:-
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A Qualification approach for HVAC Systems
PQ is used to demonstrate consistentachievement of critical parameters over
time. ( under manufacturing conditions) PQ is ongoing. PQ and OQ tests are sometimes
performed in conjunction with oneanother.
Practical aspects of PQ:
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A Qualification approach for HVAC Systems
PQ tests can consist of the following :-Air flow direction tests
Room pressure testsRoom temperature monitoring
Room relative humidity monitoring
Room particle monitoringMicrobiological monitoring
Practical aspects of PQ (cont.) :
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Retrospective qualification
What happens when a detailed DQ, IQ and PQprocess has not been performed ?
Evidence should be available (or prepared), tosupport and verify the operating parameters and
limits for the critical variables of the operatingequipment. Additionally, the calibration,cleaning, preventative maintenance, operatingprocedures and operator training procedures
and records should be documented. ( PIC/SAnnex 15)
Basically only OQ and PQ is carried out.
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Inspection of HVAC Systems
Check that the manufacturer has :
A VMP and a multi-functional team for
validationA planned approach with definedrequirements
Identified and described processes
An analysis of the amount of validationwork to perform
Inspectors checklist for validation :
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Inspection of HVAC Systems
Check that the manufacturer has :
Selected methods & tools for validation
Created protocols for execution of thework
Performed DQ, IQ, OQ, PQ and
documented the results Exerted change control
Inspectors checklist for validation (cont.) :
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Inspection of HVAC Systems
Check that the manufacturer has :
Authentic electronic records & signatures
Operating & Maintenance ManualsAs-built drawings of the ECS (HVAC
System)
Schematic layout of the ECS (NB) Maintenance schedules
Inspectors checklist for validation (cont.) :
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Maintenance of HVAC systems
The validation process should ensure thatall maintenance information is obtained
prior to the handover and use of thesystem.
The validation process should ensure that
preventative and planned maintenance areput into practice.
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Maintenance of HVAC systems
HVAC systems will not achieve the requiredcritical parameters.
Correct air flows may not be guaranteed Correct room temperature and relative
humidities may not be achieved.
Room cleanliness can be compromised Cross contamination could be promoted
instead of being prevented.
What happens when maintenance is done poorly or notat all ?
V lid ti Q lifi ti d
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Validation, Qualification andMaintenance
Qualification is a quality tool A planned risk assessment based activity
consisting of DQ, IQ, OQ and PQ. Expensive and time consuming Requires the manufacturer to assess which
systems are critical and which are less critical.
Used to demonstrate that the systems are undercontrol.
Summary
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AirflowMeasurement
Questions & Answers
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Presenter contact details:
Deryck Smith Consulting Engineers Inc,
PO Box 39853,
Faerie Glen, Pretoria, 0043Tel 27 12 991-4010
Fax 27 12 991-7791
Cell 27 82 564-5330E-mail: [email protected]
Web site: www.dsce.co.za
Questions & Answers
http://www.dsce.co.za/http://www.dsce.co.za/http://www.dsce.co.za/http://www.dsce.co.za/http://www.dsce.co.za/http://www.dsce.co.za/http://www.dsce.co.za/http://www.dsce.co.za/