hvac5_0506

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MCC PRESENTATION - GMP MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTSMANUFACTURING ENVIRONMENTS

Presented by :Presented by :

Deryck Smith Consulting Deryck Smith Consulting EngineersEngineers

Module 5

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GMP Manufacturing EnvironmentsGMP Manufacturing Environments

Air Handling SystemsAir Handling Systems

HVAC SystemsHVAC Systems HHeatingeating

VVentilationentilation

AAir ir CConditioningonditioning

Module 5: Validation, Qualification Module 5: Validation, Qualification

& Maintenance& Maintenance

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Validation / Qualification of HVAC Validation / Qualification of HVAC SystemsSystems

Topics for this Module:

1. The definition and need for validation of HVAC Systems

2. A qualification approach for HVAC Systems3. Retrospective qualification4. Inspection of HVAC Systems5. Maintenance of HVAC Systems

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The documented act of proving that any procedure, process, equipment, material, activity or system, actually leads to the expected results.

Definition of Validation :

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PIC/S Definition 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 Qualification Validation or Qualification of a HVAC System ?of a HVAC System ?

Qualification :

The action of proving that any equipment works correctly and actually leads to the

expected results.

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Validation or Qualification Validation or Qualification of a HVAC System ?of 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 Qualification / Validation IssuesIssues

A good design is essential, but it has to be complemented by:

Qualification of air handling systems

Process validation

Maintenance and periodic re-qualification

Adequate documentation

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A Qualification approach for HVAC A Qualification approach for HVAC systemssystems

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 A Qualification approach for HVAC SystemsSystems

A Validation Master Plan

Design Qualification

User requirement document

Installation Qualification

Operational Qualification

Performance Qualification

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A Qualification approach for HVAC A Qualification approach for HVAC

systemssystems

Qualification requires :

1. Collaboration of experts

2. Budget

3. Planning

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A Qualification approach for HVAC A Qualification approach for HVAC systemssystems

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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Critical vs non-critical systems :

(Risk or Impact assessment)

Impact assessment

Critical component

Non-critical component

ISPE Definition: Impact assessment is the process by 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 ComponentsCritical Components

• A critical component within a system A critical component within a system where the operation, contact, data, where the operation, contact, data, control, alarm or failure will have a control, alarm or failure will have a direct impact on the quality of the direct impact on the quality of the product.product.

• Eg. Supply air fan in an AHU, HEPA Eg. Supply air fan in an AHU, HEPA filters, HVAC control system. filters, HVAC control system.

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Non-critical ComponentsNon-critical Components

• A non-critical component within a A non-critical component within a system where the operation, contact, system where the operation, contact, data, control, alarm or failure will data, control, alarm or failure will have an in-direct, or no impact on have an in-direct, or no impact on the quality of the product.the quality of the product.

• Eg. Main facility chiller, Eskom high Eg. Main facility chiller, Eskom high tension transformer on site. tension transformer on site.

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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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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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• Validation policyValidation policy• Organizational structure of validation activitiesOrganizational structure of validation activities• Summary of facilities, systems, equipment Summary of facilities, systems, equipment

and processes to be validatedand processes to be validated• Documentation format to be used for Documentation format to be used for

protocols and reportsprotocols and reports• Planning and schedulingPlanning and scheduling• Change controlChange control• References to existing documents References to existing documents

The Validation Master PlanThis document should contain :

Ref : PIC/S Annex.15

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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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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 thoroughly executed DQ process ensures the following :

Compliance with GMP’s 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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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 design layouts detailed in the DQ and what has been constructed (‘As-built” status)

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IQ should include, but not be limited to the following :

a) Installation of equipment, piping, services and instrumentation checked against current engineering drawings and specifications

b) Collection and collation of supplier operating and working instructions and maintenance requirements

c) Calibration of measuring instruments requirements

d) Verification of materials of construction


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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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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 process A thoroughly executed IQ process ensures the following :ensures the following : A fully verified installation that complies with A fully verified installation that complies with

the documented design. (all deviations will the documented design. (all deviations will have been recorded and assessed.)have been recorded and assessed.)

All equipment documentation and All equipment documentation and maintenance requirements would be maintenance requirements would be documented.documented.

Completed calibration of measuring Completed calibration of measuring instruments.instruments.

Materials of construction would have been Materials of construction would have been verified. verified.

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Operational Qualification Operational Qualification (OQ)(OQ)• The purpose of OQ is to verify and The purpose of OQ is to verify and

document that an HVAC system document that an HVAC system provides acceptable operational provides acceptable operational control under “at-rest” conditions.control under “at-rest” conditions.

• ISPE definition : The purpose of OQ is ISPE definition : The purpose of OQ is to establish, through documented to establish, through documented testing, that all critical components are testing, that all critical components are capable of operating within established capable of operating within established limits and tolerances. limits and tolerances.

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Operational control / operation within established Operational control / operation within established limits and tolerances can be demonstrated by any limits and tolerances can be demonstrated by any of the following :of the following :

Ability to maintain temperature, relative Ability to maintain temperature, relative humidity and pressure set points.humidity and pressure set points.

Ability to provide air of sufficient quality Ability to provide air of sufficient quality and quantity to ensure achievement of and quantity to ensure achievement of specified cleanroom conditions.specified cleanroom conditions.

Ability to maintain any critical parameters Ability to maintain any critical parameters stated in the DQ consistently. stated in the DQ consistently.

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Operational Qualification should Operational Qualification should include, but not be limited to the include, but not be limited to the following :following :

• Tests that have been developed from Tests that have been developed from knowledge of processes, systems and knowledge of processes, systems and equipment.equipment.

• Tests to include a condition or a set of Tests to include a condition or a set of conditions encompassing upper and lower conditions encompassing upper and lower operating limits, sometimes referred to as operating limits, sometimes referred to as ‘worst case’ conditions. ‘worst case’ conditions.


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Practical aspects of OQ :Practical aspects of OQ :– IQ reports must be completed and signed off.IQ reports must be completed and signed off.– OQ protocols to be written and approved prior to OQ protocols to be written and approved prior to

completion.completion.– Measurement reports are required to demonstrate Measurement reports are required to demonstrate

achievement of critical parameters as detailed in DQ.achievement of critical parameters as detailed in DQ.Eg:Eg: * * Temperature measurement reportTemperature measurement report

* Humidity measurement report* Humidity measurement report* Differential pressure measurement report* Differential pressure measurement report* Air flow direction measurement report * Air flow direction measurement report * Room particle count measurement report* Room particle count measurement report* All drawings etc. – done in ‘as-built’ status* All drawings etc. – done in ‘as-built’ status* All maintenance/ cleaning instructions available* All maintenance/ cleaning instructions available* All O & M staff to be trained to use and maintain the HVAC * All O & M staff to be trained to use and maintain the HVAC

system. system.

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• The purpose of PQ is to verify and The purpose of PQ is to verify and document that an HVAC system provides document that an HVAC system provides acceptable operational control under ‘ full acceptable operational control under ‘ full operational ‘ conditions.operational ‘ conditions.

• PQ verifies that over time, the critical PQ verifies that over time, the critical parameters , as defined in the DQ are parameters , as defined in the DQ are being achieved.being achieved.

• PQ should follow successful completion of PQ should follow successful completion of IQ and OQ. IQ and OQ.

PERFORMANCE QUALIFICATION ( PQ)

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• Tests, using production materials, Tests, using production materials, qualified substitutes or simulated qualified substitutes or simulated product, that have been developed product, that have been developed from knowledge of the process and from knowledge of the process and facilities, systems or equipment.facilities, systems or equipment.

• Test to include a condition or set of Test to include a condition or set of conditions encompassing upper conditions encompassing upper and lower operating limits. and lower operating limits.

PQ should include , but not be limited to the following:-

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• PQ is used to demonstrate consistent PQ is used to demonstrate consistent achievement of critical parameters achievement of critical parameters over time. ( under manufacturing over time. ( under manufacturing conditions)conditions)

• PQ is ongoing.PQ is ongoing.• PQ and OQ tests are sometimes PQ and OQ tests are sometimes

performed in conjunction with one performed in conjunction with one another. another.

Practical aspects of PQ:

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• PQ tests can consist of the PQ tests can consist of the following :-following :-

Air flow direction testsAir flow direction testsRoom pressure testsRoom pressure testsRoom temperature monitoringRoom temperature monitoringRoom relative humidity monitoringRoom relative humidity monitoringRoom particle monitoringRoom particle monitoringMicrobiological monitoring Microbiological monitoring

Practical aspects of PQ (cont.) :

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Retrospective qualificationRetrospective qualification

• What happens when a detailed DQ, IQ and PQ What happens when a detailed DQ, IQ and PQ process has not been performed ?process has not been performed ?

• Evidence should be available (or prepared), to Evidence should be available (or prepared), to support and verify the operating parameters support and verify the operating parameters and limits for the critical variables of the and limits for the critical variables of the operating equipment. Additionally, the operating equipment. Additionally, the calibration, cleaning, preventative calibration, cleaning, preventative maintenance, operating procedures and maintenance, operating procedures and operator training procedures and records operator training procedures and records should be documented. ( PIC/S Annex 15)should be documented. ( PIC/S Annex 15)

• Basically only OQ and PQ is carried out.Basically only OQ and PQ is carried out.

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Inspection of HVAC SystemsInspection of HVAC Systems

Check that the manufacturer has :Check that the manufacturer has :• A VMP and a multi-functional team A VMP and a multi-functional team

for validationfor validation• A planned approach with defined A planned approach with defined

requirementsrequirements• Identified and described processesIdentified and described processes• An analysis of the amount of An analysis of the amount of

validation work to perform validation work to perform

Inspector’s checklist for validation :

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Check that the manufacturer has :Check that the manufacturer has :

• Selected methods & tools for Selected methods & tools for validationvalidation

• Created protocols for execution of the Created protocols for execution of the workwork

• Performed DQ, IQ, OQ, PQ and Performed DQ, IQ, OQ, PQ and documented the resultsdocumented the results

• Exerted change control Exerted change control

Inspector’s checklist for validation (cont.) :

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Check that the manufacturer has :Check that the manufacturer has :

• Authentic electronic records & Authentic electronic records & signaturessignatures

• Operating & Maintenance ManualsOperating & Maintenance Manuals

• ““As-built” drawings of the ECS (HVAC As-built” drawings of the ECS (HVAC System)System)

• Schematic layout of the ECS (NB)Schematic layout of the ECS (NB)• Maintenance schedules Maintenance schedules

Inspector’s checklist for validation (cont.) :

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Maintenance of HVAC Maintenance of HVAC systemssystems

• The validation process should ensure The validation process should ensure that all maintenance information is that all maintenance information is obtained prior to the handover and obtained prior to the handover and use of the system.use of the system.

• The validation process should ensure The validation process should ensure that preventative and planned that preventative and planned maintenance are put into practice. maintenance are put into practice.

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Maintenance of HVAC Maintenance of HVAC systemssystems

• HVAC systems will not achieve the HVAC systems will not achieve the required critical parameters.required critical parameters.

• Correct air flows may not be guaranteedCorrect air flows may not be guaranteed

• Correct room temperature and relative Correct room temperature and relative humidities may not be achieved.humidities may not be achieved.

• Room cleanliness can be compromisedRoom cleanliness can be compromised• Cross contamination could be promoted Cross contamination could be promoted

instead of being prevented. instead of being prevented.

What happens when maintenance is done poorly or not at all ?

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Validation, Qualification and Validation, Qualification and MaintenanceMaintenance

• Qualification is a quality toolQualification is a quality tool

• A planned risk assessment based activity A planned risk assessment based activity consisting of DQ, IQ, OQ and PQ.consisting of DQ, IQ, OQ and PQ.

• Expensive and time consumingExpensive and time consuming

• Requires the manufacturer to assess Requires the manufacturer to assess which systems are critical and which are which systems are critical and which are less critical.less critical.

• Used to demonstrate that the systems are Used to demonstrate that the systems are under control. under control.

Summary

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AirflowAirflowMeasuremenMeasurementt

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Presenter contact details:Presenter contact details:

Deryck Smith Consulting Engineers Inc,Deryck Smith Consulting Engineers Inc,

PO Box 39853, PO Box 39853,

Faerie GlenFaerie Glen,, Pretoria, 0043 Pretoria, 0043

Tel 27 12 991-4010Tel 27 12 991-4010

Fax 27 12 991-7791Fax 27 12 991-7791

Cell 27 82 564-5330Cell 27 82 564-5330E-mail: [email protected] Web site: www.dsce.co.za

Questions & Answers

http://www.dsce.co.za/



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