Validation and Qualification of HVAC

7/28/2019 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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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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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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Qualification requires :

1. Collaboration of experts

2. Budget

3. Planning


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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 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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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



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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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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 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.



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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 designlayouts 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 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



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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 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.



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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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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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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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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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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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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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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
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Validation and Qualification of HVAC