HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

HVAC Systems and the Pharmaceutical Manufacturing Environment

Part 06: HVAC Commissioning

Mike James, Validation in Partnership

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Part 06 HVAC Commissioning - Page 1

HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Definition / Meaning

Commissioning is Part of Good Engineering Practice

Defined as
A A well well planned, planned, documented, documented, and and managed managed engineering engineering approach approach to to the the start-up start-up and and turnover turnover of of facilities, facilities, systems, systems, and equipment to the End-User that results in a safe and equipment to the End-User that results in a safe and and functional functional environment environment that that meets meets established established design design requirements requirements and and stake-holder stake-holder expectations expectations

In other words
Planning, Planning, managing managing and and documenting documenting the the start start up up and and set set up of equipment systems to demonstrate that the user up of equipment systems to demonstrate that the user requirements requirements and and design design requirements requirements have have been been met. met.

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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Objectives of Commissioning

Provided Documented Evidence

System correctly installed System correctly set-up and operating properly
Meeting Meeting design design + + user user requirements requirements

Ensure
Engineering documentation present and correct Drawings are accurate and raised to as built status

System ready for validation.

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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Importance of Commissioning [1] [1]

Historically HVAC commissioning has been weak

Often found to be poorly documented Resulted in failed validation
Incorrect Incorrect air air balancing balancing (flows (flows + + pressures) pressures) Lack of supporting manufacturers Lack of supporting manufacturers information information Rebalancing Rebalancing and and requalification requalification required required

ISPE baseline guides have helped to change emphasis

GEP incorporating good commissioning essential to support systems impact approach to validation
HEPA HEPA filters filters may may be be the the only only direct direct impact impact equipment equipment items. items.
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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Importance of Commissioning [2] [2]

Probably one of the most significant activities in the project life-cycle

Suppliers generally present and can rectify problems there and then Training of clients staff Opportunity to write and test SOPs Set-up activity that provides the environment state for validation Engineering support documentation is compiled and checked Testing that may be used in validation
DOP DOP filter filter testing testing Other??? Other???
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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Commissioning and Qualification Certainly need an integrated approach to avoid duplication of effort Very difficult to substitute all qualification testing with commissioning
Air Air and and pressure pressure balancing balancing is is an an iterative iterative process process
Would Would not not meet meet validation validation acceptance acceptance criteria criteria initially initially Require Require flexibility flexibility within within method method to to balance balance and and bring bring conditions conditions within within limits limits

Range of approaches to integration

Carry Carry out out commissioning commissioning to to validation validation documentation*** documentation*** Transpose commissioning data to validation Transpose commissioning data to validation documentation*** documentation*** Carry out validation testing immediately after Carry out validation testing immediately after commissioning commissioning set set up up and and testing testing

*** *** not not recommended recommended

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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Commissioning Activities [1] [1]

Installation checks
Equipment correctly installed
All All items items present present and and configured configured correctly correctly Air-breaks Air-breaks for for drains drains
Water Water present present in in drainage drainage loots loots (AHU) (AHU)

Belt Belt tension tension Wiring Wiring Control Control system system installation installation

Drawings correct
Mark-up Mark-up process process

Instruments and loops calibrated Utilities available and connected properly.

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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Commissioning Activities [2] [2]

Setting to work
Operation Operation of of fan fan motors motors
Ampage Ampage checks checks Belts and Belts and pulley pulley operation operation Direction Direction of of fans fans

System proving
Duct Duct work work leaks leaks Balancing of Balancing of system system
Return Return air air set-up set-up Volumetric Volumetric air air supply supply Differential Differential pressure pressure (adjusting (adjusting extracts) extracts) Laminar Laminar flow flow velocities velocities

Filter Filter integrity integrity tests tests Filter Filter DPs DPs or or pressure pressure drops drops Facility Facility lighting lighting checks checks Temperature Temperature and and humidity humidity control control set-up set-up and and testing. testing.
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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

Cleaning Stages

The following slides show the typical stages that are involved in the construction / installation of clean rooms and HVAC through to and including qualification The schematics will pay particular attention to the cleaning stages that are involved.

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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

1. Construction to Filter Installation

Clean rooms Constructed Clean during early construction, i.e. cleaning visible contamination from ceilings, walls, floors and filter mountings Prepare for air conditioning ductwork installation, i.e. cleaning dust from ductwork sections before installing Clean before mounting all filters into the system, i.e. removing deposited or settled dust from ceilings, walls and floors See Next Slide
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ISO 14644-5 Stage 3 Clean

Install HVAC Systems

Install HVAC Support Systems

ISO ISO 14644-5 14644-5 Stage Stage 4 4 Clean Clean

Introduce Positive Pressure

ISO 14644-5 Stage 5 Clean

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HVAC Systems and the Pharmaceutical Manufacturing Environment

Radisson SAS Hotel - Amsterdam 2008

2. Filter Installation to Commissioning

Mount HEPA/ULPA Filters

Clean up any contamination caused by the mounting operation

ISO 14644-5 Stage 6 Clean

IQ Clean Rooms

IQ HVAC and IMS Systems (BMS if used for CGMP data)

Certify GEP components of HVAC

Certify GEP HVAC Support Systems

ISO 14644-5 Stage 7 Clean

Adjust Adjust airairconditioning conditioning equipment, equipment, removing removing suspended suspended dust dust from from airflow airflow and and creating creating over over pressure pressure See Next Slide
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Radisson SAS Hotel - Amsterdam 2008

3. Commissioning to OQ

Commission BMS and IMS System

Commission HVAC Systems

Commission HVAC Support Systems

OQ IMS System

OQ HVAC Direct Components (if any)

ISO 14644-5 Stage 8 Clean

Upgrade Upgrade room room to to prescribed prescribed Classification Classification

Environmental OQ Testing

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Radisson SAS Hotel - Amsterdam 2008

Commissioning Documentation

Normally carried out to detailed method statement

Supported by check/test sheet templates Should be buy in by the client and vendor(s)

Should be a formal report

Approved by vendor and client

Remember
If you wish to use commissioning data for your validation
Commission Commission documentation documentation needs needs to to be be as as for for validation validation
Same Same standards standards Pre-approved Pre-approved acceptance acceptance criteria. criteria.
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Radisson SAS Hotel - Amsterdam 2008

End of Presentation
Any further questions?

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