An Eurotherm HVAC

Automation & Validation of A HVAC System

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Eurotherm Life Sciences Group

Only Invensys…Only Invensys…

…can deliver leading brand solutions, from the production line to the bottom line.

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The Life Science Solution Provider

• Specialist Life Science Team with validation expertise

• Global expertise, local supply and support

• Rapidly delivering solutions with optimum ROI

• Over 35 years’ experience

• Scalable Data Management & Automation Solutions

• Cost effective solutions

• Total Life Cycle support

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Life Science Applications

Some of Our applications:

• Reaction Vessels • Fermentation• Freeze Drying• Building Management Systems• Environmental Monitoring

Systems• Autoclave Control• Spray Dryer Control• Clean Steam• Purified Water/ WFI• Equipment Sterilisation• Mixers and Blenders• Tank Farm• Pressure/Ph/Temperature/Flow

Control• Many more ….

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HVAC System Components

Source: Commercial Energy Systems

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HVAC System Components

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BMS VS EMS

• Building Management System• New Plant

• Control Of Key Critical Parameters

Temperature, Humidity, Pressure, Particle • Monitoring Key Critical Parameters

• Generating Reports

• Environmental Monitoring System• Existing HVAC System

• Monitoring Key Critical Parameters

• Generating Reports

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Why Automation?

• Provide accurate & reliable control

• Continuous logging of all critical parameters, more frequent and doesn’t rely on the operator

• Help to support regulatory requirement by generating reports for inspection

• Provide alarm for critical parameters, reduce human errors

• Improve Efficiency by controlling the energy consumption

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Report Format (1/2)Sample Data/time Report Warehouse Daily Report

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Report Format (2/2)Monthly Report Weekly Report

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Particle and Environmental Sensor

Typical Sensors:

1) Temp & Humidity

Sensor

2) Air velocity Sensor

3) Different Pressure

Probe

4) Particle Sensor

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IDAS

Molding

4-20 mA signal cable

Temp Sensor

Air Current

Temp & Humidity Sensor1. Power : 24VDC

2. Range : -20 ~ 80Deg C

0~100%RH

3. Output : 4 to 20mA

4. Connection Methods

- Sensor 2500 I/O : 4-20mA

5. Utility Required

- 4-20mA Signal Cable

- Install Bracket

6.Sensor Location

- Low point on a Filter

Temp & Humidity InstallationTemp & Humidity Installation

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IDAS

Molding


Air velocity Sensor

Air Current

Air Velocity Sensor

1. Power : 24VDC

2. Range : 0 -1 m/sec


4. Connection Method

- Sensor 2500 I/O : 4-20mA

5. Utility Required

- 4-20mA Signal Cable

- Install Bracket

6. Air Velocity Sensor Location

- Below the Filter

Air Velocity Sensor Installation Air Velocity Sensor Installation

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Molding

IDAS


Deferent

Pressure Sensor

High

Low

Model : Different Pressure Sensor

1. Power : 15VDC

2. Range : -6.35 ~ 6.35 mmH20


4. Connection Method- Sensor Sensor 4-20mA:2500 I/O

5. Probe Installation

- High Pressure Zone connect to High

6. Sensor Location

- Wall of Room Door

- Line between High Class and Low Class

Different Pressure Installation Different Pressure Installation

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Door Gate Sensor

Particle Sensor Installation Particle Sensor Installation

S am pleIn le t P ort

E xhaust P ort

In le t P ressureS ensor

D iffe ren tia lP ressure S ensor

A m bien tP ressureS ensor

A tm osphere

LASAIR IISam ple Cham ber

Flow Control & Particle counter

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E-Suite

HP5100N

Hub

LTH1 LTH2 LTH3 LTH4 LTH5 LTH6 LTH7

LDP1 LDP2 LDP3 LDP4 LDP5 LDP6 LDP7 LDP8

3100#1 3100#2 3100#3 3100#4 3100#5 3100#6 3100#7 3100#8 3100#9

10Base-T

Temperature/Humidity Sensor

Differential Pressure Sensor

Particle Count

T800 Visual Supervisor

Ethernet

RS-485

Laser Printer

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NOTA BENEIl presente schema a blocchi è da intendersi PROVVISORIO e può essere soggetto a revisione o modifica in fase di realizzazione.

Rete di Processo

Chiron S.p.A.- HE21048 ver.1 HVAC Alarm management

WorkstationServer 2

WorkstationClient 1

Building 1

Pressure AI: 39Temperature AI: 18

Humidity: 12

2500

Rete Ethernet di Stabilimento.

WorkstationServer 1

WorkstationClient 2

2500

WorkstationClient 3

2500

WorkstationClient 4

2500

WorkstationClient 5

2500

WorkstationClient 6

2500

WorkstationClient 7

2500

Hardware stazioni operatore non previsto in fornitura

Building 2


Humidity: 12

Building 3


Humidity: 12

Building 4


Humidity: 12

Building 5


Humidity: 12

Building 6


Humidity: 12

Building 7


Humidity: 12

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Poste visu

Poste visuPoste visu

Poste serveurRedondant

Développementavec Visu et Base SQL

Runtimeavec Visu en option

Racks T2550 Panels Eycon 10

Switchs Ethernet

Réseau MonitoringEthernet

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HVAC Validation Discussion Topics

• Definitions

• Validation Target Factors

• BAS Validation considerations

• GAMP Lifecycle approach

• Validation Master Plan

• Change Control

• V-Model

• User Requirements

• Functional Design

• IQ, OQ and PQ

• Maintenance

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HVAC Qualification and Validation• FDA Regulations ensure products are safe for sale to the

public which includes validation of:

• Computer Systems controlling the process

• HVAC systems that provide the tempered environment around these processes

• Room air can effect the product

• RISK TO PATIENT

• Some 483 items regarding HVAC systems

• Record Keeping

• Maintenance and Testing procedures not followed

• Alarm Responses

• Performance Issues

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Some 483’s from the FDA related to HVAC

• “Inability to balance rooms in classified areas during OQ. Construction staff “added” additional supply line to supervisor’s office which was not accounted for in the design specifications.”

• “Pressure inversions of environmentally classified areas (filling to capping areas).”

• “SOP for integrity testing (performed by contractor) not approved, nor available in-house.”

• “No specified life-spans for the HEPA filters.”

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Validation Target Factors• Factors that create validation target

• Interpretation of the FDA/EMEA codes

• The environmental impact to product/employees

Product Quality

Employee Safety

• Company’s internal policies

• Show “Nothing bad is going on”

• Documented HVAC parameters that affect the product

• Parameters are monitored to show they haven’t effected the product

• If parameters become out of spec

The product was discarded OR

Testing showed no adverse effect on product

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GAMP Lifecycle Approach

• URS - User Requirements Specification

• Validation Master Plan

• FS - Functional Specification

• DDS - Detailed Design Specification• HDS - Hardware Design Specification

• SDS - Software Design Specification

• DQ – Design Qualification

• FAT – Factory Acceptance Test

• SAT- Site Acceptance Test

• IQ, OQ, PQ

• On-going Operation

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Validation Master Plan (VMP)

• All inclusive plan that lists projects approach to validation

• Includes step by step approach to validation tasks

• Identifies full scope of efforts

• Provides FDA with an introduction to the facility, equipment and processes

• Most critical document in facility validation

• Living document

• Referenced and updated throughout the life cycle of the facility

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Items to include in VMP• Introduction

• Facility and Process description

• Facility layout

• Critical Utilities

• Process equipment list

• Materials and personnel flow

• Air Handler service boundaries

• Environmental Classifications

• Pressurization and differential air flow

• Project Scope

• Project Timeline

• SOPs

• Responsibilities

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Items to include in VMP (continued)

• Validation Program Overview

• Validation Cycle

• Document Flow Diagrams

• Validation Test Methods

• Maintenance of validation

• Design Review

• IQ, OQ, PQ protocols

• Process qualification protocols

• Definitions

• References

• Validation Summary

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Change Control

• Validation includes life cycle of the system

• Process must include Change Control Procedures

• Hardware and Software

• Maintenance Staff must live with Change Control Procedures

• Must include scheduling and documentation of maintenance

• Change Control should apply to:

• Documentation: URS, Functional Design etc.

• Equipment

• SOPs or manufacturing instructions

• Environmental conditions

• Any other aspect of the process system that has an effect on its state of control and state of validation

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V-Model for an HVAC SystemUser Requirements

(What HVAC Must do…

Acceptance Criteria) PQ Test Plan

Functional Design

(“How it works as

Schematic & Narrative)

Detail Design

(How to make or install)

Implementation

(Buy or Build)

Performance

Qualification

(Can we make the product?)

Operational

Qualification

(Do the systems work?)

Installation

Qualification

(Is it all there?)

OQ Test Plan

IQ Test Plan

Impact Assessment

DQ SAT

Enhanced

Design R

eview

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User Requirements• Know the Product

• At least enough to know what HVAC variables affect it

• HVAC Critical Parameters that affect Product Operation

• Temperature, RH, air quality

• Acceptance Criteria

• Facility Layout

• Requirements for each room or area

• Cleanliness Levels and classifications

• Typical responses to process or HVAC upsets

• Cleanups, lockdowns etc..

• Reliability

• Redundancy, shutdowns, actions on failure

• Identify GMP vs. Economic issues

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Functional Design• HVAC Airflow Diagram (AFD)

• Short Description of each HVAC System including:

• Areas Served

• Critical Parameters and Acceptance Criteria

• How the HVAC works and WHY

Table of Direct Impact Systems with critical parameters

• Maintenance Activities

Frequency or Schedule

Training

• Interaction/Interlocks with other HVAC systems

• Action & alert alarm points: what, who, why, when and where?

• Control System and Level of Automation

• Energy Concerns

• Safety Concerns

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Design Criteria

DesignTarget

Normal Operating Range

Normal Op Range – Validated Acceptance Criteria

Alert Point

Alert Point

AlarmActionPoint

AlarmActionPoint

Allowance

for

Instrument

error

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Design Qualification (DQ)• Design Qualification (DQ)

• Evaluates and documents the project requirements

• Evaluates and determines the user needs

• Identifies requirements and design criteria

• Identify, Evaluate, and Document

• The Projects criteria

Example: A documented method to maintain positive room pressurization in the clean room

• Project User’s’requirements

Example: 24 hr/day monitoring that allows building maintenance personnel remote, real time access to the facility controls

• HVAC Systems

Example: HVAC system must control room airflow and pressurization

• BAS

Example: Must connect to existing system

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Installation Qualification (IQ)• Ensures all elements of the system are:

• Installed per the design requirements

• All Elements installed are correct and function as intended

• Each element of the system is tested and documented

• Elements of the system include• Components

• Devices & sensors

• Programs & Application controllers

• Communication Signals

• Evaluates component identification, materials and safety features

• Includes Calibration and Loop Checks

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IQ Documents• Documentation of Checks against Design Spec

• Layout of system including rooms

• Location of Critical Parameter sensors

• HVAC arrangement vs. AF&ID

• HEPA filter and Hood map (locations)

• From Instrument and Air Handling Unit Spec

Materials in contact with cleaning agents

Material in contact with product contact air

• Duct Tests

• HEPA Filter Manufacturer Test Certification

• Installation Records for control system

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Operational Qualification (OQ)• Verifies that the HVAC System, associated equipment,

controls and monitoring systems have been tested under operating conditions

• by certified technicians using calibrated instruments

• to demonstrate that the system achieves specific environmental parameters under representative operating conditions

• Validate general operation of building BAS/DDC

• maintain the proper environmental conditions

• components and equipment can operate within the specified limits

• provides proper response to specified alarm conditions

• that peripheral instrumentation accurately measures and records critical parameters

• Validate the Calibration and control functions

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OQ Activities & Tests• HVAC Start-up Operation test

• Test all critical Parameters• Alarms, monitors, recorders

• As Balanced Air Flow Diagram• Usually from FAT test results

• Air change calculations and/or recovery tests• Include balance report

• Air Patterns

• Finalization of SOPs• Training on SOPs

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OQ Activities & Tests

• Temperature Mapping

• Storage Areas

Hot and Cold Day

• Product Exposure Sites

• Under HEPA hoods

• Differential Pressure Testing

• Room Pressure Map

• Minimum DP with one airlock door open

• Room Integrity Tests (when DP < 0.02”)

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Clean Room OQ Activities & Testing

• Gowning

• Temperature and Humidity Tests

• Recovery at Maximum Occupancy

• Clean Room testing

• HEPA Filter Leak

• Temperature and Humidity tests

• Ventilation Rate test

• Pressurization test (also Differential Pressures)

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Performance Qualification (PQ)

• HVAC System, associated equipment, controls and monitoring systems have been tested

• Under occupation conditions

• Representative of standard batching procedures

• System Operation is documented to validate• That the system performs properly as a whole

• Meets specified accuracy requirements

• Meets environmental control requirements

• Includes 72 hour trending test

• May require seasonal validation• typically 1 year in length

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PQ Activities and Tests• Critical Parameter Testing

• Are Values OK in production mode?

• “Normal” and extreme values

• Temperature and RH testing

• At climatic extremes

• Clean Room

• Ventilation Rate test

• Pressurization test (also Differential Pressures)

• Non-Viable Particle Count test

• Gown Rooms and Airlocks

Maximum People Loads

Recovery time to “at rest” conditions

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PQ Activities & Tests• Validate Frequency of Data Logging

• Frequency of logging should reflect typical rates of change of parameter

DP has rapid change

Temp and RH change slowly

• Alarms

• Establish Action Alarms

Gives engineer time to act before there is a GMP event

• Verify Alarm Time Delays

Extreme particle count in lower class room based on time to reach action levels in cleaner room

• Brownouts and Power Outage

• Time limits

• Operator Procedure

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Maintenance Activities• Keep HVAC Critical parameters within Acceptance Criteria

• Include periodic calibration of measuring devices

• Include plan for when criteria is not met

Troubleshooting

Determining effect on product

• Trend the Data

• Calibration - Usually 1x year

• Can be more frequent. Example: RH sensors

• Testing

• HEPA 2x year

• Alarms 1x year

• Air Patterns every 2-5 years

• Cleaning – Interior of Air Handling Unit and Ducts

• Don’t forget about Change Control Procedures!!

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Summary of HVAC Qualification Considerations

• Classification of HVAC Systems as GMP or non GMP systems.

• Determination of what documentation you have and what documentation you need to create before validation begins.

• Concentration of validation efforts on the areas where there is a direct product impact.

• Development of targets for differential pressure, room air changes, temperature, and humidity.

• Validation of Building Monitoring Systems that are connected to the HVAC Systems.

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Thank you for your attention!

Questions?

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