Automation & Validation of A HVAC System

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

Eurotherm Life Sciences Group

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

Eurotherm Life Sciences Group

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 .

Eurotherm Life Sciences Group

HVAC System Components

Eurotherm Life Sciences Group

Source: Commercial Energy Systems

HVAC System Components

Eurotherm Life Sciences Group

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

Eurotherm Life Sciences Group

Why Automation?
Provide accurate & reliable control

Continuous logging of all critical parameters, more frequent and doesnt 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

Eurotherm Life Sciences Group

Report Format (1/2)

Sample Data/time Report
Warehouse Daily Report

Eurotherm Life Sciences Group

10

Report Format (2/2)

Monthly Report Weekly Report

Eurotherm Life Sciences Group

11

Particle and Environmental Sensor

Typical Sensors: 1) Temp & Humidity Sensor 2) Air velocity Sensor 3) Different Pressure Probe 4) Particle Sensor

Eurotherm Life Sciences Group

12

Temp & Humidity Installation

Temp & Humidity Sensor
Air Current

1. Power : 24VDC 2. Range : -20 ~ 80Deg C 0~100%RH 3. Output : 4 to 20mA

Temp Sensor
Molding

4. Connection Methods - Sensor 20mA 5. Utility Required - 4-20mA Signal Cable - Install Bracket 2500 I/O : 4-

4-20 mA signal cable

IDAS

6.Sensor Location - Low point on a Filter

Eurotherm Life Sciences Group

13

Air Velocity Sensor Installation

Air Velocity Sensor 1. Power : 24VDC

Air Current

2. Range : 0 -1 m/sec 3. Output : 4 to 20mA 4. Connection Method - Sensor 2500 I/O : 4-20mA

Air velocity Sensor

Molding

5. Utility Required - 4-20mA Signal Cable - Install Bracket 6. Air Velocity Sensor Location - Below the Filter

4-20 mA signal cable IDAS

Eurotherm Life Sciences Group

14

Different Pressure Installation

Model : Different Pressure Sensor 1. Power : 15VDC 2. Range : -6.35 ~ 6.35 mmH20 3. Output : 4 to 20mA
Low
Deferent Pressure Sensor

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
4-20 mA signal cable IDAS

High

Molding

- Line between High Class and Low Class

Eurotherm Life Sciences Group

15

Particle Sensor Installation

Flow Control & Particle counter
Sample Inlet Port Atmosphere Inlet Pressure Sensor

Door Gate Sensor

LASAIR II Sample Chamber

Differential Pressure Sensor

Exhaust Port

Ambient Pressure Sensor

Eurotherm Life Sciences Group

16

E-Suite
Laser Printer HP5100N 10Base-T Ethernet

Hub
Temperature/Humidity Sensor LTH1 LTH2 LTH3 LTH4 LTH5

LTH6

LTH7

Particle Count 3100#1 3100#2 3100#3 3100#4 3100#5 3100#6 3100#7 3100#8 3100#9 T800 Visual Supervisor

RS-485

Differential Pressure Sensor LDP1 LDP2 LDP3 LDP4 LDP5 LDP6 LDP7 LDP8

Eurotherm Life Sciences Group

17

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

Rete Ethernet di Stabilimento.
Hardware stazioni operatore non previsto in fornitura

Workstation Workstation Server 1 Server 2

Workstation Client 1

Workstation Client 2

Workstation Client 3

Workstation Client 4

Workstation Client 5

Workstation Client 6

Workstation Client 7

Rete di Processo

2500

2500

2500

2500

2500

2500

2500

Building 1

Building 3 Building 4

Building 5

Building 7

NOTA BENE Il presente schema a blocchi da intendersi PROVVISORIO e pu essere soggetto a revisione o modifica in fase di realizzazione.

Pressure AI: 39 Building 6 Pressure AI: 39 Pressure AI: 39 Building 2 Pressure AI: 39 Temperature AI: 18 Temperature AI: 18 Temperature AI: 18 Temperature AI: 18 Pressure AI: 39 Humidity: 12 Pressure AI: 39 Humidity: 12 Pressure AI: 39 Humidity: 12 Humidity: 12 Temperature AI: 18 Temperature AI: 18 Temperature AI: 18 Humidity: 12 Humidity: 12 Humidity: 12

Eurotherm Life Sciences Group

18

Eurotherm Life Sciences Group

Poste visu

19

Switchs Ethernet

Racks T2550

Panels Eycon 10 Poste serveur Redondant

Dveloppement avec Visu et Base SQL Runtime avec Visu en option

Rseau Monitoring Ethernet

Poste visu Poste visu

Eurotherm Life Sciences Group

20

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

Eurotherm Life Sciences Group

21

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

Eurotherm Life Sciences Group

22

Some 483s from the FDA related to HVAC

Inability to balance rooms in classified areas during OQ. Construction staff added additional supply line to supervisors 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.

Eurotherm Life Sciences Group

24

Validation Target Factors

Factors that create validation target Interpretation of the FDA/EMEA codes The environmental impact to product/employees Product Quality Employee Safety Companys internal policies Show Nothing bad is going on Documented HVAC parameters that affect the product Parameters are monitored to show they havent effected the product If parameters become out of spec The product was discarded OR Testing showed no adverse effect on product

Eurotherm Life Sciences Group

27

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

Eurotherm Life Sciences Group

28

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

Eurotherm Life Sciences Group

29

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
Eurotherm Life Sciences Group

30

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

Eurotherm Life Sciences Group

31

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

Eurotherm Life Sciences Group

32

V-Model for an HVAC System

User Requirements (What HVAC Must do Acceptance Criteria) PQ Test Plan Performance Qualification (Can we make the product?)

Functional Design (How it works as Schematic & Narrative)

OQ Test Plan

Operational Qualification (Do the systems work?)

Detail Design IQ (How to make or install) Test Plan Impact Assessment

Installation Qualification (Is it all there?)

DQ

Implementation
(Buy or Build)

SAT

Eurotherm Life Sciences Group

33

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
Eurotherm Life Sciences Group

34

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
Eurotherm Life Sciences Group

35

Design Criteria
Alarm Action Point Alert Point
Design Target Normal Operating Range

Alert Point

Alarm Action Point

Allowance for Instrument error

Normal Op Range Validated Acceptance Criteria

Eurotherm Life Sciences Group

36

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 Usersrequirements 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
Eurotherm Life Sciences Group

37

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
Eurotherm Life Sciences Group

38

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
Eurotherm Life Sciences Group

39

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
Eurotherm Life Sciences Group

40

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

Eurotherm Life Sciences Group

41

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)

Eurotherm Life Sciences Group

42

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)

Eurotherm Life Sciences Group

43

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
Eurotherm Life Sciences Group

44

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

Eurotherm Life Sciences Group

45

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
Eurotherm Life Sciences Group

46

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 Dont forget about Change Control Procedures!!
Eurotherm Life Sciences Group

Maintenance Activities

47

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.
Eurotherm Life Sciences Group

49

Thank you for your attention!

Questions?

Eurotherm Life Sciences Group

End Slide