Automation & Validation of A HVAC System

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Automation Validation of A HVAC System
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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 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

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Report Format (1/2)
Warehouse Daily Report
Sample Data/time Report
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Report Format (2/2)
Weekly Report
Monthly 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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Temp Humidity Installation
Temp Humidity Sensor 1. Power 24VDC 2. Range
-20 80Deg C 0100RH 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
Air Current
Molding
Temp Sensor
4-20 mA signal cable
IDAS
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Air Velocity Sensor Installation
Air Velocity Sensor 1. Power 24VDC 2. Range
0 -1 m/sec 3. Output 4 to 20mA 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 Current
Molding
Air velocity Sensor
4-20 mA signal cable
IDAS
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Different Pressure Installation
Model Different Pressure Sensor 1. Power
15VDC 2. Range -6.35 6.35 mmH20 3. Output 4
to 20mA 4. Connection Method- Sensor
Sensor 4-20mA2500 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
Low
Deferent Pressure Sensor
Molding
High
4-20 mA signal cable
IDAS
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Particle Sensor Installation
Flow Control Particle counter
Door Gate Sensor
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E-Suite
Laser Printer
HP5100N
Hub
10Base-T
Ethernet
Temperature/Humidity Sensor
LTH1
LTH2
LTH3
LTH4
LTH5
LTH6
LTH7
Particle Count
31008
31009
31004
31005
31006
31007
31001
31002
31003
T800 Visual Supervisor
Differential Pressure Sensor
LDP1
LDP2
LDP3
LDP4
LDP5
LDP6
LDP7
LDP8
RS-485
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Chiron S.p.A.- HE21048 ver.1 HVAC Alarm management
Rete Ethernet di Stabilimento.
Hardware stazioni operatore non previsto in
fornitura
Workstation Server 2
Workstation Client 1
Workstation Server 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 7 Pressure AI 39 Temperature AI
18 Humidity 12
Building 5 Pressure AI 39 Temperature AI
18 Humidity 12
Building 1 Pressure AI 39 Temperature AI
18 Humidity 12
Building 3 Pressure AI 39 Temperature AI
18 Humidity 12
Building 4 Pressure AI 39 Temperature AI
18 Humidity 12
Building 6 Pressure AI 39 Temperature AI
18 Humidity 12
Building 2 Pressure AI 39 Temperature AI
18 Humidity 12
NOTA BENE Il presente schema a blocchi è da
intendersi PROVVISORIO e può essere soggetto a
revisione o modifica in fase di realizzazione.
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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 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.

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Some Key Terms.

• Validation
• Qualification
• System Lifecycle
• cGMP Current Good Manufacturing Practices
• GAMP Good Automation Manufacturing Practices
• SOP Standard Operating Procedures
• BAS Building Automation System
• DDC Direct Digital Control
• AHU Air Handling Unit

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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
• 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

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Validation Considerations for BAS

• Should GMP and non-GMP systems be combined on the
  same network?
• The direction chosen effects
• Initial validation efforts AND
• How the networks will need to be maintained
• Three Options
• Combine validated and non-validated systems on
  the same BAS network
• Place validated systems on dedicated Network
  controllers all connected to common BAS network
• Provide physically separated networks for
  validated and non-validated BAS networks

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BAS networking options

• Common Networks
• One staff can manage and maintain both systems
• Change control will apply to non-validated
  systems
• Segregated Networks
• Dual operating staffs (or training in both)
• Dual graphical user interfaces
• Keeping track of what network the system is on
• Change control not required for non-validated
  networks
• Simplifies validation maintenance
• Weigh decision based on
• Operating staff capabilities
• Legacy system installations
• Complexity of validation efforts
• Use extreme caution when not validating something
  connected to a validated system!!!!

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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 System
User Requirements (What HVAC Must do Acceptance
Criteria)
Performance Qualification (Can we make the
product?)
PQ Test Plan
OQ Test Plan
Enhanced Design Review
Detail Design (How to make or install)
Installation Qualification (Is it all there?)
IQ Test Plan
Impact Assessment
SAT
DQ
Implementation (Buy or Build)
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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
Alarm Action Point
Alarm Action Point
Alert Point
Alert Point
Allowance for Instrument error
Design Target
Normal Operating Range
Normal Op Range Validated Acceptance Criteria
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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 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

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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. AFID
• 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 lt 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
• Dont 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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HVAC Control System Validation

• Standard GAMP V Model
• Form of a Network Validation
• Leverage of the SAT / FAT and equipment
  validation docs.
• Interfacing

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Thank you for your attention!

• Questions?

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End Slide