Post on 17-Oct-2014
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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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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
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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 ….
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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
4-20 mA signal cable
Air velocity Sensor
Air Current
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 Velocity Sensor Installation Air Velocity Sensor Installation
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Molding
IDAS
4-20 mA signal cable
Deferent
Pressure Sensor
High
Low
Model : Different Pressure Sensor
1. Power : 15VDC
2. Range : -6.35 ~ 6.35 mmH20
3. Output : 4 to 20mA
4. Connection Method- Sensor Sensor 4-20mA: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
Pressure AI: 39Temperature AI: 18
Humidity: 12
Building 3
Pressure AI: 39Temperature AI: 18
Humidity: 12
Building 4
Pressure AI: 39Temperature AI: 18
Humidity: 12
Building 5
Pressure AI: 39Temperature AI: 18
Humidity: 12
Building 6
Pressure AI: 39Temperature AI: 18
Humidity: 12
Building 7
Pressure AI: 39Temperature AI: 18
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?
End Slide