Transcript Slide 1

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.
Eurotherm Life Sciences Group
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The Life Science Solution Provider
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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:
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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
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Warehouse Daily Report
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Report Format (2/2)
Monthly Report
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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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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
2500 I/O : 4-
5. Utility Required
- 4-20mA Signal Cable
- Install Bracket
4-20 mA
signal cable
6.Sensor Location
- Low point on a Filter
IDAS
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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
Air velocity Sensor
Molding
- Sensor
2500 I/O : 4-20mA
5. Utility Required
- 4-20mA Signal Cable
- Install Bracket
6. Air Velocity Sensor Location
- Below the Filter
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
4-20mA:2500 I/O
Low
Deferent
5. Probe Installation
Pressure Sensor
High
- High Pressure Zone connect to
High
6. Sensor Location
Molding
- Wall of Room Door
- Line between High Class and Low
Class
4-20 mA
signal cable
IDAS
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Particle Sensor Installation
Flow Control & Particle counter
Sample
Inlet Port
Door Gate Sensor
LASAIR II
Sample Chamber
Exhaust Port
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Atmosphere
Inlet Pressure
Sensor
Differential
Pressure Sensor
Ambient
Pressure
Sensor
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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
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Differential Pressure Sensor
LDP1 LDP2 LDP3 LDP4 LDP5 LDP6 LDP7 LDP8
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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 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
2500
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Rete di Processo
Building 1
Building 5
Building 3
Building 4
Building 7
Building 6 Pressure AI: 39
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:
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Humidity: 12
Humidity: 12
Temperature AI: 18
Temperature AI: 18
Temperature AI: 18
Humidity:
12
Humidity: 12
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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Poste visu
Switchs Ethernet
Racks T2550
Panels Eycon 10
Poste serveur
Redondant
Développement
avec Visu et Base SQL
Runtime
avec Visu en option
Réseau Monitoring
Ethernet
Poste visu
Poste visu
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HVAC Validation Discussion
Topics
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Definitions
Validation Target Factors
BAS Validation considerations
GAMP Lifecycle approach
• Validation Master Plan
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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 System
User Requirements
(What HVAC Must do…
Acceptance Criteria)
PQ Test Plan
Functional Design
(“How it works as
Schematic & Narrative)
OQ Test Plan
Detail Design
IQ
(How to make or install) Test Plan
Performance
Qualification
(Can we make the product?)
Operational
Qualification
(Do the systems work?)
Installation
Qualification
(Is it all there?)
Impact Assessment
DQ
Implementation
(Buy or Build)
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SAT
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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 Alert Point
Alert Point
Design
Target
Normal Operating Range
Normal Op Range – Validated Acceptance Criteria
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Alarm
Action
Point
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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End Slide