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Common Problems in EMS Qualification
Alan Loughlin, 25 July 2017
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Agenda
Background
The Importance of URS
Aspects to consider when specifying EMS requirements
Case Study
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Current Landscape
Environmental monitoring is a critical program in ensuring product quality.
Separation of Building Management Systems from Environmental Monitoring Systems
Must have capability to access accurate and complete records throughout the record-retention period as required by FDA 21 CFR Part 11 and EU GMP Annex 11
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EMS Regulatory Citations
“Qualification, monitoring and control of the ambient temperature and accelerated stability rooms is inadequate..” (211.166)
“No evidence that your firm investigated temperature failures that occurred for the incubators and refrigerators” (211.22(a))
“Failure to establish and maintain procedures for monitoring and control of processes to ensure that the specified requirements continue to be met” (820.75)
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The importance of URS
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User Requirement Specification (URS)
• Arguably the most important document in successful validation exercises
• URS’s includes all musts that users require and includes a lists of wants that are desirable
• The final system should be built against the URS
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URS - The Starting Point of a Project
GAMP 5 A Risk-Based Approach to Compliant GXP Computerised Systems. Copyright ISPE 2008. All rights reserved
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Who Writes the URS?
• The regulated company should always write the URS.
• Avoid delegating ownership to an external party. This may result in requirement's that don't satisfy the business’ needs.
• Subject Matter Expert involvement is crucial.
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URS
The URS must be a regulated company responsibility
A URS can act as a tender document, particularly for category 4 and 5 systems
Category 3 software may feature known solutions and suppliers and this may form the basis of the URS
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Methods of Monitoring
Various monitoring methods can be employed, each posing different risks and costs of ownership
These include:
• Chart Recorders
• Stand alone Data Loggers
• Wired networked Data Loggers
• Wireless Data Loggers
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Wired or Wireless loggers?
The answer depends on several factors including a given facility’s network, the physical layout and resultant wireless range, and where the datalogger is to be installed.
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Chart Recorder
Risk Risk Rating
Power Loss Moderate
Human Error High
Data Security High
NetworkDowntime
Low
Training Gaps (IT)
Low
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Standalone Data Logger
Risk Risk Rating
Power Loss Moderate
Human Error High
Data Security Low
NetworkDowntime
Low
Training Gaps (IT)
Low
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Wired
Risk Risk Rating
Power Loss Low
Human Error Lowest
Data Security Low
NetworkDowntime
Low
Training Gaps (IT)
Low
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Wired – Power Over Ethernet
Risk Risk Rating
Power Loss Low
Human Error Lowest
Data Security Low
NetworkDowntime
Low
Training Gaps (IT)
Low
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Wireless Sensors – Driving Factors
The major factors for driving adoption of wireless networking:
• Ease of installation
• reduction in cabling cost,
• ability to measure in inaccessible areas
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Wireless WiFi
Risk Risk Rating
Power Loss Low / Moderate
Human Error Low / Moderate
Data Security Moderate
NetworkDowntime
Low
Training Gaps (IT)
Low
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Continuously Improving
Better signal strengths & penetration, reduced interference
Self-deploying “Ready-to-use” devices
Self-healing functions such as automatic recovery, reconnection and data backfill
Intuitive setup with minimal network administration experience required
Browser-based access
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Wireless Mesh
Risk Risk Rating
Power Loss Low / Moderate
Human Error Moderate
Data Security Low
NetworkDowntime
Low
Training Gaps (IT)
Moderate
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Define Your Alarms
Environmental Measurement types (temperature, humidity etc.) will behave and alarm in different ways
Need to consider:
• Typical Frequency of Occurrence
• Typical Magnitude
• Typical Duration
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Alarm Considerations
Alarm Condition Frequency of Occurrence
Magnitude Duration
Room high/ low temperatures
Rare Low Short
Room high/ low humidity
Infrequent Low Moderate
Freezer high temperature
Very Rare Variable Long
Refrigerator high / low temperature
Rare Low Short
CO2 Incubator high / low concentration
Common Low Short
Room high / low differential pressure
Common Low Very Short
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Case Study
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Nuisance Alarms
• GMP facility
• Comprising of 10 cleanrooms
• Approx. 250 loggers and sensors
• > 10,000 alarms / warnings per day
• Alarms become largely ignored due to high volume
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Rapid Pressure Fluctuation and Spikes
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How Widespread is the Problem?
Localised to certain rooms / areas?
Associated with any operations or time of day?
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What are the Options?
Increase Sample frequency
Sensor replacement or enhancements
Review measurement and alarm philosophy
Alarm delays
Increase alarm limits
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Room Pressure Measurement
The system is monitoring room pressure
Room pressure measured calculated against a zero reference point
Affected by changeable nature of atmospheric pressure
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Good Manufacturing Practice
• A filtered air supply should maintain a positive pressure and an air flow relative to surrounding areas of a lower grade under all operational conditions and should flush the area effectively. Adjacent rooms of different grades should have a pressure differential of 10-15 pascals (guidance values).
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Measure relative to adjoining room
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Differential Pressure Analysis
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Root Cause
Monitoring requirement poorly specified in URS
Software change implemented
Marked reduction in alarms
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Time Synchronisation and Accuracy
• EMS typically comprises of
a number of distributed
units where each unit has
its own internal clock
• Time synchronisation is
crucial to ensure accurate
time and date stamps to a
known clock source
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EMS and Part 11
Data Logging is a key requirement of an EMS system.
21 CFR 11 requires that logged data will be tamper proof and will include critical environmental parameters
• Temperature, humidity, differential pressure, particulate sizes etc.
• Accurate time and date stamps
• Alarms and events
• User actions and details (e.g. setpoint changes)
• User notes
• Electronic Signatures
• Login / Logout
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ANY QUESTIONS?
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