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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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