Legacy equipment considerations
Presented by Marc Fini
21 May, 2013
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Tablet Press - Legacy
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Tablet Press - Modern
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Equipment validation
A lot of equipment on the market is ‘legacy’ type equipment.
• This equipment is not necessarily novel and extensive time for improvements to be incorporated into the most recent design and build are valid considerations
• The manufacturer of the equipment has likely considered market feedback and continually improved the equipment with each new version released
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Equipment validation
Standard equipment compared with customised systems.
• Low levels of customisation are common to standard equipment
• In a validation context this may translate into more available knowledge with manufacturer and a piece of equipment
Detailed supplier knowledge
Market feedback and experience
Significantly improved risk management process
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Equipment validation
Customised systems may require a more extensive validation effort because they are unique and may not have been tested over time in the market place
Standard equipment compared with customised systems:
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Equipment validation
Commissioning, qualification and validation are the final parts of a long process
Quality by Design aspects may have been incorporated, to some extent, into the design and build of the machine
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Equipment validation
• Good Manufacturing Practice and Good Engineering Practice both aim for a common outcome.
• Quality should be achieved by good design.
• Criticality assessments are especially important. Consider the following criticality assessment criteria:
• Patient Safety
• Product Quality
• The business impact of the product and processes
• All of these items must be traceable back to the URS
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Equipment validation - suppliers
Construction, URS evaluation
Configuration, Test functions
Factory Acceptance Testing
Delivery
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Equipment validation - user
Commissioning and Qualification, Installation, Site Acceptance Testing (SAT), FAT, Training
Start production
• Ongoing operation
• Maintenance Life Plan and spare parts
• Training
Preventative and Reactive Maintenance
Change Management
Periodic Review
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Equipment validation
User and supplier cooperation is fundamental to success. Consider the following requirements:
Specifications Design Manufacture and routine operations
Qualification and
validation
Control strategy
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Equipment validation A case study
Packaging machinery validation:
• Older piece of machinery, may have been refurbished
• Exclude the printing system
• This is not a comprehensive validation of a new system but a consideration of legacy equipment and the associated validation
Jonathan Davey et al, ISPE Pharmaceutical Engineering, Volume 27, Number 3
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Equipment validation
What has an impact on patient safety and product quality?
Identify what is GxP critical within the machine
Avoid testing the software code, instead focus on functionality testing
Test the identified,
critical functionality
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The Basic ‘V’ Model
.
System Build
related to
related to
related to User
Requirements Specification
Performance Qualification
Functional Specification
Installation Qualification
Design Specification
Risk Assessment
Risk Assessment
Risk Assessment
Design Review
Operational Qualification
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Equipment validation
HMI
Label rollers,
unwinders
Speed,
tensioners,
splice
detection
Production
data,
counters
Reject
station
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Equipment validation
Key User Requirements for the labelling machine may include:
Splice detection
Run out detection
Web tensions
Speed controls
Reject functionality
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Equipment validation
• Reverse engineer the process and identify documentation gaps.
• Use the machine as the starting point.
This process will rely heavily on the knowledge and expertise of the people using the machine.
• This includes maintenance engineers and production technicians.
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Equipment validation
How to perform a GxP criticality assessment:
• Document clear descriptions and boundaries
of operation
• Detail the interfaces, so which machines are immediately next to this one?
1. Divide the machine into sub assemblies
• Determine the impact this has on product quality
• Reference these impacts to the URS
• Establish a team of people to contribute; engineers, experienced operators, QA...
2. Detail the functionality of the machine sub assembly
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Equipment validation
• If this fails the impact is...
3. Determine the failure mode impact
• Functionality testing
• SOPs and administrative controls
• Detection of failure mechanisms
• Maintenance and calibration requirements
4. Determine the controls needed
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Equipment validation
A more detailed risk assessment could further assist with developing an appropriate strategy.
For example:
1. Product critical, sterility
2. Product efficacy
3. Aesthetics
4. Efficiency
5. No criticality
Reducing validation effort
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Control strategy considerations
• For process variable components
• Validation is required
• Consider the label reel system; speed, pressure are variables
• Testing the variable across a range of parameters to establish an operational criteria
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Control strategy considerations
Functionality testing should provide a capability of a particular components reliable operation range.
What would be the control strategy for the following?
• Splice detector
• Reject gates
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Control strategy considerations
Calibration
• To support and verify operating ranges over time
Operational instruction
• Line clearances
• Cleaning and appropriate reagents
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Control strategy considerations
Maintenance
• Maintain desired functionality
• Spare parts catalogue
• Maintenance Life Plan
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Revalidation considerations
Revalidation may not be required.
• Consider a review with evidence
• The need to perform product quality reviews (Section 1.4 of the PIC/S GMP code) may be apparent and there are 12 items that need to be considered in the product quality review effort.
• These include failed batches, significant changes and deviations
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Revalidation considerations
The data that you are basing revalidation decisions on must be reliable.
How is the data collected? Is the data analysed for
its significance?
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Revalidation considerations
Troublesome performance
Targeted requalification/revalidation of the components causing issues
Significant change/major deviations
A revalidation/requalification may be required to ensure performance aspects can be fulfilled
Good performance
Review with evidence to verify the consistency of the machine
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Control strategy considerations
Before we establish and effective control strategy, we need to build data and knowledge regarding the routine, repeatable performance ranges for the following sensitive components:
Complex sensors Speed controllers
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Summary
Legacy equipment and the knowledge within the organisation are critical
Criticality assessment is performed to identify components with a GxP critical function based on a set criteria
The validation effort is scalable based on the criticality assessment
The control strategy considerations should not be foreign to what you currently do, but need to verify the adequacy of the control strategies