Lyophiliser Shelf Mapping and Steam In Place Qualification
Freeze Dryer shelf mapping and steam in place qualification performed across the UK and Ireland. Book a free 15 minute exploration call with one of our experts to see how we can help.
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Benefits
Lyophilisation Validation Services
Lyo Shelf Mapping
- 75+ 0mm Shelf Mapping Sensors
- Hot and Cold spot identification and Uniformity assessment
- Bespoke Report to your requirements
Steam In Place
- Chamber Mapping Of SIP Process
- 75+ Flexible Wireless Dataloggers
Vacuum and Pressure Sensors
- Vacuum Sensors 0.001 mBar to 100 mBar
- Pressure Sensors for Steam In Place 10mBar-4Bar Absolute
Documentation and Quality Assurance
- IQ/OQ/PQ Protocol Generation
- Traceable or ISO 17025 Sensor Calibration
Freeze Dryer Qualification
Flexible Validation Approach
Flexible Freeze Dryer Validation
Onsite Validation Engineer
Our Validation Team will work with your team to prepare protocols, execute testing and generate reports. Using Thermal Compliance Ellab Systems or your own equipment.
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Protocol Generation
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Test Equipment Calibration
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Onsite Test Execution
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Protocol Execution
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Report Generation
Remote Validation
Remote Validation allows you to execute the testing utilising Thermal Compliance protocols and Test Equipment. With remote support and training from our engineers.
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Protocol Generatiion
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Online Training in Protocols and Execution
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Testing perform by your personnel
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Report Generation by Thermal Compliance
Equipment Hire
If you need support for additional sensors, we can help. Please get in touch to discuss your requirements.
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75+ 0mm Shelf Mapping Sensors
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75+ Flexible Sensors for SIP Mapping
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Vacuum Sensors
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75+ 0mm Shelf Mapping Sensors
Frequently asked questions
Does performing Lyophiliser Mapping disrupt production?
Lyophiliser (freeze dryer) shelf mapping is normally carried out during a planned shutdown or between production campaigns. We align qualification work in line with routine maintenance to minimise production downtime.
With wireless, calibrated sensors, shelves can be mapped quickly without additional leak testing, further reducing equipment downtime. This approach ensures shelf mapping and validation are completed efficiently with minimal impact on your manufacturing schedule.
With wireless, calibrated sensors, shelves can be mapped quickly without additional leak testing, further reducing equipment downtime. This approach ensures shelf mapping and validation are completed efficiently with minimal impact on your manufacturing schedule.
What are the benefits of using Ellab Tracksense Pro dataloggers for Lyophilization Processes?
Ellab Tracksense Pro dataloggers are used widely in lyophiliser validation because they combine accuracy, compliance and advanced reporting. For lyophiliser (freeze dryer) shelf mapping their key benefits include:
Using Ellab Tracksense Pro dataloggers allows us to perform lyophiliser shelf mapping, qualification and validation faster, more accurately and with minimal disruption to production.
- Wireless Dataloggers - Fast and efficient placement without the need for feedthroughs and leak tests.
- High accuracy and reliability - fully calibrated sensors (Traceable to ISO 17025) provide precise measurement for shelf and chamber conditions.
- Regulatory compliance - fully compatible with FDA 21 CFR Part 11 and EU GMP Annex 1 requirements for electronic records and audit trails.
- Flexible applications - suitable for shelf mapping, product mapping and Steam In Place (SIP) validation.
Using Ellab Tracksense Pro dataloggers allows us to perform lyophiliser shelf mapping, qualification and validation faster, more accurately and with minimal disruption to production.
Why is sensor contact so important for Lyophiliser Shelf Mapping?
Accurate lyophiliser (freeze dryer) shelf mapping relies on direct thermal contact between the sensor and the shelf surface. Without good contact, the datalogger may measure chamber conditions under vacuum rather than the true shelf temperature, which can create false hot spots and lead to unreliable validation results.
Are your sensor calibrations traceable to national standards?
Yes, all of our calibrations are traceable to national standards. All calibrations are documented and included in the validation documentation. As standard we perform pre and post temperature calibrations against our ISO 17025 Reference probes, however we can also arrange ISO 17025 Calibrations upon request.
Does does this support EU GMP Annex 1 ?
Your validation documentation includes traceable methods, calibration, agreed acceptance criteria, deviations and a clear statement of results. Reports are generated in a validated and secure 21 CFR Part 11 compliant environment, with clear pass/fail criteria.
