Freeze Dryer (Lyophilizer) Validation

We perform validation of pharmaceutical Freeze Drying processes (Lyophilisation). Our engineers can assist with Installation Qualification, Operational Qualification (OQ) and Performance Qualification (PQ). 

We have two systems we use for freeze drier validation, the Kaye Validator 2000 or Ellab Tracksense Pro X dataloggers. The dataloggers help reduce timelines and also have some great systems for sensor placement for both Shelf Mapping and the Product Mapping.
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Shelf Mapping

Freeze Drier shelf mapping requires good shelf contact, 0mm dataloggers are ideal for this purpose. Our sensors also have the option for collars to support the logger for easier placement. This reduces the setup time significantly.

We use vacuum sensor with a range of 0.0001to 1000mBar.

As the system is faster to setup and non invasive we can significantly reduce overall setup times.

Product Mapping

We have a broad spectrum of sensors allowing us to place sensors within a range of vials. We work with ellab to ensure that the correct method of sensor entry is used for your product setup. Our sensors can be placed within specifically designed trays to fit with your vial format.

Dual channel sensors can be utilised to perform shelf mapping and product mapping together.

SIP Validation (Steam in Place)

Wireless dataloggers are ideal for performing Steam In Place validation. The ellab system offers fast setup and clear reporting with a variety of sensor heads for bespoke setups.

We have a vacuum sensor we use for the Lyophilisation process, for steam in place we use a different pressure sensor with a range of 10mBar to 6Bar Absolute.

Software 

The Ellab Tracksense pro software enables us to setup the dataloggers quickly and efficiently. With the initial setup taking around 30minutes. At the end of testing our reports are usually generated in under 1 hour.

Reports are clear with Pass/Fail criteria, the system is 21 CFR Part 11 Compliant and we have performed IQOQ validation of the Valsuite Pro software.
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If you would like to know more about how we can help with validating your freeze drying process please email chrism@thermalcompliance.ie