Horeshoe Crab - LAL Test

Depyrogenation

Our engineers perform validation on depyrogenation tunnels and ovens. We can work to your own in house procedures and protocols or generate bespoke protocols for your processes. We can assist with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Requalification (RQ).We perform testing to PDA Technical Report 3.

Endotoxin spiked glassware is used to demonstrate at least a 3 log reduction in endotoxin units in accordance with the US Pharmacopeia. After the Depyrogenation cycle the spiked vials use a LAL Test to show less than 1EU recovery.
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Dry Heat Sterilization

Dry heat sterilization is usually performed at 180°C for 30minutes, 170°C for 1 hour or 160°C for 2 hours. We perform testing to PDA Technical Report 3. We use wired systems for dry heat sterilization over 150°C, either the Ellab E-Val Pro or the Kaye Validator 2000. Its usually used for products that could be damaged by moist heat, oil based products or powders.

Our engineers can assist with protocol generation, IQ, OQ, PQ and requalification of your processes.

Ellab E-Val Pro Datalogger - Dry Heat Sterilization

Low Temperature Dry Heat Sterilization

Low Temperature Dry Heat Sterilization is used for products that cannot take moist heat sterilization and are also unable to take high temperature dry heat sterilization, for example some medical devices, for example implants. Therefore sterilisation cycles are performed at a lower temperature for longer sterilization cycles.

We can assist with the setup of low temperature dry heat processes and the validation of them. We can work to your own onsite procedures or generate bespoke documentation for you. Our engineers can support  IQ,OQ,PQ and Requalification of your processes.

We can use wireless or wired dataloggers for low temperature dry heat sterilization.

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For more information on how we can help with you dry heat process validation please contact us.