Autoclave Thermal Qualification
Temperature mapping of autoclaves and sterilizers
Temperature Mapping of Autoclaves and Sterilizers in Pharmaceutical Manufacturing
Honeyman Validation offers a variety of thermal mapping and validation services designed to meet your requirements and to ensure you meet cGMP, Eur.Ph and USP requirements.
Thermal mapping of sterilisation processes is a key part of the overall sterility assurance program for sterile products.
Porous Load Sterilisation
For Porous Load Sterilisation, EN285 requires the measurement of physical parameters only to demonstrate the repeatability of the process using a standard test pack, this includes measurements of:-
- Equilibration time
- Temperature stability during sterilisation
- Verification that the process controls within the desired temperature band
Terminal Sterilisation of Product
For terminal sterilisation, thermal mapping is used to determine the location of slow to heat points within the load, to determine appropriate location for cycle control and to determine the effect of different load presentations on cycle performance.
Typical thermal mapping activities include:-
- Determination of slow to heat locations within the product or load items
- Determination of worst case challenges to perform during Cycle Development and PQ
- Verification of repeatable process performance and achievement of thermal acceptance criteria
- Verification of correlation between temperature and biological data
- Calculation of Sterility Assurance Level for the product or process.
Honeyman Group have worked with a vast range of finished products, medical devices and sterile components and have the experience to quickly design and test cycles using a Doing It Right First Time (DIRFT) approach.
All cGMP guidelines and regulations for Sterilisation processes require good correlation between physical (temperature and pressure) and biological parameters during Performance Qualification and periodic requalification of the process.
Our approach will ensure that the testing is performed quickly, without error, and in a cGMP compliant manner, giving you confidence that the process will meet your sterility assurance objectives during initial qualification and routine operations.
Examples of equipment qualified include:
- Autoclaves for terminal sterilisation of fluids in sealed containers (glass, plastic and prefilled syringes)
- Autoclaves for porous load sterilisation in compliance with EN285
- Benchtop autoclaves for laboratories, dentists and veterinary clinics
- Stopper washer processors
- Disinfectant washers
- Depyrogenation tunnels
- Sterilisation of medical devices by dry heat in compliance with ISO 20857
- Lyophilisers / freeze dryers
- Steam-in-Place (SIP) applications (fermenters, vessels, process piping)
Honeyman can also supply a range of thermal validation consumables to ensure compliance with regulatory standards and practices. For detailed information on our range of consumables, please visit our consumables section.
Whether you require regular contract work, short-term validation resource, consultancy or training, Honeyman has you covered.
To speak to one of our validation experts regarding your qualification and validation needs, please contact us with your details and a brief introduction, so we can arrange a call back at a time convenient to you.