Pharmatherm the dry heat sterilisation thermal mapping specialists we excel in providing you with the most competitive validation qualification solution.
Pharmatherm support your business with over 20 years industry validation experience from working with multinational Pharmaceutical, Biotechnology, API and related Life Science organisations.
Depyrogenation 'dry heat sterilization' thermal mapping validation qualification from Pharmatherm, please down load the brochures below and complete the request form below and we will get back to you ASAP.
- Independent thermal validation
- trained engineers familiar with depyrogenation systems
- Familiar with ampoules, injection bottles, vials
- Stainless loads and packaging cans
- Calibrated test equipment
- cGMP standards
- GDP good documented practise
- Detailed protocols, reports
- Defined SOP's and risk assessments
The validation packages that we offer meet with EN 285, CFPP 01-01 formerly HTM2010 and we understand the regulatory codes of practice defined by HPRA formerly the IMB and FDA, MHRS and the European EMEA.
Pharmatherm's thermal validation test equipment is maintained and calibrated to NSAI, INAB NIST Certified, European Accreditation (AE) and International Laboratory Accreditation Cooperation (ILAC) and DAkkS (DKD) standards.
Pharmatherm use the Amphenol Advance Sensors Kaye validator thermal validation system, Isopharm Fluke Netdaq data logging system supported with AMETEK and Haven thermal baths and the Isopharm reporting software TQS reports.
Depyrogenation process uses dry heat for sterilization using hot air to inactivate Endotoxin (Pyrogens). Pharmatherm completes thermal mapping using Endotoxin challenges for the validation and qualification of the dry heat process.
Pharmatherm recommends GKE Cleaning and Sterilization Monitoring who supply us with Endotoxin indicators test kits for dry heat sterilization and support us with Fh value, D-value and Z-value for depyrogenation calculations. Failed results let Pharmatherm help you with the experience
For more information and prices please complete the form below and we will contact you asap
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