We offer complete GMP Services including Thermal Process Validation.
CAS Clean Air Services Services/ Particle Measuring Systems (PMS) is certified and accredited by SN EN ISO 9001 and SN EN ISO/IEC 17025 which allows us to provide you with highly trained personnel for thermal process validation between -196 °C bis +350 °C.
Our highly qualified and experienced team for thermal process validation provides services based on current standards:
- EU GMP Guideline Annex 1 & 15
- FDA Guideline
- SN EN 285
- SN EN ISO 17665
- SN EN 13060
The quality of our measurements as well as our elaborate quality management system ensures high-precision measurements which are completely traceable to national standards. We provide services for the following industries:
- Pharmaceutical
- Chemical
- Biotechnology
- Medical technology
- Laboratories and hospitals
- Cosmetics
- Food and Beverage
- And more
Thermal Validation Portfolio
Steam Sterilisation
Autoclaves
- Sterilisation of materials
- Sterilisation of products/ hot water cascade sterilisation
- Sterilisation of inline filters
- Steam quality testing according to SN EN 285
SIP processes
- Filling lines
- Fermentation lines
- Stopper sterilisation
- Freeze dryers
- Vessels and storage tanks
- Other thermal decontamination processes
Thermal Process Simulation
Temperature Studies
- Heating & cooling processes for material & liquids
Freezing & thawing processes
- Solutions in bottles & bags
- Lyophilizers / Freeze drying (product temperatures)
Dry Heat Sterilisation & Depyrogenation
Hot Air Sterilisation Tunnel
- Sterilisation and depyrogenation of primary packaging materials, vials & ampoules
- Sterilisation of cooling zones
Hot/ Dry Heat Steriliser
- Laboratory / hospital / Production equipment
- Sterilisation of products and materials
Temperature and Humidity Mapping
- Devices and rooms for cooling, deep-freezing and ultra-low freezing
- Freeze dryers (shelf mapping)
- Storage rooms and clean rooms
- Nitrogen tanks
- Container/ Bagtainer
- Incubators
- Climate chambers
- Stability chambers
- Transporters
Document creation
- Qualification and validation plans
- Risk analyses
- SOP
- URS
- Templates
Report preparation
- Qualification and validation reports according to cGMP standards
- 21 CFR Part 11 compliant measurement evaluation
- Consulting
- Troubleshooting
- Consulting for process optimization
- Development of risk-based qualification and validation concepts
Training
- Performance of technical seminars
- Training and workshops for personnel to increase quality and to optimize process flows
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