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.
We offer a complete solution – from (paperless) document creation, through qualification and report preparation to consulting, instructing and training support.
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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