Thermal Process Qualification
Particle Measuring Systems AG in Switzerland offers highly qualified personnel for thermal processes from -196 °C to +350 °C. We offer complete solutions from document creation, qualification, and report creation, to consulting & training.
Our highly qualified and experienced thermal process team offers services based on the applicable standards:
- EU GMP Guidelines Annex 1 & 15
- FDA Guidelines
- EN 285
- EN ISO 17665
- EN 13060
Thanks to the quality of our measurements and our quality management system, measurements are always carried out with high precision and are fully traceable. We operate in the following industries:
- Pharma
- Chemistry
- Biotech
- Medical Technology
- Laboratories and Hospitals
- Cosmetics
- Groceries
and, more.
Thermal process qualification portfolio
STEAM STERILIZATION
Autoclaves
- Material sterilization
- Product sterilization/ hot water spray
- Inline filter sterilization
- Testing of steam quality according to SN EN 285
- Bowie Dick Test
SIP processes
- Filling lines
- Fermentation lines
- Plug sterilization
- Freeze dryer
- Boilers and storage tanks
HOT AIR STERILIZATION & DEHYROGENIZATION
Hot air tunnel
- Sterilization and dehydrogenation of primary packaging
- Refrigeration part sterilization
Hot air sterilizers
- Product sterilization
- Material sterilization
THERMAL PROCESS SIMULATION
Temperature studies
- Heating and cooling processes for materials and solutions
Freezing and thawing processes
- Solutions in bottles and bags
- Freeze drying (product temperature)
TEMPERATURE & HUMIDITY MAPPING
Temperature mapping
- Refrigeration / deep-freezing / ultra-low-freezing equipment and rooms
- Freeze-drying systems (shelf mapping)
- Storage and clean rooms
- N2 storage tanks
- Container/Bagtainer
- Incubators
- Climate cabinets/chambers
- Stability chambers
- Transporters
Document creation
- Qualification / validation plans
- Risk analyses
- SOP
- URS
- Templates
Reporting
- Qualification / validation reports according to cGMP standard
- CFR Part 11 compliant measurement evaluations
Consulting
- Troubleshooting
- Consulting on process optimization
- Development of risk-based qualification concepts
Training
- Conducting technical seminars
- Training and workshops for staff to improve quality and optimize processes
