• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+41 71 987 01 01

  • Youtube
  • Linkedin
  • English / CH
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português, Brazil
    • Español
Newsletter

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Air
    • Liquids
    • Microbial Samplers
    • Compressed Gases
    • Molecular
    • Software / Data Management
  • CAS Clean Air Services
    • Cleanroom Measurement Services
      • Smoke Studies
    • Thermal Validation
  • Education
    • PMS™ Knowledge Center
      • Particle Counting Education
      • Beginner Guide to Particle Counting
      • Contamination Monitoring Videos
      • Webinars – Archived
    • Blog
  • Applications
    • Industries
      • Hospital Regulatory Compliance Services
      • Pharma
      • Cosmetics & Personal Care
      • Aerospace
      • Photonics & Optics
      • Semi
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • Annex 1
    • 21CFR 11
  • Service and Support
    • Product Calibration & Service
      • Balometers
      • Anemometers
    • Project Management
    • Hardware & Software Support
    • Customer Service
  • About Us
    • Contact Particle Measuring Systems
    • Why Outsource With CAS
    • Why Choose US
    • Credibility & Registrations
    • Careers
    • Executive Team
    • Press Releases
    • Corporate Responsibility, Sustainability, Health & Safety
    • COBE
    • About Spectris
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance

Thermal Process Validation – GMP Services

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

 

Complete the form to tell us about your application needs or get a quote:

Get a Quote

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

Knowledge Center

  • COBE
  • Contact Particle Measuring Systems

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems EN-CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt® Certificate of Analysis (CofA)
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

Education and Training

  • PMS™ Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2023 - Particle Measuring Systems is a Spectris company