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

+1-303-443-7100

 

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

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Particle Counters
    • Airborne Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gases Particle Counters
    • Molecular Monitors
    • Environmental Monitoring Systems
  • Education
    • Knowledge Center
      • Papers
      • Webinars
      • Videos
      • Beginner Guide
    • Particle College
    • Training Services
    • Blog
  • Applications
    • Industries
      • Pharmaceutical
      • Semiconductor
      • Photonics & Optics
      • Aerospace
      • Cosmetics & Personal Care
      • Food & Beverage Safety
    • Annex 1
    • ISO 14644
    • 21CFR 11
    • ISO 21501-4
    • USP 788
    • USP 797
    • Continuous Viable Monitoring
    • Parts Cleanliness Testing
  • Services and Support
    • Product Calibration & Service
    • FMS/EMS Project Management
    • Contamination Control Advisors
    • Hardware & Software Support
    • Customer Service
  • About PMS
    • About Us
    • Contact Us
    • Why Choose PMS
    • Executive Team
    • Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • ISO Registrations & Quality Policy
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance

Cleanroom Contamination Control Advisors

Learn more about Particle Measuring Systems’ Cleanroom Contamination Control Advisory services. Our experts can support you at every step, whether it be non-compliance issues, setting up a new process, GAP Analysis, or training employees.

Advisory Services

Environmental Monitoring Risk/Gap Analysis

Define or review the monitoring sampling points for your environment with a scientific and risk-based approach.

  • Air (total particle, microbial active and passive)
  • Surfaces
  • Filling machines
  • Both sterile and non-sterile production environments
  • Environmental microbial load
  • Objectionable microorganisms

Environmental Monitoring Trend Analysis

Using a combination of collected data, facility assessment and statistical process, Particle Measuring Systems analytical experts will define action and alert limits to control OOS events before they occur.

  • Assess whether your environmental data are truly under statistical control
  • Identify data trends and prevent outliers before they happen
  • Define your alert and action levels using statistical discipline

Utilities

Analyze the production and the points-of-use with a scientific and risk-based approach and set the right monitoring sampling frequency for your process.

  • Purified water (PW) and tap water
  • Water for Injection (WFI)
  • Pure steam
  • Compressed gases (air, nitrogen, carbon dioxide, …)

Cleaning and Disinfection

Identify the correct cleaning and disinfection strategy and create a preemptive plan to control and prevent contamination according to your specific environment, surfaces and manufacturing processes. Our experts help you provide documented rationale for:

  • The cleaning and disinfection agents.
  • The cleaning techniques.
  • The disinfectants’ application, rotation, and frequency according to the different surface typology.

Gowning Processes

Identify the correct cleaning and disinfection strategy and create a preemptive plan to control and prevent contamination according to your specific environment, surfaces and manufacturing processes. Our experts help you provide documented rationale for:

  • Cleaning and disinfection agents
  • Cleaning techniques
  • Application, rotation, and frequency of cleaning application consistent with surface characteristics

Process Risk Assessment

Increase the quality and the sterility assurance of your manufacturing processes using the most innovative and robust risk analysis techniques, preventing sterility deviations and microbiological events.

  • Filling processes
  • Upstream and Downstream manufacturing processes
  • Process scale up
  • Critical Control Points definition
  • Definition of the microbiological control on the primary packaging for no-sterile products

Aseptic Process Simulation

Use our experts to assist you in designing an Aseptic Process Simulation or “Media Fill” that will not only fulfil the requirements of your aseptic process validation, but will also act as a building block for characterizing critical contamination points in your process.

  • Design a “media fill” simulation for your filling process
  • Using a risk-based approach, assess the critical interventions made during the production phase which must be simulated during the Aseptic Process Simulation.
  • Verify the compliance of the simulation you have in place

New Filling​ Line Quality by Design (QbD)

Design your new filling line and process in quality from the beginning using our expert microbiological and sterility assurance support.

  • Mock-up inspection
  • Environmental monitoring risk assessment for sampling points
    • Air (total particle & microbial)
    • Surfaces
  • Process optimization
  • Project Management support (on-field and remote)
  • Final drawing approval

Crisis Management

Our expert support team of aerosol engineers and viable contamination experts can help you to recreate, remedy and prevent deviation events in the future.

  • Investigation result review for sterility/microbiological deviation
  • Root cause investigation support using risk-based techniques
  • Trend analysis for alerting and preventing future events

Sterility Assurance Audits

Our Advisory Team can help you prepare for regulatory inspections by characterizing and defining the most critical points of contamination control in your process and then helping you understand where and why these are important. Once your process is understood from this perspective, we provide mock audits to solidify your awareness and confidence in your system. Our audits cover:

  • Filling processes (with viable and non viable contamination focus)
  • Upstream and downstream processes
  • Cleaning and disinfection
  • Sampling and monitoring (including action and alert limits)
  • Utilities: water, gases and chemicals
  • Gowning process

PMS has got your back and supports you from first-time use to full implementation. Our team of experts can help you by designing quality into your operations using gold standard PMS tools and processes.

PharmaIntegrity™

  • User Requirement Specification
  • Process Mapping
  • Performance Qualification (PQ) protocol writing and assistance performing the approved procedure
  • SOPs

BioCapt® Single-Use

  • Performance Qualification protocol (PQ2) for Standard Application
  • Performance Qualification protocol (PQ2) for Non-Standard Application
  • Support for review and interpretation of qualification results

FacilityPro®

  • Installation Qualification (IQ) protocol writing and assistance performing the approved procedure
  • Performance Qualification protocol (PQ2) for Standard & Non-Standard Applications
  • Support for review and interpretation of qualification results

Our experts can train you at your site or organize events and company seminars. Basic training includes:

  • Environmental and personnel monitoring
  • Cleanroom behavior and best practices
  • Cleaning and disinfection strategy
  • Good Distribution Practices (GDP)
  • Microbiological laboratory best practices
  • Qualification vs. Monitoring

Advanced training includes:

  • Aseptic Process Simulation
  • Quality Risk Management approach
  • Fundamental of Statistics and trend analysis
  • The New EU GMP Annex 1 Draft

Coaching (one-on-one training):

  • Quality Risk Management
  • Sterility Assurance
      • Manufacturing processes
      • Documentation
      • Corporate procedure and organization
  • Microbiological Laboratory
      • Analytical methods
      • Procedure and organization

The New Normal requires New Ways of Working. Particle Measuring Systems’ contamination control advisors can still assist you with many services and partner with you to get them done remotely, including:

  • Environmental Monitoring Risk Assessment
  • Environmental Monitoring trend analysis
  • Cleaning and disinfection strategy
  • Manufacturing process scale-up
  • Critical Control Point definition
  • Aseptic Simulation Process (media fill) Design
  • Regulatory compliance of an existing media fill process
  • Project management for new filling lines (e.g., kick-off and initial design)
  • Support for investigation result
  • Microbial root cause investigation support
  • Training
  • Support and services about PharmaIntegrity and  BioCapt Single Use Microbial Monitors

Frank Panofen, Global Marketing Manager at Particle Measuring Systems (PMS) , discusses how the PMS Contamination Control Advisory Services team can support customers remotely, even during a global pandemic. He discusses innovated approaches using technology, and the benefits to customers.

Get more information

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Particle Counting Education
  • Particle College – Electronics Industry Focused
  • Contamination Monitoring Videos
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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

© Copyright 2021 - Particle Measuring Systems is a Spectris company