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.
- User Requirement Specification
- Process Mapping
- Performance Qualification (PQ) protocol writing and assistance performing the approved procedure
- SOPs
- Performance Qualification protocol (PQ2) for Standard Application
- Performance Qualification protocol (PQ2) for Non-Standard Application
- Support for review and interpretation of qualification results
- 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
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- Manufacturing processes
- Documentation
- Corporate procedure and organization
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- Microbiological Laboratory
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- Analytical methods
- Procedure and organization
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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 the innovative approaches that came out of necessity using technology and the benefits of those new approaches to our customers.
