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.
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)
- Filling machines
- Both sterile and non-sterile production environments
- Environmental microbial load
- Objectionable microorganisms
Environmental Monitoring Trend Analysis
Verify if your environmental data are under statistical control, identify the data trending, find and solve the issues that you have, and define your alert and action level in statistical way.
Analyze the production and the points-of-use with a scientific and risk-based approach and set the right monitoring sampling frequency based on 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 right cleaning and disinfection strategy and plan according your environment, surfaces, and manufacturing processes, providing the rationale for:
- The cleaning and disinfection agents.
- The cleaning techniques.
- The disinfectants’ application, rotation, and frequency according to the different surface typology.
Identify the gaps in the gowning procedure in use, set the personnel qualification and monitoring points with a scientific and risk-based evaluation of the gowning process and the exposure of your clothes during the manufacturing.
Process Risk Assessment
Increase the quality and the sterility assurance of your manufacturing processes using the most innovative and strong risk analysis techniques, preventing sterility deviations and microbiological OOSs. (Out of Specifications)
- 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
Design the “media fill” simulation for your filling process or verify the compliance of the simulation you have in place. Assess the critical interventions made during the production and which must be simulated during the Aseptic Process Simulation using a risk-based approach.
New filling line (Quality by Design)
Design your new filling line and process in quality from the beginning using our strong microbiological and sterility assurance support.
- Mock-up inspection
- Environmental monitoring risk assessment for sampling points
- Air (total particle & microbial)
- Process optimization
- Project Management support (on-field and remote)
- Final drawing approval
Our microbiologists can help you to handle the deviations and to find the root cause of a contamination outbreak.
- Investigation result review for sterility/microbiological deviation
- Root cause investigation support using risk-based techniques
We can help you to prepare the regulatory inspection with a mock audit or to define how to increase the quality and the sterility assurance of your manufacturing. Our audits cover:
- Filling processes
- Upstream and downstream processes
- Cleaning and disinfection
- Sampling and monitoring
- Gowning process
PMS does not leave you alone and support you during the first use and the implementation of its solution. Our team of experts can help you, providing
- User Requirement Specification
- Process Mapping
- Performance Qualification protocol and the assistance for the execution
- Performance Qualification protocol (PQ2) for Standard Application
- Performance Qualification protocol (PQ2) for No-Standard Application
- Support for the review and the interpretation of the qualification results
- Coming Soon
Our experts can provide training at your site or organize events and seminaries.Basic training
- Environmental and Personnel Monitoring
- Cleanroom behavior and best practices
- Cleaning and disinfection strategy
- Good Distribution Practices (GDP)
- Microbiological laboratory best practices
- Qualification vs Monitoring
- Aseptic Process Simulation
- Quality Risk Management approach
- Fundamental of Statistics and trend analysis
- The new EU GMP Annex 1
Coaching (one-to-one training)
- Quality Risk Management
- Sterility Assurance
- Manufacturing processes
- Corporate procedure and organization
- Microbiological Laboratory
- Analytical methods
- Procedure and organization