Cleanroom Contamination Control Advisors

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

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.

Utilities

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.

Gowning processes

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)
  • Surfaces
• Process optimization
• Project Management support (on-field and remote)
• Final drawing approval

Crisis Management

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

Audits

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
• Utilities
• Gowning process

Microbiological laboratory

PMS has got your back and supports you from first-time use to full implementation. Our team of experts can help you with our unique solution of:

PharmaIntegrity™

• User Requirement Specification
• Process Mapping
• Performance Qualification protocol and the assistance for the execution
• SOPs

BioCapt® Single-Use

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

FacilityPro®

• Coming Soon

Our experts can train you at your site or organize events and seminaries. 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-to-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