Advisory Services

Advisory Services

Will you define the contamination control strategy for your manufacturing, or will it be a collection of changes over time?

At Particle Measuring Systems we have the experts to support you at every step in your contamination control process. Whether it be non-compliance issues, setting up a new process, or training employees, our team has the background, education and industry expertise you need. Our ongoing dialogue with worldwide regulatory agencies ensures you are on the cutting edge of the latest requirements and we have the knowledge and background to support you at all stages of your operation. Whatever your contamination control hurdle is, you can trust that the experts at PMS have seen it and are equipped to remedy the problem for good, setting you operations on a path to gold-standard success.

Advisory Services
Environmental Monitoring Risk/Gap Assessment

Environmental Monitoring Risk/Gap Assessment

Define and/or review the monitoring sampling points in your clean environment from both design and process perspective using a scientific and risk-based approach, allowing you to measure and mitigate the contamination events.

  • Air (total particle, microbial active and passive)
  • Surfaces
  • Filling machines & isolators
  • Sterile and non-sterile production environments
  • Environmental microbial load
  • Objectionable microorganisms
Environmental Monitoring Trend Analysis

Environmental Monitoring Trend Analysis

The majority of the information you need to predict future contamination events is already present in your day-to-day activities. Using a combination of collected data, process assessment, and statistical methods, Particle Measuring Systems analytical experts will define action and alert limits to help control processes, thereby reducing Out of Specification (OOS) events.

  • Assess whether your environmental data are truly under statistical control
  • Identify data trends and overcome outliers
  • Define your alert and action levels using statistical methods
Cleaning and Disinfection

Cleaning and Disinfection

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

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

Gowning

Gowning may seem like a well-controlled activity as it relates to your aseptic process, but there are many aspects to consider that our experts have come across in their years of experience and benchmarking.

  • Identify gaps that contribute to contamination in gowning procedures
  • Set gowning qualification sampling points
  • Set monitoring points for routine processes with a scientific and risk-based evaluation of gowning processes and personnel exposure to the process
Process Risk Assessment

Process Risk Assessment

Increase quality and sterility assurance in your manufacturing processes using the latest innovative and robust risk analysis techniques to prevent sterility deviations and microbiological events.

  • Performed using: Failure Mode and Effects Analysis (FMEA), Hazard
  • Analysis (HACCP) and other appropriate scientific & statistical methods
  • Development of programs and procedures for:
    • Process Sterility Assurance
    • Impact analysis for filling areas and up/down-stream manufacturing processes
    • Scale up process analysis
  • Define critical control points
  • Define microbiological control for primary packaging of non-sterile products
Aseptic Process Simulation

Aseptic Process Simulation

Use our experts to assist you in designing an Aseptic Process Simulation or “Media Fill” that will not only fulfill the requirements of your aseptic process validation but will also act as a building block for characterizing critical points for intervention 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 compliance for the process simulation you have in place
New Filling Line Quality by Design (QbD) & Process Analytical Technology (PAT)

New Filling Line Quality by Design (QbD) & Process Analytical Technology (PAT)

Plan contamination control principles into your new fill line or process with quality built-in from the design stages. Use our expert microbiology and sterility assurance support to assist in:

  • Mock-up inspection
  • Environmental monitoring risk assessment for sampling points
    • Air (total particle & microbial)
    • Surfaces
  • Design and Process optimization
  • Project Management support (on-field and remote)
  • Final drawing approval
  • Advice on how QbD / PAT may be incorporated into the business system
Crisis Management

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 review support for sterility deviations
  • Root cause investigation support using risk-based (QRM) techniques
  • Data trend analysis to support OOS investigations and CAPA plans
Utilities

Utilities

Analyze critical production input systems and their points-of-use from a design and process impact perspective using a scientific and risk-based (QRM) approach. Set the right monitoring sampling frequency based on your unique process needs and utility characteristics.

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

Contamination Control Strategy (CCS)

Design a Contamination Control Strategy for an individual process or a complete facility developed from an in depth understanding of your operation. Our experts use risk-based approaches to design a strategy that will control the impact of viable and non viable contamination on the product. Our experts use the following tools to build your personalized CCS:

  • Process Mapping
  • Process understanding using Quality Risk Management (QRM) tools –
  • Qualitative approach
  • Risk Evaluation using Quality Risk Management (QRM) tools – Quantitative approach
  • Risk Mitigation – CCS Plan
Sterility Assurance Audits

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. We can then help you understand where and why these are important and how to overcome vulnerabilities. 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