Particle Loss Studies
Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.
Why It Matters
In aseptic pharmaceutical production, undetected airborne particle contamination from tubing systems can jeopardize sterility assurance and lead to audit failures.
EU GMP Annex 1 and ISO 14644-TR21 now require a deeper understanding and control of particle transport risks in all types of installations, including traditional legacy systems, isolators, and RABS-based filling machines.
Our Solution: 3-Step Particle Loss Measurement Study
A comprehensive, standards-aligned service that evaluates and mitigates the risk of particle loss from tubing transport systems.
Step 1: Criticality Assessment
We assess your installed tubing layout to identify the most particle-sensitive and high-risk configurations, considering all the variables that can impact the transportation.
Step 2: Measurement Campaign
On-site or laboratory-based testing to measure the impact of tubing configuration on the reliability of your clean room airborne particulate environmental data.
Step 3: Sterility Assurance Risk Assessment
Expert analysis of findings with full documentation, helping you assess potential impact on your aseptic process, defining appropriate alert and action limits to meet regulatory expectations.
Service now available in EMEA, US, Brazil, Japan, and Taiwan.
Why Choose Our Particle Loss Measurement Service
Accurate particle monitoring is the foundation of a compliant and effective contamination control strategy — yet even the most advanced systems can suffer from undetected particle loss during transport.
Our Particle Loss Measurement Service offers a data-driven, risk-based approach to identify, quantify, and mitigate particle losses in your sampling system. By simulating actual process conditions and testing various tubing lengths, materials, and layouts, we help you understand how your system performs in reality — not just in theory.
Key Advantages of Relying on the PMS Advisory Team:
ISO 14644-21–Aligned: We help ensure your monitoring system meets the latest standards for representative and justified sample locations.
Objective Validation: Quantifies particle loss across different configurations, providing traceable, documented evidence to support regulatory audits.
System Optimization: Helps you select the ideal tubing length, material, and routing for maximum measurement accuracy.
Supports Annex 1 Compliance: Reinforces the integrity of continuous monitoring in Grade A/B environments, as required by EU GMP Annex 1 (2022).
Available Resources
Our experts compiled a selection of free resources to provide a foundational understanding of the topic.
- Isokinetic Sampling in Unidirectional Flow
Why is isokinetic sampling essential — and how do you ensure you’re achieving it? This application note explains the principles and offers actionable recommendations. Read the full paper here. - Mitigating Measurement Variability
Environmental factors and equipment configurations can introduce variability in aerosol particle measurements. Learn how to detect, understand, and reduce it. Read the full paper here. - Particle Losses in Tubing
When sampling through tubing, particle loss is inevitable — but how much is it? This technical paper breaks it down by tubing type, length, and flow rate. Read the full paper here. - Managing Particle Loss in Transport Tubing
Watch this expert-led session to learn how to minimize loss and improve data reliability in real-world setups. On demand webinar available here.