---
type: "WebPage"
title: "Particulate counting on tubing for the medical industry"
description: "If you are a medical industry manufacturer, do you need particulate counting on tubing? Plastic tubing in medical devices Plastic tubing in the medical sector are devices used to transfer fluids, gases, and medicines. They are made from various plastic..."
resource: "https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-tubing/"
tags: ["EN", "pll_68b6b20037f90", "Thomas GAUTIER"]
timestamp: "2026-08-18T14:20:37Z"
published: "2025-09-02T09:18:30Z"
language: "en"
author: "Laure Durieux"
---

# Particulate counting on tubing for the medical industry

## If you are a medical industry manufacturer, do you need particulate counting on tubing?

### Plastic tubing in medical devices

Plastic [tubing](https://filab.fr/en/our-services/our-analysis-services/polymer-materials-analysis-laboratory/plastics-processing-polymers/testing-plastic-tubing.md) in the medical sector are devices used to transfer fluids, gases, and medicines. They are made from various plastic materials, each with specific properties suited to precise applications.

The manufacture of these tubing products is subject to strict standards to ensure safety and performance. They must be sterile, non-toxic, and biocompatible. Regulatory bodies, such as the [FDA](https://filab.fr/secteur-activite/analyse-dispositifs-medicaux/analyse-dispositifs-medicaux-fda/) in the United States or the EMA in Europe, ensure that these devices meet rigorous standards before being placed on the market. In addition, material traceability and sterilization are crucial aspects of their production.

### Particulate counting on plastic tubing

Particulate counting on plastic tubing in the medical sector aims to quantify the presence of impurities such as dust, fibers, or polymer residues on or within the device. This analysis is essential to ensure patient safety and the regulatory compliance of [medical devices](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md).

## The FILAB laboratory supports you in particulate counting analysis on tubing

### Why choose FILAB for particulate counting on tubing?

The [FILAB](https://filab.fr/) laboratory is currently the only laboratory in France accredited ISO 17025 by COFRAC for both particle counting and particle identification by SEM-EDX and Infrared Microscopy.

FILAB offers medical device manufacturers technical expertise and [state-of-the-art analytical equipment](https://filab.fr/en/our-technical-resources.md) to respond as effectively and quickly as possible to their needs.

### Our particle counting and identification services for medical devices

To address these issues accurately and reliably, FILAB offers tailor-made support for the identification of particles on the surface of your medical devices, and for the validation of your cleaning processes. The laboratory is [ISO 17025 accredited by COFRAC](https://filab.fr/en/about-us/accreditations-en/laboratory-analysis-iso-17025.md) for the following scopes:

**Particulate counting** by [Optical Microscope](https://filab.fr/en/our-technical-resources/laboratory-of-analysis-and-observation-by-optical-microscope-mo.md) according to the current standards: ISO 19227 (AAMI TIR), [ISO 10993-19](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-device-characterization-in-a-laboratory-iso-10993-19.md), [USP 788](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-according-to-usp-788.md), [PE 2.9.19](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-laboratory-according-to-ep-2-9-19.md), [AAMI TIR 42](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices/particle-counting-laboratory-according-to-the-aami-tir42-standard.md)

**Particle identification** by [SEM-EDX](https://filab.fr/nos-moyens-techniques/laboratoire-d-analysis-par-microscopie-electronique-a-balayage-meb-edx/) and [µ-IRTF](https://filab.fr/en/our-technical-resources/laboratory-analysis-ftir-microscopy.md) according to the current standards: ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42

### Our other services dedicated to medical devices

[Biocompatibility study](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing.md) according to ISO 10993 (-[18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md) / -[12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md) / -[13](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md) / -[14](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md) / -[15](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/study-of-degradation-products-in-your-medical-devices-according-to-iso-10993-15.md) / -[19](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-device-characterization-in-a-laboratory-iso-10993-19.md) / -[22](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md))

[Problem solving](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures.md): non-compliance, [failure analysis](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures/laboratory-analysis-ruptures.md), [adhesion issues](https://filab.fr/paroles-d-expert/metallurgie-fonderie-automobile/filab-vous-accompagne-dans-les-problematiques-d-adhesion.md), [corrosion expertise](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-expertise-and-analysis-of-corrosion.md)...

[Support for R&D](https://filab.fr/en/our-services/rd.md): [custom chemical analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-biomedicine.md), [material and surface characterization](https://filab.fr/en/our-services/our-analysis-services/laboratory-material-testing.md), [analytical development](https://filab.fr/en/our-services/our-expertise-services/analytical-development.md)

Process validation: [cleaning residue analysis](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) (ISO 19227), [surface treatment analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-surface-characterization/laboratory-analysis-expertise-surface-treatment.md)

## FAQ

 What is particulate counting?
Particulate counting is a quality control method that consists of **quantifying impurities** present on a medical device. These particles may be production residues (fibers, polymer dust) or environmental contaminants. For tubing, the goal is to ensure that none of these contaminants can be injected into the patient's body.

 Why is it so important for medical tubing?
Cleanliness is critical for any medical device in contact with bodily fluids. For infusion tubing, dialysis tubing, or catheters, the presence of particles, even microscopic ones, can lead to serious complications.

 How are tubing particles analyzed?
Analysis is generally carried out in a specialized laboratory.

1. **Leaching:** the tubing is rinsed with a sterile liquid to detach particles from its surface.
2. **Filtration:** the rinse liquid is then filtered through a very fine membrane.
3. **Analysis:** the membrane is analyzed either under a microscope for visual counting or by SEM (Scanning Electron Microscope).

 What standards and regulations govern this test?
Several international standards govern the cleanliness of medical devices and particle counting. [**ISO 19227 standard**](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227/particle-counting-laboratory-on-dm-according-to-iso-19227-standard.md), although specifically for orthopedic implants, serves as a reference for many devices in terms of cleanliness. Other standards, such as those of the **European Pharmacopoeia ([Ph. Eur. 2.9.19](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-injectable-drugs/particle-counting-laboratory-according-to-ep-2-9-19.md))** and the **USP (United States Pharmacopeia [USP 788](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-particulate-contaminant/particle-counting-laboratory-according-to-usp-788.md))**, set strict thresholds for particles in injectable preparations and the associated devices. These regulations impose limits on the number and size of acceptable particles for a device.