As a manufacturer in the medical sector, you wish to perform particle counting on tubing.
Plastic tubing in medical devices
Plastic tubing in the medical sector is used to transfer fluids, gases and medicines. It is made from various plastic materials, each with specific properties suited to particular applications.
The manufacture of this tubing is subject to strict standards to ensure safety and performance. It must be sterile, non-toxic and biocompatible. Regulatory bodies, such as the 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 sterilisation are crucial aspects of their production.
Le comptage particulaire sur tubulure en plastique
Particle counting on plastic tubing in the medical sector aims to quantify the presence of impurities such as dust, fibres or polymer residues on or in the device. This analysis is essential to ensure patient safety and regulatory compliance of medical devices.
The FILAB laboratory assists you with particle counting analysis on tubing
Why choose FILAB for particle counting on tubing?
The FILAB laboratory is currently the only laboratory in France to be ISO 17025 accredited by COFRAC for both particle counting and identification using SEM-EDX and infrared microscopy.
FILAB offers medical device manufacturers technical expertise and state-of-the-art analytical equipment in order to respond to their requests in the most effective and responsive manner possible.
Our particle counting and identification services for DM
In order to respond accurately and reliably to these problems, FILAB offers tailor-made support for the identification of particles on the surface of your medical devices, and to validate your cleaning processes. The laboratory is accredited ISO 17025 by COFRAC on the following scopes:
Particle Counting by Optical Microscope according to the current referentials : ISO 19227 (AAMI TIR), ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
FAQ
Particle counting is a quality control method that involves quantifying impurities present on a medical device. These particles may be production residues (fibres, polymer dust) or environmental contaminants. For tubing, the aim is to ensure that none of these contaminants can be injected into the patient's body.
Cleanliness is critical for any medical device that comes into contact with bodily fluids. For infusion tubing, dialysis tubing, or catheters, the presence of even microscopic particles can lead to serious complications.
The analysis is usually carried out in a specialised laboratory.
- Leaching: the tubing is rinsed with a sterile liquid to remove particles from its surface.
- Filtration: the rinsing liquid is then filtered through a very fine membrane.
- Analysis: the membrane is analysed either under a microscope for visual counting or using a scanning electron microscope (SEM).
Several international standards govern the cleanliness of medical devices and particle counting. ISO 19227, although specifically for orthopaedic 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) and the USP (United States Pharmacopeia USP 788), set strict thresholds for particles in injectable preparations and associated devices. These regulations impose limits on the number and size of particles acceptable for a device.
