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 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 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.
The FILAB laboratory supports you in particulate counting analysis on tubing
Why choose FILAB for particulate counting on tubing?
The FILAB 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 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 for the following scopes:
Particulate counting by Optical Microscope according to the current standards: ISO 19227 (AAMI TIR), ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
Our other services dedicated to medical devices
Problem solving: non-compliance, failure analysis, adhesion issues, corrosion expertise...
Support for R&D: custom chemical analysis, material and surface characterization, analytical development
Process validation: cleaning residue analysis (ISO 19227), surface treatment analysis
FAQ
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.
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.
Analysis is generally carried out in a specialized laboratory.
Leaching: the tubing is rinsed with a sterile liquid to detach particles from its surface.
Filtration: the rinse liquid is then filtered through a very fine membrane.
Analysis: the membrane is analyzed either under a microscope for visual counting or by SEM (Scanning Electron Microscope).
Several international standards govern the cleanliness of medical devices and particle counting. ISO 19227 standard, 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) and the USP (United States Pharmacopeia USP 788), 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.
