Contaminates on medical devices can lead to biocompatibility failures and complications during use, potentially putting the patient at risk. Contaminates can be introduced from a variety of different operations. Detergents and disinfectants can contaminate the device after cleaning and disinfection operations. Lubricants, oils and solvents can contaminate the device during the manufacturing process. Manufacturers should establish acceptable levels of residues on their devices based on their intended use and patient contact.
It is critical to make sure that the levels of residual ethylene oxide, ethylene chlorohydrin (ECH), and ethylene glycol (EG) represent the least amount of harm to the patient during routine product usage when evaluating the suitability of ethylene oxide for sterilization of medical equipment.
Because of its broad material compatibility, ethylene oxide (EO) is frequently used to sterilize medical equipment. It’s possible for EO to leave a residue on the material being sterilized. The following are the residues that may remain following sterilisation:
- Ethylene Oxide (EO) is a possible byproduct of processing.
- Ethylene Chlorohydrin (ECH) is a potential by product of EO’s interaction with free chloride ions.
- Ethylene Glycol (EG), a byproduct that may result from the interaction of EO with water.
The categories of medical devices that have been identified are based on the duration they are used on the final patients and will determine the maximum allowable levels of such EO residues in the final device. The ISO 10993–7 (2008) on Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals is the guiding document generally accepted for the evaluation of EO residuals in medical devices.
For the assessment of EO residuals in medical devices, this guideline documents the authorized limit of each residue, the suggested technique of extracting and testing the residues, and comprehensive quality control on the analytical procedure.
After performing an ethylene oxide sterilization process, a device may still contain considerable concentration of residues for a variety of causes.
Material: Some compounds will absorb and hold onto gas molecules more so than others. Natural compounds with high absorption capacities include cellulose and cotton. Some plastic materials have also demonstrated a high rate of absorption when subjected to EO processing.
Packaging: Breathable packaging, such Tyvek or medical-grade paper, are necessary for EO processing in order to let gas molecules to flow through. The gas won’t be able to penetrate the breathable barrier as effectively if the packaging has a restricted or blocked surface area (like a big sticky label).
Volume, density, and general load arrangement of the load on a pallet can all be considered.
Medistri will perform Ethylene Oxide Residual Analysis in our GMP Accredited In-House laboratory in Switzerland (also certified with ISO 17025) to analyse and demonstrate the safety of your sterile medical device.
Medistri's contract Laboratory is located in the heart of Switzerland to continuously serve the countries most innovative universities, research institutes, start-up companies & large enterprises from the Pharmaceutical, MedTech & BioTech industries.
Complex Medical Devices need to assess the biocompatibility of their medical device materials and processes by taking a risk-based approach to their biological safety evaluations.Our laboratory takes into consideration the materials, processing, and historical use of the device. This allows to perform a comprehensive assessment of biological responses for each medical device in relation to its safety.
Medistri’s Biocompatibility testing performed according to: ISO 10993
Our Quality Certificates
Explore our list quality certificates and discover why the world's most innovative healthcare companies choose to work with Medistri.
Are you ready to get started?
Contact us and our qualified team will respond.