Laboratory Testing
Our tests are done in accordance with international standards. In addition we can provide validations of the methods that we use. The documentation we provide will be adequate for inclusion in a CE dossier.
Bioburden
A bioburden test is performed to determine the number and nature of microorganisms on a product prior to sterilization. Any sterilization process can kill only a finite number or organisms. Monitoring the bioburden ensures that the challenge to the sterilization process is not too great to maintain an assurance of sterilization efficiency. Bioburden testing can also assist in monitoring the entire manufacturing process, from raw materials through clean room procedures.
According to standard EN ISO11137-1:2006: “Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products”.
- Routine testing
- Germ determination
- Method validation
Sterility assurance testing
To ensure that validated sterilization processes provide the required Sterility Assurance Level (SAL) either during validation or for routine process monitoring. In order to label a product as "sterile," specific requirements for validation and routine monitoring of sterilization processes must be met. For most products, a theoretical SAL is set so the probability of a non-sterile product making it through the validated sterilization process is one unit per million sterilized. This is referred to as an SAL level of 10-6.
According to the standard EN ISO 11737- 2:2010 “Sterilization of medical devices - Microbiological methods -Part 2: Tests of sterility performed in the validation of a sterilization process” and European pharmacopée, section 2.6.1.
- Routine testing
- Method validation
Population assays of biological indicator
Counting the population of the biological indicator used (spores strips or self-contained) to confirm the manufacturer data.
Residues testing: Ethylene oxide (EO), Ethylene Chlorohydrin (ECH), Ethylene Glycol (EG)
When a product is sterilized with ethylene oxide, some of the gas may be absorbed by the product and/or its packaging and retained after sterilization. There may also be traces of EO bi-products present after sterilization. The extent of degassing and aeration used during the sterilization process will have a significant effect in reducing these residue levels. The International Standard ISO10993-7 describes the categorization of products, methods of testing and allowable limits:
- Limited exposure : up to 24h
- Prolonged exposure: 24h to 30 days
- Permanent contact devices: more than 30 days.
The Exhaustive Extraction Method extracts residues by heating the product in a sealed system and testing aqueous extraction of the samples.
Determination of the Shelf-Life: Ageing Studies
According to ISO 11607, FDA and European Medical Device Directive (MDD) all sterile medical devices must be given an expiration date, which indicates how long they may be stored prior to use. Therefore, documented shelf life evidence must exist to substantiate those claims, by verifying product and package, following ageing. Accelerated ageing is achieved by storing the product at an elevated temperature; a rise in temperature of 10°C will cause approximately a doubling of the rate of chemical reaction, assuming that the rate of decay of packaging and product is doubled (60°C is the maximum temperature that is suitable for most products according to ASTM F1980).
What Andersen tests:
Tests according to ASTM standards ASTM F1980 “Standard Guide for Accelerated Ageing of Sterile Medical Device Packages”
* Ageing studies: Store customer sterilised items in a specific chamber with controlled temperature and relative humidity.
* Physical tests:
- Visual verification (labeling, printing, global aspect).
- Leak testing (bubble emission, Dye penetration).
- Seal strength testing.
* Microbiological tests: Sterility tests