Producing safe products is a core goal of all medical device manufacturers and sterility assurance is a key component in achieving that goal.
Many single-use medical devices are terminally sterilised using EO, Steam or radiation technologies. Medical device manufacturers are required to validate the sterilisation process and these validations typically require both bioburden and sterility testing. Sterility testing and bioburden testing are also performed on devices as part of routine quality control.
Understanding and controlling the bioburden of a product is a prerequisite for any proper sterilisation. It is also a quality prerequisite in the medical and pharmaceutical industries.
Medistri SA has STS 0504 accreditation for the analysis of microbial load, analysis approaches and validation (determining the rate of recovery and conversion factor). Our procedures meet the requirements of appropriate and current versions of European and United States Pharmacopeia and ISO standard.
The bioburden is a method that must be validated in order to assess the actual results of routine analysis. This determines a conversion factor indicative of the recovery of organisms of a particular device. The bioburden validation should be reviewed at regular intervals.
The routine determination of bioburden must be performed using a documented sampling plan defining the sample size and the sampling frequency. The application of statistical methods to determine the sample size, sampling frequency, and/ or acceptable limits can be advised by Medistri. It must be established and documented. This sampling plan is determined by factors such as the number of lots, the health risks associated with the use of products with a level of unacceptable contamination, product characteristics, and the degree of alleged contamination.
Medistri can also search germs specified by macroscopic characterisation (colony characteristics), microscopic (cell characteristics) by farming methods (biochemical characteristics), and colorations. Research specified germs allow at the end to get good information on the origin of the contamination and to act on the source of it.
In case of exceeding the limits of acceptance, Medistri offers its expertise in action at the source of the problem.
Prior to beginning routine sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met.
Work with Medistri to Mitigate risks. Improve your product's safety. Strengthen your Supply Chain.
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
Contract Sterilisation Services
Medistri’s sterilisation infrastructure was engineered to allow you to save time and distribute your products on the market faster. We have optimised our sterilisation processes to provide you with the fastest sterilisation services available to date.
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