Sterilization validation service

Sterilization validation service

Cosmos Biomed has established strategic partnerships with China’s internationally certified EO Sterilization Service Facility to provide a comprehensive EO sterilization validation plan to improve the quality of medical device customers and the safety of consumer use. We bring together senior sterilization specialists and ISO 17025 accredited microbiology laboratories to assist you achieve a complete sterilization validation report to keep your product safe and meet international standards.

Service Portfolio

 

EO Sterilization validation study and EO Sterilization service

Introduction of EO gas

  1. EO can be used for sterilization of temperature and moisture sensitive items
  2. It is considered to be the best chemical sterilization agent for sterilization, killing all microorganisms (including bacterial spores)
  3. EO has strong penetrability, can be used for sterilization of various difficult-to-penetrate parts (such as some thinner, longer catheters).It is difficult to achieve sterilization with other low temperature sterilization methods. Only EO or irradiation can be used.
  4. EO damage to the item is minor, because EO kills microorganisms by using the principle of alkylation instead of oxidation. Therefore, it has a very wide range of uses for the sterilization of heat-resistant precision instruments.
  5. When sterilizing, it can be wrapped with permeable and impervious packaging materials, which is convenient for storage, transportation and opening the package.
    Use to avoid the risk of cross contamination.
  6. Sterilization method is low-cost, easy to monitor, suitable for most medical grade plastics, requires a long week to eliminate the EO/ECH residue.

Introduce of Bioburden

What is Bioburden？
The total number of microorganisms that survived the detection of unsterilized medical device products that have been packaged, or defined as population of viable microorganisms on or in product and/or sterile barrier system

Why mandatory to perform “Bioburden Test”?
According to the bioburden of the device, it can be decided sterilization parameter

Sterility test

Purpose
In order to assure the sterilization effectiveness of sterilized medical device products, refer to the US Pharmacopoeia USP-30<71> and ISO 11737.

Scope
The test method is applicable to the sterility test of the medical device product after sterilization; the main purpose of the method and the result thereof is to assist the sterilization effect of the product and increase the confidence level of the routine sterilization batch quality assurance, and it is not recommended to use the routine sterilization batch separately. The release is not repeated to ensure that the products in the batch are completely sterilized or sterilized.

Sterility check
Sterility tests include microfiltration membrane filtration and direct inoculation. When performing sterility inspection of the product, the method a condition used shall be the same as the verification method

EO sterilization residue test

According to ISO10993-7 Biological evaluation of medical devices —Part 7: Ethyleneoxide sterilization residuals method, the residue analysis and estimate the criteria by device contact period with ISO 10993-1.