It is not only important assuring the medical device’s safety and efficacy, but it is also fundamental that the medical reaches the end user intact.

Mérieux NutriSciences - Packaging validation

Physical-chemical analysis

  • Visual inspection test – ASTM F1886 / F1886M-09
    Standard test method for determining integrity of seals for medical device packaging by visual inspection.
  • ​​​Dye penetration test– ASTM F1929
    Standard test method for assessing resistance and detecting the presence of fractures, channels or abnormalities of the packaging containing the medical device by dye penetration assay (Toluidine Blue).

Microbiological analysis

  • Sterility test – <71> STERILITY USP 41-NF36
    Standard test method for verifying the absence of microbial growth.
  • Microbial barrier test – DIN 58953-6:2010
    Standard test method for verifying the resistance to the microbial passage through the material used for the medical device packaging, in wet and dry conditions.

Mechanical analysis 

  • Seal strength test – ASTM F88/F88M-15
    Standard test method for the determination of maximum force needed for opening the packaging, the package integrity as well it measures the ability of the process to produce consistent seals. 
  • Peel or stripping strength test of adhesive bonds – ASTM D903-98
    Standard test method for the determination of maximum and mean force needed for peeling it.

Sterilization dose determination - ISO 11137

Determining the sterilizing dose using microbial load information (Bioburden):

  1. select the sterility assurance level: it’s important to select samples that must be representative of routinely sterilized products;
  2. determine the average microbial load of the batches - method based on ISO 11737-1;
  3. obtain the verification dose - referring to table 5 of ISO11137-2;
  4. conduct verification dose experiments on irradiated pieces - (method based on ISO 11737- 2;
  5. interpret the results;
  6. establish the sterilisation dose based on the results. 

Sterilization site validation - β e γ rays

Verification of the ability of the site to sterilize the packaging of medical devices:

  1. spiking: inoculation of relevant strains with a known title on the packaging;
  2. sending the packaging to the site for the sterilization procedure execution;
  3. verification of the effective ability of the sterilization procedure by our laboratories.

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