The modern company laboratory is equipped for carrying out visual checks using optical microscopes, technological and biological trials.
All the equipment has been recently acquired and subjected to regular checks and calibration.
The laboratory thermostats ensure that the temperature set is maintained within acceptable ranges for carrying out trials, and for the maintenance of growth mediums and chemical/biological testers…
There are at the moment amongst the technological trials:
- tests for air tightness on PVC bags for infusion solutions and blood bags (even subjected to the autoclave at 121°C);
- pressure drop tests (holding) on sets and related components;
- Stress-cracking tests on tubing with visual checks using optical microscopes;
- seepage tests;
- speed and stability of flow tests on elastomeric pumps at controlled temperatures
The biological trials are carried out on the biological indicators used during the process of sterilization.
Atrophaeus Bacillus spores are used (Bacillus subtilis var. niger) with pop. > 10 6 spores/unit (ATCC 9372), either in strip form or in self-contained phials, conforming with ISO 11138-1:2017 and ISO 11138-2:2017.
The sterility checks on the process biological indicators is necessary to guarantee a good outcome for the sterilization process, and to allow for the release of a sterile product.