This part of ISO 11737 lays down the general criteria for testing the sterility of medical devices that have undergone treatment with the sterilising agent, reduced to the level expected in routine sterilisation procedures. These tests are foreseen when a sterilisation procedure is defined, validated or maintained.
The test for bacterial endotoxins is used for the detection or determination of endotoxins of Gram-negative bacteria using the using amoebocyte lysate from the horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). The CUP laboratories offer three techniques for this test: the gel formation technique, the turbidimetric technique and the technique with chromogen, which are based on the formation of a gel, the development of a turbidity after cleavage of an endogenous substrate or a color development after cleavage of a synthetic peptide-chromogen complex.
This part of ISO 14644 contains the classification of air purity in clean rooms and associated clean room areas and refers exclusively to the concentration of airborne particles. For classification purposes, only particle groups whose cumulative frequency distribution is based on the threshold particle size (lower (detection) limit) ranging from 0.1 μm to 5 μm are considered.
Special requirements apply to the manufacture of sterile products in order to minimise the risk of contamination with micro-organisms, particles and pyrogens. Much depends on the skill, training and behaviour of the personnel concerned. Quality assurance is of particular importance here and production must be carried out strictly according to carefully defined and validated methods and procedures. Sterility or other quality aspects must not be based solely on the final manufacturing step or testing of the final product.