Sterilisation

All non-aseptic production processes end with a sterilisation step and EMCM provides the full range of finished product sterilisation by in-house steam sterilisation as well as outsourced sterilisation services:

  • Steam sterilisation

    A series of steam sterilisers, under which a steam-air steriliser (low and high volume autoclaves), are available at EMCM for the heat sterilisation of closed containers, filled syringes and the final heat treatment of gel products.

  • Sterilisation by gamma-radiation, beta-radiation, Ethylene-oxide

    EMCM offers sterilisation services for all products where steam sterilisation is not an option. Years of experience with reliable partners for the sterilisation of products through gamma-irradiation, beta-irradiation and Ethylene-oxide.

  • Supercritical carbon dioxide

    EMCM’s experience in supercritical CO2 (scCO2) started off with treating musculoskeletal tissue, because the nature of the tissue makes it difficult to penetrate and render it clean and sterile. In particular, femoral heads containing blood, fat, marrow and attached soft tissues are hard to process in other ways. The scCO2 technique is based on carbon dioxide which will become supercritical at a specific pressure and temperature (critical point). In this condition, the scCO2 has the penetrating ability of a gas and the dissolving power of a liquid. Therefore, scCO2 cleaning is considered a mild process and maintains the intrinsic properties of the musculoskeletal tissue after cleaning. Due to this mild process, the supercritical approach can also be applied for a wide range of soft tissues from various origins.

    Furthermore, scCO2 is not only limited to cleaning tissues, but it also has excellent sterilisation properties. Terminal sterilisation is often seen as a hurdle in product development like hydrogels and products which are temperature sensitive or ‘fragile’ for harsh circumstances. While EMCM explores various process parameters for sterilisation of different grafts at this time, the scCO2 approach is a promising final sterilisation form for various kinds of products which is not limited to tissues only. Actually, supercritical processing is an established method to impregnate substances, and it is mainly used in the textile industry to dye clothing and shoes. This principle of impregnation can be used in the pharmaceutical and biological industry as well.

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