Sterilisation

LIGASANO® white is available both sterile and non-sterile.

LIGASANO® orange is available both sterile and non-sterile.

LIGASANO® green is available both sterile and non-sterile.

Those three products can also be sterilized on site with steam. Below is our Technical Information: Sterilization 15243 / Status 27 Jan. 2006 / LH.

Description of the routine sterilization of LIGASANO® white and LIGASANO® green in a validated procedure:

  • The products LIGASANO® white, LIGASANO® orange and LIGASANO® green are PUR foams with special properties for medical applications.
  • The products are offered by LIGAMED® medical Produkte GmbH (hereinafter referred to as LIGAMED®) non-sterile and partly also sterile.
  • In our experience, sterilization with moist heat in steam sterilization is very suitable for LIGASANO® white, LIGASANO® orange and LIGASANO® green. The procedure is safe and the material properties of the products are not influenced by the validated sterilisation procedures with moist heat used by us.
  • Several years ago we also gained experience with sterilization by cobalt irradiation (gamma sterilization) with a minimum dose of 25kGy. During this procedure, LIGASANO® white showed a slight discoloration, which can also be observed under UV radiation. The material properties also remained unchanged here, it was a purely cosmetic defect.
  • If the products are purchased from LIGAMED® in sterile form, these products are individually packaged in sterile packaging and sterilized with moist heat in a validated sterilization cycle. Sterilisation takes place in "large steam sterilisers" in accordance with DIN 58946-6 and DIN EN 285.
  • Validation and routine monitoring for sterilisation with moist heat in accordance with the requirements of DIN EN 554 and the DGKH recommendation for validation and routine monitoring of sterilisation with moist heat for products used in hospitals and other medical facilities in the health care sector. Other applicable standards according to current status, e.g. DIN EN 285, DIN EN ISO 10993-1 Biological evaluation of medical devices.
  • The packaging materials for sterile goods packaging are selected in accordance with DIN EN 868 and their marking has been carried out in accordance with DIN EN 980.
  • The packaging of the products into the sterile goods packaging and the introduction of the packed products into the steam sterilizer is carried out in clean rooms of ISO class 8 (corresponds to class 100,000). The quality of these clean rooms is regularly qualified in accordance with DIN EN ISO 14644.
  • Quantitative determinations of the bioburden are carried out for each production batch. DIN EN 1174 part 1-3 and LAL tests according to USFDA LAL-Guideline 1987. These tests and investigations were carried out in external laboratories accredited by the ZLG.
  • Steam sterilization is carried out at the factory for 5 minutes at 134 °C under validated conditions. In our experience, these standardized parameters best meet the requirements for adequate product safety and economy, and there is no measurable effect on the properties of LIGASANO® white, LIGASANO® orange and LIGASANO® green.
  • Other variants tested in validated procedures and their effects on LIGASANO®:
  • 121 °C / 15 minutes - without measurable effects on the properties of LIGASANO® white and LIGASANO® green
  • 134 °C / 20 minutes - low loss of hardness with LIGASANO® white, no measurable effects on the properties of LIGASANO® green.

Legal requirements and applicable standards have been complied with until 27.01.2006.

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