Commitment to Quality

ICSION’s commitment to quality is paramount. We are ISO 13485 certified to ensure a robust and thorough quality management system and our manufacturing facility is state-of-the-art.


An ultraclean manufacturing environment ensures ultraclean micropipettes. This is achieved as follows:

  • Multiple tiers of air filters to remove VOCs, bacteria and particles from the air.
  • Use of cleanroom coveralls, hoods, overshoes, masks and gloves.
  • Use of ultrapure water (18.2 MΩ-cm, TOC < 20 ppb) for all relevant cleanroom processes.
  • Extensive cleaning of borosilicate glass capillaries in ultrapure water.
  • Heat treating borosilicate glass capillaries to destroy potential endotoxins, RNA and DNA.
  • Comprehensive ultraclean environmental and manufacturing controls and procedures.


ICSION has a comprehensive array of rigorous QA and QC measures including:

  • 100% in-process inspection by experienced technicians with strict rejection standards covering cleanliness and dimensional tolerances.
  • Additional production lot inspections undertaken prior to packaging.
  • Post-sterilisation testing by an experienced embryologist using ICSI equipment to ensure proper functionality with fertility media, oil and PVP.
  • 96h 1-cell to expanded blastocyst mouse embryo assay (MEA) product testing by an ISO 17025 accredited independent laboratory.
  • Endotoxin (LAL) product testing by an ISO 17025 accredited independent laboratory.
  • Regular independent bioburden testing of the cleanroom, airlock and gloves worn by staff.
  • Regular independent bioburden and endotoxin testing of ultrapure water used in production.
  • Packaging validated as per ISO 11607-1 and ASTM D4169.
  • Packaging and sterilisation validated to a Sterilisation Assurance Level (SAL) of 10-6 as per ISO 11137.