USP (United States Pharmacopoeia) and EP (European Pharmacopoeia) standards, recommend the use of bioindicators during irradiation sterilization processes of pharmaceuticals, drugs in vials, culture media, medical instruments and more.
What is gamma irradiation sterilization?
Gamma irradiation sterilization is a cold sterilization method based on the use of ionizing radiation. High-energy gamma photons penetrate deeply through packaging and materials, damaging microbial DNA and essential cellular structures and thereby preventing replication and survival. Because the process is carried out at ambient temperature and without pressure, gamma irradiation is particularly suitable for heat-sensitive and pre-packaged products.
- Strips
This BIs are special filter paper strips, previously inoculated with Bacillus pumilus (ATCC 27142) spores in predefined concentrations and enclosed in a special envelope. They are manufactured under strictly controlled conditions to comply with the current editions of USP and EP, and in accordance with ISO 11138 and EN 866 standards.
- Spore suspensions
Spore suspensions consist of Bacillus pumilus (ATCC 27142) spores suspended in distilled water in predefined concentrations. They are manufactured under strictly controlled conditions to comply with the current edition of USP and in accordance with ISO 11138 and EN 866 standards.
View the complete range of Biological indicators Irradiation