USP (United States Pharmacopoeia) and EP (European Pharmacopoeia) standards, recommend the use of bioindicators during steam sterilization processes of pharmaceuticals, drugs in vials, culture media, medical instruments and more.
What is steam sterilization?
Steam sterilization is one of the most effective and widely used methods for eliminating microorganisms and spores from heat-resistant materials. It relies on the action of saturated steam under pressure. To ensure the effectiveness of the process, proper load configuration and steam penetration are essential; the use of biological indicators is therefore strongly recommended to verify that the sterilization cycle has achieved the required conditions and to provide reliable assurance of process performance.
- Self-contained
Self-contained biological indicators consist of a thermoplastic tube equipped with a steampermeable cap
and an internal ampoule containing a nutrient broth with a pH indicator, together
with a carrier disc impregnated with Geobacillus stearothermophilus (ATCC 7853) spores 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.
- Ampoules
Ampoules are sealed vials containing bacterial spores suspended in a nutrient broth with a pH
indicator. They can be placed directly in the sterilizer chamber or within representative materials.
Following sterilization process, incubation reveals whether any spores have survived: growth
causes the medium to turn yellow and/or become turbid, while no change indicates a successful
sterilization cycle.
- Steel coupons
Coupons BIs use a stainless steel support, previously inoculated with Geobacillus
stearothermophilus (ATCC 7953) spores in predefined concentrations and enclosed in a steam
permeable 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.
- Strips
This BIs are special filter paper strips, previously inoculated with Geobacillus stearothermophilus
(ATCC 7953) 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 Geobacillus stearothermophilus (ATCC 7953) spores suspended in a
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.
