Steam sterilization

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.

• Self-contained
• Ampoules
• Coupons
• Strips
• Spore suspensions

Self-contained

STERILtest GST E6/E5 self-contained are made of a thermoplastic tube, with a cup permeable to steam, that contains an ampoule with a nutrient broth with a pH indicator and a disc impregnated with Geobacillus stearothermophilus (ATCC 7953) spores in predefined concentrations (E6 = 1-5 x 106 UFC/disc; E5 =1-5 x 105 UFC/disc). These bioindicators are used for regular control of steam sterilization cycles and control of any steam autoclave functionality.
Biological indicators STERILtest GST E6/E5 self-contained are produced under strictly controlled conditions in order to satisfy the requirements indicated in the USP current edition and in accordance with ISO 11138 and EN 866 standards.

Ampoules

Ampoules are biological indicators (BIs) used for regular monitoring of steam sterilization cycles and monitoring of any steam autoclave functionality.
Ampoules may be placed inside representative materials or within the sterilize chamber directly. After incubation, if viable spores are present a color change to yellow and/or turbidity of the medium will result as a consequence of bacterial growth. If no microbial growth occurs (no viable spores), the medium remains red-orange and without turbidity, indicating a successful sterilization cycle.

Coupons

Steam Control GST E6 SS are used for regular control of steam sterilization cycles and validation of sterilizers. These biological indicators use a stainless steel support (coupon) previously inoculated with Geobacillus stearothermophilus (ATCC 7953) spores and enclosed in a steam permeable envelope. The coupons are produced under strictly controlled conditions in order to satisfy the requirements indicated in the current editions of USP and EP and in accordance with ISO 11138 and EN 866 standards.

Strips

Biological indicators strips are special filter paper strips, inoculated with Geobacillus stearothermophilus spores (ATCC 7953) in predefined concentrations and contained in a special envelope. These bioindicators are used for regular control of steam sterilization cycles and control of any steam autoclave functionality. Biological indicators STRIP CONTROL GST E8/E6/E5/E4/E3 are produced under strictly controlled conditions in order to satisfy the requirements indicated in the USP current edition and in accordance with ISO 11138 and EN 866 standards.

Spore suspensions

Spore suspensions are used for regular control of steam sterilization cycles and control of any steam autoclave functionality and they are produced under strictly controlled conditions in order to satisfy the requirements indicated in the USP current edition and in accordance with ISO 11138 and EN 866 standards.