ProSpore Ampoule

ProSpore Ampoule is a self-contained Biological Indicator available for use in healthcare or industrial steam sterilization. It is intended for use as a challenge to steam sterilization at 121°C. ProSpore Ampoule is ideal for use in validating the sterilization of volumes of liquid that take a longer time to reach sterilizing conditions. ProSpore Ampoule is also acceptable for use when placed in the sterilizer (non-liquid loads). No activation is required: just expose the unit in sterilizer and incubate afterwards. It is available in the following configurations:

4 ml  Catalog# Min. Pop. Qty/Box PS-4-10 1.0 x 104 10 PS-4-50 1.0 x 104 50 PS-5-10 1.0 x 105 10 PS-5-50 1.0 x 105 50 PS-6-50 1.0 x 106 50

1 ml  Catalog# Min. Pop. Qty/Box PS1-4-15 1.0 x 104 15 PS1-4-100 1.0 x 104 100 PS1-5-15 1.0 x 105 15 PS1-5-100 1.0 x 105 100 PS1-6-15 1.0 x 106 15 PS1-6-100 1.0 x 106 100 PS1-5-60NC 1.0 x 105 50+/10  PS1-6-60NC 1.0 x 106 50+/10

Specifications

ProSpore Ampoule is a hermetically sealed, type I borosilicate glass ampoule. The ampoule is filled with a modified Soybean Casein Digest Broth containing bromocresol purple acid indicator. Each ampoule also contains a population of G. stearothermophilus spores¹. ProSpore Ampoule has received 510K notification for sale to healthcare facilities with a 48 hour incubation period. Growth is evident by either turbidity and/or a color change from a purple to or toward yellow. Expiration is 18 months from the date of manufacture.

Certification

ProSpore Ampoule is certified for species, 48-hour outgrowth, Population, Expiration, D-value and z-value.