USP<55> Biological Indicators-Resistance Performance Tests
Organism: G.stearothermophilus
Key words:
Classification:
Keyword: VPHP Biological Indicator-Ribbon
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Manufacturer:
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Additional information: | |
Brand: Microdome Labs | Expiration: 9 months from date of manufacture |
Storage: 2-8 ℃ | Field of activity: Healthcare, Pharmaceutical |
Description: VPHP-R biological indicator uses stainless steel chip as carrier. The chip is horizontally inserted inside the plastic cap. Removable foam dot adhesive is provided for mounting at various monitoring locations. The indicator microorganism is highly purified spores of Geobacillus stearothermophilus (Cell Line #12980). For use with Recovery Media (Bromocresol Purple Media).
Application fields: Used for verification and monitoring of sterilization cycle efficacy of vaporized hydrogen peroxide , cold-evaporated hydrogen peroxide/peracetic acid, and hydrogen peroxide plasma.
Instructions for Use: Place this product at various monitoring points. After sterilization is complete, transter thebiological indicator carrier to bromocresol purple medium, and incubate at 55-60"C incubatefor 7 days as per the requirements of "ISO 11138-1 Sterilization of health care products -Biological indicators - Part 1: General requirements". After incubation, if the medium remains purple/clear, it indicates a negative result; if the medium turns yellow/turbid, it indicates a positive result. Refer to the instructions for details.
Product Advantage: Convenient: Color-changing medium for easy result reading. Safe: The spore-bearing steel strip is placed inside a plastic vial. Simply twist off the cap before use to avoid cross-contamination. Flexible: Removable foam dot adhesive can be attached to the cap for fixing at various monitoring points. Professional: Complies with USP<1229.5> and manufactured in strict accordance with ISO 11138. Stable and high spore load: Various spore load levels (103-106) are available.
Disposal: This product contains active microorganisms (WHO Risk Group 1). It must be autoclaved or treated as medical waste before disposal.
Standards Followed: ● USP <1229.5>Biological Indicators for Sterilization ● USP<55> Biological Indicators-Resistance Performance Tests ● ISO 11138-1 Sterilization of health care products-Biological Indicators-Part1: General requirements ● FDA Biological Indicators(BI) Premarket Notification [510(k)]Submissions
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Product Specifications
| Produce Name | Organism | Item No | Spore Count(cuf) | Package |
VPHP Biological Indicator-Ribbon | G.stearothemophilus Cell Line #12980 | BIHPG1-4/R | 104 | 25 vials/box |
BIHPG1-5/R | 105 | |||
BIHPG1-6/R | 106 | |||
Bromocresol Purple Media | N/A | MD-RMB | N/A | 25/50 bottles/box |
Spore Counting Eluent | N/A | MD-WF | N/A | 5 bottles/box |
Biological Indicator spore counting kit | N/A | MD-VD | N/A | 1set/box |
Note: The biological indicator spore count kit includes spore counting eluent, spore counting diluent, and spore counting medium (TSA-OXOID).
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