USP<55> Biological Indicators-Resistance Performance Tests
ISO 11138-1 Sterilization of health care products-Biological Indicators-Part1: General requirements
Keywords: Convenient、Safe、Flexible、Unique、Professional、
G.stearothermophilus
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.
Storage Conditions:2-8℃
Validity:9 months
Key words:
Classification:
Keyword: VPHP Biological Indicator-Ribbon
Agency:
Manufacturer:
Details
Product Information: 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 Microdome Labs bromocresol purple medium (MD-RMB). 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. | Instructions for Use: Place the product at each monitoring point, After sterilization, transfer the biological indicator carrier into bromocresol purple medium(MD-RMB), and incubate at 55-60℃ for at least 48 hours(or incubate for 7 days as required by GB1828.1.0 Sterilization of health care products-Biological indicators-Part1:General ). Purple/Clear medium after incubation negative: yellow/turbid medium indicates positive.
Disposal: This product contains active microorganisms(WHO Risk Group 1). It must be autoclaved or treated as medical waste before disposal.
Standards Followed: ①USP <1229.5>Biological Indicators for Sterilization ②USP<55> Biological Indicators-Resistance Performance Tests ③ISO 11138-1 Sterilization of health care products-Biological Indicators-Part1: General requirements ④FDA Biological Indicators(BI) Premarket Notification [510(k)]Submissions |
Product Specifications
| Produce Name | Organism | Item No | Spore Count(cuf) | Package |
VPHP Biological Indicator-Ribbon | G.stearothemophilus ATCC #12980 | BIHPG1-4/R | 10^4 | 25(vials/box) |
BIHPG1-5/R | 10^5 | |||
BIHPG1-6/R | 10^6 | |||
Bromocresol Purple Medium | N/A | MD-RMB | N/A | 25(vials/box) |
Spore Counting Eluent | N/A | MD-WF | N/A | 5(vials/box) |
Biological Indicator spore counting kit | N/A | MD-VD | N/A | 1(set/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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