Biological & Chemical Indicators
Description
Self-Contained Biological Indicators
Stainless Stell Coupons for VHP / STEAM
Spore Ampules
Spore Ampules - Low Temperature Steam Cycles. Spores of Bacillus subtiis
Spore Strips
Spore Suspensions
Plasma multi-parameter indicator VH202 (P-C)
Bowie Dick Test 121°C for16.9 mins & 10 mins (Class 2 indicator)
All BIs are certified for species, population, purity, resistance, (D value, Z value and survival/kill data). They are developed and manufactured under ISO 9001:2000 and ISO 13.485:2003 certified systems & are in compliance with USP (United States Pharmacopoeia), EP (European Pharmacopoeia) & DAB (Deutsches Arzneibuch ) standards. The quality parameters are determined at time of manufacture according to ISO 11138 (Parts 1, 2, 3, 4 and 5) standards.
| 2016032 | Self-Contained Biological Indicators |
|---|---|
| ► | Self-contained biological indicators for Steam and Ethylene Oxide contain a known quantity of bacterial spores inoculated onto filter paper placed inside a plastic culture with a crushable glass ampoule containing the culture medium traceable to recognizable culture identified in USP and ISO 11138. |
| ► | Contains Geobacillus stearothermophilus for Steam sterilization and Bacillus Atrophaeus for Ethylene Oxide sterilization |
| ► | Easy to incubate – no culturing |
| ► | Dramatic colour change for positive cultures |
| ► | Results in 48 hours for Steam and Ethylene Oxide |
| ► | Non-toxic |
| 2016033 | Stainless Steel Coupons for VHP / STEAM |
|---|---|
| ► | SS Coupons inoculated with Geobacillus stearothermophilus (ATCC 7953) spores packed in Tyvek ® / Polytene envelope. SSC are available in predefined concentration of 1-5 x 10 & 1-5×10 spores. SSCs are used for regular control of H2O2 vapour superficial sterilization cycles, fogging validation Area disinfectant Efficacy studies & Validation of sterilizers. Tyvek ® side of envelopes is permeable to H2O2 vapour, while the Polytene side of envelopes is not permeable. |
| ► | SS Coupons inoculated with Bacillus atrophaeus (ATCC 9372) spores packed in special envelope. |
| ► | SSC are available in predefined concentration of 1-5 x 10 & 1-5×10 spores |
| ► | SSCs are used for regular control of Dry Heat & Ethylene Oxide sterilization cycles & validation of sterilizers |
| 2016034 | SPORE AMPULES |
| ► | Spore ampules are hermetically sealed Type I borosilicate glass containing a modified Soybean Casein Digest Broth with bromocresol purple pH indicator and the specified population of Geobacillus stearothermophilus spores. Incubate ampules at 55 – 60°C for 48 hours |
| ► | Growth is evident by either turbidity and/or a color shift from a purple to a yellow color |
| ► | Spore ampules are labeled for 24 months of shelf life when stored under refrigerated conditions (5°C ± 3°C) |
| ► | Do not freeze spore ampules. |
| 2016035 | SPORE AMPULES – Low Temperature Steam Cycles. Spores of Bacillus subtiis |
| ► | Spore ampules are hermetically sealed Type I borosilicate glass containing a modified Soybean Casein Digest Broth with bromocresol purple pH indicator and the specified population of Geobacillus stearothermophilus spores. Incubate ampules at 55 – 60°C for 48 hours |
| ► | Growth is evident by either turbidity and/or a color shift from a purple to a yellow color |
| ► | Spore ampules are labeled for 24 months of shelf life when stored under refrigerated conditions (5°C ± 3°C) |
| ► | Do not freeze spore ampules. |
| 2016036 | SPORE STRIPS |
| ► | Spore strips were developed to control steam, dry heat, ethylene oxide, hydrogen peroxide plasma, gamma radiation and formaldehyde sterilization processes |
| ► | Spore strips are conventional paper strip biological indicator that contain bacterial spores on a filter paper carrier sealed within a special envelope |
| ► | The strips could be fit into small areas of a device, where a standard self-contained biological indicator can not be used, such as within a syringe, inside a tubing, inside a product or in a product package. |
| ► | Upon removal from the sterilizer, the strip must be aseptically cultured in modified SCD mediums, and incubated at the appropriate temperature |
| 2016037 | SPORE SUSPENSION |
| ► | Spore Suspensions are pure suspensions of viable spores of known resistance to various sterilization processes. They are suspended in Water For Injection (WFI) and provided in 10 mL pharmaceutical vials. Suspensions are available in populations of 102 to 108 spores per 0.1 mL. |
| ► | Spore Suspensions are typically used for product inoculation to verify sterility of areas on or within adevice where a traditional BI cannot be used |
| ► | Suspensions are also used in cleaning effectiveness studies, bioburdenpercent recovery, bacteriostasis/ fungisatsis and media growth promotion testing |
| 2016038 | Plasma multi-parameter indicator VH202 (P-C) |
| ► | The first CT Indicator of H2O2 Concentration & Time Control. Check for indicator ink color change: |
| ► | Riverside green when processed |
| ► | Hydrogen peroxide vapor concentration : i.e.30mg/L |
| ► | Time : i.e. 15min. |
| ► | H2O2 : i.e. 40g/M Temperature : 40OC(104OF) |
| ► | Relationship between Hydrogen peroxide vapor Concentration and time : i.e. time 7.5 min, concentration 60 mg/L. |
| ► | Waffle surface prevents indicator from sticking to film pouch |
| 2016039 | Bowie Dick Test 121°C for16.9 mins & 10 mins (Class 2 indicator) |
| ► | A Bowie-Dick Test Pack designed for daily monitoring of pre-vacuum steam sterilizer operating at 121 °C for16.9 mins. as per HTM 2010 guidelines & for 10 mins. Check for air removal and leak, inadequate steam penetration and vacuum pump failures by wine-red/bordeaux -red to green ink technology, Conforms to ISO 11140-1 & ISO 11140-4 Class2 |
| ► | Vacuum pump failures |
| ► | Low steam or water pressure |
| ► | Inadequate air removal or air leak. |
| ► | Clogged drain line or control valves |
| ► | Steam indicator tape autoclave tape |
