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Liofilchem® STERIL CONTROL GST E4 Ampoules
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Specifications:
| Application | sterilization | ||
| Storage Temperature | 2-8°C | ||
| Product Type | Indicators | Forms | Liquid |
| Product Brand | Liofilchem | ||
| Product Grade | Laboratory grade | ||
The STERIL CONTROL GST E6/E5/E4 Ampoules are biological indicators for steam sterilization processes, containing Geobacillus stearothermophilus (ATCC® 7953) spores in different concentrations (E6, E5, E4). These ampoules are designed for monitoring the efficacy of sterilization cycles in autoclaves used for pharmaceuticals, medical instruments, and culture media. Compliant with USP, EP, and DAB standards, as well as ISO 11138 and EN 866, these indicators provide reliable and precise validation of sterilization processes.
Key Features
- Biological Indicator:
- Contains spores of Geobacillus stearothermophilus, a thermophilic bacterium ideal for testing steam sterilization processes.
- Different Concentrations:
- Available in varying spore concentrations:
- E6: 1–5 × 10⁶ CFU/ampoule.
- E5: 1–5 × 10⁵ CFU/ampoule.
- E4: 1–5 × 10⁴ CFU/ampoule.
- Available in varying spore concentrations:
- Color-Based Results:
- Medium changes color from violet/clear to yellow/turbid upon microbial growth, indicating unsuccessful sterilization.
- Incubation:
- Requires incubation at 55–60°C for 24–48 hours.
- Positive control ampoule confirms spore viability.
- Applications:
- Regular monitoring of autoclave cycles.
- Validation of sterilization for pharmaceuticals, instruments, and other medical products.
- Sterilization Post-Use:
- Positive ampoules can be autoclaved at 121°C for 30 minutes before disposal.
Comparison with Sterikon® Plus Bioindicator
| Feature | STERIL CONTROL GST E6/E5/E4 Ampoules | Sterikon® Plus Bioindicator |
|---|---|---|
| Organism | Geobacillus stearothermophilus (ATCC® 7953) | Geobacillus stearothermophilus (ATCC® 7953) |
| Spore Concentration | E6: 1–5 × 10⁶, E5: 1–5 × 10⁵, E4: 1–5 × 10⁴ CFU/ampoule | Fixed spore concentration, typically ≥10⁵ CFU/ampoule |
| Medium | Nutritive broth with pH indicator (violet to yellow upon growth). | Nutritive broth with pH indicator (purple to yellow upon growth). |
| Incubation Requirements | 55–60°C for 24–48 hours | 55–60°C for 24–48 hours |
| Standards Compliance | USP, EP, DAB, ISO 11138, EN 866 | USP, EP, ISO 11138 |
| Packaging Options | 1 mL or 4 mL ampoules; packs of 20 or 50 ampoules | Fixed sizes; typically 50 ampoules per pack |
| Application | Broad applications: culture media, medical instruments, etc. | Primarily for autoclave validation in healthcare and pharma. |
| Ease of Use | Multiple spore concentrations for tailored monitoring. | Single spore concentration simplifies use but lacks flexibility. |
| Post-Sterilization Treatment | Positive ampoules require autoclaving before disposal. | Positive ampoules require autoclaving before disposal. |
Key Advantages of STERIL CONTROL GST E6/E5/E4 Ampoules
- Tailored Monitoring:
- Offers multiple spore concentrations (E6, E5, E4) to match sterilization validation needs.
- Flexible Packaging:
- Available in 1 mL and 4 mL ampoules for specific application volumes.
- Wide Application Range:
- Suitable for pharmaceuticals, vials, medical devices, and more.
- Global Standards Compliance:
- Fully compliant with USP, EP, DAB, ISO 11138, and EN 866 for international usability.
Both the STERIL CONTROL GST E6/E5/E4 Ampoules and Sterikon® Plus Bioindicator are robust solutions for monitoring steam sterilization processes, with similar incubation and interpretation methods. The STERIL CONTROL GST ampoules stand out with their tailored spore concentrations and broader packaging options, making them more versatile for diverse sterilization validation scenarios. Sterikon® Plus offers a simplified approach with a fixed spore concentration, which may be more suitable for routine validations in healthcare settings.
- Pack Size: 50 ampoules x 4 mL 20 ampoules x 4 mL