Bowie-Dick autoclave test, steam penetration test, ISO 11140-4, Class 2 chemical indicator, CSSD autoclave validation, pre-vacuum sterilizer air removal
Ensure absolute sterile assurance in your Central Sterile Services Department (CSSD) and clinical reprocessing units with our single-use Bowie-Dick Test Pack. Engineered specifically for pre-vacuum (Class B) steam autoclaves, this diagnostic indicator pack verifies effective dynamic air removal and uniform saturated steam penetration prior to processing surgical instruments and porous loads.
Air leaks, vacuum pump degradation, and non-condensable gases (NCGs) form insulating pockets inside autoclave chambers, causing hidden cold spots where microorganisms survive. Placed in an otherwise empty chamber at the beginning of each working day, the test pack reproduces the challenge of a standard 7 kg cotton load in a compact, disposable format.
Featuring a lead-free, non-toxic chemical indicator sheet positioned at the core of calibrated barrier sheets, the test yields a distinctive, permanent color change. Any residual air or steam quality issue results in an incomplete or patchy color pattern, instantly alerting technicians to mechanical failure before patient loads are compromised.
Critical Fault Detection: Immediately flags mechanical faults including door gasket leaks, vacuum pump decay, solenoid valve failure, and trapped air pockets.
Definitive Color Transition: High-contrast thermochromic ink delivers a permanent, non-reversing color endpoint (e.g., yellow to dark brown/black or blue to pink, depending on chemical formulation) with no ambiguity.
Audit-Ready Documentation: The inner test sheet remains completely flat after processing and features dedicated documentation fields (date, autoclave ID, operator name, cycle number) for traceable compliance logs.
Ready-to-Use Convenience: Pre-assembled, single-use pack eliminates manual cotton towel folding, eliminating assembly error and saving technician time.
Eco-Friendly & Non-Toxic: Manufactured with recyclable medical-grade barrier paper and 100% lead-free, heavy-metal-free indicator ink.
Warm-Up Cycle: Pre-heat the autoclave chamber by running an empty cycle without extended drying.
Placement: Place the Bowie-Dick test pack flat over the chamber drain (typically 100 mm to 200 mm above the base) in an empty chamber.
Run Test: Run the dedicated Bowie-Dick cycle at 134°C for 3.5 minutes.
Interpretation: Remove and unwrap the pack. A completely uniform color across the entire sheet confirms complete air evacuation and steam penetration. A lighter center indicates air entrapment.
Log & Archive: Sign the sheet, attach it to the daily autoclave logbook, and release the machine for patient load processing.
| Feature | Details |
|---|---|
| Classification | Type 2 (Class 2) Chemical Indicator (ISO 11140-1 / ISO 11140-4) |
| Applicable Standards | EN 285, ISO 11140-4, EN ISO 17665 |
| Cycle Compatibility | Pre-vacuum / Dynamic air-removal steam sterilizers |
| Standard Operating Parameters | 134°C for 3.5 minutes (or 121°C for 15 minutes, program-dependent) |
| Indicator Formulation | Water-based, lead-free, non-toxic thermochromic ink |
| Testing Frequency | Daily, prior to processing the first surgical/instrument load |
| Placement | Over chamber drain (lowest/coolest point) in an empty pre-heated chamber |
| Shelf Life & Storage | 24–36 months; store in cool, dry conditions (15°C–30°C, 30–60% RH) |
Supplying advanced, dependable medical technology tailored for your healthcare facility.