Sterility tester AST series

for the pharmaceutical industryautomaticfloor-standing

Product overview
The AST Series Rapid Sterility Test System is a laboratory system for pharmaceutical and biotechnological sterility testing. It integrates a temperature-controlled incubation cabinet, automated visual detection unit, incubation containers with color-change microbial sensors, and a camera/PC analysis chain to convert images into growth signals and automated sterility results.

Principle of operation
Sensors on incubation containers change color in response to CO2 produced by microbial respiration. A camera continuously captures sensor areas and linked QR codes; software performs image analysis and signal extraction. Trend analysis and validated algorithms determine sterility outcomes from the extracted growth indicators.

Key features

• CO2-based visual detection using color-change sensors for early microbial growth indication.
• Continuous image capture with real-time QR code reading to ensure sample–result traceability.
• Advanced image-analysis algorithms reduce false positives and accelerate detection (validated detection limit <5 cfu).
• Compatible with pharmacopeial incubation workflows and dedicated rapid-test incubation systems.
• Detection cycle configurable; standard dynamic detection every 15 minutes.
• Software designed to support GMP computerized system validation and FDA 21 CFR Part 11 compliance for electronic records and signatures.
• Robust performance against typical environmental interferences.

Models and capacities

• AST-80 — Direct inoculation method; total capacity 80 incubation bottles (2 chambers × 40 bottles).
• AST-300 — Direct inoculation method; total capacity 300 incubation bottles (3 chambers: 90 + 90 + 120 bottles).
• AST-180MF — Optimized for membrane filtration method; total capacity 180 incubation devices (3 chambers × 60 devices).
• AST-180D — Supports membrane filtration and direct inoculation; total capacity 180 units (3 chambers × 60 units); includes rapid-test-specific incubation option.

Incubation conditions
Multiple independently controlled temperature zones with precise regulation from 20–45°C. Typical modes: high-temperature incubation 30–37°C and low-temperature incubation 20–25°C. AST-80 has two chambers; AST-300, AST-180MF and AST-180D have three chambers. AST-180D supports both membrane filtration and direct inoculation and offers an incubation mode optimized for rapid-test performance.

Compliance

• Meets EP 5.1.6 (Alternative Methods for Control of Microbiological Quality).
• Supports USP guidance for validation of alternative microbiological methods.
• Complies with FDA 21 CFR Part 11 for electronic records and electronic signatures.

Applications
Intended for sterility control in pharmaceutical production, biopharmaceutical and vaccine manufacturing, cell therapy quality control, contract testing laboratories and research institutions requiring rapid sterility assessment.

Technical specifications

• AST-80 — Method: Direct Inoculation; Dimensions: W720 × D600 × H780 (mm); Chambers: 2 (independent temperature control); Capacity: 80 bottles; Incubation: Rotary table; Power: 1.5 kW; Temp. range: 20–45°C; Accuracy: ±0.1°C; Uniformity: ±0.8°C; Fluctuation: ±0.3°C; Input: Scanning / Manual; Weight: 125 kg; Power supply: AC220V, 50Hz; Control: PID; Display: Capacitive touch screen; Detection: Microbial respiration (CO2).
• AST-180D / AST-180MF — Method: Membrane Filtration (180MF) / Membrane Filtration & Direct Inoculation (180D); Dimensions: W1130 × D740 × H1770 (mm); Chambers: 3 (independent control); Capacity: 180 bottles / canisters / devices; Incubation: Static chamber; Power: 2 kW; Temp. range: 20–45°C; Accuracy: ±0.1°C; Uniformity: ±0.5°C; Fluctuation: ±0.3°C; Input: Scanning / Manual / Split-screen; Weight: 460 kg; Power supply: AC220V, 50Hz; Control: PID; Display: Capacitive touch screen; Detection: Microbial respiration (CO2).
• AST-300 — Method: Direct Inoculation; Dimensions: W1130 × D740 × H1770 (mm); Chambers: 3 (independent control); Capacity: 300 bottles; Incubation: One static chamber + two shake-flask cultivation chambers; Power: 2 kW; Temp. range: 20–45°C; Accuracy: ±0.1°C; Uniformity: ±0.5°C; Fluctuation: ±0.3°C; Input: Scanning / Manual / Split-screen; Weight: 530 kg; Power supply: AC220V, 50Hz; Control: PID; Display: Capacitive touch screen; Detection: Microbial respiration (CO2).