The Rapid Sterility Test System is designed for pharmaceutical sterility testing. It consists of a constant temperature incubation box, an automated detection unit, incubation containers, and microbial growth signal sensors.
The principle behind its operation involves detecting CO2 produced by microbial respiration, which causes a change in the color of sensors on the incubation containers. The system’s visual camera continuously scans the sensor images and their corresponding QR codes. A computer system then performs visual analysis and converts this into growth signals. Finally, the sterility testing results are determined based on trend analysis and specialized algorithms.
| AST-80 | |
| Sterility Test Method: Direct Inoculation | Dimensions: W720×D600×H780(mm) |
| Number Of Incubation Chambers: 2 Chambers (independent temperature control) | Incubation Chamber Capacity: 80 Bottles |
| Incubation Method: Rotary Table Incubation | Power: 1.5kW |
| Temperature Control Range: 20-45°C | Temperature Control Accuracy: ±0.1°C |
| Temperature Uniformity: ±0.8°C | Temperature Fluctuation: ±0.3°C |
| Information Input: Scanning/ Manual | Weight: 125kg |
| Power Supply: AC220V, 50Hz | Control Method: PID control |
| Display: Capacitive Touch Screen | Microbial Detection Method: Microbial Respiration |
| AST-180D/180MF | |
| Sterility Test Method: Membrane Filtration (180MF), Membrane Filtration/ Direct Inoculation(180D) | Dimensions: W1130×D740×H1770(mm) |
| Number Of Incubation Chambers: 3 Chambers (independent temperature control) | Incubation Chamber Capacity: 180 Bottles or 180 canisters (180D only) |
| Incubation Method: Static Incubation Chamber | Power: 2kW |
| Temperature Control Range: 20-45°C | Temperature Control Accuracy: ±0.1°C |
| Temperature Uniformity: ±0.5°C | Temperature Fluctuation: ±0.3°C |
| Information Input: Scanning/ Manual/Split-screen | Weight: 460kg |
| Power Supply: AC220V, 50Hz | Control Method: PID control |
| Display: Capacitive Touch Screen | Microbial Detection Method: Microbial Respiration |
| AST-300 | |
| Sterility Test Method: Direct Inoculation | Dimensions: W1130×D740×H1770(mm) |
| Number Of Incubation Chambers: 3 Chambers (independent temperature control) | Incubation Chamber Capacity: 300 Bottles |
| Incubation Method: A Static Incubation Chamber, Two Shake Flask Cultivation Chambers | Power: 2kW |
| Temperature Control Range: 20-45°C | Temperature Control Accuracy: ±0.1°C |
| Temperature Uniformity: ±0.5°C | Temperature Fluctuation: ±0.3°C |
| Information Input: Scanning/ Manual/Split-screen | Weight: 530kg |
| Power Supply: AC220V, 50Hz | Control Method: PID control |
| Display: Capacitive Touch Screen | Microbial Detection Method: Microbial Respiration |
EP: 5.1.6 Alternative Methods for Control of Microbiological Quality
USP: 1223 Validation of Alternative Microbiological
FDA 21 CFR Part 11 Electronic Records; Electronic Signatures
The system is applied in biopharmaceutical production, cell therapy quality control, vaccine production, and rapid sterility testing for research and service institutions.
The AST-80 is designed for direct inoculation method, with a total capacity for 80 incubation bottles, divided evenly between two chambers, each holding 40 bottles.
The AST-300 caters to direct inoculation method, offering a total capacity for 300 incubation bottles. It features three chambers, with capacities of 90, 90, and 120 bottles, respectively.
The AST-180MF is optimized for membrane filtration method, with a total capacity of 180 incubation devices, divided into three chambers, each holding 60 devices.
The AST-180D is versatile, accommodating both direct inoculation incubation bottles and membrane filtration culture devices, with a total capacity of 180 units. It features three chambers, each with a capacity of 60 units.
The Rapid Sterility Test System features dual temperature zone incubation chambers, with each chamber capable of precise temperature control from 20-45°C, allowing for high-temperature incubation at 30-37°C and low-temperature incubation at 20-25°C.
The AST-80 model has dual incubation chambers, while the AST-300, AST-180MF, and AST-180D models feature three incubation chambers, accommodating a wide range of incubation conditions.
AST-180D supports both membrane filtration and direct inoculation methods. Its proprietary rapid test-specific incubation system delivers superior results in terms of detection capability, process, and time.
Powerful software system that enhances the rapid sterility test system’s intelligence and professionalism.
Meets GMP requirements for computer system validation, ensuring data integrity and audit traceability.
Comply with FDA 21 CFR Part 11 for electronic records and signatures.
Dynamic and continuous detection, performed every 15 minutes.
Utilizing various algorithms to quickly identify microbial growth while minimizing the risk of false positives.
This system is capable of efficiently differentiating the growth of bacteria, molds, and yeasts, with a validated detection limit of <5 cfu.
Compared to manual observation, this reduces subjective error as well as the time and cost associated with manual operations.
