SS Series Pulsating Vacuum Steam Sterilizer
Product Overview
The SS Series Pulsating Vacuum Steam Sterilizer stands as a cutting-edge sterilization solution, meticulously designed and developed in accordance with the latest Good Manufacturing Practices (GMP) requirements and guidelines. This versatile equipment finds extensive application in the pharmaceutical industry, scientific research, biotechnology engineering, and various other domains. Utilizing saturated steam, it ensures thorough moist heat sterilization for a wide array of items, including filter housings, cartridges, pharmaceutical components, rubber stoppers, aluminum caps, fabric auxiliaries, metal and glass utensils, as well as open or sealed liquid products, animal bedding, feed, cages, and boxes. As a pivotal piece of process equipment for maintaining sterile production, the SS Series Sterilizer plays a crucial role in diverse comprehensive solution scenarios, robustly safeguarding our clients' sterility standards.
Performance Features
Temperature Uniformity
Throughout the entire sterilization phase, the temperature in the sterilization chamber is controlled within the range of the set sterilization temperature to the set temperature +3°C.
At any given moment during sterilization, the temperature difference between any two pointsin the sterilization zone does not exceed 2°C.
Equilibration Time
For sterilization cabinets ≤800L: 15 seconds
For sterilization cabinets >800L: 30 seconds
Post-Sterilization Dryness
Textiles: Weight increase due to moisture <1% after sterilization cycle
Stainless steel instruments: No visible water marks, no moisture detected by touch (completely dry), weight increase < 0.2% after sterilization cycle
Sterilization Cycle
Instruments: Complete cycle (including drying and cooling) ~70 minutes (varies by sterilization process)
Textiles: Complete cycle (including drying and cooling) ~100 minutes (varies by sterilization process)
Sterilization Performance Guarantee
ADS Air Detection System
The ADS is used to detect the presence of excessive non-condensable gases in the chamber, which can cause the temperature at the center of the sterilization load to be too low, risking reduced sterilization efficacy. It provides alarm notifications when issues are detected. This system complies with EU GMP Annex 1: Manufacture of Sterile Medicinal Products regulatory requirements. Compared to the traditional BD test, the ADS can operate concurrently with sterilization cycles and generate electronic batch records. It represents a more intelligent and efficient method for detecting non-condensable gases.
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Contamination Risk Control
Ensures the door seal system maintains a high level of cleanliness throughout long-term equipment use by implementing online sterilization of the sealing system.
Positive Pressure Leak Test: Compressed air is introduced into the sterilizer cabinet, and the pressure drop is monitored to verify the sterilizer's sealing performance. This prevents toxic gases from the chamber from leaking and contaminating the external environment.
Negative Pressure Leak Test: The chamber is evacuated to a preset vacuum level, and any pressure increase is monitored to verify the sterilizer's vacuum sealing performance, ensuring biological safety during equipment operation.
The built-in high-efficiency filters can be sterilized simultaneously during the sterilization cycle without removal. This not only ensures filtration efficiency but also improves work efficiency and sterilization process continuity, reducing the risk of cross-contamination. After filter sterilization is complete, sterile compressed air is introduced to provide positive pressure protection for the filters, preventing secondary contamination.
Regulatory Compliance of the Control System
Secure and Reliable Data Recording
The system operates on a SCADA platform with control software compliant with 21 CFR Part 11. We provide a white paper and computer system validation documentation. The system generates real-time PDF electronic batch reports and runs on the Windows operating system, utilizing a secure and reliable Windows SQL database management software. It can store data for tens of thousands of batches (at least 5 years' worth). A switch is configured for rapid data export, enabling data transmission for remote printing via an Ethernet interface. The system boasts sleek design and user-friendly interface, with superior operability compared to touchscreens.
Electronic Batch Record Functionality
Batch reports include sterilization recipe parameters, batch timing and information, process curves, statistical analysis of maximum and minimum temperatures during sterilization with corresponding timestamps, audit trails, and alarm information. Electronic batch records are generated in real-time and output in non-editable PDF format. A front-facing USB interface allows for quick and convenient export of report data. An industrial switch is configured with a standard EMS communication interface reserved for remote printing of electronic reports.
Equipment Safety Assurance
Door Seal Pressure Maintenance System
The sterilizer cabinet employs a compressed air storage tank to maintain the door sealing system's air supply. During normal operation, this stored air ensures stable pressure in the door sealing system, minimizing fluctuations. In the event of a sudden power outage, the valve upstream of the storage tank immediately closes. The stored air then maintains normal pressure levels in the sealing system, preventing depressurization of the door and subsequent exposure of the chamber to the external environment, which could contaminate sterilized items. If the air source is disconnected, the upstream check valve closes slowly. This gradual closure could potentially lead to rapid pressure loss in the door seal. However, the stored air effectively slows down the rate of pressure loss, enabling the system to maintain pressure for up to 24 hours.
Conclusion
The SS Series Pulsating Vacuum Steam Sterilizer exemplifies unparalleled excellence in design, precise temperature control, efficient sterilization performance, and comprehensive safety measures across pharmaceutical, scientific research, biotechnology, and numerous other fields. Aligning with the latest GMP requirements, its intelligent and automated features enhance sterilization efficiency and quality control. From temperature uniformity and post-sterilization dryness to contamination risk control, data recording, and regulatory compliance, the SS Series Sterilizer stands as an industry benchmark. We are confident that this sterilizer will continue to provide robust support for our clients' sterile production, driving various industries towards higher standards in sterilization solutions.