| Chamber Material |
SUS 304L stainless steel |
| Cleanliness Level (Cabin) |
Class A |
| Biological Decontamination Efficiency |
6-log killing rate |
| Residual H₂O₂ Concentration |
≤ 1 ppm |
| Decontamination Cycle Time |
< 60 minutes |
| Filtration System |
Supply Air HEPA: H14 level |
| Exhaust Interface |
DN50 sanitary interface |
| H₂O₂ Circulation Interface |
DN32 sanitary interface |
| Inlet/Outlet Design |
Pneumatic double doors with sealing, locking, and interlocking |
| Ventilation & Exhaust System |
Independent fan, pneumatic butterfly valve, exhaust pipeline |
| Real-time Monitoring |
Temperature, humidity, pressure |
| Alarm System |
High/low pressure alarm, door open overtime alarm, door lock alarm |
| Control System |
SIEMENS Programmable Logic Controller (PLC) |
| Audit Features |
Electronic signature and data tracking |
| Work Space |
1000×1000×1000 mm |
| Dimension |
1700×1030×1750 mm |
FAQ for Sterile Transfer Chamber NSTC-200
1: What makes the Sterile Transfer Chamber NSTC-200 suitable for GMP cleanroom applications?
Sterile Transfer Chamber NSTC-200 complies with GMP regulations by offering Class A clean conditions, HEPA filtration, and automated control via a Siemens PLC system. Its traceable logging features ensure audit readiness and regulatory compliance.
2: Can I monitor the chamber’s environment during operation in Sterile Transfer Chamber NSTC-200?
Yes, Sterile Transfer Chamber NSTC-200 includes real-time sensors that monitor internal temperature, pressure, and humidity. These readings are critical for maintaining environmental integrity during sterile material transfer.
3: How does the dual-door system enhance contamination control in Sterile Transfer Chamber NSTC-200?
The pneumatic double-door system includes interlocking and sealing features. Sterile Transfer Chamber NSTC-200 ensures that both doors cannot open simultaneously, minimizing the risk of cross-contamination.
4: What kind of alarm systems are integrated in Sterile Transfer Chamber NSTC-200?
Sterile Transfer Chamber NSTC-200 includes high and low-pressure alarms, door-open time alerts, and lock status warnings. These systems help protect both the process and personnel from unsafe operation.
5: Does the Sterile Transfer Chamber NSTC-200 support data management?
Yes, Sterile Transfer Chamber NSTC-200 features an electronic signature and data tracking, enabling full traceability. It also supports data saving and printing of decontamination cycle records for documentation and audits.
6: What is a sterile transfer chamber used for?
A sterile transfer chamber is used to safely transfer materials between classified environments without introducing contamination, ensuring aseptic conditions are maintained.
7: What type of filtration is used in sterile transfer chambers?
Most chambers use H14-grade HEPA filters, capable of capturing 99.995% of airborne particles, offering Class A cleanliness as per cleanroom standards.
8: Can the system log and track data?
Yes, advanced models include electronic signature and data tracking, ensuring traceability for all decontamination cycles, essential for GMP compliance.
9: Is it suitable for hydrogen peroxide vapor sterilization?
Absolutely. These chambers support bio-decontamination cycles using hydrogen peroxide vapor and feature automatic ventilation and exhaust systems to remove residuals.
10: Are validation documents provided with the system?
Yes, most systems come with complete IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) documentation for compliance and on-site verification.