Pharmaceutical Sterile Detection/Testing/Feeding Isolator System
As a decontamination equipment separating operators and machines and complying with the requirements of Class A environment, the sterile isolator is mainly used for the protection of sterile testing, sterile product dispensing and other key process. It can reduce the background or environment requirements, improve the reliability of inspection results, meet the requirements of China GMP and Pharmacopoeia, EU GMP/FDA and cGMP/USP-NF, and can carry out "continuous" or "batch" operation.
Characteristic and Performance
1
New VHPS Technology
Control the concentration and saturation of H2O2; good sterilization reproducibility; shorten sterilization time.
2
Modular Design
Including transfer chamber, operation chamber, bacteria collector and other modules; easy to install and transport.
3
Intelligent Control System
Siemens PLC+IPC system; intelligent alarms for pressure, H2O2, temp/humidity; FDA 21 CFR part 11 compliant.
4
CDCV Service
Sterilization cycle development, validation studies and professional services.
5
Wireless Glove Leakage Detector
Integrated or wireless glove leakage detector is optional for enhanced safety.
6
Energy Saving
Optimized airflow handling; energy consumption reduced by 20% during eight-hour continuous operation.
7
Real-time Door Monitoring
Online monitoring of door status and continuous tracking of airtight seals.
8
High-quality Materials
Inner chamber made of 316L or PTFE; polishing grade of 0.4μm~0.6μm.
Technical Data
| MOC |
316 stainless steel wire drawing board |
| Sealing |
Leakage rate < 5% within 10min under 500Pa pressure |
| Wind Speed |
0.35~0.65m/s (adjustable); 20~60Pa during operation |
| Removal Efficiency |
<1PPM, 10~20min |
| Cleanliness Degree |
Class A |
| Power Source |
AC220V±22V, 50Hz±1Hz |
| Size |
Inner: 1800*710*850mm; Outer: 1900*800*2200mm (Customizable) |
| Verification Content |
Sterilization efficiency: biological indicator, chemical test |
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Frequently Asked Questions
What environment class does this sterile isolator maintain?
The sterile isolator is designed to comply with Class A environment requirements, providing a high-level decontamination space for pharmaceutical processes.
What sterilization technology is utilized in the system?
The system uses advanced VHPS (Vaporized Hydrogen Peroxide) technology to control H2O2 concentration and saturation, ensuring excellent sterilization reproducibility and shorter cycle times.
Is the control system compliant with international pharmaceutical standards?
Yes, the Siemens PLC+IPC control system is fully compliant with FDA 21 CFR part 11 requirements, featuring multi-level access and intelligent monitoring for all key parameters.
Can the isolator be customized for specific dimensions?
While there are standard inner (1800*710*850mm) and outer dimensions, the system can be customized according to specific laboratory or facility requirements.
How does the modular design benefit the user?
The modular design includes functional sections like transfer and operation chambers, making the system significantly easier to install, transport, and maintain within limited lab spaces.
What materials are used for the internal chamber?
The internal chamber is manufactured using high-quality 316L stainless steel or PTFE, with a high polishing grade between 0.4μm and 0.6μm to prevent contamination.
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