Marya GMP Standard Pharmaceutical Cleanroom Sterility Testing Isolator for Injectables
Product Details
| Customization: | Available |
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| Certification: | GS, RoHS, CE, ISO9001 |
| Noise: | >100db |
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Basic Info.
- Model NO.
- MY-Isolator
- Application
- Industrial
- Control Mode
- Touch
- Usage
- Fragrance, Dust Removal, Smoke Removal, Adding Negative Ion, Humidification, Formaldehyde Formaldehyde, Adding Oxygen, Sterilization
- Material
- Stainless Steel 316L
- Power Supply
- 380V 50Hz
- Design
- Modular Design
- Control System
- Siemens PLC+Ipc Control System;
- Transport Package
- Wooden Package
- Specification
- Customized
- Trademark
- Marya
- Origin
- Shanghai, China
Packaging & Delivery
- Package Size
- 1300.00cm * 1180.00cm * 200.00cm
- Package Gross Weight
- 500.000kg
Product Description
Marya GMP Standard Pharmaceutical Cleanroom Sterility Testing Isolator for Injectables
Introduction
The Sterility Testing Isolator is an advanced containment system designed to provide a sterile environment for the inspection and handling of pharmaceutical products, particularly in aseptic manufacturing processes. It ensures the highest level of product protection by preventing contamination from operators and the surrounding environment.
Features
1.New VHPS technology: control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber;.
2.Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport.
3.Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H2O2 solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements.
4.CDCV service: sterilization cycle development, validation studies and services.
5.Wireless glove leakage detector: integrated or wireless glove leakage detector is optional.
6.Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%.
7.Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door.
8.High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm.
9.Decomposition filter: the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H2O2 sterilization, and effectively reduce the concentration level of residues.
10.Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.
Product Parameters
Introduction
The Sterility Testing Isolator is an advanced containment system designed to provide a sterile environment for the inspection and handling of pharmaceutical products, particularly in aseptic manufacturing processes. It ensures the highest level of product protection by preventing contamination from operators and the surrounding environment.
Features
1.New VHPS technology: control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber;.
2.Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport.
3.Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H2O2 solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements.
4.CDCV service: sterilization cycle development, validation studies and services.
5.Wireless glove leakage detector: integrated or wireless glove leakage detector is optional.
6.Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%.
7.Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door.
8.High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm.
9.Decomposition filter: the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H2O2 sterilization, and effectively reduce the concentration level of residues.
10.Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.
Product Parameters
| Name | Parameters |
| Material | 316L |
| Polishing grade | 0.4μm~0.6μm |
| Protection level | OEB 5 (OEL<1ug/m³) |
| Internal arc angle | R≥20 |
| Cleanliness level | Class A |
| Power supply | 380V 50Hz (Note: Other voltages require a transformer) |
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