Basic Info.
Model NO.
SGL-15
Finished Dosage Form
Capsule
Precision
High Precision
Certification
CE, GMP, ISO
Voltage
380V
Computerized
Computerized
Customized
Customized
Condition
New
Transport Package
Wooden Case Packing
Trademark
Medigrade
Origin
Shanghai, China
HS Code
8422303090
Production Capacity
100 Sets/Year
Product Description
Product Description
The hard cabin laminar flow type aseptic isolator is a hard-walled structure composed of stainless steel and tempered glass, and the internal environment is dynamic A-level. Use gloves for operation. The gloves can be thickened and anti-breakage or thin and high-feeling; the system is equipped with a Siemens logic controller (PLC) for fully automatic control of pressure and air flow, and has a pressure loss alarm function. Industrial-grade tablet computer control meets the verification requirements of the 2010 version of the GMP computer system.
Performance characteristics
1. Dry vaporized hydrogen peroxide (VHPS*) sterilization, reaching the 6-log spore killing level, with the function of monitoring and controlling the concentration of hydrogen peroxide;
2. The interior of the cabin is cleaned by manual wiping, and there is no dead angle;
3. The VHPS concentration in the cabin after ventilation is less than 1ppm, which can meet the VHPS residual concentration detection;
4. After sterilization, the cabin body is in full compliance with GMPA level cleanliness standards, and online dust particles and planktonic bacteria sampling systems can be integrated and installed;
5. The cabin body pressure reduction test, under 2 times the test pressure, the hourly volume leakage rate is less than 0.5%; it has a leakage alarm function;
6. The isolator can be adjusted according to the needs of use-80pa~80pa, the normal product maintains 40pa~60pa during aseptic operation, the pressure is maintained to the set value ±5pa under static conditions, and the two modes of positive pressure and negative pressure can be preset and stored , Adjust according to demand;
7. The system design meets the requirements of GMP, 2015 Pharmacopoeia, USP/EP, and the control system can meet the 21CFR part11 electronic signature and electronic record requirements;
Specification
If you are interested in this, please contact me: Nana Zhang
Shanghai Medigrade Industry Co.,Ltd
Waigaoqiao Free Trade Zone, Shanghai,China. 200137
medigrade.en.made-in-china.com
The hard cabin laminar flow type aseptic isolator is a hard-walled structure composed of stainless steel and tempered glass, and the internal environment is dynamic A-level. Use gloves for operation. The gloves can be thickened and anti-breakage or thin and high-feeling; the system is equipped with a Siemens logic controller (PLC) for fully automatic control of pressure and air flow, and has a pressure loss alarm function. Industrial-grade tablet computer control meets the verification requirements of the 2010 version of the GMP computer system.
Performance characteristics
1. Dry vaporized hydrogen peroxide (VHPS*) sterilization, reaching the 6-log spore killing level, with the function of monitoring and controlling the concentration of hydrogen peroxide;
2. The interior of the cabin is cleaned by manual wiping, and there is no dead angle;
3. The VHPS concentration in the cabin after ventilation is less than 1ppm, which can meet the VHPS residual concentration detection;
4. After sterilization, the cabin body is in full compliance with GMPA level cleanliness standards, and online dust particles and planktonic bacteria sampling systems can be integrated and installed;
5. The cabin body pressure reduction test, under 2 times the test pressure, the hourly volume leakage rate is less than 0.5%; it has a leakage alarm function;
6. The isolator can be adjusted according to the needs of use-80pa~80pa, the normal product maintains 40pa~60pa during aseptic operation, the pressure is maintained to the set value ±5pa under static conditions, and the two modes of positive pressure and negative pressure can be preset and stored , Adjust according to demand;
7. The system design meets the requirements of GMP, 2015 Pharmacopoeia, USP/EP, and the control system can meet the 21CFR part11 electronic signature and electronic record requirements;
- The air source is clean filtered compressed air or nitrogen, and the air source pressure is 0.4MPa~0.6MPa.
Specification
| Name | VHP Aseptic Isolator |
| Power | 380±38V, 50±5Hz, 25A |
| Maximum power | ≤4000W |
| Built-in bacteria collector | 1-2 |
| Airflow method | Unidirectional flow |
| Display | 12.1 inch tablet |
| Noise | <65dB(A) |
| Application | Aseptic filling, sampling |
| Internal environment | Class A |
| System | PLC |
| Cusom | Provided |
If you are interested in this, please contact me: Nana Zhang
Shanghai Medigrade Industry Co.,Ltd
Waigaoqiao Free Trade Zone, Shanghai,China. 200137
medigrade.en.made-in-china.com