Marya GMP Cell Therapy Preparation Station Pharmaceutical Isolator for Medicine Manufacturing

Product Description

Marya GMP Cell Therapy Preparation Station Pharmaceutical Isolator for Medicine Manufacturing

 

Product Description

Introduction
       This Cell Preparation isolator is meticulously designed to meet the stringent requirements of Good Manufacturing Practice (GMP) in the field of cell drug preparation. It features an intelligent control system that offers precise and reliable regulation of various parameters. It provides a controlled and sterile environment, minimizing the risk of contamination during the cell drug preparation process. The system is capable of maintaining optimal temperature, humidity, and air quality levels, ensuring the stability and integrity of the cell drugs being processed.

 

Characteristic and Performance:
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
MOC	316 stainless steel wire drawing board
Sealing	The leakage rate of the cabin is less than 5% within 10min under the pressure of 500Pa
Wind speed	0.35~0.65m/s, adjustable wind speed, keep 20~60Pa during aseptic operation, maintain the pressure under static conditions to a set value of not less than 10Pa
Automatic removal efficiency	<1PPM, 10~20min
Cleanliness Degree	Class A
Power source	AC220V±22V, 50Hz±1Hz
Size	Standard inner compartment 1800*710*850 Standard outer dimensions: 1900*800*2200, can be customized according to requirements
Verification content	Sterilization efficiency: biological indicator, chemical test

Company Profile