Marya Pharmaceutical Cell Drug Preparation Isolator with GMP Standard Manufacturer

Marya Pharmaceutical Cell Drug Preparation Isolator with GMP Standard Manufacturer

Introduction

The cell drug preparation station can guarantee the sterility of the whole process of cell preparation, and realize various operations such as separation and extraction. Combined with the self-developed management system, it is suitable for batch production and clinical trials of cell therapy drugs.

Features

1.Environmental protection: provide class A clean environment for the whole process of cell production and operation, and meet the sterile requirements of GMP.

2.New VHPS technology: integrated vaporized H2O2 biological decontamination system for effective bio-decontamination of operating areas and material channels.

3.Modular design: freely combined multiple functional modules and configurations according to customer needs.

4.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.

5.Online environmental monitoring: online detection of sterile production environment, which complies with regulatory requirements, with higher sterility assurance.

6.Wireless glove leakage detector: integrated or wireless glove leakage detector is optional.

7.Energy saving and consumption reduction: installed in the environment whose cleanliness is above class D, reducing the construction and operation cost of high-class cleanrooms.

8.Full data record: configured with control system to record key parameter data and ensure traceability.

9.High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm. 

10.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.

11.CDCV service: sterilization cycle development, validation studies and services.

Product Parameters