Marya Pharma Isolator Production Center for High-Quality Pharmaceutical Barrier Solutions

• Customization: Available
• Certification: GS, RoHS, CE, ISO9001
• Noise: >100db
• 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
• Package Size: 1300.00cm * 1180.00cm * 200.00cm
• Package Gross Weight: 500.000kg

Product Description

Marya Pharma Isolator Production Center for High-Quality Pharmaceutical Barrier Solutions

Introduction

Marya's Pharma Isolator Production Center presents premium isolators. These are expertly crafted to be seamlessly attached to sterile filling machines and alike. They create a secure, controlled enclosure, isolating operators from products. When utilized in sterile filling, it drastically cuts drug contamination risks, enhancing drug quality, providing reliable pharmaceutical barrier solutions
 

Features

1.Comprehensive product portfolio: isolation systems for water injection, powder injection, prefilled syringe and sterile powder production lines.

2.Stable and reliable environment: reliable and stable class A environment, which meets cGMP, FDA, ISO, ISPE, and pharmacopoeia requirements.

3.New VHPS technology: the latest H2O2 sterilization system, which can achieve rapid sterilization, control the concentration and saturation of H2O2, with good sterilization reproducibility.

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.Independent temperature and humidity control mode: with the integrated independent air conditioning system, it can realize that the internal temperature and humidity in the chamber is not affected by the external environment.

6.MOCK-UP: complete wood model verification service, ergonomic operation qualification and 3D model display service in the middle of the project.

7.Sterilization process development support: qualification and validation services for sterilization cycle development of the whole process can be provided.

8.Customization: support customized isolation system design, and provide systematic closed isolation solutions and CE certification services.

9.Integrated monitoring system: integrated monitoring systems of temperature and humidity, differential pressure, air speed, H2O2 concentration, optical grating, particles and airborne viable bacteria, etc.

10.Multiple sterile transfer solutions: multiple and combined sterile transfer solutions are available to meet customers' diversified production needs.

11.Complete life cycle support: covering consulting, project design, installation scheme design and verification design, etc.

12.Wireless glove leakage detector: multi-head wired glove leakage detector or wireless glove leakage detector is optional.

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

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)