Marya Pharmaceutical Smart Monitoring Precision Sterility Testing Isolator Manufacturers

Customization: Available
Application: Chemical, Medical, Food
Material: Stainless Steel, Stainess Steel

Product Description

Basic Specifications
Model
MY-Isolator
Needle Gauge
27G
Usage
Medical
Warranty
1 Year
Driven Type
Electric
Certificate
CE, ISO, SGS
Machine Power
1 Kw
Precision
High Precision
Voltage
220V
Condition
New
Type
Pharmaceutical Workshop
Package Size
350cm * 180cm * 300cm
Smart Monitoring Precision Sterility Testing Isolator

The sterility testing isolators are engineered with the utmost precision and incorporate cutting-edge smart monitoring technologies. These technologies enable real-time and continuous surveillance of critical parameters within the isolator, such as temperature, humidity, pressure, and particulate levels.

Data collected is instantly analyzed and presented in a user-friendly interface, allowing for immediate detection of any deviations. This proactive approach ensures the highest level of sterility and maximizes the efficiency of testing processes.
Sterility Testing Isolator
Performance and Features
Feature Description
New VHPS technologyControl concentration and saturation of H2O2; good sterilization reproducibility; shorten cycle time.
Modular designIncludes transfer chamber, operation chamber, bacteria collector; easy to install and transport.
Intelligent control systemSiemens PLC+IPC; alarms for pressure, H2O2, temp, humidity, and air speed; FDA 21 CFR part 11 compliant.
CDCV serviceSterilization cycle development, validation studies and services.
Wireless glove leakage detectorIntegrated or wireless glove leakage detector is optional for safety.
Energy savingOptimized airflow system; 8-hour continuous operation consumption reduced by 20%.
Real-time door statusOnline monitoring of door opening and continuous airtight seal verification.
High-quality materialsInner chamber made of 316L or PTFE; polishing grade 0.4μm~0.6μm.
Workshop & Production
Workshop 1
Workshop 2
Workshop 3
Project Case & Certification
Project Case
Certificate Display
Global Standards
Global Customer & Team Exhibition
Customer Visit
Team Work
Exhibition
Packaging & Shipping
Shipping Package
Waterproof Loading
Frequently Asked Questions
What is the main advantage of the new VHPS technology?
The new Vaporized Hydrogen Peroxide (VHPS) technology allows for precise control over H2O2 concentration and saturation, ensuring high sterilization reproducibility and significantly shortening the sterilization cycle time.
Does the system comply with international pharmaceutical standards?
Yes, the intelligent control system is Siemens PLC+IPC based and fully complies with FDA 21 CFR Part 11 requirements, suitable for GMP-compliant pharmaceutical environments.
Is the isolator easy to maintain in a small laboratory?
Absolutely. The maintenance surface is located at the front, and the modular design ensures that the required footprint is minimized, making it ideal for laboratories with limited space.
What materials are used for the internal chamber?
The inner chamber is constructed from high-quality 316L stainless steel or PTFE, featuring a professional polishing grade of 0.4μm to 0.6μm to prevent microbial accumulation.
Can the isolator monitor the integrity of the gloves?
Yes, the system supports an optional wireless glove leakage detector which can be integrated into the unit to perform regular safety checks on glove integrity.
How does the system achieve energy saving?
Through an optimized airflow handling system, the energy consumption during continuous eight-hour operation is reduced by approximately 20% compared to standard models.

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