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Home > Real-Time Clinical Monitoring Solutions > Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
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Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier
Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier

Shanghai Marya China Pharmaceutical Aseptic Filling Line Isolator Solutions Supplier

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Product Description

Pharmaceutical Aseptic Filling Line Isolator Solutions
Sterile Isolator Description

As a decontamination equipment separating operators and machines and complying with the requirements of Class A environment, the sterile isolator is mainly used for the protection of sterile testing, sterile product dispensing and other key process. It can reduce the background or environment requirements, improve the reliability of inspection results, meet the requirements of GMP, EU GMP/FDA and cGMP/USP-NF, and can carry out "continuous" or "batch" operation.

Aseptic Filling Line Isolator
Sterile Isolator Equipment
Characteristic and Performance
01
New VHPS Technology Control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber.
02
Modular Design Including transfer chamber, operation chamber, bacteria collector and other functional modules; easy to install and transport.
03
Intelligent Control System Siemens PLC+IPC control system; intelligent alarms for pressure, H2O2 concentration, temperature, and humidity; complies with FDA 21 CFR part 11 requirements.
04
CDCV Service Professional sterilization cycle development, validation studies, and comprehensive services.
05
Wireless Glove Leakage Detector Optional integrated or wireless glove leakage detector for enhanced safety monitoring.
06
Energy Saving Optimized airflow handling system design; energy consumption reduced by 20% during continuous operation.
07
Real-time Door Monitoring Online monitoring of door status and continuous airtight seal verification.
08
High-quality Materials Inner chamber made of 316L or PTFE; polishing grade of 0.4μm~0.6μm.
Isolator Detail 1
Isolator Detail 2
Isolator Detail 3
Technical Data
MOC 316 stainless steel wire drawing board
Sealing Leakage rate < 5% within 10min under 500Pa pressure
Wind Speed 0.35~0.65m/s (adjustable), maintain 20~60Pa during operation
Removal Efficiency <1PPM, 10~20min
Cleanliness Degree Class A
Power Source AC220V±22V, 50Hz±1Hz
Size Inner: 1800*710*850mm; Outer: 1900*800*2200mm (Customizable)
Verification Sterilization efficiency: biological indicator, chemical test
Technical Layout 1
Technical Layout 2
Technical Layout 3
Manufacturing Capacity
Production Capacity
Workshop Overview
Modern Workshop
Quality Certificates
Quality Certificates
Project Cases
Global Projects
Global Customers
Customer Base
Exhibition & Team
Exhibition
Team
Packaging & Shipping
Secure Shipping
Frequently Asked Questions
Q: What are the main applications of a sterile isolator? A: It is primarily used for sterile testing, sterile product dispensing, and other key pharmaceutical processes requiring a Class A environment.
Q: Does the system comply with international pharmaceutical standards? A: Yes, our solutions meet the requirements of China GMP, EU GMP/FDA, and cGMP/USP-NF standards.
Q: How does VHPS technology improve sterilization? A: Vaporized Hydrogen Peroxide (VHPS) technology allows for precise control of H2O2 concentration, ensuring high reproducibility and shorter sterilization cycles.
Q: Can the size of the isolator be customized? A: Yes, while we have standard dimensions, the inner and outer dimensions can be customized according to specific laboratory or production requirements.
Q: How is the airtight integrity of the chamber verified? A: The system features real-time door status monitoring and maintains a leakage rate of less than 5% within 10 minutes under 500Pa pressure.
Q: What materials are used for the chamber construction? A: The inner chamber is constructed from high-quality 316L stainless steel or PTFE with a polishing grade of 0.4μm to 0.6μm.

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