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Home > Nucleic Acid Detection Systems > Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
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Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection
Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection

Marya China Pharmaceutical Negative Pressure Isolator Equipment System for Detection

Customization: Available
After-sales Service: Engineers Available to Service Machinery Overseas, Free Spare Parts, Online Support, video Technical Support
Application: Clinical Diagnosis, Food Safety, Forensic Science, Pharmaceutical Industry
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Product Description

Basic Information
Model NO.
MY-01
Certification
CE, FDA, GMP, ISO, UL
Condition
New
Customized
Customized
Detection Range
Hormones, Metabolites, Nucleic Acids, Proteins, Small Molecules
Material Compatibility
Capsules, Crystals, Granules, Herbs, Liquid, Powder, Tablets
Portability
Benchtop
Power Source
Battery Operated
Sensitivity
High Sensitivity
Technology
Infrared Spectroscopy
Voltage
220V-380V
Material
304/316 Stainless Steel
Production Capacity
50000 pieces/Year
Product Description

Pharmaceutical Negative Pressure Isolator Equipment System

Sterile Isolator Overview

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 China GMP and Pharmacopoeia, EU GMP/FDA and cGMP/USP-NF, and can carry out "continuous" or "batch" operation.

Negative Pressure Isolator System
Negative Pressure Isolator System Detail

Characteristics and Performance

  • New VHPS technology: Control the concentration and saturation of H2O2; good sterilization reproducibility; shorten sterilization time.
  • Modular design: Includes transfer chamber, operation chamber, bacteria collector; easy to install and transport.
  • Intelligent control system: Siemens PLC+IPC; intelligent alarms for pressure, concentration, temperature, and humidity; FDA 21 CFR part 11 compliant.
  • CDCV service: Sterilization cycle development and validation studies.
  • Wireless glove leakage detector: Optional integrated or wireless detector.
  • Energy saving: Optimized airflow handling reduces energy consumption by 20% during 8-hour operation.
  • Real-time monitoring: Online monitoring of door status and airtight seals.
  • High-quality materials: Inner chamber made of 316L or PTFE; polishing grade 0.4μm~0.6μm.
  • Decomposition filter: Effectively shortens degradation time after sterilization and reduces residues.
  • Simple maintenance: Front-facing maintenance surface reduces space requirements.
Isolator Workshop View
Isolator Detail View
Isolator Functional Module
Technical Data
Parameter Specification
MOC316 stainless steel wire drawing board
SealingLeakage rate < 5% within 10min under 500Pa
Wind speed0.35~0.65m/s (adjustable), keep 20~60Pa during operation
Automatic removal efficiency< 1PPM, 10~20min
Cleanliness DegreeClass A
Power sourceAC220V±22V, 50Hz±1Hz
SizeInner: 1800*710*850; Outer: 1900*800*2200 (Customizable)
Verification contentSterilization efficiency: biological indicator, chemical test
Equipment Display 1
Equipment Display 2
Equipment Display 3
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Frequently Asked Questions
What is the primary function of a sterile isolator?
The sterile isolator is designed to separate operators from machines and processes, maintaining a Class A environment for sterile testing, dispensing, and other critical pharmaceutical processes.
What sterilization technology does this system use?
It utilizes advanced VHPS (Vaporized Hydrogen Peroxide Sterilization) technology to control H2O2 concentration and saturation, ensuring reproducible and efficient sterilization cycles.
Is the equipment compliant with international standards?
Yes, the system is designed to meet the requirements of China GMP, EU GMP/FDA, and cGMP/USP-NF standards, ensuring global compliance for pharmaceutical production.
What materials are used in the construction of the chamber?
The inner chamber is constructed from high-quality 316L stainless steel or PTFE, with a polishing grade of 0.4μm to 0.6μm to prevent contamination and ensure easy cleaning.
Can the dimensions of the isolator be customized?
Absolutely. While there are standard dimensions (e.g., 1800*710*850mm inner), the unit can be customized according to specific laboratory requirements and spatial constraints.
How does the system handle residue after sterilization?
The air exhaust module can be equipped with a decomposition filter that effectively shortens the degradation time of H2O2, significantly reducing residue concentration levels.

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