Marya Pharmaceutical Aseptic Gloves Sterilization-Enabled Linkage Production Line Sterile Isolator Solution

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Marya Pharmaceutical Aseptic Gloves Sterilization-Enabled Linkage Production Line Sterile Isolator Solution

Customization:	Available
Certification:	GS, RoHS, CE, ISO9001
Noise:	>100db

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Product Description

Pharmaceutical Aseptic Gloves Sterilized Linkage Production Line Sterile Isolator System

The linkage production line isolator system is integrally installed on the sterile filling machine or other equipment to form a controlled enclosure or barrier that completely isolates operators and products. By equipping this system for sterile filling, the risk of drug contamination will be effectively reduced and the quality of drugs be greatly improved.

Basic Specifications

Model NO.MY-Isolator

ApplicationIndustrial

Control ModeTouch

MaterialStainless Steel 316L

Power Supply380V 50Hz

DesignModular Design

Control SystemSiemens PLC+Ipc System

UsageSterilization, Dust/Smoke Removal, Humidification, Oxygenation

Package Size1300cm * 1180cm * 200cm

Gross Weight500.000kg

Technical Features

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Diverse Portfolio: Isolation systems for water/powder injection, prefilled syringes, and sterile powder lines.

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Standard Compliance: Reliable Class A environment meeting cGMP, FDA, ISO, ISPE, and pharmacopoeia standards.

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VHPS Technology: Latest H2O2 sterilization system for rapid cycles and excellent reproducibility.

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Intelligent Monitoring: Real-time alarms for pressure, H2O2 concentration, airflow, and 21 CFR part 11 compliance.

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Independent Climate Control: Integrated AC ensures internal temperature and humidity remain stable regardless of external conditions.

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Validation Support: Complete MOCK-UP wood model verification and sterilization cycle development (CDCV) services.

Product Parameters

Parameter Name	Specifications
Material	316L Stainless Steel
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 (Other voltages require transformer)

Visual Presentation

Frequently Asked Questions

Q1: What is the primary purpose of the Linkage Production Line Isolator System? A: It is designed to create a completely isolated environment between operators and sterile products, significantly reducing contamination risks during the filling process.

Q2: Does the system meet international pharmaceutical standards? A: Yes, it is designed to comply with cGMP, FDA, ISO, and ISPE requirements, maintaining a stable Class A cleanliness level.

Q3: What kind of sterilization technology does it use? A: The system utilizes the latest VHPS (Vaporized Hydrogen Peroxide) technology for rapid and highly reproducible sterilization.

Q4: Can the isolator maintain its own temperature and humidity? A: Yes, it features an integrated independent air conditioning system so the internal environment is not affected by external room conditions.

Q5: Is the control system user-friendly and compliant? A: It uses a Siemens PLC+IPC control system with a touch interface, including intelligent alarms and compliance with FDA 21 CFR part 11.

Q6: What materials are used in the construction of the isolator? A: The system is primarily built from 316L Stainless Steel with a high-grade polishing of 0.4μm~0.6μm for optimal sterility.

Product Detail

Marya Pharmaceutical Aseptic Gloves Sterilization-Enabled Linkage Production Line Sterile Isolator Solution

Product Description

Basic Specifications

Technical Features

Product Parameters

Visual Presentation

Frequently Asked Questions

Related Products

Product Detail

Marya Pharmaceutical Aseptic Gloves Sterilization-Enabled Linkage Production Line Sterile Isolator Solution

Product Description

Basic Specifications

Technical Features

Product Parameters

Visual Presentation

Frequently Asked Questions

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