Advanced Positive Pressure Isolation System for Sterile Powder Injection

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Advanced Positive Pressure Isolation System for Sterile Powder Injection

Customization:	Available
Application:	Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Food Safety, Forensic Science, Pharmaceutical Industry
Automation Grade:	Automatic

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Product Description

Basic Specifications

Model NO.

FDNPI05

Features

Batch Coding, Sterilization Capability, Vacuum Packaging

Material

Stainless Steel

Warranty

24 Months

Origin

China

Capacity

1000 Pieces/Year

Product Description

Aseptic Positive Pressure Isolation System For Sterile Powder Injection

System Overview:
The aseptic mixing isolation system is designed for multi-component and single-component dosing, mixing, and secondary filling following container loading. The critical operation area employs ISPE-recommended RABS protection. The system interfaces with the vaporized hydrogen peroxide (VHP) pass-through window to perform self-cleaning and manual aluminum lid opening operations.

Performance Characteristics

Integrates equipment for aluminum drum loading, lid opening, dosing, mixing, and filling.
Employs ISPE-recommended RABS (Restricted Access Barrier System) protection.
Vaporized hydrogen peroxide (VHP) interface for automated self-cleaning.
Advanced feeding method utilizing U-shaped chuck, traction rod, and feeding hopper.
Expandable integrated capping and heat sealing with inert gas protection.
Applicable for single or multi-component sterile raw materials.

Technical Parameters

No.	Item	Parameter
1	Cavity Cleanliness	Grade A Positive Pressure Laminar Flow
2	Air Volume	85-500m³/h
3	HEPA Filter Type	H14 High-Efficiency Air Filter
4	Air Velocity	0.45m/s ±20%
5	VHP Concentration	0-5000 ppm
6	Biological Indicator	6 log reduction
7	Sterilization Time	20-60min
8	Leakage Rate	0.5 % vol/h @100 Pa
9	Noise Level	≤65 dBA

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Manufacturing & Services

The facility currently boasts over 100 sets of state-of-the-at automated production and processing equipment. With experienced engineers and highly skilled technicians, the manufacturing team provides comprehensive validation and construction services. We are committed to simplifying material handling through superior technical capabilities and professional manufacturing expertise.

We provide ETO (Engineered-to-Order) powder and solids systems designed to offer comprehensive, enclosed, automated, and intelligent solutions for complex production challenges.

Certifications & Exhibitions

Packaging & Shipping

Frequently Asked Questions

Can the equipment be customized for my facility?

Yes. Our technical team interfaces with you directly to provide optimized solutions. All dimensions and interfaces can be adjusted to match your existing production lines.

What international standards do you comply with?

Our equipment complies with multiple industry standards, including EU CE, US UL/OSHA, German TÜV, and Southeast Asian IEC requirements.

What is the typical production lead time?

Standalone equipment is often available from stock. For custom engineering projects, we offer competitive lead times with guaranteed on-time delivery and free storage if needed.

What kind of after-sales support do you provide?

We offer round-the-clock response, remote technical assistance, and localized service. Spare parts are kept in long-term stock to ensure rapid supply.

How are transactions and quotations handled?

Comprehensive quotations include detailed breakdowns for equipment, testing, and transportation. We also offer flexible payment terms to suit different project needs.

Is the isolation system suitable for multi-component materials?

Yes, the system is specifically designed for feeding, mixing, and filling single-component, two-component, or multi-component sterile raw materials.