Advanced Isolation Systems for Safe High-Potency Drug Manufacturing

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Advanced Isolation Systems for Safe High-Potency Drug Manufacturing

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

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Basic Information

Model NO.

FDNPI05

Machine Material

Stainless Steel

Packaging Material

Aluminum, Glass, PVC

Warranty

24 month

Capacity

1000 Pieces/Year

Origin

China

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Product Description

Sterile API Isolation and Filling System

This system is a fully integrated solution developed in strict compliance with the new GMP requirements, applicable to sterile powder production processes such as sterile lyophilization, crystalline drying, spray drying, and sterile powder injections. It utilizes automation and containment measures to minimize and isolate manual interventions, thereby ensuring aseptic process integrity.

Core Application Scenarios:

Sterile post-processing integrated three-in-one system
Lyophilization and spray drying post-processing system
Sterile powder injection batching, mixing, and filling
RABS isolation operating system

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Performance Parameters

Item	Parameter
Chamber cleanliness	Grade A positive-pressure laminar airflow
Air Velocity	0.45m/s ±20%
VHP Concentration	0-5000 ppm
Biological Indicator	6 log Including VHP Sterilization
Leakage Rate	0.5 % vol/h @100 Pa
Noise	≤65 dBA

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Main Products Showcase

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Profile & Capability

The factory currently boasts over 100 sets of state-of-the-art, automated production and processing equipment. Our mission is to "Simplify the Ordinary and Make Material Handling Easier." We provide comprehensive, enclosed, automated, and intelligent solutions for the global pharmaceutical industry.

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Packaging & Shipping

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Frequently Asked Questions

1. Can the equipment be customized for my production line?

Yes. Our technical team interfaces directly with you to provide optimized solutions. All equipment dimensions and interfaces can be adjusted according to your existing requirements.

2. What industry certifications do your products hold?

Our equipment complies with major international standards, including EU CE, US UL/OSHA, German TÜV, and Southeast Asian IEC certifications.

3. What is the standard production lead time?

Standalone equipment is often available from stock. For engineering-heavy projects, we offer competitive lead times with guaranteed on-time delivery.

4. How do you handle after-sales technical support?

We provide a 24-hour response system, remote technical support, and maintain a long-term stock of spare parts to ensure stable maintenance prices and availability.

5. What are the available payment and transaction terms?

We provide detailed, transparent quotation documents. Flexible payment terms are available to suit different project requirements.

6. What is the typical warranty period for the machinery?

Most of our sterile isolation and filling systems come with a 24-month warranty to ensure reliable long-term operation.