Findou API Filling, Isolation, and Capping Isolation System for Aseptic Environments

• Customization: Available
• Application: Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Food Safety, Forensic Science, Pharmaceutical Industry
• Automation Grade: Automatic
• Model NO.: FDNPI04
• Features: Batch Coding, Print Registration Control, Sterilization Capability, Tamper-Evident Packaging, Temperature Control, Vacuum Packaging
• Machine Material: Stainless Steel
• Packaging Material: Aluminum, Glass, PVC
• Warranty: 24month
• Transport Package: Wooden Package
• Specification: Customized
• Trademark: Findou
• Origin: China
• Production Capacity: 1000 Pieces/Year
• Package Size: 500.00cm * 200.00cm * 300.00cm
• Package Gross Weight: 3000.000kg

Product Description

Product Description

Sterile API Isolation and Filling System

System Overview:

      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. It overcomes limitations of traditional production, including discontinuous operation and low automation levels, and reduces the risks of cross-contamination and secondary contamination associated with the inability to perform CIP/SIP. The key aseptic processes include vacuum discharge into the powder mixing tank, manual sealed transfer of the mixing tank, sterile powder milling and granulation, automated lifting and mixing, automatic filling, automatic capping, automated nitrogen purging, automated heat sealing, ultimately yielding qualified sterile products. The system's key operational areas employ ISPE-recommended RABS (Restricted Access Barrier System) protection, which maximally reduces personnel and material contact probability, thereby effectively lowering the risk of product contamination by particles and microorganisms, in compliance with the updated GMP requirements. To meet different process requirements, we have developed isolation systems including ORABS, CRABS, and ISLATOR.

 

  

Application scenarios: 

Sterile post-processing integrated three-in-one system;

Lyophilization and spray drying post-processing system;

 Sterile powder injection batching, mixing, and filling isolation system;

Sterile raw material sampling isolation operation system;

Based on different sterile powder production processes, the system integrates the following functional equipment:;

Vacuum-sealed transfer;

Sterile powder milling/granulation;

Automated lifting and mixing; 

Automatic filling; 

Automatic capping;

 Laminar flow transfer of equipment;

αβ sterile transfer valve; 

RABS isolation operating system ;

System CIP/SIP station ;

Online particulate monitoring. 

Performance parameters:

No.	Item	Parameter
1	Chamber cleanliness	Grade A positive-pressure laminar airflow
2	Air volume	85-500m3/h
3	HEPA filter type–inlet	HEPA High-Efficiency Particulate Air Filter, H14 Grade
4	Air Velocity	0.45m/s ±20%
5	Number of Gloves and Chambers	As Required
6	VHP Concentration	0-5000 ppm
7	Biological Indicator	6 log Including VHP Sterilization
8	Sterilization Time	20-60min
9	Airflow Configuration	Grade A positive-pressure laminar airflow
10	Leakage Rate	0.5 % vol/h @100 Pa
11	Pressure Differential	0-85pa ±5pa
12	Illumination	≥500 Lux
13	Noise	≤65 dBA
14	Power Supply	220V,50HZ 3P

Main Products

Company Profile

The factory currently boasts over 100 sets of state-of-the-art, automated production and processing equipment, integrated throughout all manufacturing processes. The company also boasts experienced engineers, highly skilled technicians, a dedicated manufacturing team, and a validation and construction service engineering team. Currently, our products are trusted by over a thousand pharmaceutical companies, both domestically and internationally, including Merck, Pfizer, Novozymes, Nippon Shokubai, China Resources Pharmaceutical, Qilu Pharmaceutical, North China Pharmaceutical, and Shanghai Pharmaceuticals.

Findou's mission is to "Simplify the Ordinary and Make Material Handling Easier." Leveraging our superior technical capabilities, professional manufacturing expertise, and dedicated service, we stand with our customers to address every challenge. From solution design and equipment manufacturing to project execution and value-added services, Findou is committed to providing professional support throughout the powder handling lifecycle—helping customers solve complex challenges and build efficient, flexible, and sustainable production facilities.

Findou is a leading trusted global supplier of powders and solids handling solutions. Our ETO (Engineered-to-Order) powder and solids systems are designed to provide customers with comprehensive, enclosed, automated, and intelligent solutions.

Certifications

Exhibitions

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FAQ

1. About Customization?  
Our professional technical team will interface with you directly, and we can provide comprehensive technical solutions multiple times until they are optimized. All equipment can be adjusted in dimensions and interfaces according to your existing production lines.  

2. About Certifications?  
Our equipment complies with multiple industry standards, including EU CE, US UL/OSHA, German TÜV, Southeast Asian IEC, etc.  

3. Production Lead Time?
Standalone equipment is available from stock. For engineering equipment, our production lead time is shorter than that of industry peers, with on-time delivery guaranteed. We also offer free storage services based on customer needs.  

4. About After-Sales Service?  
We provide 24-hour response, remote technical support, and localized after-sales service. Spare parts are kept in long-term stock to ensure timely supply at stable prices.  

5. About Transactions?  
We provide comprehensive quotation documents, with separate listings for equipment, packaging, testing, transportation, services, etc. Flexible payment terms are available.