Sterility Aseptic Isolator for API Dispensing and Testing

• Customization: Available
• After-sales Service: Engineers Available to Service Machinery Overseas
• Analysis Speed: High Throughput
• Application: Food Safety, Pharmaceutical Industry, Chemical, Medical, Food
• Certification: CE, GMP, ISO
• Condition: New
• Customized: Customized
• Detection Range: Proteins
• Material Compatibility: Capsules, Granules, Herbs, Liquid, Powder, Tablets
• Portability: Benchtop
• Power Source: Electric Operated
• Sensitivity: High Sensitivity
• Technology: Ultraviolet-Visible Spectroscopy
• User Interface: Touchscreen
• Voltage: 220V
• Driven Type: Electric
• Certificate: CE, ISO, SGS
• Capacity: Cutomized
• Machine Power: 1 Kw
• Precision: High Precision
• Computerized: Computerized
• Type: Pharmaceutical Workshop
• Finished Dosage Form: Pharmaceutical Workshop
• Transport Package: Inner Water Proof Bag, Outer Sea Worth Case
• Specification: Customized
• Trademark: Marya
• Origin: China
• HS Code: 8409919100
• Production Capacity: 300 PCS/Year
• Package Size: 1000.00cm * 800.00cm * 1000.00cm
• Package Gross Weight: 1000.000kg

Product Description

Sterile Testing Isolator







Main Applications
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.














Performance Features

• New VHPS technology: control the concentration and saturation of H₂O₂; good sterilization reproducibility; shorten the sterilization time of the chamber;
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• Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport;

 

• Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H₂O₂ solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements;

 

• CDCV service: sterilization cycle development, validation studies and services;

For more information please contact us.

 

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