Engineering Control Solutions for USP 797/800 and Fed 503B cGMP Compliance
A. USP 797 Sterile Non-Hazardous Drugs
Horizontal Laminar Flow Cabinet
• ULPA filter, creating ISO 3 workzone, cleaner than standard ISO 5
• ECM blower, creating stable airflow at energy-efficient 150 Watts
• Comfortable low noise at 55 dBA, full legroom, dished work tray
B. USP 800 Non-Sterile Hazardous Drugs
Class I Ventilated Enclosure
• Two HEPA filter in series, allowing exhaust to room instead of ducting
• Comfortable low noise at 57 dBA and full-width front access opening
• Dished phenolic resin worktop, preventing spill, scratch, and corrosion
C. USP 800 Sterile Hazardous Drugs
Class II Type A2 Biosafety Cabinet
• 7” Touchscreen Controller With built-in user guide, and 21 CFR Part 11 compliance
• ULPA filter, creating ISO 3 workzone, cleaner than standard ISO 5
• Comfortable low noise at 58 dBA, dished work tray, built-in armrest
• Lowest height in the market at 55”, suitable for cleanroom
D. Full cGMP Filling Line for Fed 503B Facilities
Filling Line Isolator
• High-grade stainless steel 316 construction
• Multi-step stations combining several isolators
• Optional integrated VHP generator and freeze dryer
• Fully customizable according to your needs
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