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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