Engineering Control Solutions for USP 797/800 and Fed 503B cGMP Compliance

Are you building or upgrading your compounding facility to comply with USP 797 / 800 or Fed 503A / 503B compliance? This might seem to be a daunting task, but our expertise in pharmaceutical compounding equipment can help you. 

We manufacture a wide range of equipment for USP 797 Non-Hazardous compounding, USP 800 Hazardous compounding for your Fed 503A facility, and also fully customizable cGMP equipment if you have Fed 503B facility. Below are some of our most widely used product ranges for each specific application:

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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

     More Information >>

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 work surface, preventing decontaminant spill to the floor

     More Information >>

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C. USP 800 Sterile Hazardous Drugs

     Class II A2 Biosafety Cabinet

     • ULPA filter, creating ISO 3 workzone, cleaner than standard ISO 5

     • ECM blower, creating stable airflow at energy-efficient 200 Watts

     • Comfortable low noise at 58 dBA, dished work tray, built-in armrest

     • Lowest height in the market at 55”, suitable for cleanroom

     More Information >>

D. Full cGMP Filling Line for Fed 503B Facilities

     Filling Line

     • 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

     More Information >>

ALSO AVAILABLE:

                         Pass Boxes                                                 Air Showers

                         Downflow Booths                                                 Bioreactors

Allow us to be your trusted partner in providing engineering control solutions for your compounding facilities—from strip mall start-ups to the largest global biopharma companies.

Cabinet Selection Guide  |  Request Quotation  |  USP 797/800 Equipment Guide

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