Quick-Start Operating Guide
USP 797 Modular Cleanroom
©
Copyright 2015 Terra Universal Inc. All rights reserved. • Revised Dec 2019 • Document No. 1800-90
Terra Universal, Inc. • TerraUniversal.com • 800 S. Raymond Ave. • Fullerton, CA 92831 • TEL: (714) 578-6000 • FAX: (714) 578-6020
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3.0 Operation and Maintenance
Recommended Operation Guidelines
The guidelines below are intended as general recommendations for cleanroom operation, not strict operation
protocol. Always confirm your operation protocol with the appropriate certification agency before you place
the cleanroom into service.
Environmental Monitoring
UPS 797 and other regulations stipulate monitoring of environment conditions, including positive pressure inside the
antechamber and the buffer room, particle counts, and air change rates. Measurements of these environmental
conditions should be taken and recorded at intervals appropriate to your application.
To assist in environmental monitoring, Terra’s USP 797 cleanrooms include two Magnehelic differential pressure
gauges (mounted on the control panel) with a range of -0.25” to +0.25”WG. Recommended pres
sures: ≥ 0.025”WG in
Anteroom; ≥ 0.05”WG in Buffer Room (minimum difference of 0.025”WG between Anteroom and Buffer Room).
External baffles on the Air Exhaust Vents can be adjusted to attain these recommended values.
Cleaning/Sterilizing
Before initial use, clean the side panels and uprights thoroughly with appropriate cleaning or sterilizing agent. See
“Recommended Cleaning Protocol” below.
Initial Start-Up
Once installation has been completed and electrical connections checked, turn ON fan filter units by pressing the
green ON button
. When the cleanroom is initially commissioned, FFUs should be set in the “Medium” power
setting, as specified in the installation procedures above.
Turn on the light by pushing up on the 2-position
switch.
At initial start-up, allow the cleanroom to operate for several minutes before entering the room. This allows the
sweeping action of the airflow to remove any loose particles inside the room and for the room to fully pressurize.
Always verify that the Magnehelic gauge indicates a positive pressure (generally, > 0.02”WC) before entering the
room.
Operating Tips
For optimal cleanliness in the Buffer Room (main processing area), always allow the main entry door to close fully
before opening the swing door that separates the Anteroom from the Buffer Room.
USP 797 stipulates that an ISO 5 PEC (Primary Engineering Control, generally a laminar flow hood) be installed
inside the buffer room. All sterile preparations should be made inside the PEC. The buffer room is configured to allow
installation of a PEC on a bench up to 6-ft. wide inside the buffer room. A duplex outlet, positioned on the vertical
upright on the rear wall of the cleanroom, provides power for the PEC and additional process equipment that may be
required.
Continuous Cleanroom Operation
Once a cleanroom is certified for operation, Fan Filter Units (FFUs) should be allowed to operate continuously.
Turning off the FFUs eliminates the positive pressure inside the room that sweeps away particles and prevents
contaminant influx. Interrupting this positive pressure may require extensive cleaning and revalidation, depending on
application.
