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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Appendix I:
Terra Universal USP 797 Compliance Testing for
Compounding Clean Rooms
Terra Part Numbers: 2900-52A, 2900-53A, 2900-54A, 2900-55A
Terra’s Compounding Cleanroom has been compliance-tested by an independent certifier to the environmental
requirements specified by USP 797. Sample test protocol and data are furnished below. Factory testing is intended to
demonstrate compliance with USP 797; however, it does not constitute certification, which must be conducted on-site by
an authorized testing company.
Unless otherwise noted, all testing is performed with FFUs in the “Medium” speed setting. As filters clog or other
operating conditions change, FFU speeds can be adjusted upward to “High” settings in order to increase air change rate,
internal pressure level, and air displacement rate between buffer and anterooms.
1.0
Buffer Room Pressure Test
Purpose:
Verifies: pressure > 0.04”WC
Apparatus:
Magnehelic gauge installed inside Buffer Room (Terra P/N 6600-86; Mfgr: Dwyer No. 2300-0; 0.25 – 0 -
0.25”WC bidirectional scale range)
Results:
Meets pressure requirement
with FFUs on medium speed and exhaust vents open (unobstructed), at a pressure
value of
≥
0.02”WC.
2.0
Ante Chamber Pressure Test
Purpose:
Verifies: pressure > 0.02”WC
Apparatus:
Magnehelic gauge installed inside Ante Chamber (Terra P/N 6600-86; Mfgr: Dwyer No. 2300-0; 0.25 – 0 -
0.25”WC bidirectional scale range)
Results:
Meets pressure requirement
with FFUs on medium speed and exhaust vents open (unobstructed), at a
pressure value of
≥
0.02”WC.
