NuAire LabGard NU-560-400, Operation & Maintenance Manual

Page: 61 / 103

OM0295
Rev 2 September 2020 Page 61 of 103
7.9 Cleanliness Classification Test for Pharmacy Application
If this cabinet is going to be used within pharmacy, per USP797 1 , the cabinet must be tested to assure compliance to ISO
14644-1:2015, Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness
2
. The
cleanliness classification test is performed using a particle counter to measure particle counts within the cabinet workzone.
Turn on cabinet and let warm up for several minutes. Turn on particle counter and flush out sample tubing line to remove
latent particles. Set the particle counter to measure 0.5 micron or larger particles at the appropriate measuring rate.
“Operational Particle Count Test 3 ”
Position the particle counter isokinetic probe at a point 6 inches (152mm) upstream of the aseptic manipulation area (hand
convergence point) and mounted so as not to interfere with the operator’s hand movement. The pharmacy operator will
simulate IV manipulation during the particle count test using non-hazardous materials. A minimum of three (3) 1-minute
particle counts shall be sampled and recorded while the user simulates aseptic compounding manipulations.
“At Rest Particle Count Test”
Take 5 test points in 1-minute intervals on a grid, in a horizontal plane as measured approximately 6 inches (152mm) above
the worksurface. The grid location is designed as the workzone center point and each corner measured 6 inches (152mm)
from the inside perimeter.
Record the 5 particle count values for each of the test points over the 1-minute sample time. All final count particle
concentrations and calculated 95% upper confidence limit shall not exceed 3520 particles per cubic meter (ppcm) or (100
particles per cubic feet (ppcf).
1
USP28-NF23: United Stated Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, USA, www.usp.org .
2
ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments-Classification of Air Cleanliness, International Organization for Standardization,
Case Postale 56, CH-1211 Geneve 20, Switzerland
3 CAG-002-2006: CETA Compounding Isolator Testing Guide, Controlled Environment Testing Association, 1500 Sunday Drive, Suite 102, Raleigh, NC 27607,
USA, www.cetainternational.org