Professional Documents
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Pressure Change
Measurement Leak
Testing Errors
by: Jeff M. Pryor and William C. Walker
Article on page 8
Departments:
Advertisers:
Controlled Environments Magazine...... 5
Honeywell ........................................... 11
Jenessco Industries, Inc........................ 7
Leak Testing Specialists, Inc................. 7
MBraun, Inc........................................... 9
Merrick & Company............................... 4
Renco Corporation.............................. 15
Premier Technology, Inc...................... 20
Spring Fab Adv. Technology Group...... 3
Vacuum Atmospheres Company........... 2
The Enclosure
Editors
Advertising Manager
Crissy Willson
Publisher
Officers
Board Members
President
Scott Hinds
Western Refining
Bus: (505) 500-7776
sshinds972@gmail.com
Carl Fink
CTL Corp.
Bus: (860) 651-9173
crlfnk@aol.com
President-Elect
Justin Dexter
MBraun, Inc
Phone: (603) 773-9333 X-254
j.dexter@mbraunusa.com
Secretary/ Treasurer
Lyle Freeman
Premier Technology, Inc.
Bus: (208) 785-2274
lfreeman@ptius.net
Tony Heinz
Leak Test Specialists
Phone: (407) 737-6415
Heinz@leaktestingspec.com
Greg Wunderlich
URS
(303) 843-3135
greg.wunderlich@urs.com
Rick Hinckley
Los Alamos National Laboratory
Phone: (505) 667-9931
hinckley@lanl.gov
Bradley Hodges
B&W Y-12
Bus: (865) 576-5850
hodgesbw1@y12.doe.gov
Liaisons
Ike Dimayuga, Canadian
Liaison
Atomic Energy of Canada, Ltd.
Bus: (613) 584-8811
dimayugaf@aecl.ca
Martyn Page, UK Liaison
AWE, plc
Bus: 44 1189850633
Martyn.page@awe.co.uk
Russ Krainiak
Integrated Containment System
Bus: (252) 946-0166
russ@integratedcontainmentsystems.com
John Newman
Springs Fab Advanced
Technology Group
Bus. (303) 438-1570
johnn@springsfabatg.com
Gary Partington
Walker Barrier Systems
Bus. (608) 562-7761
gpartington@walkerbarrier.com
Ron Smith
Bus: (803) 613-969
rbsmith78@bellsouth.net
James Spolyar
Aseptic Barrier Systems LLC
jim.spolyar@us.skan.ch
Moving ?
Please let the AGS Central Office know of any changes in address. Send your name, address, city, state
and zip code information to:
American Glovebox Society
526 So. E Street
Santa Rosa, CA 95404
Bus: (800) 530-1022 or (707) 527-0444
Fax: (707) 578-4406
Presidents Message
By: Scott Hinds
Only people who listen to my style of rock and roll from the late 70s
would know where that phrase came from. On the back of the first Boston
album (yes - vinyl), the verbiage that described the members and recording style of the band Boston ended each paragraph with listen to the
record! in an enthusiastic request to hear the music. Well, in borrowing
that style from one of my favorite bands, I apply it to my favorite society
and say Come to the Conference!
July 27-29, 2015 Town and Country Resort and Conference Center - San Diego, CA
Keynote Speaker:
Donna S. Heidel
Biosketch
Donna S. Heidel is the Technical Director for Industrial Hygiene for Bureau Veritas North America where
she leads the development of industrial hygiene services to support the effective management of occupational health risks associated with emerging technologies. Prior to her employment with Bureau Veritas she
coordinated the Prevention through Design program at the National Institute for Occupational
Safety and Health, including the occupational health and safety management systems for
safely synthesizing manufactured nanoparticles and commercializing nano-enabled products.
Ms. Heidel also has experience in the pharmaceutical industry, including 15 years at Johnson
& Johnson, as the World Wide Director of Industrial Hygiene. While at J&J, she supported
the development and implementation of engineering containment and control systems for
high-potency drugs. She is certified by the American Board of Industrial Hygiene (CIH), and
is an AIHA fellow. She has received the AIHA Presidents Award in 2011 and in 2013. She
also serves on the AIHA Board of Directors. She is the past chair of the AIHA Control Banding
Working Group.
Abstract
The guidelines developed by the American Glovebox Society for design, fabrication and
testing of glovebox isolators have been successfully implemented by the pharmaceutical
industry not only to control worker exposure to hazardous drugs but also to provide contaminant control for sterile products. Innovative designs, including flexible walls, materials
transfer systems, and clean-in place capabilities have supported the need for occupational
exposure control while meeting the specific process requirements for pharmaceutical dosage form manufacture. The successful application of this technology by the pharmaceutical
industry is now being applied to safely synthesize manufactured nanoparticles and nanoenabled products. The occupational health challenges associated with hazardous drugs and
manufactured nanoparticles and the application of glove box solutions to significantly reduce
worker exposure risks will be discussed.
CONSULTING:
TRAINING:
TESTING:
LTS
(407) 737-6415
INC.
www.leaktestingspec.com
7
Reprint Permission
From Materials Evaluation, Vol. 72, No. 5. Reprinted with permission of the American
Society for Nondestructive Testing, Inc.
Introduction
Q=
where
( P V)
( StdAtm t )
System Resolution
System resolution is the smallest measurement that can be seen
with a specific test and setup. This calculation must be taken in
the context of the test system, not just the individual instruments
increment. One must take into account the complete system,
under test conditions, and then use this system information to
find out what a particular instruments effects are on the test. It is
only through this process that the system resolution of a particular
instrument can be defined. Resolution must be defined for each
instrument used in the testing system. The test resolution as a
whole cannot be greater, or more sensitive, than the least sensitive
instrument. Using the standard PCMT formula (Equation 3) and
some mathematical manipulation, substitution of each instruments
resolution into the actual test conditions produces the following
formulae for evaluating component resolutions:
initial leakage rate formula
(3)
pressure resolution
(4)
temperature resolution
(5)
time resolution
(6)
where
Q = measured leakage rate,
Gres = pressure gage resolution
(smallest pressure increment measured during test),
Pi = initial absolute pressure,
Pf = final absolute pressure,
Continued on page 14
10
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Resolution Example
In this example, only the pressure resolution will be evaluated.
The system undergoing the test has an acceptance criteria of 6.5
102 Std L/min (2.3 103 SCFM). The test volume is determined
to be 1360 L (48 ft3), and test pressure is planned to be established
at +102 mm (4 in.) water column. Finally, the test duration is
planned to be one hour. The pressure gage used for the test had
subdivisions of 704 mm (27.7 in.) water column (6895 Pa [1 psi]).
The evaluated resolution of the pressure instrumentation is as
follows:
= (Gres V) / (StdAtm rt)
= (704 mm water column 1360 L) / (10340 mm water
column 60 min)
System Repeatability
Although closely related, there is a difference between test
resolution and repeatability. System repeatability or sensitivity
is defined as the smallest test increment that is considered
repeatable. Just because it is theoretically possible to see a leak as
small as the resolution does not mean that it would be expected to
read this every time, which speaks to the repeatability requirement.
A prudent test engineer would require that the test sensitivity be
between two to ten times the maximum test resolution to ensure
repeatability. If the test sensitivity were greater (larger) than the
smallest allowable leak, then the test, as configured, would be
incapable of delivering the desired results. It would therefore be
unacceptable for use. In the case of inadequate sensitivity or
resolution, either different instruments or another test configuration
would be needed. While more accurate gages are often the best
long-term solution, this pricy alternative is not the only solution.
Changes in any of the test variables will affect the test sensitivity.
Repeatability Example
Again, evaluating only at the pressure component, a PCMT test
to be performed on a system where the acceptance criteria is 9
102 Std L/min (3.2 103 SCFM). The test volume is determined
to be 2832 L (100 ft3) and testing will be conducted at a pressure
of +102 mm (4 in.) water column for one hour using a pressure
gage that had subdivisions of 12.7 mm (0.5 in.) water column. The
following pressure resolution result is obtained:
= (Gres V) / (StdAtm rt)
= (12.7 mm water column 2832 L) / (10340 mm water
column 60 min)
= 5.8 102 Std L/min
or
= (0.5 in. water column 100 ft3) / (407 in. water
column 60 min)
= 2.0 103 SCFM
The repeatability (also known as sensitivity) is defined as 2X
minimum resolution. Therefore, this pressure gage has a minimum
sensitivity of 0.12 Std L/min (4 103 SCFM). This pressure gage
does have the required resolution (less than the acceptance
criteria); however, it is incapable of repeatedly seeing the required
leakage rate in this test system (the sensitivity is greater than the
acceptance criteria). Therefore, this gage is not compatible with
this test. See the PCMT decision tree (Figure 1) for a graphic
example of how system resolution and repeatability affect testing.
System Accuracy
or
Continued on page 16
14
Each
instrument
component
also has some uncertainty involved
Figure 1. Pressure change measurement test (PCMT) decision tree. RSS = root sum square.
with accuracy called measurement
uncertainty. This is different than component resolution;
The three elements that make up a measurement uncertainty measurement uncertainty has to do with just how accurate
are resolution, repeatability and accuracy.
the specific component actually measures the value. Most
The total uncertainty of the system as a total is the most complex manufacturers give a specification on accuracy of instrument
of the three BPVC required elements to calculate. Uncertainty of as percent of full scale. For instance if a 2000 kPa (290 psi)
measurement is often compensated for during the test to ensure gage had an accuracy of 3% full scale, then the measurement
the most reliable test results. Uncertainty becomes more critical as could be otherwise stated as 60 kPa (9 psi). This means that a
the test results require more accuracy and precision. Depending reading of 1000 kPa (145 psi) could represent an actual pressure
on the specific objectives of the test, uncertainty could be left of somewhere between 940 and 1060 kPa (136 and 154 psi),
out of the calculation set if the test engineer determined these provided no other uncertainties are entered into the equation.
calculations are insignificant in the particular test, that is, very During the gage selection process, getting a highly accurate gage
small in comparison to the expected results. It is important to note compatible with the leak test is of paramount importance.
that resolution, repeatability and uncertainty calculations must be
Continued on next page
performed for each different testing scenario.
16
17
Weighted Uncertainties
Beginning with Equation 3:
(7)
where
(8)
and
LR = Q + UQ
(15)
where
(16)
where
k = coverage factor.
(9)
(10
(11)
(12)
Uncertainty Example
If a system has an acceptance criteria leakage rate of 10 and
a PCMT evaluated leakage rate yields a result of 8 1, the test is
acceptable since the variability of the leakage rate does not exceed
the acceptance criteria. In another example, if a calculated leakage
rate of 8 3 is obtained, the result is ambiguous because of the
range for the result overlaps the evaluation criteria, that is, the
possibility that the leakage rate is 11 cannot be ignored. When the
uncertainty of the calculated leakage rate overlaps the acceptance
criteria, the result cannot be designated as acceptable.
Conclusion
(13)
(14)
18
19