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Packaging
Deconstructing The
Blue Dye Leak Test Method
Answering the right questions and challenging the effectiveness of the method may actually improve detection capability and resolve
quality issues many are experiencing today.
by Oliver Stauffer
B
lister package manufacturing for tablets and To determine if the dye ingress method can
capsules has process and material parameters be successfully deployed for a certain package,
that are unique to each product. Barrier a simple four-step procedure can be followed
properties of blister packaging are primarily using a few measurements and basic gas laws
designed to eliminate moisture ingress, a (P1V1=P2V2). This article aims to codify the blue dye
result of H2O molecules passing through micro leaks leak test, deconstructing common assumptions and
over extended periods of time. misconceptions of one of the most widely used and
Moisture ingress into blister packaging is best highly subjective methods in the market.
measured and evaluated by conducting a desiccant In tablet and capsule manufacturing, why has the
weight gain study. Past desiccant weight gain studies blue dye test traditionally been the go-to method? It
have shown that significant moisture is perceived as simple, relatively
ingress begins to occur with pin effective, and has low capital cost.
hole defects of 15μm and greater. Despite its wide acceptance, this
However, results vary based on a method is often applied under
variety of package, product, and circumstances in which the package
environmental variables, including: or the test variables render the
n Differences in pressure from inside method ineffective for many package
the package cavity to the outside; formats with certain attributes.
n Differences in relative humidity from In its most common form, a
inside the package cavity to the outside; package is placed in a bath of
n Air temperature; methylene blue dye within a test
n Defect dimensions and chamber and a set vacuum is drawn
characteristics; on the package, which we will call
n Package cavity dimensions and head Phase 1. During Phase 1, the method
space attempts to draw air out of the
n Hydrophilic properties of tablet/ package cavity. Following Phase 1,
capsules. the vacuum is released from the test
chamber and Phase 2 begins. If
The dye ingress leak test is the package cavity leaks air during
currently the most common method Phase 1, the package cavity will
for leak testing blister packaging. have a negative pressure, drawing
It has variable leak testing capabilities depending blue dye inside the package cavity. After this stage
on package characteristics, and is one of the most of the test, the lab operator must inspect the package
misunderstood and misused leak tests in the industry. for any blue dye ingress. The test has three main test
A variety of factors impact the effectiveness of the dye inputs; the test vacuum level (Phase 1), the dwell time
ingress leak test, including: at the test vacuum level (Phase 1), and the dwell time at
n Package characteristics; atmospheric pressure (Phase 2).
n Surfactant concentration; We can begin by making a very broad sweeping
n Vacuum level; and potentially controversial statement. The blue dye
n Vacuum dwell time; ingress test as described above is ineffective in test-
n Ambient pressure dwell time. ing flexible packaging. A flexible bag will expand
Step Three
Calculate at what pressure the blister package will
reach maximum expansion under vacuum.
Using inert gas laws, one can calculate at what
pressure the blister package cavity will reach maximum
expansion. For the purpose of this study, convert all
of your measurements to metric values (millibar and
Step one of the four-step method to determine blue dye ingress capability. milliliter).
locking down variables that may be taken for granted. what leak rate operators can provide.
Once you have completed steps one through four, and n Challenge the method regularly and its ability to
determined that your package does in fact have the achieve reliable and repeatable detection of defects.
adequate headspace characteristics to test using the
blue dye ingress method, begin to develop a standard The blue dye ingress test is more complicated than
operating procedure that captures all inputs of your one may think and may not be an all-around solution
test method: for leak testing all types of packaging (flexible, semi-
n When preparing the blue dye bath, is the methylene rigid, and rigid). Answering the right questions and
blue concentration standardized? Is surfactant added to challenging the effectiveness of the method may
the mixture? If so, to what concentration? actually improve detection capability and resolve
n What amount of dye is an operator actually able to quality issues many are experiencing today. n
visually see? Using a micropipette, inject microliters of
blue dye into the blister package to validate operator
Oliver Stauffer is VP of inspection technologies for PTI Inspection
detection capability. Will the lab operators actually Systems. Stauffer received his bachelors of science degree from
see the dye leak into the package? This is not a cut the University of Michigan and completed his MBA at Georgetown
University’s McDonough School of Business. Stauffer joined
and dried response, and it’s important to test different PTI Inspection Systems in 2005 as a member of the research
and development team working on non-destructive testing of
operators as you may receive different results. blister packaging. In 2006, he joined PTI’s sales team as sales/
n The final challenge would be to make positive applications engineer. Stauffer was an international business
development manager for PTI through 2010, focusing on global
controls (calibrated laser drilled leaks) and challenge quality solutions for package inspection. In 2011, Stauffer was
the entire standard operating procedure to determine appointed to his current position.
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