Innovations at Interphex 2023 - 10

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dies, and stamps are all regularly cleaned in ultrasonic apparatuses.
This newest edition of the book has a section specifically dedicated to
ultrasonic cleaning technology.
What are the benefits to using ultrasonic cleaning?
Michael Moussourakis: From the perspective of aqueous cleaning,
employing an ultrasonic cleaning system allows for the use of higher
foaming, better emulsifying detergents. But unlike other clean-out-ofplace
(COP) methods where foaming detergents are used, the ultrasonic
cleaning method is automated. This reduces cleaning variability from
run to run. While some cleaning applications require more manual
COP methods, the automation, reliability, and reproducibility provided
by an ultrasonic system is a definite asset.
How is ultrasonic technology used in conjunction
with cleaning agent?
Michael Moussourakis: Alconox Inc. experts work with our customers
to ensure the most appropriate cleaning chemistry is chosen for the
residue and material/substrate being cleaned.
This can be verified
if there are concerns (such as in the cases of uncommon residues or
surface materials) on bench top or small-scale ultrasonic unit testing.
We then work with customers to ensure scale up accuracy and provide
cleaning validation direction and guidance. Using our relationships
with ultrasonic unit manufacturers we can often ensure the right
Alconox Inc. detergent is specified at the onset.
Are there any cleaning situations where the use of
ultrasonic technology is not recommended? What
are these situations and what is done when they
are encountered?
Michael Moussourakis: There are some. Certainly, any solvents that
are flammable, explosive, or combustible should not be used in an
ultrasonic. Alconox Inc. aqueous detergents are not. Other times parts
are too large to accommodate or accommodate cost-effectively. They
may be cleaned with scrubbing or large soaking tanks. Other times,
parts with complex geometries cannot always be effectively cleaned in
an ultrasonic. At these times other technologies are employed such as
Vacuum Cyclic Nucleation.
Measuring Cleanliness
Is it possible to measure cleanliness? If not, what is
actually being measured?
Stacy Silverstein: There is not really a way to directly measure
cleanliness, as defined as the absence of residue. What you really
measure is amount of detectable residue or amount of detectable
surface altering residue.
Specifically, what types of testing are available, what
are their benefits, and, are there certain situations
where they are best used?
Malcolm McLaughlin: The book reviews the use of 8 different
techniques for measuring at the 10 mg/cm2 level of cleanliness;
11 different techniques for measuring at the 1-10 mg/cm2
cleanliness; and then 12 techniques for measuring at levels below 1
ug/cm2
. You want to match technique to level of desired detection.
Some techniques give you broad information about the fact that
something is there, but not much specific information about what it is.
Other techniques can very specifically identify what the residue is, but
perhaps not identify anything else. For getting good adherence with
surface coatings, cleaning down to 10 mg/cm2
levels can be sufficient
using surface energy sensitive test methods such as an atomizer test
or water break test. Perhaps augmented by a tape test or " white glove "
test. More demanding applications require more sensitive tests.
What are some best practices to be employed to
measure cleanliness?
Malcolm McLaughlin: For pharmaceutical cleaning validations, it is
best to use a sensitive method that can specifically identify residues
of concern. In a detergent cleaning validation residue detection you
want a technique that had a limit of quantitation that is below the
acceptance criteria for the residue, ideally at least 50% below the
acceptance limit. Typically, you would use HPLC or UPLC analytical
methods with swab sampling to achieve these goals. Other techniques
can be used, but this would be the best practice.
Stacy Silverstein: In non-cGMP industries, best practices for measuring
cleanliness or the absence of residue ranges anywhere from visual
inspection, rinse water pH testing, to simply " squeaky " clean surfaces.
Following your specific industry's guidelines is the way to go.
Combination Devices
Can you give us a general definition of a
combination device?
Jeff Phillips: A combination device is a pharmaceutical and medical
device in one. This can be an inhaler, autoinjector, or drug eluting stent.
Why are they becoming more popular?
Jeff Phillips: There are different reasons for popularity of combination
devices.
In the case of drug eluting stents there are studies that show
increased health outcomes from stents that elute drugs such as Paclitaxel.
level of
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Innovations at Interphex 2023

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