Biologics and regenerative therapies are driving the pharma industry deeper into the cold chain. Vials
and pre-filled syringes that require
refrigeration and sub-zero storage are
becoming more commonplace. As
anyone involved with the inspection and
packaging of these products knows, the
time spent out of cold storage is limited
and, when not handled properly, adds
stress to the process.
For years, we have looked at methods to
increase our efficiency through process
improvement methods. One of the first
things Lean teaches is "One Piece Flow,"
meaning that if possible, perform an action
on a product and immediately send it to the
next step. Don't accumulate hundreds or
thousands of products that are only partially
finished. This simplifies scheduling and
prevents the production of large numbers of
products that might be defective.
Now enter a cold chain product in a
vial. There are many possible technical
reasons One Piece Flow is not always
possible in vial processing: balancing
filling to inspection to packaging is not
always feasible, settling time after filling is
needed, sub-lots may be labeled for multiple
markets, inspection results may initiate
additional inspection processes (which can't
be done on a labeled product), etc.
So often during vial processing, the vials
are accumulated after one process, placed
in cold storage, and when needed, brought
out to warm up to room temperature before
being processed through the next step
(inspection or packaging).
This wasted time adds no value to the
product. The warming period adds to the
excursion time, the warming vials take up
space that could be used for something
productive, and the stress to the operations
staff increases as their allotted processing
time slowly ticks away. Often, these are not
short amounts of time; eight to 24 hours
are not uncommon equilibration times.
So why do they need to come up to room
Condensation forms on these cold vials and
wreaks havoc down the line. Inspection
equipment detect condensation droplets as
defects. Manual visual inspectors can't see
real defects with water droplets in the way.
Normal pressure sensitive labels don't stick
to wet glass. Wet vials slip out of operators'
gloved hands. Cardstock cartons soften and
warp when wetted. Furthermore, standard
packaging equipment is not designed to run
in wet environments.
There are methods to eliminate
condensation or mitigate its effects.
Low humidity rooms can decrease the
temperature requirement for equilibration
which decreases the excursion time. This
method requires a balance to ensure staff is
comfortable in these rooms (below 30%RH
does not agree with the human body).
An accumulation conveyor with downdraft
fans can warm vials quickly by pulling
ambient air around the vials as they slowly
move down the conveyor. Placed upstream
in a small climate controlled room, the vials
are dry and at room temperature often in
less than 30 minutes and can be processed
Specialty components can work with slightly
damp vials. There are pressure sensitive
label adhesives that can stick to wet and/
or cold vials. Different carton materials
can withstand water droplets. Many ink
formulations are not water soluble. And
keep in mind, condensation may occur later
in the supply chain or while with the end
user. The components need to be able to
withstand moisture at these points anyway,
so why not incorporate water resistant
technology to make the packaging process
more efficient also.
The point is, do not just accept that
cold chain products need hours of nonproductive time to warm up before being
processed. Be creative. Talk to component
and machine vendors. Talk to your facility
engineers. Equilibration time reduction will
save you money in the long term and will
decrease your stress in the short term. n
Temperature Equilibration –
The Thorn in the Side of Efficiency
◗ By Kevin Swartz, Packaging SME, Sr. Process Engineer
IPS - Integrated Project Services, LLC