Rollprint Packaging Products, Inc. expected to be the first
sterile packaging manufacturer to convert pouches in a certified cleanroom
environment in the United
States. The company is announcing the
construction of a 6,000 sq. ft. clean room expected to be fully operational in
the second quarter of 2012.
The ISO Class 8 cleanroom will be enhanced via Rollprint’s
vertical integration which means that the rollstock from which the pouches are
made is also produced at the same facility in Addison, Ill.
No other pouch manufacturer has both vertical integration and cleanroom
capabilities in the United
States, making it another “first” for
Rollprint.
By definition, a cleanroom environment has a controlled
level of contamination that is specified by the number of particles per cubic
meter at a specified size. ISO Class 8 Cleanroom certification dictates the
following maximum concentration limits for airborne particulate (particles/m3)
according to ISO 14644-1: 3,520,000 at 0.5 μm; 832,000 at 1 μm, and 29,300 at 5
μm.
“We started preparing for this two years ago with
investments in vision systems, web cleaners and other equipment and procedures
to minimize particulates in our film converting area. We wanted to properly
address upstream criteria before taking the next step,” said Dwane Hahn, vice
president of sales and marketing, Rollprint.
The upgraded capability has been driven by customer demand
for domestic supply that has been produced in a clean room environment. Pharmaceutical,
medical device and diagnostic/life science manufacturers are constantly looking
for ways to reduce the number of contaminants that come in contact with their
products.
“There is a big difference between ‘cleanroom environments’
that some manufacturers claim they have, and actual cleanroom certification. In
a few months time, we expect to be able to announce to the industry that we
have met the rigorous certification criteria and are producing pouches in our
cleanroom,” Hahn explained.
The cleanroom will house five production lines capable of
producing a variety of pouch structures for which Rollprint is known. This
includes header bags, chevron, vented, three-side weld seals, corner peels,
etc.
“Many of the packaging structures used today for pharma and
medical device applications—such as film and foil header pouches, coextruded,
peelable heat-seal films and silicon oxide/aluminum oxide
composites—were first introduced to the industry by Rollprint. The new
cleanroom capability builds on that legacy,” said Hahn.
Rollprint Packaging Products
512-869-6620; www.rollprint.com