Pharmaceutical Process Control
Controlled Environments spoke to Tee Noland of Pharma Tech Industries,
an end-to-end supply chain solutions company that provides turnkey, for-
mula-to-finished product manufacturing solutions for customers in phar-
maceutical, nutraceutical, and greater healthcare sectors.
Controlled Environments (CE): What went into
designing your cleanroom facility?
Tee Noland (TN): With our first prescription (Rx)
product launching in 2010 in our Georgia facility,
we had to learn what type of production space was
necessary. Through the combined efforts of our
engineering staff coupled, outside consultants, and
input from our customers, Pharma Tech was able
to design a cleanroom capable of meeting not only
immediate needs but those in the foreseeable future.
We essentially used ISO 8 guidance to design
the room with cleanable surfaces, controlled
entry access, and positive, dedicated HVAC systems. We have since built six additional rooms
on similar design for both Rx and relevant OTC
products, including those necessitating New Drug
CE: What kind of equipment is used in the
TN: We have several Bartelt-style sachet fillers,
various blenders, and a high speed bottling line in
our rooms. We also have low-dose capsule filling.
Among our most recent addition is a 10-lane stick
packaging line, which served as an expansion of our
overall packaging capabilities.
CE: Who cleans and maintains your cleanroom
TN: In-house staff.
CE: What’s in store for the future?
TN: As the FDA continues to raise the bar for consumer product quality – nutritional products are a
good example here – I believe there will be more and
more need for cleanroom production space. While
there is considerable capital expense associated with
these rooms, in the end the consumer is benefiting
from a more controlled, higher quality environment
for their critical products. We are looking forward to
launching a novel Rx powder inhalation product later
this year that we believe will offer unique benefits to
consumers for a variety of afflictions.
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