4 FACILITY MONITORING
Containment of highly potent APIs in a phar- maceutical manufacturing environment has not always been compatible with efficiency. While containment technology provides necessary safety features for operators and the environment, it has historically added complexity, time, and
inefficiency to manufacturing processes, and was
However, recent advances in containment
on pharmaceutical process equipment based on
streamlined design and automation have made
containment features more efficient and capable of
running on continuous production lines.
First, let’s make sure we’re clear on terminology.
In the pharmaceutical solid dose sector, high-con-
tainment process equipment can be traditionally
defined as a set of hardware and software additions
to various machinery (tablet presses/dedusters,
capsule fillers/polishers, metal detectors, etc.) that
help avoid or reduce operator exposure to certain
APIs that have either been rated as toxic at low
concentration (typically OELs of 10μg/m3/8h TWA
or lower corresponding to OEB 3, 4, and 5), or to
APIs that have not yet been rated as precautionary
Ideally, these add-ons perform their safety duties
without interrupting overall production workflow.
Generally, it can be assumed that high containment features added to process equipment do not
improve the process in any way and, conversely,
may have at least a minimally adverse effect on production. Logic dictates that creating one or more
barriers or safeguards to protect operators may
restrict or complicate certain equipment operations.
Of course, any potential impediments have huge
upsides. The first, of course, is safety. Another is
freedom of movement: these barriers usually allow
the operator to work in the production room without full PPE and respirators, and can help reduce
other production site containment measures that
might otherwise be necessary.
Let’s discuss the types of containment barriers
typically utilized on two of the pharmaceutical
industry’s most prominently used equipment categories: tablet presses and complementary tablet
• α/β split butterfly valves can be connected
on inlet and outlet ports of tablet presses or
dedusters. These valves allow disconnection
and reconnection in a contained manner. When
disconnected, the outer surfaces of the valve
remain clean while its inside is contaminated;
some come with liners for easier disconnection.
A drawback is that, since they are typically
stainless steel, α/β split butterfly valves tend
to be quite heavy and require adequate support, often in the form of a dedicated cart or
support arm. To counteract this pitfall, lighter, semi-disposable versions of split butterfly
valves comprised of sanitary polymer have
been introduced in the last few years, and are
For pharmaceuticals manufacturers, the best method of ensuring containment
is minimizing human contact.
Look, But Don’t Touch
A dedusting configuration
highest-possible (OEB 5)
Pharma Technology Inc.