Who is driving innovation in this segment of the
Brian Ward, Ph.D. CChem, CSci, FRSC, FabOhio, Inc.:
Any company that’s already familiar with containment technology will be the driving force; they know what they want
and they are asking for it. They’ve already got containment
experience, so they can better counsel the contractor who’s
making their devices. It’s a split business, and the mature
part of the business – the top ten – are pretty far along;
they already know who to go to in terms of architecture
engineering firms for a new facility. The days of big investments are probably behind us.
Now we’re seeing the catch-up
business with the third parties,
contractors, and generics as they
try to break into the market to make
these compounds, but they’re about
twenty years behind the major manufacturers. Because this newer part
of the market has never done containment before their vendors have
a much larger job to do in educating
and training them before they even
know what they need, much less how a vendor can help
them meet those needs.
Dr. Johannes Rauschnabel, Chief Pharma Expert at
Bosch Packaging Technology: I’d say that both sides influence each other as the use of high-potency pharmaceuticals
grows. Protecting products from contact with operators and
vice versa has continuously been moving up the agenda for
pharma companies and equipment vendors alike. Recent
equipment solutions favor the use of automation and robotics technology to reduce human contact with the product.
Due to ever-stricter guidelines for aseptic filling operations,
manufacturers have turned towards sophisticated isolator
Manufacturers of solid dosage forms also have recognized
the need for containment solutions. They prevent biological
agents from escaping either into the working surroundings
or the external environment, thus protecting operators from
potent pharmaceutical compounds. Containment systems
require closed containers or biological cabinets, and the
use of rooms with specially designed air handling and se-
cure operating procedures. Some drug manufacturers have
already built entire containment facilities, where building
and equipment are optimally fine-tuned to one another.
Involving the equipment supplier at an early planning stage
ensures flexible, modular and space-saving solutions.
What impact does operator training have on effective
containment system operation?
Rauschnabel: Operator training has a significant and
direct impact on the entire operation.
Effective containment is about the reli-
able protection of workers from highly
potent substances. In industrialized
countries operators typically no longer
use full protection suits. If the product
is not transferred properly into or out
of the system, there is a high contam-
ination risk. Training is also essential
for the operator to handle any small
problems that require manual interven-
tion without compromising the integ-
rity of the containment system.
Gary Partington, Technical Sales & Marketing Manager,
Walker Barrier Systems: Operator training is very important, it ensures that the containment equipment is used and
maintained properly. There are often different components
within a system – whether that be a bag-in/bag-out solution
or air locks or split butterfly valves – and they all operate
a bit differently, so the operator needs to understand how
each component works so that the system works properly
and safely. Especially when using an isolator, which provides less chance of human error and exposure, operators
simply must be trained on the proper use.
Ward: The operator is the holy grail of any containment
system, no matter how well it is engineered and designed.
Whenever you’re introducing a project where the operator
is going to be asked to do something quite different from
the normal operating procedure, they get quite upset if their
viewpoint is not solicited from the get-go and that decision
■ By Nikita Ernst, Associate Editor
Experts in containment weigh in on recent trends and share
their views on the future of isolation technology
Containment / Isolator
“Protecting products from
contact with operators and
vice versa has continuously
been moving up the agenda
for pharma companies and
equipment vendors alike.”