a bag-in/bag-out – which is highly operator dependent and
can easily expose that operator. Customers and the firms
helping them build their systems must have a better understanding of how the solutions will work in order to match
them to the proper safety & OEL requirements.
What do you think the future holds for containment
Partington: I think that as the demand for more potent
and possibly even hazardous products continues to rise,
we will see a similarly heightened demand for containment
technology. It might even drive containment technology more
towards the use of isolators. The industry always tends to be
a bit more conservative, so I think down the road we could
even see robotics or other automation systems used within
an isolator as a way to further protect operators.
Ward: For many of the major manufacturers we are in the
future, and we now have to face the problem of the cyclical 7
year turnaround between the new guard and the old guard.
At that point you have a whole new influx of young engineers
who do not have the years of experience with the existing
devices. They haven’t lived through the growing pains and
the training issues and the weaknesses, so there’s a need to
reeducate the workforce as it progresses through its cycle.
The future will be defined by this continuing education. ■
PHARMACEUTICAL PROCESSING | SEPTEMBER 2014 19 ■
■ CON TAINMENT
can often lead to project failure. The operator is the most
critical person and really should be included in the design
team. They’re the ones in there 24 hours a day, when management, engineers, and quality control are not.
What are the top pitfalls or mistakes pharma man-
ufacturers make when specifying, designing and
installing/qualifying containment systems? How can
they be avoided?
Rauschnabel: One issue pharmaceutical companies sometimes overlook in aseptic filling is that there have to be
enough hand glove ports for access. Also, the operators have
to be involved in mock-up studies. In fact, pharma producers
should develop a scenario for all filling operations. For instance, the locations of glove ports must fit for the smallest
and the tallest operator. And thirdly, processes need to be
defined carefully and sufficiently. If the cycle design parameters are not matched precisely enough, this may lead to long
cycle times. It makes sense for manufacturers to spend more
time for the development of cycles. This will eventually pay
off. In general, manufacturers can avoid mistakes by involving
equipment vendors at a very early stage of planning.
Ward: Obviously, leaving your operator out of the design
collaboration process is a major mistake, but number two would
probably be going for the cheapest vendor, as with everything
else, you get what you pay for. It is more than worth it to pay for
the experience of the manufacturer who, in some cases, will provide the education and training that’s needed when the product
goes into the workplace. The key is finding a vendor who can be
a partner, where your success is their success.
Another mistake is that oftentimes the ability to clean a
containment system is taken for granted. The surface finish
on the inside of a system determines how cleanable from, a
quality perspective, that the product will be. Surface finishes
have a very critical effect on cross contamination, especially
as we’re moving toward biotechnology in large facilities. It’s
going to become more and more important, because without
a completely clean and sterile enclosure, you’re not going to
be able to use it, or it will be dedicated to one product only,
making it a very costly system to just sit in a corner. For maximum usability, the vendor must be well aware of the surface
finish and conditioning of their products.
Partington: Often when a customer engages with an engineering firm to develop the URS, those URS are sometimes
too vague if there is not enough specific information on the
process to be able to determine the best containment solution. They’ll definitely need to spend some time educating
the engineering company on what the process is and what
the containment levels need to be, so that a better URS can
be written and better quotes can be submitted.
Another thing that you’ll see sometimes is that some of
the integrated transfer systems don’t always meet with the
OEL requirements that the customer may have. For example,
the customer may need a very low OEL (operator exposure level) yet select a mismatched transfer system – like