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pa r ent erals
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Perfecting Parenteral Product
Handling
Q
&
A
An interview with Ryan Hawkins, Vice President & Chief Operating Officer,
Cook Pharmica, Bloomington, IN
n By Mike Auerbach, Editor In Chief
Pharmaceutical Processing: What is
the current thinking regarding safely
and cleanly handling and transporting
parenteral products?
Ryan Hawkins: When one looks at the
recent warning letters and/or listens to
the FDA discuss their perspective(s),
it is clear that the prevailing view is
that either Restricted Access Barrier
Systems (RABS) or Barrier Isolators
are the standard for safely manufacturing parenteral products; those manufacturers that are using conventional aseptic processing lines, whether clinical or commercial scale,
can certainly expect to beunder increased scrutiny.
 
Pharmaceutical Processing: Can you describe some technological innovations that have made sterile/aseptic transfer
of parenteral products more efficient?
Ryan Hawkins: There is no doubt that the manufacturing equipment continues to be improved and is evolving in
terms of handling product containers and associated components.  Equipment manufacturers have piggy-backed toolless changeovers – virtually eliminating changeovers – by either designing multiple format size parts into their handling
system(s) or by further leveraging robotics technology. 
Innovations in the design of components also continue
to help manufacturing efficiency, allowing companies to
get products to market faster, which the patients who need
them.  For instance, components help manufacturers focus
on the things that add value. Safety syringes represent another innovation that targets quick and safe drug delivery in
a cost-effective manner.
In addition, disposable technology has also certainly had
an impact on the industry,as regards efficiency.  Whether
talking about sterile quick-connect devices or ready-to-use
assemblies (formulation – bags and mixing containers; filling - peristaltic filling) set-up and overall process times have
been decreased substantially as Clean-in-Place/Clean-Out
of-Place or Steam-in-Place cycles are virtually eliminated for
product contact equipment.
Lastly, the follow-on integration of various testing systems or vision systems – such as oxygen headspace analysis, or crimp inspection immediately following capping, for
example – have helped reduce product rejects that would
likely been found at a later downstream process as opposed
to being discovered in real time.   
Pharmaceutical Processing: What are the FDA’s requirements for processing, handling and transporting parenteral
products? Do they mandate certain thresholds of cleanliness, etc. as a product travels through the various processing steps?
Panoramic view of the syringe packaging line at Cook Pharmica.
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october 2012 | Pharmaceutical Processing
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is operator training to the overall quality and
efficiency of parenteral product handling?
Ryan Hawkins: In my opinion personnel
training is the single biggest key to any parenteral operation’s success.  Management
is responsible to ensure that Good
Manufacturing Practices are understood and
followed, but it is also management’s job to
paren t e r a l s
be proactive and set people up for success
in this challenging environment.  Training
affects everything, including the accuracy
and clarity of documents and a technician’s
measurable level of subject matter expertise. You can learn a lot about a company
and their culture simply by taking a glance
at their approach to training.
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Top and middle: The vial filling line at Cook Pharmica
can process up to 15 million units a year.
Bottom: An alternate view of the syringe filling line at
Cook Pharmica.
Ryan Hawkins: The go-to document for
anyone manufacturing parenteral products
in the United States is “Guidance for Industry
- Sterile Drug Products Produced by Aseptic
Processing —Current Good Manufacturing
Practice” from 2004.  Expectations regarding
cleanliness of facilities and equipment, as
well as processing requirements, are clearly
outlined in this non-binding, but all-important guidance document.
 
Pharmaceutical Processing: Are there any
steps in the parenteral processing process
that you might describe as weak links, or
areas of concern that processors should pay
especially close attention to?
Ryan Hawkins: Anytime that people are involved in aseptic processing, you’ll find some
of the highest risks, given we shed viable and
non-viable particles all the time.  This is part
of the reason why personnel must be well
trained so that they can effectively perform
the steps in any given process.
 
Pharmaceutical Processing: How important
Pharmaceutical Processing | october 2012
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