Medical Design Briefs - February 2023 - 60

The Case for Rapid Transfer Ports in Life Science Applications
M
anufacturers of high-value products in life science industries
share two common challenges as these products are
moved into and out of cleanrooms, isolation chambers, and
gloveboxes: 1) ensure that the purity or sterility of these products
are not compromised and 2) make certain that any hazardous
materials that are used or waste products that are created are
handled safely and securely.
Serving as an indispensable aid in meeting and overcoming
these challenges are rapid transfer ports (RTPs), which were developed
as a way to provide safe, contained transfer of sterile or
hazardous materials and waste as they are moved into and out of
containment or isolation.
Over the years, Central Research Laboratories (CRL), for example,
has created a full stable of RTP technologies that have
been designed around the capabilities of an innovative double-door
transfer system, which allows all types of materials to
be rapidly transferred into and out of cleanroom, isolation
chamber, or glovebox without breaking containment. This capability
helps ensure product purity, quality, and integrity while
helping to maintain an expected level of safety for operators.
This article looks at the ways that RTPs can help optimize
product-handling operations in the life science industries.
n Safe Environments
Building and maintaining a safe and secure work environment
is a top-of-mind concern for all operators within the life
science industry. This requires the creation and maintenance
of highly reliable isolated environments that can protect against
product contamination and exposure to potentially hazardous
or dangerous materials.
Three operational areas within the life science realm are ideal
for the use of RTPs:
* Aseptic manufacturing: Keeping products free from contaminants
is a priority in any aseptic-manufacturing process.
From sterile active pharmaceutical ingredient (API) produc60
tion
and product formulation to the transfer of sterile
liquids/components and aseptic-filling processes, sterility
must be maintained at every stage with no chance that outside
contaminants can infiltrate the production process.
* Potent manufacturing: Ensuring product containment is
essential when working with toxic materials, not only for
the operator, but for the surrounding environment. Therefore,
RTPs can play a significant role in keeping contaminants
at bay during such high-value applications as high
potency active pharmaceutical ingredient (HPAPI) production,
the development of potent oral solid dose (POSD)
pharmaceuticals, and the packaging and transport of finished
APIs and POSDs.
* Aseptic/potent manufacturing: This category combines the
requirements of aseptic and potent manufacturing, with
special emphasis placed on the production of sterile high
potency active pharmaceutical ingredients (SHPAPI), biologics,
radio pharmaceuticals, and highly concentrated formulations.
RTPs can play a leading role in transferring
these substances into and out of isolation safely through
the prevention of exposure to toxic, hazardous, or dangerous
materials.
n The Role of RTPs
RTPs have evolved through the diligent work of a design and
engineering team that is constantly looking for ways to improve
product performance. This innovative mindset has revealed itself
again with CRL's recent introduction of the new E Rapid Transfer
Port, or ERTP (see the sidebar, " A New RTP Option " ), which
promises to make RTP operation easier than ever while maintaining
the same product purity and containment capabilities that are
the bedrock of life science production processes.
All RTP models feature the double door transfer system, but
additional features have been developed over the years that
give the technology more flexibility, including:
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