Biomedical Engineering Reference
In-Depth Information
What are the primary benefits
of SUSs?
Quality and safety:
Single-use offers reduced risks of
cross-contamination, reduced risk of bioburden
contamination, reduction of cleaning (and cleaning
validation) issues, and other benefits that can help satisfy
the requirements of regulatory agencies.
Sustainability:
Single-use bioprocesses systems can provide a range of
environmental benefits beyond those of stainless steel
systems. Although SUSs may generate additional solid
waste, benefits include reduction in the amount of water,
chemicals, and energy required for cleaning and sanitizing,
as well as avoiding the labor-intensive cleaning processes
required with stainless steel systems.
Are SUSs limited to specific
stages of the manufacturing
process?
Currently, single-use technology can be utilized in a variety
of stages as well as unit operations in bioprocessing
manufacturing. However, some unit operations and
process scales currently have limitations due to existing
capital installed and lack of technologies available in SUS
formats. Historically, media and buffer preparation were
some of the first-unit operations to utilize single-use
technologies. As technologies have evolved, there are now
larger scales and more unit operations such as cell culture,
mixing, purification, formulation, and filling. As the
single-use industry continues to evolve and the
bioprocessing industry realizes the benefits, further
investments will be required from the supply base to
develop even larger scales as well as newer technologies.
Do manufacturers need to
replace all stainless
technology to take
advantage of the benefits of
SUSs?
Not necessarily—the benefits of integrating SUSs into unit
operations can be achieved by making either a full
conversion to plastic-based solutions or an appropriate
combination of single-use and stainless technologies.
Manufacturers can increase process flexibility and improve
efficiencies even with partial conversion to single-use
technologies. Examples include cell culture operations
integrating single-use bioreactor technology with
traditional stainless reactors and final fill operations
combining SUSs with traditional vial-filling equipment.
Are SUSs limited to specific
stages of the manufacturing
process?
Currently, single-use technology can be utilized in a variety
of stages as well as unit operations in bioprocessing
manufacturing. However, some unit operations and
process scales currently have limitations due to existing
capital installed and lack of technologies available in SUS
formats.
What are the factors to
consider when
implementing a single-use
technology?
There are four basic questions/areas to ask when thinking
about implementing single-use technologies: application,
capital for investment, data available, and risk tolerance.
What is my
application
(product and process)? Will I be
performing upstream and/or downstream processing of
cell therapy, drug product, or other biopharma process?
What part or stage of the process will I be working? Is my
process/product scope and overview well understood and
documented?
