IMPLEMENTING SINGLE-USE SYSTEMS IN TRADITIONAL STAINLESS-STEEL FACILITIES
BioPharm: What are some of the advantages of implementing single-use systems?
Odum (IPS): Advantages include reduction of cleaning costs via the decrease in the size or elimination of costly clean-in-place (CIP)
systems because you are now getting away from fixed stainless-steel equipment. Along that same line, there can be a reduction
in floor space because equipment is smaller and easier to move in equipment modules. Work is being done to consider how the
implementation of single-use systems can reduce the amount of classified space that you must maintain during your manufacturing
operations, via validation of system closure. Perhaps the biggest advantage of single-use systems is flexibility, especially
if you are looking at the issues related to process changes in early-stage development.
Many developments in the biopharmaceutical industry have added to the challenges of designing, building, and operating the
traditional manufacturing facilities that we've used over the past three decades. As our insights into product requirements
and product characterization increase, the crucial path for the development of many new products is now shifting to the process
development stage, and manufacturing timelines are being condensed. Speed and flexibility are thus becoming crucial to many
of our clients.
Future manufacturing systems must be agile enough to deliver on this flexibility with regards to a wider variety of product
types and in a shorter timeframe. Single-use systems can provide a means to allow for this increased flexibility and a focus
on speed to market, even if you are dealing with a stainless steel-based facility.
BioPharm: Who should consider implementing at least some single-use systems?
Odum: Implementing single-use technology must be driven by the product and process attributes, the need for flexibility, and an
understanding of the critical process parameters. Any number of manufacturing organizations could benefit from the implementation
of single-use technology.
One group that I think is going to see a significant benefit is contract manufacturers. Because their business model is driven
by both speed and flexibility, single-use technology could provide some distinct advantages in terms of their ability to adapt
to new processes based on not only new clients but existing clients. Single-use technology gives them the flexibility to change
their platform technology rather rapidly and probably with a lower cost. Lower need for classified space would also decrease
Other business models would also benefit from this type of technology. Organizations that are focused on process development,
such as research-driven organizations that do high-level development work, would benefit. Manufacturers focused on pandemic
response would benefit from the ability to adapt very rapidly. Flexibility and adaptability, again, are key.
Another group that could benefit from single-use technology, in a way that perhaps they haven't started to look at in depth,
is the academic institutions, which are being squeezed by their ability to fund capital expenditures for facility infrastructure.
Any manufacturing organization should really explore the potential advantages of this type of technology.
BioPharm: What are some of the unique challenges of implementing single-use systems, particularly when you have an existing stainless-steel
Odum: We work with a number of clients who have a stainless steel-based platform and are creating what we refer to as hybrid facilities.
Three challenges stand out. First is a real understanding of the process definition and description. Although this may seem
obvious, we have found that companies sometimes have a knowledge gap, especially from a developmental standpoint, on exactly
how a specific process-unit operation may or may not be impacted by going to this technology.
The second challenge is looking at flows. Single-use systems are very flexible and modular in their approach from an equipment
standpoint, and the ability to move components in and out of a particular space creates some logistical issues. As a part
of that, there also needs to be a close investigation of accessibility. When your scenario includes a fixed stainless-steel
asset that resides in a particular manufacturing suite—maybe due to size or maybe due to a future need—the ability for operators
to access equipment and perform their day-to-day operations is extremely important.
The third challenge is process support. When you are dealing with single-use systems, you are now going to also deal with
many single-use components that are absolutely necessary in order for each process unit operation to be executed and work
the way it's supposed to. Tube sets, for example, are needed to connect components and allow the process to occur. Instruments,
such as those to measure flow or temperature, must be integrated into the system. The design and development of these support
items becomes a complex effort because there are a lot of parts and pieces that are going to have to be put together. Some
companies get outside vendors to do this for them. Others have chosen to do some of it internally, but it's very different
from designing a fixed piece of stainless-steel pipe in a building to run from point A to point B. Because of the fact that
you're dealing with tubing, you have issues with regard to accessibility and logistics. Where do these hang? How do you support
them? How do you make sure that they do not get damaged, or stepped on, or run over during the movement of equipment?
Wrapping around all these issues is the idea of closure. One of the things that we pay very close attention to is the idea
of looking at system-closure analysis to make sure that, as all these components are designed, we are doing everything that
is necessary to, first and foremost, protect the product from any potential contamination source and, in doing so, making
sure that the system components are designed properly so that this closure can be validated.
Single-use technology is not without its challenges, but these are challenges that are being addressed to create systems that
are efficient and bring a much higher utilization to a facility.