Single-use technology plays an integral part in nearly all bio-production processes, yet several challenges remain —challenges that are serious enough to delay or even stop the use of single-use technology.
Here is Parker's summary of the five most critical challenges in the implementation of single-use technology.
Read the full white paper: Single-Use Technology: The Next 5 Challenges to Conquer
Single-use processing has limitations with the scale of operations when compared to stainless steel setups. The largest single-use bioreactor is at a 2,000 L scale. However, several trends are mitigating the impact of these limitations.
Increased titers are driving a reduction in the size of bioreactors as is the move towards an increased number of smaller, localized manufacturing sites to address domestic supply requirements. In addition, the growth of personalized medicine and targeted treatments based on genetic profiles are pushing down patient populations and as a result overall batch sizes.
These trends allow single-use technology to meet the production requirements for processes that would have previously been dominated by stainless steel. Single-use also enables the manufacturer to flexibly manage the capacity they have in order to meet increases or decreases in demand.
Automation of single-use processes can offer numerous quality, safety, and productivity improvements. These include:
Freeing up the operator for more value-added tasks while ensuring operator safety.
Controlling process variables.
Safeguarding the process with single-use sensors that monitor and provide feedback on specific parameters.
Using a platform approach in the design and operation of systems which can simplify the supply chain and eliminate the need for costly, repeated training.
Automating data acquisition, analysis and report generation to 21 CFR part 11 for batch record creation to support manufacturers in meeting the requirements of cGMP.
Product contact materials used in single-use systems must be compliant to regulatory standards. Choosing non-standard, new or rarely used materials can lead to a potential roadblock in the implementation of single-use technology, such as extra validation; therefore employing the correct materials, carefully selected for compatibility and compliance, is critical.
Using a validated portfolio or design space of components which meet all of the compatibility and compliance criteria can ease or even eliminate the pain of extra validation. Components within the design space are pre-validated and allow for easy integration within single-use assemblies.
Extractables data has traditionally been generated using a variety of techniques, resulting in different data sets from different vendors making a direct comparison between vendors almost impossible. However, industry guidelines will pave the way for the acceptance of standard materials and testing regimes which will aid in the creation of targeted and standardized validation packages.
Creating a fully customized single-use assembly, from concept to customer delivery, can take in excess of 16 to 20 weeks due to challenges around design, validation and qualification which create delays in implementation. Alternatively, generating a configured single-use assembly from a pre-validated design space has benefits in terms of design, compatibility and lead time.
For instance, at Parker, a single-use assembly created to a customer’s design utilizing components from a pre-validated design space can be delivered in a significantly shorter time — in some instances, about half the time required for a fully customized assembly.
This lead time is further aided by the localization of automated systems and manifolds manufacturing to sites in both the US (Oxnard, CA) and Europe (County Durham, UK).
Due to the demands for contamination control and operator protection, a single-use assembly must be leak-free and fault-free.
With stainless steel systems, integrity is tested by pressurizing the system and holding at a known pressure for many hours to test for leaks. However, as single-use assemblies are made from flexible polymeric materials, this type of high-pressure hold test is not possible, so the standard test procedures for single-use assemblies are visual inspection and low-pressure decay testing.
While there may be concern over the level of assurance single-use assembly testing provides, traditional stainless steel systems are also not without risks. In fact, stainless steel systems could be viewed as having a higher potential risk of leaks when compared to single-use assemblies due to multiple line connections and the stresses of steam sterilization and temperature fluctuations.
Quality by design (QbD) can be employed to ensure integrity in building single-use systems. By applying this methodology to the integrity and quality throughout the entire manufacturing process, quality assurance is built in from the start.
If you'd like to learn about more solutions to single-use challenges read our white paper: Single-Use Technology: the Next 5 Challenges to Conquer
This post was contributed by Graeme Proctor, product manager - single-use technologies, Parker Bioscience Division, United Kingdom
Parker Bioscience Filtration specializes in automating and controlling single-use bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product. To find out more visit www.parker.com/bioscience