For most industries, scaling up with large batch sizes and high-volume production equipment is the best way to gain efficiency. This has also been true for production of many life sciences drugs, but portions of the industry are shifting toward creating smaller runs of “personalized drugs,” especially biologics, targeting smaller population segments.
In our June 2023 article in Pharmaceutical Processing World, titled Life Sciences Single-Use Instrumentation Trends, we describe how these life sciences trends are supported by single-use instrumentation.
Many drugs are chemically synthesized, following a recipe of ingredients and processing steps. However, about a third of the market now consists of biological products, also known as biologics, which are complex mixtures which can be isolated from natural sources or produced using other biotechnology methods. As manufacturers shift to biologics and smaller production runs of traditional drugs, they need practical and cost-effective automation solutions suited for this scale of manufacturing.
Single-use technology (SUT) production methods have been adopted over the past two decades to meet this need. SUT methods rely more on disposable elements, and less on permanently installed items. Instrumentation is a particular challenge because traditional sensors often need to be removed, sterilized, and recalibrated, which adds cost and the potential for damage. Measurement of pH is especially important for drug production, and these sensors typically cannot be cleaned in-situ.
Some early single-use pH technologies failed to meet the established performance of traditional versions because they were susceptible to gamma radiation used for sterilization, or they experienced high drift.
Emerson has overcome these issues by developing the Rosemount 550pH Single-Use Sensor, which features:
- A carefully constructed zero-leak form factor, so the sensor can be stored in a retracted and wetted position, and only extended into contact with the process media right before startup
- A specially developed phosphate-based buffer, which remains stable even through gamma radiation, while providing a long two-year shelf life
- The ability to perform a one-point calibration before deployment, even while the sensor is in storage
The 550pH sensor and connector excels for low-pressure applications, such as in SUT bioreactor bags, but there is also a need for SUT pH measurement in higher pressure and inline equipment. Because pH sensors are highly sensitive to pressure conditions, Emerson developed two patented improvements to address this issue:
- Created a high viscosity gel to act as the electrolyte
- Designed a means for pressurizing the reference chamber just prior to operation
Together, the gel and pressurization create a single-use pH sensor which provides accuracy—within 0.1 pH— even under changing process conditions. Single-use pH sensors designed for inline processing equipment use now make it possible for manufacturers to realize the benefits of single-use in many more applications.
Single-use methods and instruments are already used widely throughout life sciences applications. Best-in-class Emerson single-use instrumentation is making the technology even more applicable, responding to pharma manufacturers’ demands as drugs and biologics become specialized and require smaller and more frequent production runs.
For more information, visit Emerson’s Single-Use Technologies webpage.