In the world of plasma-derived therapies, even a small error in pH measurements can result in massive product loss or compliance setbacks. Protein products taken from or ‘fractionated’ from human plasma are essential in treating conditions ranging from traumatic injuries, infections, and immuno-disorders or congenital deficiencies. The pharmaceutical industry can also use these proteins as source material for plasma derivative pharmaceutical products. This process plays a critical role in medicine and demands unmatched accuracy, and pH control in plasma fractionation is one of the most crucial factors for its success.
pH Accuracy in Plasma Fractionation
We’ve previously discussed applications in the pharmaceutical/medical industries that by necessity, demand the utmost accuracy. The same principle applies increasingly so to a critical medical process like blood fractionation.
Technicians must measure pH to ensure the successful extraction of certain proteins and compounds. Components found in blood, like albumin and immunoglobulin, are pH reactive, meaning their optimal fractionation states fall within specific pH ranges. Additionally, these optimal states have specific temperatures as well. Operators must measure pH at various points along the fractionation process line—from clarification to sterile filtration—while considering specific temperatures, to ensure the plasma has been optimally compartmentalized.
Problems can manifest in several ways in applications as sensitive as plasma fractionation. The demand for real-time monitoring, manual interference with the process, buffer interference, and temperature moderation can all threaten the accuracy of pH control in plasma fractionation.
The Case for Automated pH Solutions for Plasma Fractionation
While maintaining the integrity of pH accuracy is paramount in biotech processes like blood fractionation, so is sterility. Hygienic connections are designed to minimize contamination risks and bolster the safety and quality of pharmaceutical products. Furthermore, digitizing critical data improves information security, eliminates manual transcription errors, and fulfills the need for real-time monitoring.
Meet the cCare System
The Knick cCare system is designed to extend sensor life by providing automatic retraction, cleaning, calibration, and insertion of inline process sensors. cCare systems address sensor performance issues in challenging processes that demand accuracy and consistency.
The system comprises the following components:
- Durable Sensors — Fully digital Memosens pH sensor’s like the SE 555 eliminates noise commonly found in traditional analog systems. The electrode is designed for hygienic applications and can withstand CIP & SIP cleaning methods.
- Automated Holders — Pneumatic hygienic holders such as the Sensogate WA 130H automatically retracts the pH sensor. It is equipped to allow steam delivery directly into the calibration chamber, ensuring sterilization of the sensor. This maintains a closed system, meeting FDA compliance.
- Simplified Controller — The controller is responsible for the delivery of air to drive the pneumatic holder and the application of cleaning and calibration solutions. Can be used directly in hazardous locations. Fully automatic, modular, low-wear, and low-maintenance operation.
- Intuitive Transmitter — Central programming and operating unit of the system. The Protos 4400 provides diagnostics for the Unical 9000 controller and SE 555 pH electrode. Simple plain text operation and easy setting configuration. Expandable to fieldbus communication and operation with Memosens, digital and analog electrodes.
Customer ROI: Maximum Uptime & Accuracy
Fully Automated Process: The Unical 9000 provides full automation of cleaning, calibrating, sterilization, and retraction of the sensor. This vastly reduces human error due to manual calibrations. The system significantly minimizes sensor replacement costs and process downtime.
Minimize Manual Error: cCare is purpose-built for applications looking focusing on sterility and minimizing manual intervention. The digitized and repeatable efficiency of the system is precisely the solution engineers strive for.
Intuitive Knowledge of Sensor & Process Condition: Memosens technology allows technicians to observe sensor conditions using onboard diagnostics of the cCare system. This provides an additional verification that the sensor is healthy and reading accurately.
Why This Matters
From precise pH control to minimizing contamination risks, automating pH measurements in blood fractionation supports both product quality and regulatory compliance. With the Knick cCare system, the process gains reliability, sterility, and real-time sensor insights—without the inefficiencies of manual processes.
If you’re curious about the full capabilities of the cCare system, or M4 Knick’s solutions in general, schedule a training with us for a hands-on learning experience.
