The availability of insulin is critical to the lives of over half a billion people living with diabetes worldwide. The pancreas is the organ responsible for producing insulin, allowing glucose to enter cells and lower blood sugar levels. Diabetes is the result of a deficiency in the pancreas that prevents it from naturally producing the life saving hormone.
Discovered in the early 20th century through the study of pancreatic cells, insulin production is responsible for saving countless lives. Today, insulin production is a foundational pillar of the pharmaceutical industry. So why are we writing about it? Because, like many pharmaceutical processes, pH and DO measurements are an essential element to this life-saving medicine.
How Insulin is Made
Manufacturing insulin is a carefully controlled biotechnological process that combines genetic engineering, fermentation, and protein purification. Initially, insulin production relied on harvesting necessary proteins from the pancreases of cows and pigs. These pancreas extracts contained many different proteins with various molecular sizes and chemical properties. Researchers were able to deduce that altering the pH of a solution containing these extracts helped in separating the desired compounds. pH alteration remains one of the most practiced and longstanding methods of protein acquisition in pharmaceuticals today.
Today, advances in genetic engineering and the study of amino acid structure allow insulin to be harvested from the cells of microorganisms. These engineered microorganisms are cultivated in large bioreactors where variables such as pH, temperature, and dissolved oxygen are carefully controlled. Through familiar practices such as chromatography and bio-fermentation, desired extractions are purified and formulated into stable, injectable insulin products that meet global quality and regulatory standards.
Why pH and DO Matter in Production
So what happens when the pH and DO measurements of protein solutions in insulin production are off? Accurate pH measurements are vital for insulin yield, purity, and safety. Without precision, the process risks failure at multiple stages. DO measurements are essential to maintain ideal conditions for microbial growth and development.
Challenges with these measurements mainly come from sensor limitations, harsh environments, and process variability. Each of these factors requires careful monitoring, maintenance, and quality control.
Risks With Inaccurate Measurements
Specific proteins and the types of undesirable contaminants found in pharmaceutical processes are pH-reactive. The right pH naturally dissolves these undesirables, keeping them out of the final product. If pH levels are reading inaccurately, this dissolution process is less reliable and threatens the final product.
Additionally, because of the medicinal nature of the product, insulin manufacturers must adhere to stringent, necessary scrutiny. Deviations in pH and DO can threaten not only the product but the health of those it is designed to save. Due to these standards, maintaining sterility is crucial to avoid any process-threatening contaminants from entering the final product.
Smarter Automation for Sterile Success
Automation in the pharmaceutical industry is a pivotal development in achieving maximum process yield and maintaining sterility. The Uniclean 900 and Unical 9000 are ideal solutions for enhancing the accuracy and effiency of pH and dissolved oxygen measurements.
The system comprises the following components:
- Durable Sensors — Fully digital Memosens pH sensors like the SE 555 and SE 740 eliminate noise commonly found in traditional analog systems. These sensors are 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. Equipped with third-party validation for automated assemblies.
- 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 or Uniclean 900 controller and the respective sensor. Featuring simple plain text operation and easy setting configuration, the system has expandable to fieldbus communication and operation with Memosens, digital and analog electrodes.
ROI: Maximum Accuracy, Uptime, and Peace of Mind
Reduced Contamination Risk: Automation reduces the need for manual interventions, decreasing the risk of contamination. A closed system maintains sterile operations more effectively, ensuring product safety.
Optimized Protein Conditions: Automated pH and DO systems ensure optimal conditions for microbial growth and product formation. Consistent maintenance of optimal pH and DO levels can lead to higher yields and faster production times.
Resource Efficiency: Precise control of pH and DO levels reduces the consumption of expensive reagents and raw materials. Efficient use of resources results in cost savings over time.
Validation: Peace of mind through third party, hygienic validation for fully automated retractable assembly.
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