Sensor maintenance for bio-pharma

Nicola Brittain

A system that automates and standardises cleaning and calibration for reliable pH measurements at any time.

I’m sitting in the car right now and can give you 3 minutes. What’s your pitch?” “Are you aware that manual pH sensor calibration poses one of the biggest risks around batch loss? Do you know that you can counter that with an automation solution?”. This was the conversation that catalysed the  successful partnership between Knick and a major pharmaceutical company, a partnership that resulted in a product called cCare for Pharma system, developed in response to the rigorous requirements in the pharmaceutical sector.

Automatic PH measurement optimises efficiency

In many industrial processes, the pH value is one of the most important control parameters, but these measuring points also require intensive maintenance. In many processes and media, sensors must be cleaned and calibrated several times a day. This minimises sensor drift and delivers measured values that can be trusted.

Process conditions in the pharmaceutical industry are very different from those in the chemical industry. The process media are typically less aggressive, but the equipment must meet rigorous requirements in terms of cleanability and sterility. In addition, most biopharmaceutical processes require batch rather than continuous production. They also involve specifications aimed at ensuring that the measurement technology used during the process function flawlessly. This is accomplished through pre-batch calibration and adjustment and post-batch verification, all of which must be documented.

The time required to do this, in an era characterised by staff shortages, possible transmission errors in the case of manual work steps, and the subsequent mistake of rejecting batches, makes it essential to consider optimisation activities supported by automation.

PH accuracy for cell cultures and fermentation

The upstream process of cell cultures is complex, expensive, and time-consuming. The parameters of pH and dissolved oxygen must be strictly controlled and monitored to ensure compliance with optimal cell growth conditions and maximum product quality and quantity. During the process, outside interventions are not permitted since the risk of contamination is too great and would result in the loss of the batch. This makes it even more important to have reliable pH values available at all times. However, many companies still calibrate pH sensors manually.  The process is very time-consuming, requiring an employee to ‘invade’ the cleanroom, remove the sensor, clean it, place it in a series of different buffer solutions, and wait until the pH value is stable. This poses the risk of mechanical damage to the sensor, and the employee’s actions may also influence the process. For example, whether the sensor is swirled or simply immersed in the buffer solution makes a big difference. Finally, the sensor must be reinstalled, and the system must be cleaned or sanitised. A risk assessment at the customer’s facility identified more than 80 potential sources of error during calibration and measured value transmission.

Retractable fitting for hygiene

The SensoGate retractable fitting is ideal for hygcleanienic applications. Its patented lock-gate system reliably seals the process at all times, allowing the sensor to be replaced without process interruption. A sophisticated cyclone rinsing thoroughly cleans the sensor, the seals, and the calibration chamber. Unlike other manufacturers’ retractable fittings, the SensoGate has no dead spaces that cannot be cleaned by rinsing, SIP and CIP.

Focus on product development

Knick attaches great importance to good design for new products and achieves a high level of flexibility by applying the modular principle. That Knick’s fittings have been supplied for a range of process connections enables high adaptability to almost all applications.

Automatic pH sensor calibration

Knick offers a solution for automatic pH sensor maintenance that eliminates the disadvantages of manual calibration. During the three-minute pitch, this feature also aroused the curiosity of the pharmaceutical company’s CEO. The system of automatic pH measuring loops, which Knick markets under the name “cCare”, performs a standardised calibration that is fully automatically and sends all values and the calibration report to the process control system. As a result, all batch data is digitally documented by an audit trail without the risk of manual transmission errors.

The automatic system always performs sensor adjustments in exactly the same sequence. cCare does more than just extend sensor service life and reduce labor costs. Its fully automated sequences also ensure more accurate pH measurements, which directly impact the safety and yield of the biopharmaceutical process. The cCare system is also the only sensor maintenance system on the market that is fully approved for use in Zone 1 hazardous locations.