New white paper explains how ISM measurement systems can reduce the SOP burden
Creating and managing Standard Operating Procedures (SOPs) to meet quality control system requirements, necessitates a great deal of pharmaceutical company staff’s time and effort. There therefore an understandable reluctance to update SOPs whenever a company's production department wishes to alter a process. However, technical advances in analytical measurement equipment offer improved sensor operations that lead to greater production efficiency. These benefits can outweigh the workload of updating SOPs and should not be ignored. In addition, modern process analytical systems actually simplify SOPs, as explained in METTLER TOLEDO's new white paper.
Pharmaceutical production is one of the world’s most regulated activities. Consequently, creating and maintaining documentation in a quality control system to satisfy regulatory requirements is a considerable task for drug companies. SOPs are an essential component of most quality control systems, and must document precisely all activities involved in drug production.
METTLER TOLEDO's Intelligent Sensor Management (ISM®) is an innovative digital technology for analytical measurement solutions. ISM improves sensor handling and increases process reliability and production uptime, leading to greater productivity. It also simplifies sensor-related SOPs. Kurt Hiltbrunner, pharmaceutical industry market specialist at METTLER TOLEDO, provided an example:
"When a technician is calibrating a conventional analog pH probe, they must read the sensor’s serial number printed on the sensor body and update the history for that probe in their data, for example, the number of exposures to CIP / SIP cycles, and operating hours. They then need to decide, based on the sensor’s history, if the probe can be used again or should be disposed of. ISM simplifies these operations as all relevant sensor data plus valuable sensor diagnostics data is stored on the sensor. When an ISM sensor is connected to our iSense software, this information is automatically transferred to the software, which then updates its database for that particular probe. iSense also displays the sensor diagnostics, allowing technicians to easily see what, if any, maintenance the sensor requires or if it has reached the end of its reliable lifetime. ISM therefore not only simplifies sensor related SOPs by providing sensor diagnostics, it also increases process integrity".
METTLER TOLEDO's new white paper "Simplified Compliance – SOPs for Intelligent Sensors" explains how ISM measurement systems can help reduce the SOP burden.
The white paper is available at www.mt.com/PRO-SOP