Products and applications in the chemical and pharmaceutical industries are becoming increasingly complex. There is a growing demand for additional requirements at short notice and output is under considerable time and cost pressures.
There is little leeway for setting up and testing measurement systems so there is a high demand for preconfigured measurement and testing systems and all-inclusive solutions.
At the same time, regulatory requirements are growing. Measurement technology must also comply with the strict requirements of FDA 21 CFR Part 11 (US) and GAMP/GMP Annex 11 (EU) with detailed verification and documentation requirements including full traceability.
Trends in measurement and testing technology
- Increasingly complex applications require measurement and testing technology that is easier and faster to configure. Complete solutions from a single source which include hardware, software, engineering, start-up and training are becoming increasingly important as well as the development of customer-specific applications.
- Linking to control systems such as LIMS (laboratory information and management system), building monitoring, safety control systems or to laboratory equipment from different manufacturers are part of the increase in connectivity. In addition to interfaces such as Modbus, Profibus or SQL databases, this also requires the support of open standards such as OPC DA and UA.
- These increased demands necessitate tamper-proof acquisition of measurement data with unique time and date stamping as well as encrypted and secure data transmission.
Chemicals: Simple and practical measurement technology
- Delphin's measurement technology is adaptable to the typical requirements of the industry. Applications such as laboratory data acquisition or the input of recipes for serial tests can even be implemented by laboratory technicians without in-depth knowledge of measurement and testing technology.
- The systems can be customised to specific customer requirements and be equipped, for example, with 4mm laboratory sockets. They also meet the increased requirements for documenting data.
Pharmaceuticals: IQ, OQ, DQ qualification documentation and individual reporting
- These high standards are met by Delphin via three performance elements: an audit trail provides time-stamped electronic recording of all interventions; user management enables multi-level authorisation and protection; and alarm management tracks system operation according to stored security guidelines. Validation processes according to IQ, OQ and DQ qualification documentation are already being followed by many pharmaceutical users.
- A special feature is ProfiSignal software’s detailed reporting function with customisable reports to document measurement data, alarm lists, user interventions and limit value violations.
Versatile measuring and testing technology for chemical applications
- Example of laboratory data acquisition and monitoring: To perform laboratory serial tests typically requires easy recipe input as well as functions to manage diverse peripheral devices such as stirrers, laboratory scales and gas analysers via a range of interfaces.
- Example of laboratory automation: Measurements from refrigerators and incubators, e.g. humidity, temperatures and pressures, are recorded and automatically evaluated using a dynamic reporting function. Expert Logger’s alarm function is linked to a control system for building monitoring and safety. When evaluating alarms, direct access can be made to historical alarm data to analyse, for example, pre and post alarm histories.
From clean room monitoring systems to data acquisition in production facilities
- Example of clean room monitoring: Measurement technology monitors data from particle counters and temperature and pressure sensors in pharmaceutical clean room labs. When limit values are exceeded, the system triggers a signal lamps, sirens and personnel entry areas. In the event of a central server failure, Expert data loggers will continue to operate autonomously including acquiring measurement data and switching and control functions.
- Example of process data acquisition: Delphin's measurement and testing technology is also used to monitor production facilities in compliance with FDA requirements. Modifications to operating parameters and details on batch production are recorded and archived in a secure and tamper-proof way. The ProfiSignal Web software is used to display important parameters in a visually appealing dashboard. The dashboard can be accessed from a desktop PC, notebook, tablet or smartphone.