Continuous and manipulation-safe data acquisition and documentation is especially important in the pharmaceutical industry for production and storage requirements as well as for research and development. According to FDA Part 11, data acquisition and monitoring systems in cleanrooms must operate in compliance with GAMP/GMP guide-lines. Measurement data and limit values for parameters such as temperatures, humidity, particle count and pressures need to be acquired and monitored as well as archived in a manipulation safe format. Any user intervention relevant to the processes must also be recorded to an audit trail.

Application features

• Manipulation-safe acquisition of all measurement data from cleanrooms and pharmaceutical environments
• Independent data storage within the Delphin device parallel to PC storage
• Flexible setting up of monitoring functions using email, fax, text messaging or switch outputs
• Individually adaptable process visualisation and reporting using Profi Signal
• Scalable system for large and small systems

Practical example

Testing the long-term stability of pharmaceutical substances is a particular challenge for data acquisition systems. The substances are stored in climate chambers and deep freezers where environmental conditions need to be recorded, archived and documented. Changes in operational parameters – such as preset temperatures and threshold values – as well as environmental conditions need to be recorded in a way that is reliable and manipulation proof. An integrated system of user and alarm management is therefore being used. The automated generation of protocols for alarms takes place weekly; and monthly for changes in parameters including optional comment input. All digital documents are redundantly recorded. Many hospital chemist facilities are equipped with Delphin clean-room monitoring systems

Typical areas of application

• Part 11 compliant pharmacist monitoring
• Clean-room monitoring
• Dispersed system for pharmaceutical monitoring tasks
• Monitoring of production facilities in accordance with FDA
• Integrated full monitoring solutions in pharmaceutical production
• Integrated alarm systems