Cleanroom Monitoring Systems Keep Pharma Data Secure

Delphin Technology Offers Secure Data Acquisition

Continuous and secure data acquisition and documentation is especially important in the pharmaceutical industry for its unique production and storage requirements, as well as for proprietary research and development. According to FDA Part 11, data acquisition and monitoring systems in cleanrooms must operate in compliance with GAMP/GMP guidelines.

For effective monitoring, measurement data and limit values for parameters such as Temperature, Humidity, Particle count and Pressure all need to be acquired and archived in a format safe from manipulation. Additionally, any user intervention relevant to the processes in question must also be recorded to an audit trail.

Delphin Technology’s Expert and Message series data acquisition systems, combined with ProfiSignal analysis software, offer pharma companies a complete system performing all facets of cleanroom monitoring including data acquisition, monitoring, reporting and user management. CAS DataLoggers is a longtime Delphin distributor in the USA—we offer free tech support on our products and we’ll be happy to take your call at (800) 956-4437.

Application features:

• Secure acquisition of all measurement data acquired from cleanrooms and pharmaceutical environments

• Independent data storage within the Delphin device parallel to PC storage

• Flexible setup of monitoring functions using email, fax, text messaging or switch outputs

• Individually-adaptable process visualization and reporting using ProfiSignal

• Scalable system for large and small designs

Automated Measurement and Alarms:

Testing the long-term stability of pharmaceutical substances is a particular challenge for data acquisition products. To this end, many hospital chemist facilities are equipped with Delphin cleanroom monitoring systems. Here substances are stored in climate chambers and deep freezers where environmental conditions need to be recorded, archived and documented. Any changes in operational parameters--such as preset temperatures and threshold values--also need to be recorded in a way that is both reliable and secure.

Increasingly, users are turning to integrated systems supporting alarm management. Now automated protocol generation for alarms takes place weekly, and monthly for changes in parameters including optional comment input. All digital documents are redundantly-recorded.

Typical areas of application:

• Cleanroom monitoring

• Part 11-compliant monitoring for pharmacists

• Continual monitoring of production facilities in accordance with the FDA

• Fully-integrated monitoring solutions for pharmaceutical production

• Automated alarm systems

Professional Measurement Devices:

Delphin Technologies data loggers/data acquisition systems solve a variety of measurement and control problems in environmental applications in labs and industrial settings. Delphin systems feature different analog and digital I/O modules that can be used with a wide range of signal types including: Voltage; 4-20 mA Current; Thermocouple; RTD; and Resistance. They also offer powerful alarm and programming capabilities enabling them to process measurements and initiate actions on their own. Delphin systems can be used for local data acquisition and logging when connected to a PC; for remote unattended data collection connected the internet; or as stand-alone devices.

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