Clean room monitoring

Manipulation-proof recording of all measured values according to FDA Part 11

Cleanroom monitoring: How measurement technology helps to ensure air quality

In cleanrooms where sensitive processes take place, a controlled atmosphere is crucial. Cleanroom monitoring is used to monitor the air quality in such environments and ensure that particles and contaminants remain below a certain limit. Measurement technology plays an essential role here, as it can provide precise data on factors such as air pressure, temperature, humidity and particle size. This enables early detection of deviations and allows operators to take appropriate measures to maintain air quality. By using advanced measurement technology, cleanroom monitoring can make an important contribution to ensuring process safety and product quality in sensitive environments).

During production and storage, but also in research and development in the pharmaceutical industry, particular attention is paid to complete and tamper-proof data recording and documentation. According to FDA Part 11 regulations Data acquisition and monitoring systems in cleanrooms must be validated in accordance with GAMP/GMP guidelines. Measured values and limit values for parameters such as temperature, humidity, particle count and pressure must be recorded, monitored and archived reliably and tamper-proof. Via a Audit trail all user interventions relevant to the process are also saved.

Application highlights of cleanroom monitoring

  • Tamper-proof recording of all measured values in cleanrooms and pharmaceutical environments
  • Autonomous data storage in the Delphin recording device parallel to the PC
  • Flexible set-up of monitoring functions with e-mail, fax, SMS or switching outputs
  • Individually customizable process visualization and reports with ProfiSignal
  • Scalable system for small and large solutions

Practical example of cleanroom monitoring

Long-term stability of active pharmaceutical ingredients

Testing the long-term stability of active pharmaceutical ingredients places special demands on data collection. The active ingredients are stored in climate chambers and freezers, where environmental conditions must be recorded, archived and documented. Changes to operating parameters such as target temperatures or limit values as well as the ambient conditions must be archived reliably and tamper-proof. User and alarm management are integrated for this purpose. All alarms are automatically logged on a weekly basis and parameter changes are logged monthly with comments. All digital documents are stored redundantly. Many hospital pharmacies have been equipped with Delphin clean room monitoring systems.

Typical areas of application
of cleanroom monitoring

  • Part 11 compliant pharmacy monitoring
  • Clean room monitoring
  • Distributed systems for pharma monitoring tasks
  • Monitoring of production facilities according to FDA
  • Integrated total monitoring solutions in pharmaceutical production
  • Integrated alarm systems

Hardware and software for your measurement and testing solution

Compact data logger Loggito
Loggito
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal Go
Universal measurement data acquisition Expert Logger
Expert Logger
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal Basic
Modular measured value acquisition ProfiMessage D
ProfiMessage D
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal Klicks
Modern vibration specialist Expert Vibro
Expert Vibro
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal 20 Go
Manipulation-proof recording of all measured values according to FDA Part 11
Expert Transient
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal 20 Basic
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiMessage
Central measurement data management Delphin Date Canter
Delphin Data Center
Manipulation-proof recording of all measured values according to FDA Part 11
Expert Key
Product image LoggitoLab
LoggitoLab
Manipulation-proof recording of all measured values according to FDA Part 11
LogMessage 5000
Loggito

Compact data logger

Universal small-channel data logger for industrial use | Cost-effective setup of decentralized measurement networks without channel overhead | High reliability and durability thanks to industrial-grade components | Avoidance of ground loops thanks to galvanic isolation and differential inputs

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal Go

Data acquisition and analysis

Display and monitor measurement data live | Intuitive operation and easy handling without programming knowledge | Versatile diagram and analysis functions for various measurement data | Ready for data acquisition and analysis in just a few minutes

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
Expert Logger

Universal data acquisition

Simultaneously record and analyze various measured variables | Flexible adaptation to different requirements | Continuous process monitoring to detect deviations | Increase plant availability and efficiency system availability and increased efficiency

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal Basic

Operating and monitoring

Reliably record and save measurement data | Clearly display and evaluate measured values | Quickly set up and operate projects without programming effort | Ideal for individual measuring stations up to small measuring systems

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiMessage D

Modular data acquisition

Precise adaptation to the application thanks to various I/0 modules | Expandability possible with additional modules and slave devices | Durability thanks to the use of high-quality components and parts | Cost efficiency thanks to modularity

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal Klicks

Automate and control

Monitor measurement data and control processes directly | Create automations simply by dragging and dropping | Suitable for complex test benches and automation tasks | Implement and adapt projects without programming knowledge

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
Expert Vibro

Modern vibration specialist

Precise monitoring to detect potential failures at an early stage | Cost reduction through optimization of maintenance intervals | Increased machine availability and reduction of downtimes, for more productivity and efficiency | Quality improvements through data analysis and optimization of processes

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal 20 Go

Data acquisition and saving

Display and monitor signals and processes in real time | Easy handling with no training required | Access to measurement data from PC, tablet or smartphone | Ready for many measurement and analysis tasks in just a few minutes

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
Expert Transient

Synchronous fault specialist

Recording and evaluation of transient signals over a certain period of time | Autonomous operation with long-term memory | Low energy consumption ensures cost-effective operation

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiSignal 20 Basic

Visualisation and operation

Easily create your own visualizations for measurement data | Conveniently evaluate and log measurement and process data | Intuitive interface for efficient work without programming knowledge | Ideal for individual measuring stations through to complex monitoring solutions

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
ProfiMessage

Modular measurement and control technology

Adapts modularly to measurement and automation tasks | Regulates and controls processes directly - without additional hardware | Maintenance-free continuous operation in industry and laboratories | Seamless integration into existing systems and networks

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
Delphin Data Center

Central measurement data management

Central storage of operating, maintenance and process data | Cross-site real-time monitoring of machine and process statuses | Modular structure makes it easy to adapt to growing plant and process environments

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
Expert Key

PC-supported data acquisition

Plug-and-play for fast measurement data acquisition directly on the PC | Acquires analog and digital signals with high resolution and speed | Ideal for laboratory, test bench and mobile applications | Easy measurement and analysis with measurement software and other applications

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
LoggitoLab

Mobile measurement data laboratory

Easy and space-saving laboratory measurements | Plug-and-play - ready for immediate use without complex set-up | High-resolution acquisition of measurement signals for laboratory and training | Intuitive operation, simple visualization and analysis with measurement technology software

To the product
Manipulation-proof recording of all measured values according to FDA Part 11
LogMessage 5000

Test stand for measurements with potential using an internal data memory.

The LogMessage device is a powerful data logger system designed for the reliable acquisition and recording of measurement data. It offers a variety of analog and digital inputs to connect different sensors and signals. The device records the data with high accuracy and saves it to an internal memory or external storage media.

To the product
Manipulation-proof recording of all measured values according to FDA Part 11