Chemical and pharmaceuticals

Requirements for documentation obligations and traceability

Important measurement solutions for the chemical and pharmaceutical industries

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 industrial 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.
     
  • The connection to higher-level systems such as LIMS (Laboratory Information and Management System), building monitoring, safety control technology or the connection of laboratory equipment from a wide range of manufacturers are all part of increasing networking. In addition to interfaces such as Modbus, Profibus or SQL databases, this also requires support for 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 the extensive reporting functionality of the ProfiSignal software for customizable reports to document measurement data, alarm lists, user interventions or specific limit 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: For refrigerators and incubators, measured values such as humidity, temperature and pressure are recorded and automatically evaluated in dynamic reports. The alarm function of the Expert Logger is linked to the building monitoring system and the safety control system. When evaluating alarms, direct access to historical alarm data is possible, for example to analyze the pre- and post-history of alarms.

From clean room monitoring systems to data acquisition in production facilities

  • Example of clean room monitoring: The measurement technology monitors the data from particle counters, temperature sensors and pressure sensors in the cleanroom pharmaceutical laboratories and controls signal lights, sirens and personnel locks if limit values are exceeded. The Expert data loggers continue to work autonomously even if central servers fail, including measurement data acquisition, switching functions and control functions.
     
  • Example of process data acquisition: Delphin's measurement and testing technology is also used to monitor production facilities in accordance with FDA regulations. Changes to operating parameters or details of batch production are recorded and archived reliably and tamper-proof. With the ProfiSignal or ProfiSignal 20 software, important characteristic values are displayed in a visually appealing dashboard. The visualization can be called up on a desktop, notebook, tablet or smartphone.

Hardware and software for your measurement and testing solution

Construction and testing of measuring systems with complete traceability
Loggito
Construction and testing of measuring systems with complete traceability
ProfiSignal Go
Construction and testing of measuring systems with complete traceability
Expert Logger
Construction and testing of measuring systems with complete traceability
ProfiSignal Basic
Construction and testing of measuring systems with complete traceability
ProfiMessage D.
Construction and testing of measuring systems with complete traceability
ProfiSignal Klicks
Construction and testing of measuring systems with complete traceability
Expert Vibro
Construction and testing of measuring systems with complete traceability
ProfiSignal 20 Go
Construction and testing of measuring systems with complete traceability
Expert Transient
Construction and testing of measuring systems with complete traceability
ProfiSignal 20 Basic
Construction and testing of measuring systems with complete traceability
ProfiMessage
Construction and testing of measuring systems with complete traceability
Delphin Data Center
Construction and testing of measuring systems with complete traceability
Expert Key
Construction and testing of measuring systems with complete traceability
LoggitoLab
Construction and testing of measuring systems with complete traceability
LogMessage 5000
Loggito

Flexible, scalable and expandable solution for seamless data acquisition and monitoring

The Loggito device is a compact data logger system designed for the acquisition and recording of measurement data. It has a variety of analog and digital inputs to connect different sensors and signals. The device records the data with high accuracy and stores it on an internal memory or external storage media such as SD cards.

To the product
Construction and testing of measuring systems with complete traceability
ProfiSignal Go

Data acquisition and analysis

With ProfiSignal Go you can display online data from the Message and Expert hardware in diagram form. Numerous analysis functions, such as zoom, cursor, movable axes, flags, ASCII export and calculation channels, enable fast display of measured values and post-processing.

To the product
Construction and testing of measuring systems with complete traceability
Expert Logger

Precisely record, autonomously store, automatically transmit and evaluate measured values.

The FPGA-based Expert Logger device is particularly powerful and enables the processing of up to 46 analogue input channels, both at low and high sampling rates. Measured values can be precisely recorded, autonomously stored and automatically transferred to the internet or PC via USB, LAN or WLAN and evaluated.

To the product
Construction and testing of measuring systems with complete traceability
ProfiSignal Basic

Operating and monitoring

ProfiSignal Basic combines the functions of ProfiSignal Go with operating and monitoring elements of process visualisations, e.g. digital and analogue displays, switches, buttons and signal lamps. With Basic, you can create everything from simple visualisation diagrams to complex visualisation systems.

To the product
Construction and testing of measuring systems with complete traceability
ProfiMessage D.

Modular measuring, monitoring and automation in one device.

The ProfiMessage D device is a state-of-the-art data logger system that has been specially developed for industrial data acquisition and analysis. It offers a wide range of functions such as the recording and storage of measurement data, monitoring of process parameters and alarms in the event of deviations.

To the product
Construction and testing of measuring systems with complete traceability
ProfiSignal Klicks

Automate and control

ProfiSignal Klicks supplements ProfiSignal Basic with functions for process automation. Structural diagrams for mapping the process as well as a script language (completely operable with the mouse) enable even the non-informatician to create complex test stand and automation applications with automatic report generation.

To the product
Construction and testing of measuring systems with complete traceability
Expert Vibro

State-of-the-art processor technology and extreme precision for vibration measurement.

The Expert Vibro device is a powerful vibration analysis device that has been specially developed for monitoring and analyzing machine and system conditions. It enables vibration data to be recorded and evaluated in order to detect potential problems or signs of wear at an early stage.

To the product
Construction and testing of measuring systems with complete traceability
ProfiSignal 20 Go

Fast project planning and analysis of measurement data

With ProfiSignal 20 Go you can visualise your measurement data in just a few steps, both online and offline, in various diagram types, monitor, analyse, archive as a measurement file or export directly in the appropriate file format.

To the product
Construction and testing of measuring systems with complete traceability
Expert Transient

Intelligent data recorder for synchronous recording of transient and periodic events.

The Expert Transient device enables the recording and evaluation of transient signals over a certain period of time and provides important information for the optimization of processes and systems. The device is characterized by its high accuracy, fast sampling rate and simple operation.

To the product
Construction and testing of measuring systems with complete traceability
ProfiSignal 20 Basic

Visualisation and operation

With ProfiSignal 20 Basic you can create individual diagrams using a wide range of operating and monitoring elements. Both continuous processes (e.g. production data acquisition) and discontinuous measurement tasks (e.g. test measurements) can be visualised, operated and monitored without any programming effort. You can create the operating and monitoring diagrams by assembling and configuring the prefabricated elements.

To the product
Construction and testing of measuring systems with complete traceability
ProfiMessage

Modular system for use as a measuring, control and monitoring device.

The ProfiMessage devices are a modular, expandable and easy-to-use system for measurement data acquisition, monitoring and automation of machines, systems or test benches. ProfiMessage can be used wherever measured values need to be recorded quickly, precisely and electrically isolated, as well as intelligently pre-processed or monitored.

To the product
Construction and testing of measuring systems with complete traceability
Delphin Data Center

Central measurement data management

The Delphin Data Center is the solution used for the worldwide measurement networking and control of plants, machines and test stands.

To the product
Construction and testing of measuring systems with complete traceability
Expert Key

PC-supported data acquisition and test stand

The Expert Key device is a measuring and control device that can be used in various applications. It enables the acquisition and evaluation of measurement data as well as the control of processes. The device has various interfaces and can be connected to a wide range of sensors and actuators. It is often used in automation technology, mechanical engineering and research.

To the product
Construction and testing of measuring systems with complete traceability
LoggitoLab

Compact and flexible measurement data laboratory with precision measurement technology.

The LoggitoLab device is ideal for use in laboratory environments, research projects, quality control and other applications where precise data acquisition and analysis is required. It offers a reliable and user-friendly solution for monitoring and recording measurement data.

To the product
Construction and testing of measuring systems with complete traceability
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
Construction and testing of measuring systems with complete traceability