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Test technology you can rely on.

Together with the pharmaceutical industry, we have developed climate simulation systems with which the stability testing of pharmaceutical products can be carried out safely and in accordance with legal requirements. The spectrum ranges from laboratory-scale systems to walk-in climate chambers for optimum long-term testing. All systems have the necessary documentation options according to FDA 21 CFR Part 11 as well as EU GMP Annex 11 and meet the ICH Guidelines Q1A and Q1B as well as national and international requirements. These include WHO, FDA and CPMP.

PharmaEvent has been specially developed to meet the requirements of test laboratories in the pharmaceutical industry. The series comes in four sizes and can provide a constant climate (types C/280, C/600, C1300 and C/2000) or just a constant temperature (types T/280, T/600, T/1300 and T/2000). The exceptional build quality, innovative product features, accuracy and smart controls allow for the safest and easiest stability testing. The working range easily meets the requirements of the ICH Guideline Q1A. Furthermore the systems are designed to work at 5 °C continuously without defrosting. They also permit the implementation of tests with other specifications in the performance range of the respective system. Controlling of temperature and humidity is performed with highly precise sensors in combination with a specially designed control unit. The control system responds quickly in order to correct setpoint variations caused by: • Influence of the cabinet’s contents (absorption or emission of water vapour by the test specimen or its packaging) • External influences (e.g. laboratory temperature, opening of door)

Basic equipment

• Monitoring and Control S!MPAC® with 7“ Multi-User Interface WEBSeason® and audit trail
• Ethernet and USB interface– Fully integrated user management in the control panel
• Factory calibration of 2 temperature and 2 humidity values
• Software temperature limiter, min./max.
• Alarm system according to GAMP
• Interior fittings are entirely made of stainless steel
• Door contact switch
• Water tank with automatic and manual water supply of demineralised humidification water²
• Lockable doors
• 4 castors of which 2 have brakes³
• Air-cooled refrigeration unit with low noise emission
• Patented vapour humidification system SSS²
• Capacitive humidity sensor²
• Entry port, Ø 50 mm, in the right side panel
• Operating manual
• Multi-language touch panel (German, English, French, Spanish, Czech, Russian, Chinese, Korean, Italian, Portuguese)
• 280-l units on 6 feet and stackable

Documentation

For recording of measurement values regarding temperature, humidity or light numerous documentation options are available in accordance with the respective requirements, in this context each of these options is available with independent sensors and, upon request, also with control loop sensors. In detail these are:

– Integrated datalogger for control and/or independent sensors; for viewing the Software S!MPATI® pharma is necessary.

– Software Package S!MPATI® pharma complying with FDA 21 CFR Part 11 and EU GMP Annex 11 for connection of test chambers to a PC or server according to manufacturer’s declaration. Moreover, any existing temperature or climate devices can be connected to S!MPATI® pharma using additional sensors and interfaces.1

– Digital line recorders complying to FDA 21 CFR Part 11 (line recorder with memory and display).

– To connect the chambers to other monitoring systems, analogue signals 0 to 10 V or 4 to 20 mA from the control loops or additional sensors are possible as option.

– An integration into a LIMS is also possible. 1Perhaps options required. Our contribution to medicinal safety.

Qualification

For the approval of active substances and/or providing evidence of stability tests numerous measures have to be carried out and confirmed over extremely long periods of time for the purpose of ensuring flawless functioning of stability test chambers, such as compliance with fluctuations in temperature and humidity. These requirements are documented in a sustainable manner by means of our extensive qualification documentation. The entire system qualification comprises: DAkkS ISO 17025-accredited calibrations with certificate by Vötsch Industrietechnik GmbH DQ FAT IQ OQ PQ Design Qualification Factory Acceptance Test Installation Qualification Operation Qualification Performance Qualification Alternatively we offer also qualifications according to GAMP 5. In addition to this we provide all the required documents such as circuit diagrams, component lists and certificates, e.g. ISO accreditation, EC conformity declarations or also maintenance recommendations. On request, our trained technicians carry out the qualification on site and can complement this with our comprehensive measurement and calibration facilities (DAkkS calibration by Vötsch Industrietechnik GmbH).

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