Pharma storage

    When storing pharmaceuticals, a high degree of compliance awareness is required in order to work safely and in accordance with the standards. This is because the indoor climate in storage rooms has an effect on the efficacy and quality of pharmaceuticals and, thus, on people’s health.

    Patients’ safety right from the start. Your partner for quality and compliance in pharmaceutical storage.

    With complete solutions, data loggers and metrological services from Testo, you establish a constant and standard-compliant storage climate:

    Comprehensive support by Testo enables you to respond to any deviations in good time and in addition, to reliably comply with regulations covering GSP (Good Storage Practice), GDP (Good Distribution Practice) and 21 CFR Part 11.

    Complete solutions, measuring devices and services

    • Complete solutions (monitoring systems) consisting of sensors, software and services record and document all audit-relevant environmental parameters.

    • Measurement technology such as data loggers seamlessly records the relevant environmental parameters.

    • Metrology services such as validation, qualification and mapping ensure that measurement technology is used optimally and that your premises and processes comply with current standards. The documentation is also standard-compliant, so you can look forward to the next audit with confidence.

    The complete solutions: Environmental monitoring with testo testo Saveris 1 and testo Saveris 2

    Safety, reliability and conformity to standards are important in the storage of pharmaceuticals.

    Safety: The measurement technology used must ensure that the quality and integrity of the stored products are not compromised.

    Reliability: Environmental parameters must be monitored seamlessly - 24 hours a day. And in the event of limit violations, it is mandatory that an alarm be triggered.

    Conformity to standards: Both the storage conditions themselves and the solutions used for monitoring must comply with current standards and guidelines.

    The two industry-leading monitoring solutions testo Saveris 1 and testo Saveris 2 provide automated and efficient support in complying with your regulatory requirements.

    Application report:

    GxP-compliant storage of pharmaceuticals

    With the fully automated environment monitoring system testo Saveris 1

    Download now and find out what’s important in the storage of pharmaceuticals and other temperature-sensitive goods.

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    The services

    Validation, qualification and mapping

    Goods and products that are sensitive to temperatures must be manufactured, stored and transported in qualified facilities, with qualified equipment and using validated processes. Here, the three sub-processes of validation, qualification and mapping are of particular importance. Among other things, critical temperature ranges can be identified and specifically monitored to ensure that the safety of the stored pharmaceuticals is not compromised at any time.

    No effort, no gaps, no worries

    Qualification and mapping of your storage areas

    Critical temperature ranges in storage

    Close to the roller gate

    Close to window and skylight

    Close to lamps

    Distance to the ventilation outlet

    Directly at ventilation outlet

    Close to door

    The services in a nutshell

    The purpose of validation is to ensure that a manufacturer's expected results can be guaranteed. A validation process takes place in three steps:

    1- Definition of the expected results and acceptance criteria.

    2- Verification and documentation that the process delivers the expected result.

    3- Determination of continuity, repeatability and accuracy of the validated process.

    Your service partner for validation, qualification and mapping: Testo Industrial Services

    Testo Industrial Services is your leading service provider for quality assurance and expertise in validation, qualification and mapping.

    More service and more security for your company.

    Testo Industrial Services supports you in monitoring and ensuring uniform environmental conditions in your warehouse or transport system. From individual temperature distribution measurements or metrological testing to project coordination and conceptual design of complex projects.

    The data loggers: Three model series for comprehensive monitoring

    For decades, data loggers from Testo have been used all over the world wherever precision, reliability and flexibility are required. What do our data loggers have in common? The different model series cover a wide range of applications. They simply offer you more:

    • More accuracy: Highly precise from -200 to +1000 °C

    • More security: Detailed alarm management and measurement data storage even when the battery is empty

    • More reliability: Seamless recording and documentation of up to 2 million measured values with 8 years battery life

    • More choice: Extensive probe range in brand quality from series model to custom-made

    Find the perfect Datalogger for your applications and requirements.

    Further applications

    Testo is also used in laboratories, clean rooms or in production when accurate results and reliable technology are required.

    Transport

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    Laboratory

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    Cleanroom

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    Production

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    Know more, work more efficiently:

    Services and know-how

    Full service for your logistics processes

    Testo Industrial Services GmbH supports you in the form of expertise, measuring technology and documentation.

    • Mappings for thermal sterilisation, storage and transport.

    • Service packages specifically adapted to your requirements

    • For pragmatic implementation of the requirements placed on you

    Expert knowledge

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