MPV-010 Series Multi-parameter Verification Recorder

In fields such as pharmaceutical production and laboratory research, which have stringent requirements for environmental parameters, precise and real-time monitoring and verification of key environmental indicators are crucial for ensuring product quality and the reliability of experimental results. The MPV-010 series multi-parameter verification recorder, jointly launched by Inlephi Technology and BIODECONTA, serves as a scalable continuous verification system. With its comprehensive parameter monitoring capabilities, wide adaptability to various application scenarios, and flexible version permission settings, it has become a powerful assistant for compliant environmental parameter verification.

1. Core purpose: Comprehensively monitoring key parameters of the compliance environment

    The core value of the MPV-010 series multi-parameter verification recorder lies in its ability to conduct precise and continuous inspection and recording of key parameters in a compliant environment, providing data support for environmental safety and stability. Its monitorable key parameters cover four major categories, meeting verification needs in multiple scenarios:

    Gaseous hydrogen peroxide concentration: Accurately capture the gaseous hydrogen peroxide content (PPM) in the space to ensure the effectiveness and safety of the sterilization process;

    Relative saturation: Monitor the saturation state of environmental humidity in real-time to prevent abnormal humidity from affecting product storage or experimental processes;

    Carbon dioxide concentration: Precisely control the carbon dioxide content, suitable for scenarios with specific requirements for gas environment such as cultivation and storage;

    Temperature and humidity: Basic and crucial environmental parameter monitoring, providing data basis for the stability of temperature and humidity in various environments.

    Simultaneously, the device supports the connection of up to 8 sensor probes, enabling single-point or multi-point verification of environmental parameters. It stores data in real-time and can print verification results online via a Bluetooth thermal printer, ensuring the timeliness and traceability of the data.

    II. Application Fields: Focusing on high-demand scenarios, covering various verification needs

    The MPV-010 series multi-parameter verification recorder precisely adapts to four core application scenarios, addressing the pain points of environmental verification in different fields, and ensuring compliance and safety for each scenario:

    1. Sterility test isolator and transfer window: Focus on verifying the distribution of hydrogen peroxide to ensure uniform sterilization within the isolator and transfer window, thereby avoiding the risk of microbial contamination;

    2. Drug stability test chamber: Conduct temperature and humidity distribution verification, simulate drug storage environment, and ensure the quality stability of drugs within their expiration dates;

    3. Carbon dioxide incubator: It verifies the distribution of carbon dioxide concentration, provides a stable gas environment for cell and microbial cultivation, and ensures accurate cultivation results;

    4. Space sterilization process: Monitor the concentration distribution of hydrogen peroxide in real-time to verify the comprehensiveness and effectiveness of the sterilization process, ensuring compliance with the requirements for establishing a sterile environment.

    III. Technical Parameters: Hardcore Configuration Ensures Precision and Stability

    In terms of hardware and functional configuration, the MPV-010 series multi-parameter verification recorder is designed with high precision and stability as its core, and all technical parameters meet the requirements of professional verification scenarios:

IV. Version Permissions: Select as needed, balancing fundamental and compliance requirements

The MPV-010 series offers two versions: the basic version (MPV-010A) and the audit tracking version (MPV-010B). Based on users' varying needs for data management and compliance traceability, the software functions are configured differentially to meet the full range of requirements, from basic verification to strict compliance management:

The MPV-010 series multi-parameter verification recorder strictly references multiple international and domestic regulatory documents, including the "Good Manufacturing Practice for Drugs" (revised in 2010), EudraLex "Volume IV Guidelines on Good Manufacturing Practice for Medicinal Products in the European Union", and Part 211 of the United States Code of Federal Regulations, to ensure that the device's functionality and data management comply with industry compliance standards. Whether it's basic parameter verification needs or stringent audit trail compliance requirements, the MPV-010 series provides stable and reliable solutions to assist users in efficiently completing environmental parameter verification tasks.