Business

Space Bio Decontamination Service (SBDS)

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    GCD & PQ Validation

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    HEPA Chamber

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    Semi-Isolator

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    HVAC System

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    HVAC + Room

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    Sterilization of Aseptic Environments (GMP, GLP)

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    Sterilization of Contaminated Areas (BSL-3/4)

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    BSC, Incubator

  • GCD & PQ
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    GMEBIO goes beyond performing simple sterilization tasks. By integrating our proprietary expertise in GCD (Gassing Cycle Development) and PQ (Performance Qualification), we provide validation services that meet stringent domestic and international regulatory standards, ensuring reliable sterilization validation data.

    What is GCD?

    GCD (Gassing Cycle Development) is a process that analyzes various factors such as sterilization space volume, structure, leakage, and temperature/humidity conditions to establish optimal sterilization data. It is a highly precise validation process that forms the foundation for PQ data assurance. Experience GMEBIO’s specialized space sterilization validation service.

  • HEPA Chamber Sterilization
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    The PVHP (Pico-size Vaporized Hydrogen Peroxide) system is the optimal solution for periodic maintenance of GMP facilities producing vaccines, anticancer drugs, biologics, and BSL-3 laboratories. Before HEPA filter replacement (typically every 1–3 years), vaporized hydrogen peroxide ensures safe sterilization deep inside the filter.

    HEPA Filter Maintenance Standards

    GMP facilities (vaccine/biopharmaceutical production): once per year
    BSL-3 facilities: once every 3 years
    Maintains sterile environment reliability through periodic management tailored to facility conditions.
    Due to the HEPA filter structure allowing only pico-size particles (~10–12) to pass, sterilization is essential, not optional.
    Accurate and safe sterilization validation must be completed prior to filter replacement or efficiency testing.

  • Semi-Isolator Sterilization
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    The Semi-Isolator, a core component of aseptic processing, can achieve complete sterility through the precise PVHP system. GMEBIO ensures validated sterilization and stable aseptic conditions, enabling clients to focus on production in an optimized environment. For complex Semi-Isolator systems, consult GMEBIO, your sterilization specialist partner.

    PVHP Sterilization Service

    Many Semi-Isolator systems cannot accommodate expensive built-in VHP systems.
    In such cases, cost-effective, high-quality sterilization services enable convenient validation and reliable sterility assurance.

  • HVAC System Sterilization
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    Sterilization of HVAC supply and exhaust duct lines is a highly specialized process requiring advanced spatial sterilization technology and extensive field experience. GMEBIO possesses rare expertise in dedicated HVAC duct sterilization and validation, ensuring complete contamination control within complex duct systems.

    Advanced Sterilization Technology

    HVAC duct sterilization requires top-tier sterilization technology.
    It involves complex variables and demands both technical expertise and extensive field experience.
    Failure risks can arise from seasonal factors and leakage conditions.
    Partnering with a highly reliable expert like GMEBIO ensures accurate risk management and improved productivity through proven sterilization validation.

  • PVHP Automated Sterilization
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    With increasingly stringent global aseptic regulations, sterilization of both GMP facilities and infectious environments has become critical. GMEBIO provides PVHP automated sterilization systems that comply with strict international standards.

    PVHP Automated Sterilization System

    Designed to meet EU-GMP, cGMP, and KGMP requirements, this system prevents cross-contamination while enabling efficient sterilization with minimal manpower. It ensures consistent validation results even in complex facilities, offering fast and reliable sterilization supported by proprietary technology and system expertise.

  • GMP Facility Sterilization
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    In GMP aseptic processes, time directly impacts productivity. GMEBIO delivers fast and precise sterilization services based on standardized SOPs and continuous engineer training.

    Mobile Sterilization Service

    Provides an all-in-one service using SOP-based procedures to minimize cross-contamination and ensure high-quality sterilization by skilled engineers.

  • BSL-3/4 Facility Sterilization
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    Sterilization in BSL-3/4 facilities handling high-risk pathogens requires absolute precision. GMEBIO’s expert engineering team ensures safe and accurate sterilization validation through controlled workflow management and validated processes.

    High-Risk Facility PVHP Sterilization Service

    BSL-3/4 facilities require strict separation of entry and exit zones during sterilization.
    GMEBIO ensures full compliance with safety protocols and prevents any potential external contamination or pathogen release.

  • BSC, Incubator
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    Laboratory equipment in GMP and research facilities varies in structure and requires tailored sterilization approaches.
    GMEBIO’s experienced engineers understand these structural characteristics through continuous training and provide optimized sterilization services.

    Laboratory Equipment Sterilization

    GMEBIO provides customized sterilization services tailored to the specific characteristics of equipment used in each facility.