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Home<\/a> \/ VHP Knowledge<\/a> \/ Standards<\/span><\/div>\n Reference \u00b7 Standards and guidance<\/span>\n

VHP standards and guidance: a quick reference<\/h1>\n

22 regulations, standards and technical reports that come up in VHP bio-decontamination projects \u2014 what each one covers, what it means in practice, and which ones apply to rooms, isolators, pass boxes and medical device sterilization.<\/p>\n<\/div><\/section>\n

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Which documents apply to my project?<\/h2>\n
Application<\/th>Main references<\/th><\/tr><\/thead>
Room or suite bio-decontamination<\/th>Annex 1 \u00b7 Annex 15 \u00b7 EN 17272 \u00b7 PDA TR51 \u00b7 ISO 11138-1 \u00b7 ISO 11140-1 \u00b7 ISO 14644 \u00b7 exposure limits<\/td><\/tr>
Aseptic filling isolator<\/th>Annex 1 \u00b7 Annex 15 \u00b7 Annex 11 \u00b7 ISO 13408-6 \u00b7 ISO 10648-2 \u00b7 ISO 14644 \u00b7 PDA TR34 \u00b7 PDA TR51 \u00b7 PIC\/S PI 014<\/td><\/tr>
Sterility test isolator<\/th>USP <1208> \u00b7 ISO 13408-6 \u00b7 ISO 10648-2 \u00b7 PDA TR34 \u00b7 PDA TR51 \u00b7 PIC\/S PI 014<\/td><\/tr>
VHP pass box or airlock<\/th>Annex 1 \u00b7 Annex 15 \u00b7 PDA TR51 \u00b7 ISO 11138-1 \u00b7 ISO 14644 \u00b7 exposure limits<\/td><\/tr>
Terminal sterilization of medical devices<\/th>ISO 22441 \u00b7 ISO 14937 \u00b7 ISO 11138-1 \u00b7 ISO 11140-1<\/td><\/tr><\/tbody><\/table><\/div>\n

GMP and regulation<\/a>Sterilization and decontamination processes<\/a>Indicators<\/a>Isolators and cleanrooms<\/a>Occupational safety<\/a><\/p>\n

GMP and regulation<\/h2>

The regulatory expectations that a VHP process in pharmaceutical manufacturing has to meet.<\/p>

Document<\/th>Title \/ scope<\/th>What it means for VHP<\/th><\/tr><\/thead>
EU GMP Annex 1 (2022)<\/th>Manufacture of Sterile Medicinal Products<\/td>Requires a contamination control strategy, a sporicidal agent in the disinfection programme, and \u2014 for isolators \u2014 an automated, validated bio-decontamination of the interior using a sporicidal agent in a suitable form such as vapour. Also sets cleanroom grades, airflow visualisation and monitoring expectations. EU GMP Annex 1 overview \u2192<\/a><\/td><\/tr>
EU GMP Annex 15<\/th>Qualification and Validation<\/td>The framework for URS, DQ, FAT\/SAT, IQ, OQ and PQ of VHP equipment and for validating the decontamination process. Isolator FAT and SAT \u2192<\/a><\/td><\/tr>
EU GMP Annex 11 \/ 21 CFR Part 11<\/th>Computerised systems \/ Electronic records and signatures<\/td>Apply to the control system of VHP generators and isolators: user access, audit trail, electronic records of cycles. How to write an isolator URS \u2192<\/a><\/td><\/tr>
China GMP (2010 revision) and Annex 1 Sterile Medicinal Products<\/th>\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\u53ca\u9644\u5f551 \u65e0\u83cc\u836f\u54c1<\/td>Cleanroom grades A\u2013D aligned with EU GMP, a minimum pressure differential of 10 Pa between areas of different grades, and expectations for disinfection and validation in sterile manufacturing.<\/td><\/tr>
PIC\/S PI 014<\/th>Isolators Used for Aseptic Processing and Sterility Testing<\/td>Inspector guidance on isolator design, leak testing, glove integrity, and the validation of gaseous decontamination.<\/td><\/tr><\/tbody><\/table><\/div>

Sterilization and decontamination processes<\/h2>

Standards that define how a vapour-phase process is developed, validated and controlled.<\/p>

Document<\/th>Title \/ scope<\/th>What it means for VHP<\/th><\/tr><\/thead>
ISO 22441:2022<\/th>Low temperature vaporized hydrogen peroxide \u2014 development, validation and routine control of a sterilization process for medical devices<\/td>Written for terminal sterilization of medical devices. Its structure \u2014 process characterization, cycle development, validation, routine control \u2014 is a useful model for surface bio-decontamination, but its sterility assurance requirements are not those of a room or isolator. VHP cycle development and IQ\/OQ\/PQ \u2192<\/a><\/td><\/tr>
ISO 14937<\/th>General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices<\/td>The general framework behind agent-specific standards; often cited when no specific standard covers the application.<\/td><\/tr>
USP <1229.11><\/th>Vapor Phase Sterilization<\/td>Informational chapter on vapour-phase processes including hydrogen peroxide: process parameters, indicators, and the difference between sterilization and decontamination.<\/td><\/tr>
EN 17272:2020<\/th>Chemical disinfectants and antiseptics \u2014 airborne room disinfection by automated process \u2014 test method and requirements<\/td>European test method for products and systems that disinfect rooms through the air, including bactericidal, fungicidal, virucidal and sporicidal claims. Preparing a room for VHP \u2192<\/a><\/td><\/tr>
USP <1072><\/th>Disinfectants and Antiseptics<\/td>Background on disinfectant classes, sporicidal activity and disinfectant qualification in pharmaceutical manufacturing.<\/td><\/tr><\/tbody><\/table><\/div>

Indicators<\/h2>

How efficacy and vapour distribution are demonstrated.<\/p>

Document<\/th>Title \/ scope<\/th>What it means for VHP<\/th><\/tr><\/thead>
PDA Technical Report No. 51<\/th>Biological Indicators for Gas and Vapor-Phase Decontamination Processes<\/td>The main reference for selecting, placing and interpreting biological indicators in VHP processes, including the limits of BIs for gas and vapour processes. Biological indicators and the 6-log reduction \u2192<\/a><\/td><\/tr>
ISO 11138-1<\/th>Biological indicators \u2014 General requirements<\/td>General requirements for the manufacture, labelling and performance of biological indicators, including population and resistance characteristics.<\/td><\/tr>
ISO 11140-1<\/th>Chemical indicators \u2014 General requirements<\/td>Classification and requirements for chemical indicators, which show exposure to the agent but not lethality.<\/td><\/tr><\/tbody><\/table><\/div>

Isolators and cleanrooms<\/h2>

The equipment and environments in which VHP is used.<\/p>

Document<\/th>Title \/ scope<\/th>What it means for VHP<\/th><\/tr><\/thead>
ISO 13408-6<\/th>Aseptic processing of health care products \u2014 Isolator systems<\/td>Requirements for isolator design, qualification, decontamination and operation in aseptic processing. Isolator glove integrity testing \u2192<\/a><\/td><\/tr>
ISO 10648-2<\/th>Containment enclosures \u2014 Classification according to leak tightness<\/td>Defines the hourly leak rate and Classes 1\u20134 used to specify isolator tightness; includes test methods such as pressure decay. Isolator leak rate calculator \u2192<\/a><\/td><\/tr>
ISO 14644-1 \/ -2 \/ -3<\/th>Cleanrooms \u2014 classification, monitoring, test methods<\/td>Air cleanliness classes, monitoring to prove continued compliance, and test methods including airflow visualisation and filter leak testing. Isolator smoke study \u2192<\/a><\/td><\/tr>
ISO 14644-7<\/th>Cleanrooms \u2014 Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)<\/td>Design, construction and testing of separative devices, including glove and leak considerations.<\/td><\/tr>
USP <1208><\/th>Sterility Testing \u2014 Validation of Isolator Systems<\/td>Expectations for isolators used for sterility testing, including decontamination validation and avoiding false results.<\/td><\/tr>
PDA Technical Report No. 34<\/th>Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products<\/td>Practical guidance on isolator design, decontamination cycle development and validation. Hydrogen peroxide uptake in isolator filling \u2192<\/a><\/td><\/tr><\/tbody><\/table><\/div>

Occupational safety<\/h2>

Exposure limits that define when a treated space can be re-entered.<\/p>

Document<\/th>Title \/ scope<\/th>What it means for VHP<\/th><\/tr><\/thead>
OSHA PEL \/ ACGIH TLV<\/th>Permissible exposure limit \/ threshold limit value for hydrogen peroxide<\/td>1 ppm as an 8-hour time-weighted average \u2014 the most common re-entry and release limit after aeration. VHP aeration and residual H\u2082O\u2082 \u2192<\/a><\/td><\/tr>
UK EH40 workplace exposure limits<\/th>Workplace exposure limits for hydrogen peroxide<\/td>1 ppm (8-hour TWA) and 2 ppm short-term (15-minute) exposure limit.<\/td><\/tr>
NIOSH IDLH<\/th>Immediately dangerous to life or health concentration<\/td>75 ppm \u2014 relevant to emergency planning and to the concentrations inside a space during a cycle.<\/td><\/tr><\/tbody><\/table><\/div>\n
Before you cite a document<\/b>
  • Standards and guidelines are revised. Check the current edition and its effective date before writing it into a URS, protocol or report.<\/li>
  • This page summarises scope and relevance; it does not reproduce requirements. The document itself is the reference.<\/li>
  • Local regulations and the expectations of your inspectorate take precedence.<\/li><\/ul><\/div>\n <\/div>\n<\/div><\/section>\n
    \n FAQ<\/span>

    Common questions<\/h2>\n
    Which standard covers VHP decontamination of a room or isolator?<\/summary>

    There is no single standard. EU GMP Annex 1 sets the regulatory expectation, ISO 13408-6 and PDA TR34 cover isolators, EN 17272 gives a test method for automated airborne room disinfection, and PDA TR51 is the main reference for biological indicators. ISO 22441 covers VHP sterilization of medical devices.<\/p><\/details>

    Does ISO 22441 apply to cleanroom or isolator decontamination?<\/summary>

    Not directly. ISO 22441 is written for terminal sterilization of medical devices. Its structure for characterizing, developing, validating and controlling a process is a useful model, but room and isolator decontamination are normally specified as a log reduction on biological indicators rather than a sterility assurance level.<\/p><\/details>

    What does EU GMP Annex 1 say about isolator decontamination?<\/summary>

    Annex 1 (2022) expects the bio-decontamination of an isolator interior to be automated, validated and controlled within defined cycle parameters, using a sporicidal agent in a suitable form such as vapour.<\/p><\/details>

    What is the exposure limit for hydrogen peroxide?<\/summary>

    OSHA and ACGIH set 1 ppm as an 8-hour time-weighted average; the UK sets 1 ppm (8-hour) and 2 ppm (15-minute). NIOSH gives 75 ppm as immediately dangerous to life or health.<\/p><\/details><\/div>\n<\/div><\/section>\n