{"id":29138,"date":"2026-09-21T10:18:20","date_gmt":"2026-09-21T10:18:20","guid":{"rendered":"https:\/\/www.oxypharm.net\/?p=29138"},"modified":"2026-08-27T13:11:08","modified_gmt":"2026-08-27T13:11:08","slug":"performance-qualification-pq-disinfection","status":"publish","type":"post","link":"https:\/\/www.oxypharm.net\/en\/performance-qualification-pq-disinfection\/","title":{"rendered":"PQ \u2013 Performance Qualification: Validation of disinfection efficacy under real-world operating conditions (Episode 2)"},"content":{"rendered":"

[vc_row][vc_column][vc_single_image image=”29125″ img_size=”FULL” alignment=”center” css=””][vc_column_text css=””]The validation of disinfection processes in critical industrial environments is based on a rigorous three-part approach: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)<\/strong>. Whilst the first two stages confirm technical compliance and proper operation under no-load conditions, PQ<\/strong> marks the decisive transition from theoretical performance to scientific proof under real-world conditions.<\/p>\n

 <\/p>\n

In the pharmaceutical industry and sectors subject to Good Manufacturing Practice (GMP)<\/strong>, controlling the risk of contamination is an absolute regulatory requirement.<\/p>\n

 <\/p>\n

In these environments with a high level of microbiological control, airborne surface disinfection (ASD) is now a recognised method for the terminal bio-decontamination of critical areas. But how can the effectiveness of this process be demonstrated, in a scientific and auditable manner, within a real-world environment? This article details the objectives of Performance Qualification (PQ)<\/strong>, its microbiological methodology, its success criteria, and the expert support developed to meet auditors\u2019 requirements.[\/vc_column_text][vc_column_text css=””]<\/p>\n

What is the purpose of Performance Qualification (PQ) ?<\/h3>\n

[\/vc_column_text][vc_column_text css=””]<\/p>\n

VERIFICATION OF COMPLIANCE UNDER REAL OPERATING CONDITIONS<\/h4>\n

[\/vc_column_text][vc_column_text css=””]Unlike the IQ<\/strong> and OQ<\/strong> phases<\/strong>, PQ<\/strong> must be carried out in the final production environment.<\/p>\n

 <\/p>\n

It takes into account:<\/p>\n

    \n
  1. The exact layout of the premises.<\/li>\n
  2. The presence of equipment.<\/li>\n
  3. The actual load.<\/li>\n
  4. Site-specific operational constraints (air handling systems, volume variations).<\/li>\n<\/ol>\n

     <\/p>\n

    \u21aa PQ<\/strong> no longer validates just a single machine; it validates the interaction of a process with a given industrial ecosystem.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    A KEY STEP IN ENSURING DRUG SAFETY<\/h4>\n

    [\/vc_column_text][vc_column_text css=””]In the pharmaceutical industry, PQ<\/strong> is directly integrated into the strategy for controlling contamination and protecting the Critical Quality Attributes (CQAs) of the finished product. Every surface in a controlled atmosphere zone (CAZ) represents a potential source of non-compliance.<\/p>\n

     <\/p>\n

    \u21aa PQ<\/strong> acts as the final barrier, ensuring that the cycle eliminates microbiological risk before production resumes.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    FINAL PROCESS VALIDATION WITHIN THE GMP FRAMEWORK<\/h4>\n

    [\/vc_column_text][vc_column_text css=””]PQ<\/strong> is a central requirement of the Validation Master Plan (VMP). The user site assumes direct regulatory responsibility during PQ validation<\/strong>.<\/p>\n

     <\/p>\n

    \u21aa The PQ documents the process\u2019s ability to achieve the expected performance under actual operating conditions.<\/strong> It forms part of the validation dossier used to demonstrate process control and support compliance with applicable regulatory requirements.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    How is a PQ conducted? Rigorous and auditable microbiological methodology<\/h3>\n

    [\/vc_column_text][vc_column_text css=””]The implementation of a PQ<\/strong> relies on precision. It is based on a strict protocol designed to provide evidence of repeatability and robustness.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    FUNDAMENTAL PRINCIPLE: 3 CONSECUTIVE COMPLIANT RUNS<\/h4>\n

    [\/vc_column_text][vc_row_inner content_placement=”middle”][vc_column_inner width=”1\/3″][vc_single_image image=”29118″ img_size=”FULL” css=””][\/vc_column_inner][vc_column_inner width=”2\/3″][vc_column_text css=””]The basic protocol requirement is based on the execution of three successive disinfection cycles, carried out under identical conditions. Obtaining three consecutive compliant runs is essential to validate the immediate repeatability of the process and authorise its routine deployment.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text css=””]<\/p>\n

    BIOLOGICAL INDICATORS (BI): VALIDATION REFERENCE<\/h4>\n

    [\/vc_column_text][vc_column_text css=””]Evidence of biological efficacy is based on the use of calibrated biological indicators (BI). The reference microorganism used is the spore of Geobacillus stearothermophilus :<\/p>\n

     <\/p>\n

    \u25cf Population level: each medium contains a minimum initial population of 10\u2076 spores (6-log).
    \n\u25cf Rationale: this strain is chosen for its high resistance to hydrogen peroxide, establishing it as the most demanding industry standard.<\/p>\n

     <\/p>\n

    \u21aa The BI validate microbiological destruction<\/strong>.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    CHEMICAL INDICATORS (CI): VALIDATION OF DIFFUSION<\/h4>\n

    [\/vc_column_text][vc_column_text css=””]In addition, chemical indicators (CI)<\/strong> are deployed. They allow for immediate visual verification of the correct distribution of hydrogen peroxide and the homogeneity of the treatment within the volume.<\/p>\n

    \u21aa CIs visually validate the air saturation kinetics.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    INDICATOR MAPPING: THE WORST-CASE APPROACH<\/h4>\n

    [\/vc_column_text][vc_column_text css=””]The positioning of the indicators results from a joint risk analysis aimed at identifying critical points or \u201cworst-case\u201d zones.<\/p>\n

     <\/p>\n

    As Justine Mollier, Sales Manager at Oxy\u2019Pharm, explains:
    \n\u201cDuring a performance qualification, we look for worst-case scenarios, i.e. critical points. At existing sites, the client is usually already aware of them. At new laboratories, it varies more.<\/em>\u201d<\/p>\n

     <\/p>\n

    Each location must be supported by precise documentation in the protocol.[\/vc_column_text][vc_column_text css=””]<\/p>\n

    DETAILED MICROBIOLOGICAL PROCEDURE (AUDIT LEVEL)<\/h4>\n

    [\/vc_column_text][vc_column_text css=””]At the end of each run, biological indicators are collected under aseptic conditions and then transferred to the laboratory :[\/vc_column_text][vc_row_inner content_placement=”middle”][vc_column_inner width=”1\/2″][vc_column_text css=””]<\/p>\n

      \n
    1. Inoculation: immersion in a selective culture medium, Tryptic Soy Broth (TSB).<\/li>\n
    2. Incubation: kept in an incubator at 57.5 \u00b0C \u00b1 2.5 \u00b0C for a strict period of 7 days.<\/li>\n
    3. Reading: a daily check is carried out. Any appearance of turbidity indicates bacterial growth and therefore a failed run.<\/li>\n<\/ol>\n

      [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_single_image image=”29111″ img_size=”Full” css=””][\/vc_column_inner][\/vc_row_inner][vc_single_image image=”29147″ img_size=”Full” css=””][vc_column_text css=””]<\/p>\n

      MICROBIOLOGICAL ACCEPTANCE CRITERIA<\/h4>\n

      [\/vc_column_text][vc_column_text css=””]<\/p>\n

      Validation of the run is based on three cumulative criteria:<\/h4>\n

      [\/vc_column_text][vc_column_text css=””]<\/p>\n

        \n
      1. Positive control:<\/strong> an unexposed culture medium must show the expected growth (validation of viability).<\/li>\n
      2. Negative control:<\/strong> an uninoculated culture medium tube must remain sterile (purity validation).<\/li>\n
      3. Exposed BI:<\/strong> total absence of microbiological growth across all indicators distributed throughout the area (or compliance with triplicate criteria where applicable).<\/li>\n<\/ol>\n

        [\/vc_column_text][vc_column_text css=””]<\/p>\n

        TRACEABILITY AND AUDITABILITY<\/h4>\n

        [\/vc_column_text][vc_column_text css=””]Each step generates traceable and archived data.<\/p>\n

         <\/p>\n

        \u21aa This systematic documentation ensures alignment with the ALCOA principles of data integrity and ensures inspection readiness.[\/vc_column_text][vc_column_text css=””]<\/p>\n

        6-log reduction: a key validation criterion<\/h3>\n

        [\/vc_column_text][vc_column_text css=””]The concept of logarithmic reduction is the unit of measurement for the performance of a decontamination cycle.[\/vc_column_text][vc_column_text css=””]<\/p>\n

        SCIENTIFIC DEFINITION OF LOGARITHMIC REDUCTION<\/h4>\n

        [\/vc_column_text][vc_column_text css=””]Logarithmic reduction mathematically expresses the effect of a process on a microbiological population. A 6-log reduction means that the population is reduced by a factor of 10\u2076. If a surface initially has 1,000,000 spores, the treatment must reduce this number to fewer than 1 surviving spore.[\/vc_column_text][vc_column_text css=””]<\/p>\n

        REGULATORY CONSIDERATIONS<\/h4>\n

        [\/vc_column_text][vc_column_text css=””]The validation of bio-decontamination<\/strong> cycles relies on the use of biological indicators, which generally contain a population of around 10\u2076 spores. The absence of growth after treatment constitutes proof of the cycle\u2019s efficacy, in accordance with the GMP requirements applicable to process validation.<\/p>\n

         <\/p>\n

        According to Justine Mollier:
        \n\u201cThis is precisely the objective of performance qualification: to demonstrate the efficacy of the bio-decontamination cycle on Geobacillus stearothermophilus spores, in a repeatable and reproducible manner under actual conditions of use<\/em>.\u201d[\/vc_column_text][vc_column_text css=””]<\/p>\n

        What PQ actually validates: evidence of process control<\/h3>\n

        [\/vc_column_text][vc_column_text css=””]Beyond the figures, PQ provides factual certainty on four fundamental pillars :[\/vc_column_text][vc_single_image image=”29154″ img_size=”FULL” css=””][vc_column_text css=””]<\/p>\n

        Oxy\u2019Pharm\u2019s support: ensuring a critical, audited stage is secure<\/h3>\n

        [\/vc_column_text][\/vc_column][\/vc_row][vc_row content_placement=”middle”][vc_column width=”1\/2″][vc_single_image image=”29090″ img_size=”FULL” css=””][\/vc_column][vc_column width=”1\/2″][vc_column_text css=””]Aware of the major regulatory challenges facing validation managers, Oxy\u2019Pharm has developed a bespoke support service.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=””]According to Justine Mollier, Sales Manager at Oxy\u2019Pharm<\/strong> :<\/p>\n

        \u201cEvery site has its own layout, technical constraints, installations and air treatment systems. It is therefore impossible to fully standardise a performance qualification. A preliminary study phase is essential to tailor the service to the client\u2019s specific context.<\/em>\u201d[\/vc_column_text][vc_column_text css=””]<\/p>\n

        AN EXPERT, STRUCTURED AND SUPERVISED APPROACH<\/h4>\n

        [\/vc_column_text][vc_column_text css=””]Oxy\u2019Pharm<\/strong> offers an expert, non-automated service supervised by specialists with solid experience of pharmaceutical environments and cleanrooms thanks to industry-recognised training. As a designer and manufacturer of airborne surface disinfection solutions, Oxy\u2019Pharm<\/strong> brings dual expertise in its deep knowledge of machine parameters and GMP requirements.[\/vc_column_text][vc_column_text css=””]<\/p>\n

        THE SUPPORT PROCESS IN 5 STAGES<\/h4>\n

        [\/vc_column_text][vc_column_text css=””]The service, invoiced on the basis of a quotation following an analysis phase, is structured around a comprehensive process :<\/p>\n

         <\/p>\n

          \n
        1. Requirement gathering and technical analysis :<\/strong> review of plans, room classification, dimensions to betreated and microbiological objectives.<\/li>\n
        2. Site visit and formalisation of the assignment :<\/strong> identification of physical constraints not visible on plans and preparation of the commercial proposal.<\/li>\n
        3. Planning and documentation engineering<\/strong> : provision of a customised protocol framework and assistance indefining the indicator mapping (selection of worst-case points).<\/li>\n
        4. Supervision and execution of runs :<\/strong> installation of decontamination equipment by Oxy\u2019Pharm teams,management of diffusion parameters, positioning and retrieval of biological\/chemical indicators.<\/li>\n
        5. Delivery of qualification deliverables :<\/strong> provision of a comprehensive documentation package including rawresults, their interpretation and the necessary certificates, ready for use during inspections.<\/li>\n<\/ol>\n

           <\/p>\n

          Justine Mollier highlights the benefits of this outsourcing:<\/p>\n

          \u201cUsing Oxy\u2019Pharm is, first and foremost, a way to benefit from strong technical expertise […]. The second advantage is the time saved. We already have the necessary document templates and methodologies in place. This saves the client several days, or even weeks, of drafting documents. Lastly, the involvement of an external expert also provides an objective perspective and can be viewed positively during audits.<\/em>\u201d[\/vc_column_text][vc_column_text css=””]<\/p>\n

          SECTORS COVERED<\/h4>\n

          [\/vc_column_text][vc_column_text css=””]This support is aimed at all industries subject to GMP<\/strong> and highly regulated environments, including the pharmaceutical industry, biotechnology, medical devices, biosafety laboratories (L3 \/ A3) and animal<\/strong> research facilities.[\/vc_column_text][vc_column_text css=””]<\/p>\n

          PQ: 5 key points to remember<\/h3>\n

          [\/vc_column_text][vc_column_text css=””]<\/p>\n

            \n
          1. In situ validation : PQ<\/strong> validates microbiological performance under actual operating conditions, with thesite\u2019s actual configuration and load.<\/li>\n
          2. 6-log requirement : this is based on demonstrating a 6-log reduction<\/strong> in Geobacillus stearothermophilusspores.<\/li>\n
          3. Demonstrated repeatability : successful PQ<\/strong> requires three consecutive compliant runs to validate processstability.<\/li>\n
          4. Regulatory compliance :<\/strong> this provides the documentary evidence required by Annex 1 of the GMP andensures the required standard for auditors.<\/li>\n
          5. Cross-functional approach : the final and indispensable link in the IQ\/OQ\/PQ validation<\/strong> continuum forensuring drug safety.<\/li>\n<\/ol>\n

            [\/vc_column_text][vc_column_text css=””]<\/p>\n

            Further reading<\/h3>\n

            [\/vc_column_text][vc_column_text css=””]\u21aa Find the foundations of the approach in Episode 1 :<\/strong>\u00a0IQ \/ OQ \/ PQ \u2014 Understanding process validation in the pharmaceutical industry<\/a>[\/vc_column_text][vc_row_inner content_placement=”middle”][vc_column_inner width=”1\/2″][vc_single_image image=”29083″ img_size=”FULL” css=””][\/vc_column_inner][vc_column_inner width=”1\/2″][vc_column_text css=””]Performance Qualification (PQ)<\/strong> is the cornerstone of validation: it transforms theoretical performance into scientific proof of control under real-world conditions. Against a backdrop of increasingly stringent regulatory requirements (Annex 1 of the GMP), it stands as the final, indispensable barrier to ensuring drug safety.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text css=””]Maintaining this validated status then relies on continuous monitoring, rigorous documentation control and periodic revalidations, ensuring the long-term performance of the process in routine operations.<\/p>\n

            Contact<\/a> our Oxy\u2019Pharm experts<\/strong> for structured support tailored to the most demanding environments (service provided on quotation).[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

            Discover how Performance Qualification (PQ) validates the effectiveness of disinfection processes under real operating conditions.<\/p>\n","protected":false},"author":3,"featured_media":29127,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[55],"tags":[285,382,383,384,307,87,308,120,357],"class_list":["post-29138","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-en","tag-bio-desinfection-en","tag-bpf-en","tag-efficacite-biologoique-en","tag-expert-en","tag-industrie-pharmaceutique-en","tag-nocotech-en","tag-normes-en","tag-oxypharm-en","tag-qp-en"],"acf":[],"yoast_head":"\nPQ \u2013 Performance Qualification: Validation of disinfection efficacy under real-world operating conditions (Episode 2) - Oxy'Pharm<\/title>\n<meta name=\"description\" content=\"Discover how Performance Qualification (PQ) validates the effectiveness of disinfection processes under real operating conditions.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oxypharm.net\/qualification-performance-qp-desinfection\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PQ \u2013 Performance Qualification: Validation of disinfection efficacy under real-world operating conditions (Episode 2) - 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