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Person in Schutzkleidung bedient das HMI vom Isolator
Sterility assurance
  • On-site

Microbiological (re-)qualification

Reliable proof of permanently effective decontamination cycles

Service area
Biodecontamination & process validation
Lifecycle
Operation
Microbiological (re-)qualification at a glance

Reliable bioindicator testing for safe and compliant decontamination

  • Reliable proof for authorities

    Documented confirmation of the effectiveness of decontamination and aeration cycles

  • Regular requalification

    Annual inspection to ensure sustained cycle performance over time

  • Comprehensive service

    SKAN completely takes care of execution, incubation, and documentation

  • Support in case of deviations

    Technical analysis and consulting if unexpected results occur

  • Adaptable to customer setup

    Performance also with modified loading (after individual review)

  • Proven procedures

    Use of established test methods and standardized tools

  • Experienced SKAN experts

    Execution by trained engineers with in-depth know-how

  • Suitable for all isolators

    Service can be carried out regardless of the manufacturer

Application

For permanently safe long-term aseptic conditions

  • New isolators and installations

    Validation of isolators in sterile drug manufacturing and when handling highly sensitive active ingredients.

  • image desription

    Requalification of existing installations

    Ensuring the effectiveness of decontamination cycles after scheduled maintenance or system modifications.

  • Qualification of older isolators

    Inspection of older SKAN systems or third-party systems that are being put back into operation.

Zwei Personen in Schutzkleidung stehen vor dem Isolator und prüfen etwas
Process

Structured workflow from preparation to final report

  • 1

    Needs and requirements analysis

    Joint planning with the customer, e.g., regarding number and positioning of biological indicators (BIs).

  • 2

    Preparation of test documentation

    Preparation of test plans and approval by the customer as the basis for performance.

  • 3

    Execution of cycles on-site

    Running of the decontamination and aeration cycles at the customer’s site with defined BI loading.

  • 4

    Incubation and evaluation

    Incubation of the used BIs and evaluation of the results according to defined acceptance criteria.

  • 5

    Preparation of final documentation

    Preparation of the test report and, if required, deviation reports, followed by formal release and discussion of the results.

Service highlights

Comprehensive support from the isolator experts

  • Comprehensive support from SKAN

    We manage all steps from test planning to the final report, including incubation and documentation.

  • Experience and continuity

    MBQ is performed by the same engineer who also supervised the cycle development, MBReQ by a specialized experts-team.

  • Minimized validation effort

    Only minimal resource involvement on your part, as we control and support the entire process.

Isolator mit Inhalt

Technical specifications

  • New qualification

    MBQ following cycle development

  • Requalification

    MBReQ after maintenance or at annual intervals

  • Options

    Verification of H₂O₂ distribution using chemical indicators and enzyme indicators

  • Documentation

    Development and test documentation

  • Data

    Raw data and BI evaluation results

  • For low-level evaluation

    Dedicated documentation package

  • H₂O₂ concentration measurement

    Validation with sensors (Dräger or Picarro for low-level evaluation) or Dräger tubes

  • Decontamination behavior

    Using biological indicators (BI)

  • Options

    Enzyme indicators, chemical indicators and low-level evaluation < 0.003 ppm

FAQs

  • MBQ is performed following cycle development to verify its reproducibility of the developed cycle parameters. MBReQ checks the same cycles at regular intervals, usually annually or after maintenance.

  • The actual test execution typically takes only a few days. Incubation of biological indicators typically requires seven days, followed by documentation and formal release.

  • The decontamination cycle must already be developed, and the isolator system must be technically operational and loaded. BI positions are jointly defined.

  • Yes. Microbiological (re-)qualification can be performed on any isolator with an H₂O₂ decontamination system, including older SKAN or third-party systems.

  • SKAN analyzes any deviations, supports root cause investigation, and advises on appropriate measures to restore cycle performance.

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