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Technical service
  • At SKAN
  • On-site

Glove qualification

Parameter development and qualification from the expert

Service area
Commissioning & maintenance
Lifecycle
Design & Qualification Operation
Glove qualification at a glance

Test parameters tailored to your gloves and cleanroom environment

  • Reliable glove integrity testing

    Physical testing with perforated gloves ensures reliable detection performance

  • Specific parameters

    Test recipes are precisely developed for the specific glove type and on-site conditions

  • Adapted to the environment

    The test set-up accounts for pressure differentials, temperature, and airflow conditions within the cleanroom

  • Regulatory compliance

    Standardized procedures and comprehensive documentation ensure regulatory compliance

Application

Precise parameters for your glove integrity testing

  • For initial glove qualification

    During parameter development and qualification (PD/PQ), a validated test recipe is established for your specific glove type, ensuring that glove integrity testing becomes a standardized part of your aseptic process.

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    For the commissioning of new glove types

    The service is required following the commissioning of new glove types. A dedicated set of test parameters is developed to ensure that a defined hole diameter at critical positions is reliably detected.

Glove Qualification Application
Process

Step-by-step process for parameter development and qualification

  • 1

    Execution of glove integrity testing

    A glove integrity test is performed using the SKAN WirelessGT at four predefined glove ports. In addition, the glove type and size, as well as the worst-case hole position and size, are defined.

  • 2

    Parameter development

    Relevant parameters such as start pressure, stabilization time, test time, inflation time, and allowable pressure decay are developed for both an intact glove and a deliberately damaged (perforated) glove.

  • 3

    Documentation of parameter development

    All results and parameters are documented in a test protocol, including details on glove type, hole size and position, and test environment.

  • 4

    Parameter qualification

    The developed parameters are qualified by repeating the previously performed steps at the same glove ports.

  • 5

    Documentation of parameter qualification

    A comprehensive final documentation is prepared, including test protocols and verified parameters.

Service highlights

Process knowledge directly from the manufacturer

  • Individually tailored

    Test parameters are specifically adapted to your glove type and the conditions of your cleanroom. This results in a reliable test recipe that also considers factors such as pressure differentials, temperature, and airflow patterns in the cleanroom.

  • Highest reliability in glove integrity testing

    All developed and qualified parameters are documented and recorded in test protocols, ensuring seamless integration of results into existing quality assurance processes.

  • Flexibility in execution

    Parameter development can optionally be performed in advance at one of our sites, where our glove testing experts are based. In this case, only the parameter qualification needs to be carried out at your facility.

Glove Qualification Development Process

Technical specifications

  • Initial qualification

    Commissioning of gloves for new systems

  • Qualification of new gloves

    Commissioning of new glove types or sized

  • On-site

    Parameter development and qualification performed at your site

  • Parameter development at SKAN

    Only parameter qualification performed at your site

  • Validated parameters

    Start pressure, stabilization time, test time, inflation time, and pressure decay

  • Number of gloves

    Qualification for one glove type and size, including a worst-case hole position

  • Performed tests

    Glove testing at four defined ports

  • Documentation

    Comprehensive documentation in the form of test protocols

  • Options

    Additional ports or hole positions are available upon request

FAQs

  • PD/PQ can be performed on all glove ports that can be tested with the SKAN WirelessGT. The port itself does not need to be from SKAN.

  • Usually, this service is required before the first compliant glove integrity test can be performed. This applies either during the commissioning of a new system or when changing glove types or sizes.

  • No, the gloves to be qualified must be provided by you. A total of eight gloves are required, which cannot be reused afterward due to intentional damage.

  • Yes, additional pinhole positions as well as additional glove types or sizes can be included and booked separately.

  • The process is sensitive to pressure and temperature variations. The test recipe is adapted to the prevailing cleanroom conditions.

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