Qualification and Monitoring of Glove Boxes and Isolators

Qualification and monitoring of glove boxes and isolators

Isolators are used in various applications such as the pharmaceutical industry, the medical sector, the cosmetics industry and the food industry. The equipment is used for production under aseptic conditions, microbiological control activities (e.g. sterility testing) and for the protection of personnel.

These demanding and standardised processes require isolators to be completely sealed, in accordance with the relevant standards. Thus, the qualification and control of glove boxes are essential procedures to guarantee their quality and reliability.

Qualification and testing of isolators: what is the need?

Jacomex designs and manufactures containment systems for various sectors and fields. Our solutions comply with current standards and undergo all the necessary checks to guarantee total safety and reliability. The performance of an isolator is already measured by its tightness including its safety transfer systems, gloves and external transfer systems. To do this, we carry out a leakage test on all the devices we design and manufacture. This test is performed on two types of instrumentation: an oxyfuel and a helium mass spectrometer. The former is used to validate the enclosure or fully completed installation; the latter is used for scrubbers, vacuum components, transfer airlocks and hermetic feedthroughs, with a leakage rate < 10-5 mbar l/sec.

Tests are also carried out on sealed glove rings. Indeed, the rise of the oxygen level inside a glove box, in operational mode, is largely dependent on the permeation of the gloves.

Qualifications/validations meet the following standards:

  • ISO 9001 Standard for TÜV ISO 9001:2015 Certification;
  • ISO 10648-2: Methods and classification of containments, glove boxes and isolators according to their leakage rate;
  • EN 60439-1: CE self-certification.

Compliance with the ISO 10648-2 standard for leakage testing of glove boxes and isolators

For the majority of our glove boxes, the oxygen rise method guarantees a class 1, with < 0.05 Vol%/h maximum permissible leak rate. The usual leakage rate of our containments is in the order of 0.0005 Vol%/h < Tf < 0.0025 Vol%/h.

We have developed a wide range of high performance gas purification units with enhanced oxygen removal capabilities to suit various glovebox designs.

We also recommend that you check the condition of the gloves on a regular basis, throughout the life of the device. For on-demand checks and approvals, especially for pharmaceutical, industrial and nuclear applications, we can provide specific documentation:

Material certificate, according to EN 10204 3.1 ;

  • Manufacturer’s files;
  • Seismic calculations, force calculations, etc. ;
  • Welding procedure, QMOS, Welder qualification according to EN 1418;
  • AFPIC N2 Chemistry qualification;
  • CEFRI nuclear clearance.

From the start of your project, we invite you to consult us for the qualification and control of your insulators. We will answer all your questions.

Get a Free Quote Without Obligation

Contact our commercial team to get a customized quote for a Jacomex glove box.

Our clients

Many customers from a variety of industries have trusted Jacomex to design and manufacture their glove boxes, insulators and air purification systems.

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184 Avenue du Bicentenaire
Zone Les Prés Seigneurs
01120 Dagneux – France

Made in France

All of our products are designed and manufactured in France