Barrier Integrity · Isolators · RABS
Glove Testing
Glove Testing System from MK
- Fully automatic 3-step testing procedure based on the pressure decay principle according to ISO 14644-7.
- Automated inflation of the glove to a specific pressure with integrated pump; no additional utilities such as compressed air are necessary.
- Stabilization of the glove by pre-stretching due to specific stretching properties of the glove material.
- Measurement over time using a glove-specific time-pressure curve as acceptance criteria, for example 1100 Pa.
- Reliable detection for hole diameters down to 100 µm.
- Parallel measurement of up to 35 gloves to reduce changeover time.
- Short testing procedure starting at 15 minutes, depending on glove material.
- Easy handling of the glove test lid: one button for On/Off and one for starting the test procedure.
Glove testing and how to guarantee integrity during batch
Questions around glove testing and glove integrity are becoming increasingly relevant for isolator and RABS users. The newer Annex 1 expectations appear to be one driver behind these discussions.
Gloves are among the weakest parts of a barrier system. Because of the risk of puncture or rupture, they are regarded as a potential source of contamination. Inspectors increasingly expect manufacturers to avoid unnecessary glove interventions during batches or to have a robust SOP for managing glove integrity risks.
Classification of gloves
- Classifying gloves into critical and non-critical types depending on their use in the isolator transfer process makes sense.
- Gloves in areas of open containers, especially at the point of fill, should be treated as critical and need extra attention.
Testing frequency and batch integrity
- A glove test before every batch is a strong approach and is also recommended in the new EU GMP Annex 1 guideline.
- Many customers historically tested once or twice per month.
- If a glove was OK before a batch but fails before the next batch, a procedure is needed to assess whether the failure could have occurred during the batch.
- This may support performing a glove test after a batch, although a good SOP for glove interventions, usage and monitoring during the batch remains essential.
Risk reduction during batch or campaign
Inspectors may argue with potential bioburden transfer through a pinhole when contamination is actively pressed through the glove from the inside surface.
A good argumentation is a defined procedure using IPA spray and wipes during the batch from both sides of the gloves.
- Before a batch, and additionally after glove testing, gloves are cleaned with Spor-Klenz / IPA 70% on inside and outside surfaces.
- Use a new pair of operator gloves over already worn gloves and spray with IPA at any glove intervention into the isolator.
- Use wipes or IPA inside the isolator to clean the gloves from inside while fingers are stretched in the isolator glove.
If a glove fails
- Repeating the test is acceptable; if the repeated test passes, the glove may be good for use according to procedure.
- If it fails again, a third test may be performed and, if passed, the supervisor should be informed and decide how to proceed depending on the glove and application.
Preventive actions
- General replacement of all gloves on the barrier system during the annual service shutdown.