Evaluation of particulate contamination in an isolator in accordance with the 2016 version of ISO 14644 at the various stages of manufacture of a cancer medication bag

P. Hild1, D. Meyer2 1 CH de Roanne
2 DM Compliance

The new version of the ISO 14644 standard on 0.5 and 5 ìm particulate contamination stipulates prerequisites and compliance of procedures, according to:

  • In part 1, a qualifications plan: DQ (design qualification), IQ (installation qualification), OQ (operating qualification), PQ (performance qualification / requalification), and
  • In part 2, an active monitoring plan, performed between two qualifications as per the items in part 1.

Isolators are sterile and offer an ISO class 5 airflow regime with turbulent airflow. Our aim is to analyse the factors required for contamination control, in accordance with the manufacturing procedures of hospital pharmacies. In particular, we aim to consider the suitability of the ISO 14644 standard for the various critical phases that occur during manufacture and between each batch.

To this end, we have installed a particle counter set to take continuous readings on several consecutive preparations. The counter readings are correlated with the video recording for the preparation.

The video results as to compliance with standards are encouraging, but nevertheless raise questions as to the design and use of the isolator, including:

  • Major increase in the hourly renewal rate
  • Elimination of nebulised material
  • Use of impregnated wipes
  • Unidirectional ventilation required or not?

These readings may be requested in the event of a future revision of the ISO 14644 standard. In any case, it seems to us that they have a certain role to play in the continuous quality plans implemented in production.

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