The new ANNEX 1 02/2020

ESSAY No. 1 – Acceptance criteria for germ count monitoring in cleanrooms

One of the significant revisions in the draft of the new Annex 1 is the change in the limitation of the bacterial count in cleanroom class “A”. Whereas the previous requirement was that a maximum value of “< 1” was permitted in the core zone of aseptic production, the limit is now set to “no growth”, i.e. “0” CFU/sampling.

Sampling point

This will be a challenge in the future because, in contrast to the new requirement, the current value is an average value per sampling point (air bacteria count, sedimentation plate, contact plate)1) , which means that the number of 1 bacteria can theoretically be exceeded in a sample. According to general GMP understanding, the new requirement implies that the occurrence of a germ immediately leads to an investigation as part of the company’s own deviation management, whereby the cause of the origin of the germ should be found with the greatest possible probability.

Requirement in the new Annex 1

If the requirement in the new Annex 1 is included in the ongoing discussion that in future it should be possible to fully monitor the cleanroom from outside, i.e. outside the A/B zone (suitable windows or camera systems are specifically recommended), this presents a new challenge. In FDA inspections, for example, it is already expected that monitoring activities (quality oversight) will be specifically incorporated into the evaluation of microbial findings in order to establish the greatest possible correlation between the sample train carried out and the event that took place.

For the pharmaceutical manufacturer

In the interpretation of the new Annex 1, this means for the pharmaceutical manufacturer: establishment of documented monitoring of the cleanroom with chronological allocation of sampling/monitoring and events that actually took place in the cleanroom. An exciting task!

Source: 1) ZLG Aide memoire “Monitoring of sterile manufacturers”

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Dipl. Ing. Wolfgang Rudloff

Vita

• 30 Jahre Erfahrung in der pharamzeutischen Industrie

Expertise:

• Geprüfter Sachverständiger für Reinraumtechnik und GMP-Management
• Lead Auditor und Gutachter

Stationen:

• Technischer Leiter
• COO / Gesamt-Herstellungsleiter
• Remidiation-Manager
• Projektleiter Neubau/GMP-Upgrade
• Management-GMP-Beratung
• Fachautor, GMP-Trainer, Mediator