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. 2015 Aug 20;9:4825–4834. doi: 10.2147/DDDT.S80403

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© 2015 Montemurro et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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Example of the collection form for “in operation” particle monitoring data and the “in operation” microbiological data used to build up trend analysis.

Notes: Clean areas for the manufacture of sterile products are classified according to the air cleanliness. Class A is the local zone for high risk operations, normally provided by a laminar air flow work station. Class B is the background environment for the grade A zone (for aseptic preparation and filling).

Abbreviations: CON, contact plate; DX, right; QA, quality assurance; QP, qualified person; SAS, surface air system; SED, settle plates (sedimentation); SX, left; UFC, unit-forming colony.