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Cryogenics is the study and production of low temperatures (La Vague 54)

Cryogenic cleaning enables all materials to be cleaned of any thickness of dirt, without abrasion, without water, without solvents, without secondary waste and often without disassembly.
It can be of interest to the pharmaceutical industry where strict conditions of cleanliness are mandatory.

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Cahier Pratique - Comment assurer le succès d’une auto-inspection du processus d’assurance de stérilité & des procédures associées (La Vague 54)

Cet article présente le développement des principes et des méthodes qui ont été exposées lors de la conférence du 17 novembre 2016 lors du congrès international d’A3P à Biarritz.
Nous avons souhaité développer l’ensemble des arguments et donner aussi des outils (comme par exemple des listes de questions types) qui sont des aides pour approcher au plus près et dans une vision dynamique la mesure du niveau d’assurance de stérilité d’un procédé aboutissant à la réalisation d’un produit stérile, injectable ou non.

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Cleaning Grouping Strategies for Oral Solid Dosage Forms in Multi-Product Facilities. (La Vague 54)

To this day, oral formulations are the largest category of pharmaceutical and nutritional dosage forms. Hundreds of manufacturers around the world produce thousands of products in tablet, capsules, and powder forms which are often referred as Oral Solid Dosage (OSD) products.

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Biocidal regulations applied to the disinfectants used in the pharmaceutical industry: all you need to know... (La Vague 54)

Disinfectant and detergent disinfectant products are widely used in the pharmaceutical industry for various uses including operations described as decontamination or applications referred to as “cleaning or washing or sanitation” for premises, equipment and manufacturing materials.

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The A3P Cleaning Validation GIC is preparing a practical 2017 Fall Guide on Chapter 10 of Annex 15 of the European GMPs: Presentation & discussion. (The Wave 54)

With the official publication of the new Annex 15 of the European GMPs Eudralex Volume IV in October 2015, if there was a major subject of vigilance to highlight the recent audits of the European Health Authorities, it would, no doubt , The validation of the cleaning that should be chosen. Chapter 10 of this Annex 15 has been enriched with 8 additional paragraphs for a total of 15. Therefore, this is a regulatory "upheaval"!

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