Glossary entry

French term or phrase:

classe A entourée B

English translation:

class A workstation in (or within) a class B area

Added to glossary by Bashiqa
Jan 22, 2015 18:41
9 yrs ago
5 viewers *
French term

classe A entourée B

French to English Medical Medical: Pharmaceuticals Vaccine production
Context:
Le site du xxxx (In France) produit depuis 2008 du vaccin xxxxxxxxxxx avec remplissage sur ligne R4 (ZAC conventionnelle de classe A entourée B), mirage sur îlot I6, conditionnement sur ligne C8 (format blister unitaire et format 2 blisters 5 seringues).
At a bit of a loss as to why they are are referring to the building when we are discussing what is happening inside the building.
Any bright iseas much appreciated.
TIA Chris.

Discussion

Bashiqa (asker) Jan 22, 2015:
@ Phil Grovel, grovel.
Murielle M Jan 22, 2015:
I've only just realised that "Zone à Atmosphère Contrôlée" was suggested in the Discussion! Do ignore my reply if it comes a little late in the day, it took a while finding the refs, hence posting a little out of synch...
philgoddard Jan 22, 2015:
It was my "air conditionné", not yours! But I agree that "atmosphère contrôlée" looks correct.
Bashiqa (asker) Jan 22, 2015:
@ Donal Obviously my Air Conditioned was going in the right direction but methinks you're spot on. There are several levels of 'cleanliness' within a factory, Class A being the top one. Thank you.
DLyons Jan 22, 2015:
Isn't it Zone à Atmosphère Contrôlée in this context?
Bashiqa (asker) Jan 22, 2015:
Have now checked their address and it does not say ZAC only Bvd Industriel. So perhaps ZAC refers to the section of the factory where the production actually takes place ZAC -Zone Air Conditioned, has just come to mind. Class A airconditioning within a Class B area?
Bashiqa (asker) Jan 22, 2015:
@Phil Zone aux Activités Classé assuming in my text they are referring to the factory.
philgoddard Jan 22, 2015:
Enclosed by a class B area?
Just thinking out loud here, and we really need to know what ZAC stands for.
philgoddard Jan 22, 2015:
Could entourée mean enclosed?
philgoddard Jan 22, 2015:
Air conditionnée?
philgoddard Jan 22, 2015:
How have you translated "ZAC conventionnelle"? I assume Z stands for zone.

Proposed translations

1 hr
Selected

class A workstation in (or within) a class B area

Could it be this?

ZAC: Zone d’Atmosphère Contrôlée pour les produits pharmaceutiques, avec classes A, B, C...

ZAC = Controlled Atmosphere Area in English...

http://ejhp.bmj.com/content/19/2/137.2

"The drug manufacturing conditions in hospitals have become increasingly demanding and the use of a Controlled Atmosphere Area (CAA) "

http://www.steriservices.com/en/content/new-controlled-atmos...

"New controlled atmosphere area (150m²) - We have now a larger area (150m²) for the overwrapping of medical devices with a thermoforming machine."

Class A: For points where high-risk operations are carried out, such as the distribution point, cap bowls, open ampoules and bottles, and sterile connection points. Workstations with a laminar air flow usually ensure that the required conditions exist for this type of operation. Laminar air flow systems supply air circulating at a constant speed of 0.36 – 0.54 m/s (guideline value) in non-confined systems. Keeping the air flow laminar has been
demonstrated and validated.

Class B: For preparation and aseptic filling operations, this class is the immediate
environment of a Class A working area.

Classes C and D: Controlled-atmosphere rooms intended for less critical stages in the
manufacture of sterile medicinal products

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Note added at 3 days19 hrs (2015-01-26 14:11:35 GMT)
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Quelques exemples dont un de la Commission Européenne :

ec.europa.eu/food/fvo/act_getPDF.cfm?PDF_ID=10408

“a zone within a class B can be temporarily opened as class A”

“the areas are opened as class B or can be opened as … with class A within a class B area.”

http://patents.justia.com/patent/20130334443

“ Since the shielded enclosure is Class C, it must be housed within a Class C area to ensure the environment is contiguous when the shielded enclosure is entered.”
Note from asker:
Thank you
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4 KudoZ points awarded for this answer. Comment: "Thank you."
1 hr

class A work station surrounded by class B

Calaméo - La Vague n°33 février 2012
www.calameo.com/books/0027705829ef318ef1ad3
12 Article / La pratique du contrôle particulaire des salles classées à l'usage des ..... La définition proprement dite d'une ZAC est quant à elle donnée dans le .... tout ce qui nous entoure, sans oublier notre corps et la tenue que nous manipulons. ... être réalisée à un poste de travail de classe A dans un local de classe B. 32.
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