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EFHSS Questions and Answers - Answer to Question Q00101

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EFHSS - Questions & Answers - Packaging - Q00101
Aluminium Bottles
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From: IMC   Date: 15 September 2001, 09:39 [GMT]
Subject: Aluminium Bottles

we would like to know informations about aluminium bottles for sterile medicin and names of importares, exporters and companies that share in the medical industry
thank u a lot

From: (United States)   Date: 3 November 2001, 03:09 [GMT]
Subject: Re: Aluminium Bottles

I am curious / What do you use aluminium bottles for?

From: (Belgium)   Date: 24 April 2002, 10:08 [GMT]
Subject: Re: Aluminium Bottles

Dear,

In Europe aluminium bottles are not in use for parenteral preparations.
The European Pharmacopeia says the following:
"Containers for parenteral preparations are made as far as possible from materials that are sufficiently transparent to permit the visual inspection of the contents, except for implants and in other justified and authorised cases.
Where applicable the containers for parenteral preparations comply with the rquirements for Materials used for the manufacture of containers (3.1 and subsections) and containers (3.2 and subsections).
Parenteral preparations are supplied in glass containers (3.2.1) or in other containers such as plastic containers (3.2.2, 3.2.2.1 and 3.2.9) and prefilled syringes.The tightness of the container is ensured by suitable means. Closures ensure a good seal, prevent the access of micro-organisms and other contaminants and usually permit the withdrawal of a part or the whole of the contents without removal of the closure. The plastic materials or elastomers (3.2.9) of which the closure is composed are sufficiently firm and elastic to allow the pasage of a needle with the least possible shedding of particles. Closures for multidose containers are sufficiently elastic to ensure that the puncture is resealed when the needle is withdrawn."

If you to let me know your postal address I can send you these European requirements.

Best regards,
Wim Renders

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