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ALKALI LEACHING FROM PHARMACEUTICAL GLASS CONTAINERS

Objective



Glass containers for injectable solutions must comply with specifications of the European Pharmacopoeia (also ISO 4802) which limit the release of alkaline constituents into pure water when applying a specific test. The test method consists of:
- applying a specified temperature cycle to containers, partially filled with pure water(in equilibrium with the atmosphere), in an autoclave
- subsequent determination of total alkalinity (titration) of the water or of specified elements (Na and possibly others).
The test method imposed by the European Pharmacopoeia is not ideal. The test is very sensitive to minor differences in the temperature cycle applied. It appears in fact that most cases of observed high leaching are caused by measurement errors and not by poor quality of the glass. Potential sources of error have been identified and largely eliminated in preliminary intercomparisons. A reference material will be certified to enable laboratories to check if the method is applied correctly.

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Call for proposal

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Coordinator

Institut National du Verre
Address

Charleroi
Belgium

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Participants (12)

BSN Emballage
France
Address

Givon

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British Glass
United Kingdom
Address

S10 2UA Sheffield

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Buender Glas
Germany
Address

Buende

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Forschungsgemeinschaft für technisches Glas
Germany
Address

Wertheim

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Glasforskningsinstitutet
Sweden
Address

Vaexjoe

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Glaskontor
Germany
Address

Muellheim

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Kimble Italiana
Italy
Address

56100 Pisa

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STAZIONE SPERIMENTALE DEL VETRO
Italy
Address
Via Briati 10
30141 Murano

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Schott Glaswerke
Germany
Address
Hattenbergstrasse 10
55122 Mainz

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Schott Ruhrglas
Germany
Address

Mitterteich

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Upjohn
Belgium
Address

Puurs

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Vetreria Parmense Bormioli Rocco
Italy
Address

43100 Parma

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