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.

Programme(s)

• FP2-BCR 4 - Research and development programme (EEC) in the field of applied metrology and chemical analysis (Community Bureau of Reference - BCR), 1988-1992

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Institut National du Verre

Address

Charleroi
Belgium

Participants (12)

BSN Emballage

France

Address

Givon

British Glass

United Kingdom

Address

S10 2UA Sheffield

Buender Glas

Germany

Address

Buende

Forschungsgemeinschaft für technisches Glas

Germany

Address

Wertheim

Glasforskningsinstitutet

Sweden

Address

Vaexjoe

Glaskontor

Germany

Address

Muellheim

Kimble Italiana

Italy

Address

56100 Pisa

STAZIONE SPERIMENTALE DEL VETRO

Italy

Address

Via Briati 10
30141 Murano

Schott Glaswerke

Germany

Address

Hattenbergstrasse 10
55122 Mainz

Schott Ruhrglas

Germany

Address

Mitterteich

Upjohn

Belgium

Address

Puurs

Vetreria Parmense Bormioli Rocco

Italy

Address

43100 Parma