M00015740
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ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING
British Standards Institution
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Availability date: 11/05/2021
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Requirements<br>5 Preparation of elastomeric closures for testing<br>Annex A (normative) - Test for penetrability<br>Annex B (normative) - Test for fragmentation<br>Annex C (normative) - Test for self-sealing and dye<br> solution tightness<br>Annex D (normative) - Test for dye solution tightness<br>Bibliography
Defines requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | CH/212 |
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