Test Container Closure and Integrity by Residual Seal Force (RSF) Analysis (CAT#: STEM-B-0427-CJ)

Introduction

The primary container protects the drug product from external influences, such as direct sunlight, oxygen, moisture, and particulate or bacterial contaminants. But modern primary packaging needs to fulfil several other important tasks, such as enabling simple administration by the healthcare personnel or the patient itself, avoiding the escape of hazardous drugs, and being compatible with other clinical devices such as infusion bags.

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Principle Applications Procedure Materials Notes Related Products

Principle

The RSF is determined by using a material testing system that applies an increasing force onto the top of the vial cap, measuring the point when the cap flanks lift off the lower vial neck. This force is an indicative parameter for the container closure integrity. Acceptance criteria of the RSF value, however, need to be established in correlation to other container closure integrity tests (CCITs), such as dye-based assays and headspace oxygen analysis (HOA). RSF analysis is used during process development, during stability studies as well as for lot release testing.

Applications

Biopharmaceutica

Procedure

1. Sample preparation.
2. Measured using the Residual Seal Force (RSF) instrument.
3. Analysis of data.

Materials

• Sample: Rubber-stoppered glass vials, Prefilled syringes, Double-chamber cartridges, Application devices, Closed system drug transfer devices (CSTD)
• Equipment: Residual Seal Force (RSF) monitor (such as: 6800 Series Universal Testing System, Bluehill Universal Software, 2580 Series Load Cell, Custom Test Fixture CP131410)

Other recommended products

Test Container Closure and Integrity by Headspace Oxygen Analysis (HOA)/ Frequency Modulation Spectroscopy (FMS) (CAT#: STEM-B-0426-CJ)