HLT

Blogs

03
Nov 2020

2019 PDA Container Closure Integrity Testing Workshop Presentation

2019 PDA Container Closure Integrity Testing Workshop Presentation

Presentation Summary

At the 2019 PDA Container Closure Integrity Testing Workshop in Gothenburg, Sweden, the following presentation was given as a 20 minute introduction to the use of helium leak detection for container closure integrity testing (CCIT).

Presented on behalf of Leak Detection Associates, the world’s premier manufacturer of custom-built helium leak detection solutions for pharmaceutical, biotechnology, medical device and food packaging clients, the presentation seeks to impart reviewers with an overview understanding of helium leak detection principles of operation, realistic methods for application to pharmaceutical packaging, and case study applications.

Helium gas is a small, nonreactive molecule, making it an ideal tracer for leakage testing, as employed by LDA’s SIMS 1915+ Helium Leak Detector. However, when it comes to preparing samples and subjecting them to a test, there are a range of approaches, each with respective ideal use cases. This presentation aims to illustrate some of the more common ways in which helium leak testing is applied to pharmaceutical packaging such as blisters, vials, and syringes. Reviewed approaches include the sniffer test, filling samples with helium prior to sealing, post-seal helium fill, using LDA’s proprietary vial filler and HSAM, and continuous fill using unique fixtures. Test approaches with reference to ASTM F2391 are discussed.

Important to the message of the presentation are the two case applications presented. The first discusses the application of helium leak testing to vial capping optimization, or assembly validation. In the second case application, an approach for evaluating individual ribs of a plunger is proposed. This type of approach is beneficial to those evaluating inherent integrity or defining their sterile barrier, which has implications for plunger movement during transit. This concept is becoming increasingly relevant as the expansion of prefilled syringe and cartridge-based delivery systems continues.

Readmore...
use of helium leak detection for ccit, container closure integrity testing, ccit
4534

Popular Blogs

Tags

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   11894

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is excited to celebrate the completion of its first calendar year under new management.

The Advantages of Using Helium for Leak Testing

May 13, 2020   |   6181

The use of helium gas as a medium for leak testing dates back to the 1940’s.Using helium as the “tracer” gas enables the user to discover and measure extremely small leaks.

An Overview of 21 CFR Part 11 Compliance Requirements

Nov 02, 2020   |   5578

A review of some simple and direct questions regarding Part 11 compliance to help you to understand its requirements and implementation.

Leak Detection Associates Announces New and Updated Helium Leak Detection System

Nov 01, 2020   |   4870

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments is excited to announce the launch of its newest and most advanced helium leak detection system, the SIMS Model 1915 that is engineered incorporating industry-leading Agilent Technologies components and is custom designed to meet the stringent requirements of clients in FDA-regulated industries.

2019 PDA Container Closure Integrity Testing Workshop Presentation

Nov 03, 2020   |   4534

The 2019 PDA Container Closure Integrity Testing Workshop in Gothenburg, Sweden, had the following presentation that was given as a 20 minute introduction to the use of helium leak detection for container closure integrity testing (CCIT).
Popup