HLT

Blogs

21
Dec 2021

Testing Container Closure Integrity at Low Temperature

Testing-Container-Closure-Integrity-at-Low-Temperature

The integrity of the seal between the container and the closure is a major concern when choosing packaging components for a parenteral drug product. The packaging must protect the pharmaceutical product from a number of possible sources of contamination, such as microbial ingress. Container closure integrity (CCI) is defined as the capacity of a container closure system to preserve a drug product and hence retain its efficiency and sterility throughout its shelf life. The purpose of container closure integrity testing is to determine the effectiveness of packaging closure.

To ensure CCI of pharmaceutical drugs, a number of methods are used. Helium Leak Detection is one of them. In this method, helium is used as a tracer gas, to detect leaks. This testing produces quantitative data that are more repeatable and reliable than qualitative pass/fail results. Despite the fact that it is a destructive test, helium leak testing is widely used because of its sensitivity and ability to run samples at temperatures below ambient. After the sample is prepared, it may be kept and analyzed at the proper temperature.

CCI Testing of Pharmaceuticals at Low Temperature

The CCI of pharmaceuticals may be determined using a variety of approaches. Under sub-ambient temperature circumstances, several methods of container closure integrity testing, such as blue dye ingress, microbial ingress, and vacuum decay, are insufficiently sensitive or simply unsuitable. Helium leak testing is a reliable method for testing closures and ensuring product effectiveness and sterility. This method is more sensitive than other CCI testing methods.

LDA has created the LT80, Low Temperature -80°C, Add-On test system for use with the LDA SIMS helium leak detectors to meet the market demand for analyzing leaks at cold temperatures. Concurrent temperature conditioning, temperature monitoring, and helium leak testing of packages approaching -80°C are all possible with the LT80 system. Even at temperatures as low as –80°C, helium leak detection is an effective method to ensure container closure integrity. While there are alternative methods for measuring CCI, many of them are ineffective at temperatures below –80°C. The LT150 low-temperature add-on unit allows for sample testing at temperatures as low as -150° C. The highly sensitive nature of the instrument allows for leaks as low as a 2µm hole can be recognized as a failure. The quantitative results provide the analyst with a numerical value, which allows for better data trends and greater confidence in the packaging system's performance than qualitative techniques can provide.

Container closure integrity or CCI, on packaging for parenteral drug products, is crucial for drug product preservation. The packaging closing components must be carefully chosen in order to eliminate sources of contamination that could harm the pharmaceutical product. The need to extend container closure integrity testing into the cryogenic temperature range is already becoming apparent. Container closure integrity must be achieved at cryogenic temperatures if pharmaceuticals are to be kept at cryogenic temperatures. For these types of drug items, newer packaging solutions like prefilled syringes and complex self-dosing devices are increasingly being used, and CCI will need to be proved for them as well.

Readmore...
helium leak testing, helium leak detection, container closure integrity testing, container closure integrity, helium detector
1454

Popular Blogs

Tags

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   11893

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