A “sterile barrier system” is a device’s packaging system. In order to avoid any kind of infection, this packaging system must sustain the sterility of the product’s complete shelf-life.


From production to final use, and to keep the product sterile – packaging can behave as the weak link in the chain of steps that are designed. At this stage, special care and attention is required to ensure that the packaging is perfect and does not cause any kind of harm to the consumers.


The Traditional Sterility Testing Method:

Safety and sterility are the most important aspects.


This responsibility is undertaken by a team that includes: packaging developers, development engineers, product managers, packaging managers, and quality auditors.


To test a package’s sterile barrier system at any given time of its life – it has to be bathed in a contaminated solution. This is the starting point for a traditional sterility testing. Further tests involve culturing the contents and to ensure microbes have not infiltrated the package.


However, this form of microbial challenge test has several disadvantages. Primarily, the culturing step is a growth process. It is always a time consuming scenario.


Secondly, during the testing process, mistakes in handling the package or the contents can lead to an accidental contamination and subsequently, expensive false positives.


Moreover, if the microbes used in testing behave differently than expected, there’s also a risk of false negatives.


Welcoming the method of Integrity Testing:

To support or replace traditional sterility tests – there has long been a discussion pertaining to the usage of package integrity testing instruments.


Physical testing can be employed in order to cross-check if the seals are continuous and leak-free.


Here are four advantages of closure and container system integrity tests:

  • Prior to product contamination the ability to detect a breach
  • For other stability tests the capacity to conserve samples that may be used
  • The actuality that it involves less time when compared to the other sterility test methods
  • The possibility for false positive outcomes may lessen


However, there are other benefits pertaining to integrity testing. This form of testing can be employed during the package development for periodic checks on production or when critical events occur – similar to traditional microbial challenge testing.


One of its major advantages, unlike the microbial challenge, is that this form of testing does not incur the delay that usually takes place. Subsequently, this makes it a far more usable and convenient option. Additionally, it does not require any highly trained specialists or undergo the same threat of an operator error.


Over their anticipated lifecycle, ease of testing implies that packages can be tested more often. This is crucial for packages that are shipped, handled, and also challenged in different ways that can affect its ability to keep the contents sterile.


Sensitivity, repeatability, and reproducibility are the advantages of package integrity testing. Therefore, it makes it highly reliable too.


What are the benefits of Adaptable Package Integrity Testing?

The costs of poor quality control can be enormous especially when it relates to packaging medical products. This impacts the life and health of a larger population.


The stakes are higher than ever, in today’s fast-moving global markets. The industry and its regulators have come to recognize that traditional testing methods can be slow and potentially risky as the competition and time pressures have grown.


For ensuring the safety of package systems and the products they protect, package integrity testing has been acknowledged to be an important tool.


Either by itself or as an addition to the other traditional testing methods – currently, package integrity testing is helping the designers, manufacturers to deliver medical products that are safe, cost effective and quick.


What are the challenges and complex requirements encountered?

A packaging system is a complex procedure that often consists of numerous materials assembled in a multi-step process.


The aspect of packaging cannot be taken for granted. It is not something that has to be opened and thrown away. It is a crucial and serious process.


Every package needs to be carefully designed in order to safely hold its contents and also to protect them during transport and handling. Additionally, at the point of use it should be easily opened.


The contents of the package need to be sterile until they are used. A breach at any point in the sterile barrier system can render the contents completely unusable or potentially dangerous.


Currently, the methods are not all equal and there is no universal means of package integrity testing.


Overall, as the packaging design revolves around the contents – similarly the testing must adapt to the package design, materials used, and the sealing mechanisms.