Pharmaceutical products are manufactured with precision with zero tolerance for error. For this reason, pharmaceutical manufacturers emphasize their quality control procedure to the utmost importance. This is to ensure that the products adhere to the quality standards required for their intended use.
Packaging plays a vital role in preserving the products’ quality and serves as protection from external damaging force. In addition to selecting good packaging material, package integrity testing also forms an important process in maintaining product quality. It ensures that there are no leakages within the package and thus, prevent external contamination that can detrimentally impact drug quality.
With an effective package integrity testing method, you can be sure that:
- The product is well-protected against external sources such as light, oxygen, moisture and temperature, that can alter the quality of the product
- The product is protected from any form of contamination
- There are no physical damages caused to the packaging and products during transportation
- The label carries all the correct and essential information for the end user.
It should be noted that the choice of packaging materials should be the one that does not affect the products either physically or chemically. Certain drugs, such as dry powders for asthma patient are highly moisture-sensitive and will require package materials that are water-impenetrable to achieve optimum testing results.
Similar to food and beverage manufacturers, the pharmaceutical manufacturers have zero tolerance towards leak in their product packaging as it will produce the devastating outcome. Therefore, the standards for ‘bacteria-proof’ and ‘virus-proof’ along with an index for ‘Limit of detection’ are developed. The latter is defined as an indication of small leaks that can be determined with a particular test method.
Traditionally, dye ingress testing and helium leak detection was the leading method used for container closure integrity testing. However, in recent years, there has been the use of more deterministic methods to get more precise results.. The limitations associated with these methods have led to attempts to test package integrity quantitatively.
Modern leak testing method utilize pressure and force decay testing. The leak testing device from Sealtick offer underwater leak testing method and non-destructive flexible package integrity testing. The latter offer advantages for traceability, semi-automated system and non-destructive testing while the underwater tester allow the users to visually locate the leak.
Quality packaging is pivotal in ensuring the quality of pharmaceutical products and cannot be overlooked… The packaging must be leak-tight and gas impermeable to avoid contamination and change the chemical structures of the drugs. For efficient packaging, it is important for manufacturers to consider both the products and the process used in the distribution system.
Are you looking for a testing equipment to ensure high-quality packaging?
At Sealtick, we understand your need for an effective leak testing equipment. We have a complete range of equipment for quality leak testing for various industries. We supply from conventional under-water leak testing machine to high-end flexible package integrity testing machine. With our high-quality testing equipment, you can meet rigorous quality standards and be confident that customers are satisfied with your brand. If you wish to know more about Sealtick Leak testing devices, feel free to reach out to our team. One of our application engineers will contact you to assist with your applications. Alternatively, you can also email us at sealtick@bestech.com.au or call us at +61 3 9540 5100.
