Introduction:
Pharmaceutical packaging plays a vital role in preserving the quality and safety of medicines. Hence, it is critical to ensure that the packaging materials meet the required quality standards to ensure product efficiency and safety. Packaging testing is the method of verifying if the packaging systems satisfy all the necessary requirements during and after the product’s transportation.
In this case study, we will examine the pharmaceutical packaging testing of a new antibiotic drug product.
Background:
A newly discovered antibiotic drug was in the manufacturing process, and the company needed an assessment of the packaging material’s ability to protect and preserve the drug’s quality throughout the distribution.
Approach:
Pharmaceutical packaging testing was carried out based on the classic and modern approach to ensure that the drug product’s safety is maintained, and packaging integrity meets the necessary requirements.
The classic approach or the physical testing of packaging included;
1) Seal strength testing: To assess the strength of the package’s sealing done by checking the force needed to open the package.
2) Compression testing: To determine the packaging’s ability to withstand external pressure during packaging and transportation.
3) Drop testing: To verify the ability of the packaging to resist falls from different heights to assess the packaging’s resilience.
The modern approach to the pharmaceutical packaging testing included;
1) Accelerated aging test: To forecast the shelf life of the drug product by scrutinizing the packaging performance when exposed to high temperature and humidity.
2) Transportation testing: To assess the ability of the packaging material to withstand vibrations and shock that can occur during product transportation.
3) Integrity testing: This technique indicates the packaging material’s ability to block oxygen, moisture, and light that can adversely affect the product.
Outcome:
The testing was successful and proved that the packaging material could withstand the necessary transport and storage conditions without losing the drugs’ quality or safety. This ensured effective protection against any external factors that might harm the drug product.
Conclusion:
The pharmaceutical packaging testing is a vital requirement to guarantee the drug’s safety and efficacy during storage, transportation, and distribution. The testing approach should be based on a classic and modern approach to evaluate the packaging material correctly. The successful pharmaceutical packaging testing of the new antibiotic drug product will ensure that the drug reaches the end-users in good quality and safe for consumption.
