Inhalation drug product testing
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Introduction to pharmaceutical microbiology
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Identifying sustainable alternatives to existing packaging is far from straightforward. In this case the new packaging's primary function must be to preserve the quality of a diverse range of food matrices to ensure the food product remains in the condition consumers want. Almost as important as this, we wanted to ensure the alternate packaging was able to be used in conjunction with the clients existing production line.
We used apparatus for measuring the oxygen transmission rate (OTR) and the water vapour transmission rate (WVTR) where highly sensitive sensors measure the concentration of a test gas (oxygen or water vapour) in a test chamber separated from the flow of test gas by a packaging film barrier. A measurement is obtained when the concentration of the test chamber reaches a steady value.
Seal Strength and hot tack testing was performed on candidate films to enable the clients packaging engineering team to decide if the candidate films would run on the customer’s existing packaging line as well as determining what settings were optimal to achieve the desired through-put in the factory.
Burst and leak testing was used to show that sachets of package product had mechanical integrity before a shelf-life study comparing the customers’ existing packaging. From this, a packaging material was selected suitable to replace the current packaging material.
Burst Leak Tester (Apparatus) used to fill packaging with compressed air to access leakage and ultimate pressure packaging will withstand.
During an extended shelf-life study, to assess the selected packaging options, the packaged product developed a musty smell and began to clump. Karl Fisher analysis showed that the moisture content of the product had increased from the value at which it was packed and taints analysis by GC-MS showed the presence of goemin which can be indicative of microbiological activity. The barrier properties of the particular candidate film from the package itself to water was reassessed and showed it differed greatly from the initial specification for the unconverted film.
The analysis at RSSL enabled the manufacturer to choose a recyclable alternative for their existing packaging and have confidence that the product would achieve the required shelf life in the packaging materials.
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