Plastic materials used for plastic packaging systems and plastic packaging systems used for manufacturing pharmaceutical products consist of polimers with different molecular masses and different additives such as antioxidants, stabilizators, lubricants, plastificators and colourants. Different substances can physicochemically interact with plastic packaging systems for pharmaceutical use or plastic packaging systems used for manufacturing pharmaceutical products. This can cause accumulation of leachables in components that are in contact with plastic packaging system. Due to this interaction, it is important to choose quality, safe and efficient materials.
Aim of the master thesis was to ensure safety and quality of chosen plastic packaging systems for pharmaceutical use and plastic packaging systems used for manufacturing pharmaceutical products with different physicochemical tests according to subchapters of USP <661.2> and <661.3>.
According to the abovementioned subchapters, we performed testing on seven samples. We did tests of appearance of solution’s colour and clarity on extraction solutions of samples, we tested acidity or alkalinity, we measured absorbance on UV-VIS spectrofotometer in the spectrum between 230 and 360 nm, we also measured total organic carbon (TOC).
After all the tests, the results corresponded to the specifications in USP subchapters <661.2> and <661.3>. All extraction solutions were colourless and clear, absorbances of all the extraction solutions of all samples were under 0,2, differrence between TOC of the blank solution and TOC of the extraction solutions of all samples were lower than 5 mg/mL (according to specification in subchapter <661.3>) or lower than 8 mg/L (according to specification in subchapter <661.2>).
We can therefore conclude that the exctraction solutions of all tested samples of plastic packaging systems for pharmaceutical use and plastic packaging systems used for manufacturing of pharmaceutical products are safe and have good quality.
|
