Evaluation of the chemical resistance of glass containers used in the pharmaceutical industry

Abstract

This paper assesses the chemical resistance of glass containers of types I, II, III, and NP (borisilicate, treated sodium calcium, untreated sodium calcium, and general-purpose sodium calcium), used to contain sterile liquids, non-sterile liquids, and sterile solids. It also attempts to establish a rapid method for assessing the chemical resistance of these containers and to determine the chemical resistance of type I glass containers in order to understand their behavior when used more than once. The methods used to evaluate the resistance to chemical action of glass containers are the following: those described by the United States Pharmacopoeia XX - NF XV and the International Pharmacopoeia, and qualitative methods, release of soluble alkali by observation of precipitate in solutions of monobasic sodium phosphate, sodium tartrate and sodium citrate, all at 10% / O, and release of soluble alkali by color change in solutions of phenolphthalein, 0.1% / O. The results obtained indicate that the type I, II, III and NP glass containers evaluated comply with the requirements established by the cited pharmacopoeias and are also within the limits established by the qualitative methods. The results of the qualitative methods tested are applicable for the classification of type I, II, III and NP glass containers. Regarding a rapid method for evaluating the chemical resistance of glass containers, the method proposed by the International Pharmacopoeia is practical and requires less time and equipment. It can also be seen that in the case of Type I glass containers, which were tested several times, there is an alkali release proportional to the number of times the container is tested.