Quality assurance for the production and performance testing of alcohol gel for hand sanitizers

Abstract

The demand for alcohol-based hand sanitizers containing at least 65% alcohol by weight has increased. However, the quality of these products has often been inconsistent. This research aims to ensure the quality of alcohol gel production and to test the efficiency of alcohol measurement devices in the factory. Two critical control points (CCPs) have been identified. The first critical control point (CCP1) involved verifying the quality of the main raw materials - denatured alcohol, gelling agents, and pure water by utilizing the certificate of analysis results to ensure compliance with acceptance criteria. The second critical control point (CCP2) was to measure the alcohol content before packaging using an alcohol hydrometer with an accuracy of no more than 1.25%. This measurement required a sample prepared with 5M hydrochloric acid (HCl). Additional control points include the accuracy and precision of the balances, as well as the cleanliness and neutrality of the glassware and mixing equipment. All processes were traceable via a digital data recording system, implemented using spreadsheet software (e.g. Microsoft Excel), to ensure reproducibility. The final product could be stable, with a pH of 5.8 and an ethanol content of 77% by volume. The product was considered bactericidal effective when log reduction (lg R) of the reference bacterial amount after one minute contact time was ≥ 5. This quality assurance process in alcohol gel production ensures compliance with legal standards and guarantees product effectiveness.