Sterility Testing of the sodium cromoglycate Eye Drop Formulation

Sterility Testing of the Sodium Cromoglycate Eye Drop Formulation Sterility Testing of the Sodium Cromoglycate Eye Drop Formulation Introduction: Sterile products are necessary within a pharmaceutical environment because they serve to ensure that the agents are free from any micro-organism contaminants. This assurance arises as a result of procedures conducted on the apparatus and equipment within the centre, enabling them to be safely used within a pharmaceutical setting. The environment of the pharmacy itself is most commonly associate with the activity of peering medications for sale to a customer who has a specific medical need. Because most such items sold at a pharmacy will eventually be ingested into the human body, the area in and around the pharmacy should be kept free from any microorganisms that might spread infection within the human body.
The specific eye drop formulation used in this lab consists of several different key components that increase its efficacy. In this case, the components in question are Benzylpenicillin and para-aminobenzoic acid. The effectiveness of these particular products in sterilising against the presence of microorganisms is seen once the products themselves are activated. As a result, in order for Benzylpenicillin to break down penicillin, it does need to first be inactivated by banzylpenicillinase. In addition, para-aminobenzoic acid produces folic acid that can hinder some of the processes taking place within any bacteria that is present, effectively sterilising them (Regamy 2004).
In an effort to test for the presence of a wide range of microorganisms, a number of different specimen should be used. In this case, sulfonamid, phenyl mercuric nitrate, sodium metabisulphite, and sodium edentate were used as they provide an environment that allows for the ready testing of a variety of microorganisms, as opposed to a situation that would result if the eye drop formulation were composed of only one compound.
Sterilisation is a process that involves the utilisation of chemical compounds that are designed to inactivate the functioning of disease causing microorganisms (Akers 2005). This experiment involved the use of several biological and physicochemical indicators that included quaternary ammonium compound (QAC), penicillin, sulphonamide, phenol sodium edentate (EDTA), and mercurials. The methods used to test for actual sterilisation included non-ionic detergent, beta lactase, the use of p-aminobenzoic and dilution method, and thioglycollate.
The results revealed that the oxidised and reduced Brewer’s medium solutions retained their colours of green and hello respectively. This confirms the presence of aerobic and fungal and anaerobic controls respectively (Regamey 2000). The control organisms of Clostridium sporogenes and Candida albicans were sterilised via an anaerobic and fungal control method.

The outcome of the experiment is deemed to be reliable. This is due to the fact that the experiments were conducted in a suitable environment. This is illustrate by the anaerobic control method that resulted in all traces of oxygen being eliminated by the boiling of water (Henri 2008). Additionally, a single control was utilised for the aerobic, anaerobic, and fungal control respectively. Before any experiment such as this is carried it out, it is always wise to carry out a sterilisation process to its completion. This is accomplished with the objective of killing any microorganism that would otherwise have the potential of interfering with the test or control that is under investigation. The parametric release will serve to help other individuals who are interested in carrying out the same test as a later date. They can also simplify their work in case one has the need to repeat the experiment, as they will have these results as a point of reference.
Akers, M. J. (2005). Parental quality control: Sterility, pyrogen, particulate, and package integrity testing. M. Decker.
Henri, R. (2008). Guidance for industrial validation of growth-based rapid microbiology methods for sterility testing of cellular and gene therapy. Department of Health and Human Services.
Regamey, R. H. (2004). International symposium on sterilization and sterility testing of biological substances. S. Karger.
Regamey, M. and Regamey, R. H. (2000). Recommendation of sterility testing. Pharmaceutical Inspection Convention.

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