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Knowing the expiration date of each product is one of the rights of consumers, therefore, all manufacturers are required to determine the expiration date and include it on their products. Before the expiration date, the quality and harmlessness of the product must remain within the specified and acceptable range. The expiration date is obtained through stability studies and the results are documented. One of the required documents in the regulatory systems is the information related to sustainability, the lack of which is considered one of the major non-compliances.
In this project, a study was conducted on three batches of bovine Theileriosis vaccine produced by Razi Vaccine and Serum Institute 04099011, 04099012 and 04099013, and 20 vaccine vials from each batch were kept at minus 70 degrees Celsius and at time intervals of 0, 3, 6 , 9, 12, 15, 18 months, sampling of vaccine bottles has been done and various quality control tests including Potency (viability), safety, sterility, Mycoplasma, pH, Appearance and Extractable Volume according to the sources accepted by the institute on the samples as accepted In addition, the potency test was performed on the samples stored at minus 70 degrees Celsius at intervals of one hour, two hours and five hours after melting at the laboratory temperature.
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