Titolo della tesi: Validation of Sterility ATP-based method for drug product analysis
Microbiological testing in pharmaceutical companies plays a crucial role in ensuring the safety, quality, and efficacy of pharmaceutical products. Microbial technologies are becoming increasingly crucial in pharmaceutical laboratories. Regulatory agencies have encouraged the adoption of innovative approaches to enhance the control and quality of biologics. This growing demand has driven the development of Alternative Rapid Microbiological Methods (ARMM). These methods encompass a variety of techniques that provide faster results compared to compendial methods.
This accelerated testing allows, in case of contamination in the manufacturing process, for faster decision-making, reduced testing cycles, and quicker release of raw materials, in-process materials, and finished products.
ARMMs are generally objective, removing the need for subjective colony counting or broth turbidity assessments. Besides, results can be captured electronically and archived, ensuring strong data integrity standards in accordance with CFR 21 part 11 requirements.
In this dissertation the validation of the Celsis technology for the Sterility Test application is described. Sterility testing is a critical Good Manufacturing Practice (GMP) requirement designed to confirm that products are free from viable microorganisms before their release and administration to patients. This test is especially important for injectable products, where patient safety is paramount.
The validation of this alternative method was carried out in accordance with guidelines such as EP 5.1.6, USP <1223>, and PDA TR 33.The equivalence among the ATP-based Alternative Rapid Microbiological Method, performed after 7 days of incubation, and the compendial Sterility Test, which requires 14 days of incubation, has been demonstrated.