In the process of drug production, ensuring the sterility of the production environment is one of the key steps to ensure the quality and safety of drugs. Therefore, it is particularly important to carry out regular and effective disinfection of various areas and equipment in the pharmaceutical factory, and to conduct scientific and rigorous evaluation and verification of its effects.

Pharmaceutical factories need to develop a set of disinfection effect evaluation methods suitable for themselves to ensure that the disinfection measures can achieve the expected goals and provide solid safety guarantees for drug production.

First of all, clarifying the evaluation object is the basis. This includes but is not limited to all parts that may affect product quality, such as the air, surfaces (such as operating tables and walls) in the production workshop, inside and outside the equipment, and hands of personnel. Through comprehensive coverage, the overall contamination risk caused by local omissions can be effectively avoided.

Secondly, it is crucial to choose a suitable disinfectant. According to different materials and environmental characteristics, select disinfection products that are efficient, low-toxic, and easy to remove residues. At the same time, the compatibility between disinfectants must also be considered to avoid adverse reactions or reduced bactericidal efficacy when mixed with multiple disinfectants.

In addition, a reasonable sampling plan should be formulated. According to relevant national standards and industry guidelines, samples should be collected at specific locations within a specified time after cleaning is completed. For air, the sedimentation bacteria method can be used; for the surface of objects, a sterile swab is required for smearing and sampling. A negative control should be set up for each experiment to exclude interference from external factors.

Finally, the collected samples are analyzed using microbial culture technology. The disinfection effect is judged by comparing the changes in the data before and after. In addition, rapid screening methods such as ATP bioluminescence detection can be used to assist in evaluating the degree of immediate cleaning.

Fantong Bio assists pharmaceutical factories in establishing a complete pharmaceutical factory disinfection effect evaluation system and provides disinfection effect evaluation services, which not only helps to improve the level of product quality control, but also promotes enterprises to continuously improve production processes, and ultimately achieve a win-win situation of economic and social benefits.