The pharmaceutical industry is under new regulations worldwide with the clear objective of ensuring the quality and efficacy of the medicinal product. The importance in the Quality Risk Management and particularly in the holistic risk analysis is the base of this new era.
In Vestilab, we help our customers identify current risks and propose the correct and effective solutions.
Risk Identification: Sterile filling lines require sterile alcohol for cleaning and sanitizing purposes. When the RTU alcohol is not available, companies filter alcohol and use containers that are processed and re-used several times. This introduces several risks when the inadequate containers are used.
These are the most critical RISKS associated to the reusable triggers:
Contamination of the environment. Most of the dispensers that are used to spray the alcohol are manufactured with materials that can contaminate the environment themselves. Some sprayers has metallic components that are not compatible with chemical sanitization and generate particles. The reutilization of this sprayers increase the risk for the environment.
Contamination of the alcohol (solution). The chemical sanitization of bottles or triggers, instead of autoclaving them, has a risk of contamination comming from the chemical itself. The residues left by the chemicals on the triggers may be transferred to the alcoholic solution, which will be used in the most critical sterile areas. Lack of validation: the autoclave method is easier to validate than a chemical manual sanitization.