STRATEGY FOR THE DETERMINATION OF EXPOSURE LIMITS IN THE BIOPHARMACEUTICAL INDUSTRY.

• Dr. Dania Bacardí Fernández

• Spanish / Español

• exposure limits
• multiproducts facilities
• noael
• pde

During the manufacture of medicinal products in multiproduct facilities, the chances of cross-contamination is a concern. To guarantee the safety of operators exposed to active substances, the establishment of cleaning limits is considered, which are a determining factor in the validation studies in the pharmaceutical industry. The objective of this work is to recommend a viable approach to evaluate the toxicological and pharmacological data of the active substances in the determination of the t...