European Union In the European Union, the inspection of both sub-visible and visible particles in parenteral products is governed by the European Medicines Agency (EMA) and the European Pharmacopoeia, with detailed guidelines ensuring the safety and quality of injectable medications. Here’s a comprehensive overview of the regulations: Visible Particles Sub-visible Particles Japan In Japan, the […]
Automatic Visual Inspection Machines In the pharmaceutical industry, ensuring the safety and quality of parenteral products is paramount. Any deviation from quality standards can have severe consequences for patients’ health. Among the various quality control measures employed, automatic visual inspection machines play a crucial role in detecting defects and contaminants in parenteral products. This article
Regulation and Guideline of particles inspection in parenteral products in USA In the United States, the regulation of sub-visible and visible particle inspection in parenteral products is primarily governed by the Food and Drug Administration (FDA) and outlined in the United States Pharmacopeia (USP). These regulations ensure the safety and quality of injectable medications through
intravenous (IV) solutions play a critical role in patient care, enabling the administration of fluids, nutrients, and medications directly into the bloodstream. The bottles or bags that contain these solutions are just as crucial, as they must ensure the safety, efficacy, and sterility of their contents. This comprehensive post delves into the specifications for IV
The automated hemodialysis tube assembly machine is a sophisticated piece of equipment designed to ensure the efficient, precise, and consistent production of hemodialysis tubing sets. These machines incorporate advanced automation technologies to meet the high standards required for medical devices. This document provides a detailed overview of the assembly process, inspection procedures, and the technologies
