Branch	Locations	Status	Reservations	Due date	Barcode	Floor plan	Lending note
Branch: Hauptstelle	Locations: ME-30 58	Status: available	Reservations: 0	Due date:	Barcode: 00181056	Floor plans: Floor plan	Lending note:

Table of Contents

 

Introduction to microbiology. Microbial contamination: spoilage and hazard. Microbial ecology of the production process. The design of controlled environments. Microbiological considerations for biotechnological products. Microbiological considerations in the production of medical devices. Good manufacturing practice in the control of contamination. Dispersion of airborne contaminants and contamination risks in clean rooms. Monitoring microbiological quality: conventional testing methods. Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals. Principles of sterilization. Sterilization methods. Assurance of sterility by process validation. Principles of preservation. Antimicrobial preservatives and their properties.

Preservative stability and efficacy: formulation influences. Package integrity testing. Official methods of preservative evaluation and testing. Preservative evaluation and testing : the linear regression method. Preservatives, antimicrobial agents and antioxidants: registration and regulatory affairs. Microbial standards for pharmaceuticals. Risk management and microbiological auditing.