Instead of comparing barrier systems solely in terms of investment costs, energy consumption offers another insightful approach – especially as it is in line with the recent trend towards green pharmaceutical manufacturing. Depending on ambient conditions, regulatory- and production-related parameters and the respective air supply systems, the energy consumption of Restricted Access Barrier Systems (RABS) and isolators varies significantly. For instance, isolator systems can save up to 65 percent of energy compared with RABS, while active RABS are up to 30 percent more energy-efficient than passive RABS.
The new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs.
Aseptic processing in pharmaceuticals is not without its complications, particularly as they relate to reducing patient risk. This white paper discusses an easy-to-use aseptic processing method that is based on real-world risk factors instead of theoretical concepts while emphasizing the impact of a pharmaceutical manufacturer’s personnel.
This article discusses the removal of bacterial endotoxins in a washing process and the need for a continuous monitoring activity according to common cleaning validation practices. Results of washing tests performed with different load materials following an effective cleaning strategy to remove microbiological soil are presented. In addition, this paper compares two different online assay methods: conductivity analysis and Total Organic Carbon analysis.
Mobile Clean Room (MCR) systems are preengineered, self-contained cleanroom environments that can be used wherever and whenever they are needed.
The Central Fractionation Unit of the Belgian Red Cross (C.A.F.-D.C.F.) headquartered in Brussels supplies the domestic market with plasma proteins and acts as a contract manufacturer.
With the aim of reducing costs, Normon planned to significantly increase its batch sizes for certain products. The manufacturer needed to pay close attention to the high quality and safety standards and economic aspects, as well as flexible production sizes and times.