Selecting the right barrier technology in a GMP environmen
GMP-Verlag Peither AG · Doris Borchert
DE
The use of barrier systems to protect sterile pharmaceutical products is explicitly required in Annex 1 of the EU GMP guidelines. As a result of this requirement, isolators and RABS are taking centre stage over other existing technologies. There are different designs for both systems, which differ in terms of applicability and cost.
We talk to Dr Florian Sieder about important aspects when selecting the right barrier technology. What safety and environmental aspects need to be considered in addition to the regulatory requirements? What are the contamination risks associated with the different systems and what protective measures are available? The properties of the products to be processed and the steps in the manufacturing process are further aspects that influence the selection of suitable barrier technology. The transfer steps are a critical aspect of contamination control. With regard to process safety and employee protection, the highest possible degree of automation and closed process control should be achieved.Agenda
- Regulatory and safety requirements
- Contamination risks and protective measures
- Product properties and manufacturing process
- Transfer steps
- Automation and closed process control