RT Journal Article
SR Electronic
T1 Hazard Analyses of Airborne Contamination in Clean Rooms—Application of a Method for Limitation of Risks
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 239
OP 243
VO 49
IS 5
A1 B. Ljungqvist
A1 B. Reinmüller
YR 1995
UL http://journal.pda.org/content/49/5/239.abstract
AB Hazard Analyses and establishing of Critical Control Points (HACCP) using a method with Limitation of Risks, known as the LR Method are described. This method has a concept involving visualization of air movements, particle challenge testing and calculation of a risk factor. The calculated risk factor and the estimated exposure time form the basis for the HACCP. The LR Method can also be used as an engineering tool to achieve microbiologically safe processes with regard to airborne contamination. As an alternative to the increasing extent of microbiological monitoring sampling, a system is discussed that combines continuous monitoring of particle levels with particle counters and a limited monitoring of viable particles with air samplers.