Microbial Air Sampling Plans in Cleanrooms According to Regulatory Authorities

The measurement of air supply volumes and velocities in cleanrooms

Air supply volumes and velocities in cleanrooms are monitored by airflow measuring hoods and anemometers but these measuring methods can be inaccurate if used incorrectly. It is demonstrated in this article that measuring hoods are accurate if the air supply passes evenly out of the hood, as occurs when the air volume is measured from a four-way diffuser or no air supply diffuser. However, when...

Differences in the correlation between microbiological air sampling and particle counting in operating theatres and hospital cleanrooms

Introduction / objectives The process of environmental monitoring in cleanrooms of clinical pharmacy and operating theatres is difficult, the measurement of bio burden is time consuming and the result is available several days after the operation. This study examines the correlation between the number of airborne bacteria and particles in operating theatres and cytostatic compounding cleanrooms...

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene.

European regulatory authorities and pediatric labeling.

Ethical Considerations Children should not be given medicines that have not been evaluated adequately for use in that age group. There is a responsibility, shared by applicants and the appropriate authorities, to ensure that children have timely access to safe and effective medicines that have accurate, scientifically justified prescribing information. Applicants are encouraged to investigate t...

Sampling According to the Multivariate Normal Density

This paper 1 deals with the normal density of n dependent random variables. This is a function of the form : ce ?x T Ax where A is an n n positive deenite matrix, x is the n?vector of the random variables and c is a suitable constant. The rst problem we consider is the (approximate) evaluation of the integral of this function over the positive orthant Z 1 x1=0 Z 1 x2=0 ... Z 1 xn=0 ce ?x T Ax :...