Editorial: CAPA is continuous improvement NOT failure management
George Sykes Memorial Winner Announcement
Releasing capacity of pre-sterile cotton swabs for discharging sampled microorganisms Ravikrishna Satyada and Tim Sandle
Abstract: Surface monitoring by using swabs forms a regular part of environmental monitoring of cleanrooms.
There are different factors that affect swab recovery, from tip type to enumeration method. One factor with swabs where the microorganisms are detached from the swab tip and which are then membrane filtered is the period of vortex mixing. This paper discusses microbial surface sampling, and the factors that affect swab recovery, and presents some experimental data where vortex times are considered for a range of microorganisms. The study outcome indicates that 15 seconds of vortex mixing is sufficient to obtain microbial recoveries from the swab tip above 50%.
Science and Technology Papers Assessing surface purity in clean process environments Peter Knott
Abstract: The assessment of surface quality plays a significant role in the clean process. Contact and technical surfaces near a product must be monitored to ensure an optimum clean process, and a range of relevant measurement techniques and principles are available. The assessment of surface purity is a challenge.
Summary of Chapter 2 of Technical Monograph 20 Rhett Griffiths Regulatory review Malcolm Holmes PHSS activity and initiatives report