Regulators encourage the use of restricted access barrier system (RABS) or isolator technologies. Such settings minimize direct human intervention in a process, reducing the risk of microbial ingress from operators. Transition from a classic design based on grade-A or grade-B cleanrooms to an upgraded facility is not to be taken lightly. Such a project would…
Kaizen is a Japanese term meaning change for the better or continuous improvement Kaizen fosters an environment where employees at all levels are continually involved in suggesting and implementing improvements to their workflows. This approach not only increases efficiency and productivity but also instills a sense of ownership and teamwork among employees, encouraging them to…
There are many reasons for using less than one (<1) cfu instead zero: Detection Limits Sampling Limitations False Sense of Security Risk Management Example: In a cleanroom where air samples are taken, if an active air sampler processes 1 cubic meter of air and no colonies are detected after incubation, the result is reported as…
In terms of infection control, ‘Log Reductions’ convey how effective a product is at reducing pathogens. The greater the log reduction the more effective the product is at killing bacteria and other pathogens that can cause infections. ‘Log’ is short for logarithm, a mathematical term for a power to which a number can be raised….
Bioburden is the term used to describe microbial contamination of a product prior to sterilization. Microorganisms can be introduced at any point during the manufacturing process through raw materials, the environment, humans, or during the final stage of cleaning and packaging. Since the sources of contamination can vary widely, a product’s bioburden can fluctuate from…
Problem Statement: The hydraulic pressing machine’s malfunction disrupted the assembly line. Root Causes: The pump failed because its filter was clogged and wasn’t cleaned regularly Evidence/Data/Fact: Solution Idea Corrective Action Preventive Measures Read also: Resource Person: Poonath Sekar
A settle plate is an agar plate, placed in a defined location. For consistency of sampling, for cleanroom it used in the pharmaceutical industry for semi-quantitative determination of microbial contaminations in the air. After four hours, they have undergone their maximum weight loss and should not be used for further examinations. Experiments showed that the…
At low moisture levels, termed the (pendular state), the particles are held together by lens-shaped rings of liquid. These cause adhesion because of the surface tension forces of the liquid-air interface and the hydrostatic suction pressure in the liquid bridge. When all the air has been displaced from between the particles, the (capillary state) is…
