About Me – Siva Sankar

Welcome to my blog! I am Siva Sankar, a pharmaceutical microbiology insights with over 17 years of experience in the pharma industry. I specialize in microbiological testing, sterility assurance, environmental monitoring, CAPA investigations, and regulatory compliance.

My mission is to help pharmaceutical companies maintain GMP compliance and ensure product safety and quality through professional consulting, audits, and trainings.

Through this blog, I share insights, case studies, and practical tips in pharmaceutical microbiology to help professionals and students stay updated with industry standards.


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What is the difference between Equipment and Instrument

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Equipment is the machine that's processing the work and the instrument is to measure the data that comes out of the machine to get feed back of the machine and the process. Equipment used for a specific work and instrument is measuring parameters. Like temperature and pressure. Instruments are part of equipment, number of instruments comprises a equipment. Equipment is processing (attach with large assembly) device but instrument is measuring device (small assembly). Example : Autoclave is a equipment and in autoclave pressure gauge and temperature sensor is an instrument.
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Alert and Action Limits

In pharmaceuticals alert and action limits are very important, because these limits are effective control to the process. alert and action limits are in house limits, these limits must be less than guideline limits or define limits. Alert and action limits defined based on trend analysis. alert and action limits are like a barrier before the guideline limits. Alert Limit: To be alert the microbial counts reach to this alert level. It is nor necessary to take any action. Possible deviation from normal process condition This is a trigger, that something is going wrong means microbial count increasing that area. Action Limits: When microbial count reach this action limits then action is mandatory. To control the  microbial count in the area. Signal an apparent deviation from normal process condition And require immediate action. If not controlled, we might get area failure. These alert and action limits must be less than final limits. Example : A...
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How to calculate the log reduction?

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·          "Log reduction" is a mathematical term (as is "log increase") used to show the relative number of live microbes eliminated from a surface by disinfecting or cleaning. ·          For example, a "5-log reduction" means lowering the number of microorganisms by 100,000-fold, that is, if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one. Log Reductions 1 log reduction means the number of germs is 10 times smaller (10 1 ) 2 log reduction means the number of germs is 100 times smaller (10 2 ) 3 log reduction means the number of germs is 1000 times smaller(10 3 ) 4 log reduction means the number of germs is 10,000 times smaller(10 4 ) 5 log reduction means the number of germs is 100,000 times smaller(10 5 ) 6 log reduction means the number of germs is 1,000,000 times smaller(10 6 ) 7 log reduction means the number of ger...
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