Tajamul Manzoor’s Post

View profile for Tajamul Manzoor, graphic

QC Environmental Senior Officer at SPIMACO

𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻, 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗨𝘀𝗮𝗴𝗲 𝗼𝗳 𝗡𝗼𝗻 - 𝗩𝗶𝗮𝗯𝗹𝗲 𝗽𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝗰𝗼𝘂𝗻𝘁𝗲𝗿 👉NVPC stands for Non-Viable Particle Count 👉It refers to the measurement and monitoring of the concentration of non-living or inanimate particles present in the air within a controlled environment. 👉Non-viable particles are monitored using particle counter. 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲 👉A non-viable particle is a particle that does not contain living microorganism but acts as transportation for viable particles. 👉A particle passes through a laser beam, and a photodetector is used to detect the change in the light. 👉 Basically, the particle casts a shadow, and the particle counter uses that shadow to determine the size and number of particles. 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗻𝗴 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 👉Ensure the fully charge of the equipment 👉Carryout to the working place 👉Before operation ,do purge the equipment by Zero filter(Zero Count Filter & Zero Counting-This is a filter that attaches onto the sample inlet of the particle counter and enables the user to determine that the sensor is clean, the number of falsely reported particles using filtered air at the optimum flow rate for a given amount of time.) 👉After completion of Zero filter for 0-1 min, To start the dynamic sampling (1 min) or tatic sampling (10min) on the location( Delay time 15 sec- A delayed start allows any impact or environmental contamination from the operator to be 'cleaned' from the area before the sample is taken) 👉This helps to ensure that the operator setting the samples does not influence the sample result. 👉After sampling to stop automatically and print the data. 👉Check the data within the limits 𝗦𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝗰𝗲 𝗼𝗳 𝟬.𝟱 𝗮𝗻𝗱 𝟱 𝗺𝗶𝗰𝗿𝗼𝗻 👉Most of the commonly found bacteria are in the size range of 0.5 to 5.0 micron so this size range is the main source of contamination. 𝗖𝗮𝗹𝗶𝗯𝗿𝗮𝘁𝗶𝗼𝗻 👉Once in year by approved vendor 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 👉Clean the Equipment by using 70% IPA (Before cleaning ensure OFF, unplug, close sampling probe) 👉To clean the equipment from Low grade to high grade 𝗦𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗣𝗿𝗲𝗰𝗮𝘂𝘁𝗶𝗼𝗻𝘀 👉It is an essential in pharmaceutical manufacturing to ensure the control and prevention of airborne contamination. 👉Overall, environmental monitoring for aseptic processes evaluates whether ISO-certified clean environments (such as restricted-access barrier systems (RABS) and isolators used for aseptic processing) are suitable for preventing microbial contamination of medical products during manufacturing, packaging, or testing. Reference:USP<797>

  • No alternative text description for this image

To view or add a comment, sign in

Explore topics