Working in a cleanroom under GMP isn’t easy, you have your gowning to consider, your movements, your equipment. Qualifying aseptic operators poses a significant challenge, not because it’s extremely difficult but because it requires great care and attention to detail. Training The more relevant experience the person has, the easier the training and qualification will…
Dry heat sterilization is one of the most practical and preferable forms of sterilization, using blown hot air to eliminate or deactivate all forms of life the setting must be at 160 °C (320 °F) for a duration of two hours, 170 °C (340 °F) for one hour, and up to 190°C (375°F) for 6…
Disinfection Sterilization Disinfection and sterilization have a few things in common. These include: Read also: Resource Person: Ch/Ahmed Mahmoud
High-Level Disinfectant High-level disinfectant is a type of cleaning agent that’s proven to be effective at killing certain pathogens, viruses, bacteria, fungi, spores, and other contaminants. It’s designed to eliminate a wide range of microorganisms that can cause health-related issues or contribute to an outbreak in the community. High-level disinfectants are considered the strongest form…
Fumigation is a method of pest control or the removal of harmful microorganisms by completely filling an area with gaseous pesticides, or fumigants. It involves heating a 40% formaldehyde solution to generate vapor, which is left in the sealed room for 12-24 hours. Formalin is available as 40% solution of formaldehyde in water. When Formalin…
A particle counter is a device designed to measure, monitor, and diagnose particles of any substance in a given volume of media like air, water, or other chemicals. They are also used to detect particle contamination in clean media or on surfaces present within controlled environments. During particle count, we measure only 0.5 and 5.0-micron…
To calibrate a pH meter, follow these steps: Preparation Calibrate with Buffer Solutions Final Steps Important Tips Read also: Resource Person: Fredrick Mutua Mwaniki
Errors are not a reflection of individual incompetence but a result of complex interactions between human factors, system design, & environmental influences. We must abandon the naïve belief that BETTER TRAINING will MAGICALLY ERASE ERRORS and instead embrace a holistic approach. The CAPA framework focuses on both PREVENTION and REACTION to errors: PREVENTION: BUILDING A…
