With Pen and Paper
I always try to bring few important information or available information in a simplified way. After a long time I started work with Pen and paper and try to sketch and introduced few interesting topic.
Category: Technology
Growth in BI at Moist Heat Terminal Sterilization
Terminal sterilization is the reliable process to assure the sterility of the product. Regulators more relay on the Moist heat terminal sterilization process than aseptic processing. In terminal sterilization product sterilized in the final container. Terminal sterilization should be utilized when the product and container/closure system are able to withstand the terminal sterilization process. Note: Kindly […]
COVID-19 vaccine human trials at India
India always stand in the first row whenever there is a chance to serve for humanities and social welfare. Pharmaceutical sectors in India is one of the highest contributing segments, firms are not only generating revenue and also serving patients across the globe with high quality (safe, pure and efficacious) medicines. Pharmaceutical quality is […]
Handling Planned Shut Down in Water System and Return to Service
The words “plant shutdown” — even if referring to a temporary one — can be associated with a long litany of negatives. Stopping production, no matter the duration, results in decreased revenue. The additional resources and other costs associated with the shutdown make it a very expensive endeavor. Most shutdowns are highly complex and carry […]
Vaccine manufacturing process
Vaccines are a group of pharmaceuticals that include some of the oldest biologically-made compounds. The Smallpox vaccine was introduced by Edward Jenner as early as in 1796 and Louis Pasteur created the first live attenuated bacterial (Chicken Cholera) and viral (Rabies) vaccines at the end of the 19th century. A vaccine contains an antigen that […]
Rationale for using triplicate biological indicators during VHP decontamination in Isolator
One of the key advantages of using an isolator for an aseptic processing application is that it makes a physical barrier between the operator and the core aseptic processing area. Additional main benefit is that an isolator can be totally sealed before aseptic activity starts, allowing for the exposed interior surfaces within to be bio-decontaminated, […]
Trouble with Equilibration Time
Understanding and analysis of Equilibration Time will tell, how your cycle is consistent. Recently an article in PDA journal (1) was published to understand the impact of the following autoclave variables on the consistent measurement of the equilibration time and on the reduction of the equilibration time. Based on the all demonstrated study in the […]
Root cause identification for NVPC Excursion
For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly, except where justified by contaminants in the process that would damage the particle counter or present a hazard, for example, live organisms and radiological hazards. In such cases monitoring during routine equipment set-up operations should be […]