SASIKALA CHENNIAPPAN

  Disinfectant Qualification test Introduction The use of disinfectants as agents to control microbiological contamination of an environment is well established and is governed by regulatory bodies in both Europe and the United States. Under FIFRA, chemical disinfectants are considered “antimicrobial pesticides”. For disinfectant end-users within the pharmaceutical sector, regulations also state the need for them to demonstrate disinfectant efficacy. The US Food and Drug Administration (FDA) guidance for pharmaceutical industry states “The suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces”. The disinfection process should be validated. Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner in which they are used...

  Bioburden testing Introduction The  Bioburden test ,  bioburden  or  microbial load , is a term used to describe the presence and measure the level of viable microorganisms on a surface or in a specific device before sterilization. Bioburden  is the sum of microbial contributions from a number of sources: Raw materials used in the manufacturing process. Introduced via labor or the assembly/manufacturing environment. During cleaning processes and packaging of the finished product, etc. The reason for performing the  Bioburden test , varies and depends on the field and the final application of the product tested. Qualitative/quantitative measurements help determine whether the types and numbers of microorganisms present are satisfactory or not against the predefined acceptance criteria. The  bioburden test  is designed to count the number of microorganisms (as colony forming units, CFU) in a product or materi...

  Sterility checking of pharmaceutical products - Direct Inoculation  method Introduction Reliable sterility testing and the development or validation of product-specific methods are critical steps in the drug development process. We have established a track record supporting the testing of cell lines, media, in-process, and final product testing for the pharmaceutical, biopharmaceutical, and medical device industries. We also have a robust quality infrastructure to support CGMP testing according to USP and EP methodologies. Aim To check the sterility of pharmaceutical products by various methods. Materials and Methods Direct Inoculation and Membrane Filtration Methods Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment. Procedure Sterility Testing Techniques Di...

   Cultivation of Virus – Egg Inoculation method (Demonstration) Introduction             Embryonated eggs are utilized as a laboratory host system for primary isolation and propagation of a variety of different viruses, including the avian coronaviruses, infectious bronchitis virus (IBV), turkey coronavirus (TCoV), and pheasant coronavirus. They have been extensively utilized for propagation of these viruses for research purposes and, in the case of IBV, for commercial production of vaccines. In addition, embryonated eggs provide a potential host system for studies aimed at identifying other, novel coronavirus species.             The embryonated egg is comprised of the developing embryo and several supporting membranes which enclose cavities or “sacs” within the egg. The shell membrane lies immediately beneath the shell; this is a tough fibrinous membrane that ...