An essential element in ensuring aseptic conditions is the maintenance of HEPA filter integrity. Integrity testing should be performed at installation to detect leaks around the sealing gaskets, through the frames or through various points on the filter media. Thereafter, integrity tests should be performed at suitable time intervals for HEPA filters in the aseptic […]
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 […]
Filtration is a common method of sterilizing drug product solutions. An appropriate sterilizing grade filter is one which reproducibly removes all microorganisms from the process stream, producing a sterile effluent. Such filters usually have a rated porosity of 0.2 micron or smaller. Whatever filter or combination of filters is used, validation should include microbiological challenges […]
3. Steps of Validation Validation plans for water and air systems typically include the following steps: 1. Establishing standards for quality attributes of water and air to manufacture pharmaceuticals. 2. Defining systems and subsystems suitable to produce the desired water and air by considering the quality grades of water and air. 3. Designing equipment, controls, […]
