Controlling contamination in GMP classified areas requires much more than cleaning and disinfection. Operations need to assure that a complete system of control that starts with entry of components and personnel to the facility is established. This course will identify and describe systematic elements essential to assuring an appropriate and compliant contamination control program for aseptic manufacturing facilities, classified and non-classified environments. This course will also highlight the important aspects of the new and soon to be released Cleaning and Disinfection Technical Report from PDA.
The course covers the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy micro-organisms. While sterile product manufacturing has the most stringent application, the concepts introduced during the course can also be used to design a program for the manufacture of non-sterile products.
- Sanitizers, disinfectants, sporicides
- Regulatory guidance
- Qualification of new vendors and agents
- Control of the environment
- AOAC protocol testing for disinfectant registration
- In use expiration dating
- In-situ field studies
- Sterility of solutions and cleaning agents
- Cleaning and disinfection
- Frequency for cleaning and disinfection
- Resistance and rotation
- Return from a shutdown
- Hold times for cleaning areas, non-product contact equipment and