i want to know how we minimize the bio burden in production area.what are the method for suppress microbial growth in production area.
1.Implementation of effective and validated Cleaning and Sanitization agents.
2.Review your sanitization procedure.
3.Review of Disinfectant validation.
4.Increase Frequency of Cleaning and sanitization
5. Monitor inputs for the procedure.
Need to done fumigation in the respective area once in 15 days
It is required to do filtration of surfactant solutions with 0.2 micron before mopping?
After validating the frequency of fumigation or fogging…
Generally GMP guidelines (WHO , EU (PIC/S) , FDA) and PDA require using “sterile” disinfectants and detergents inside Grade A , B areas
Therefore sterilizing filtration with 0.2 micron sterilizing grade filter is a minimum requirement
First of all check the following:
- Gowning procedures and with this swap testing of gown for testing of microbes presence.
- Material movement and it’s packing material in case of raw materials.
- Then we have to work on the cleaning agents and procedures.