Hi everyone! Im fairly new to GMP and validation, so after a week of research i still cant answer two question below:
- Is the following table from ISO 14644-1: Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration:
is applied for the number of microbial air and surface (ie floor and wall) samples ? If not, how can we determine the needed number of microbial samples ?
- In Airborne particle counts test of dispensing booth qualification, to determine the number of sampling location to find out the airborne particle, we need to calculate the size of room as the green line or red line ?
Thank everyone for reading this and hope you have a nice day!
Ps: sorry for my bad English.