u r First answer:
microbial limit for sterile facility is 25 cfu/g.
for non-sterile facility 80 cfu/g.
u r second answer:
micro monitoring is the intergral part in cleanin validation.
all guidelines says that,microbial proliferation should be in limit,during u r routine production activities.
So micro samples has to be taken in cleaning validation study.
u r third answer;
criteria for worst case selecion:
most potent ,least soluble,minimum human adult daily dose is least,
maximum allowable residue is less.
these r the parameter for worst case selection.
u r fourth answer:
for cleaning validation there must be three successful consecutive runs,for
cleaning verification one succesful run is must( ref: nash & Welcher: pharmaceutical Process validation).
there is one guideline releated to micro issue.
pls send u r mail id so that i can send u.
sop for cleaning should be available in draft,after operational qualification,
it should be finalised after Performance Qualification,
After PQ run equipment should be cleaned and can be tested for cleaning verification.