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Microbial limits in cleaning validation

Dear all,

As i’m new to validation ,can I get some guidance on

1.Microbial limits in cleaning validation for process equipments in multi-product manufacturing facility.

2.What exactly is Not more than 1 log increase in microbial count from initial results?(if initial microbial count is 10 and next count is 15)

3.Is microbial monitoring essential for all products in cleaning validation?

4.Based on what criteria worst case product is to be selected?

5.What is the difference between cleaning validation & cleaning verification?

6.At what point of new equipment qualification SOP’s for cleaning need to be verified and how?

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.

prasad
nicholas piramal india
prasadaparajit@rediffmail.com

Thanks for the answers!

Pls clarify for: At what point of new equipment qualification SOP’s for cleaning need to be verified and finalised ?and how?

Thanks in advance.

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.

prasad

Dear all,

As i’m new to validation ,can I get some guidance on

1.Microbial limits in cleaning validation for process equipments in multi-product manufacturing facility.

2.What exactly is Not more than 1 log increase in microbial count from initial results?(if initial microbial count is 10 and next count is 15)

3.Is microbial monitoring essential for all products in cleaning validation?

4.Based on what criteria worst case product is to be selected?

5.What is the difference between cleaning validation & cleaning verification?

6.At what point of new equipment qualification SOP’s for cleaning need to be verified and how?