Revised ISO 14644

(vivek) #1

Sir,

We are going to start grade a equipment re qualification and till now we are following the ISO for reference as per the ISO 14644 the limit of 0.5 micron is Not more than 3520 particles\cubic meter & for 5 micron 20 particles\cubic meter .
As ISO revised then what will the limit of 5 micron for Grade a

awaiting for your answer

Vivek Kumar

(Manoj Singh) #2

Good question I also

(Manoj Singh) #3

There is no limit for 5 micron particle size for grade A in revised ISO 14644 It means 5 micron particle size should be nil in grade A area?

(vaibhav dongare) #4

whenever we are mentioning the ISO standards then don’t use term grade A, B etc. you talk in terms of ISO 4.8, ISO 5 etc. as per revised ISO limits for ISO 5 area 0.5 micron particles NMT 1 (theoretical NIL). same to be included in your SOP but EU limits not changed. if you are commonly supplying drugs to both regulatory then specifically you need to consider stringent limit and comply the both regulatory requirement.

(vaibhav dongare) #5

make it correction in earlier reply. 0.5 micron to be read as 5 micron. Actually in revision 5 micron limit is removed.

(vivek) #6

If it is removed then there is no need to measure ? is it right

(Manoj Singh) #7

5micron particle should be measured and it should be nil for class ISO 5

(vaibhav dongare) #8

the word removed to be considered as the 5 micron particles concentration will not be accepted in ISO 5 grade area. monitoring to be done to justify and comply the zero / theoretically nil concentration of 5 micron particle size…