5 replies to this topic

[nagalingam.jkpm]

Hi respected members,

Greetings! I am new to this forum.  This is my first discussion

Basically i am a pharmacist worked with sterile products. Currently working as manager- production in food fortification sector (vitamin & mineral premix ).

Can you support me any standard reference for defining CFU per swab in working person cloths . We have in-house laundry. We want to qualify this process with some acceptable standards . Reference with other pharma standards generally recommends 50CFU/swab which is difficult to maintain in food industry because the laundry area is in un-clean zone.

[MsMars]

Sounds like you should clean up your laundry area. 

[nagalingam.jkpm]

Just to add more clarity, Our laundry is not a defined clean room. It is not supported with HEPA filters. But it will be subjected to normal cleaning and disinfection .

[Charles.C]

Hi respected members,

Greetings! I am new to this forum.  This is my first discussion

Basically i am a pharmacist worked with sterile products. Currently working as manager- production in food fortification sector (vitamin & mineral premix ).

Can you support me any standard reference for defining CFU per swab in working person cloths . We have in-house laundry. We want to qualify this process with some acceptable standards . Reference with other pharma standards generally recommends 50CFU/swab which is difficult to maintain in food industry because the laundry area is in un-clean zone.

 

can try this post -

 

https://www.ifsqn.co...ry/#entry122942

[nagalingam.jkpm]

Thanks Mr.Charles,

Your reference given me the better insight 

Then we have to verify the 'commercially sterile' by swabbing . What will be limit for TMC ?

[Charles.C]

Thanks Mr.Charles,

Your reference given me the better insight 

Then we have to verify the 'commercially sterile' by swabbing . What will be limit for TMC ?

 

Commercially sterile invariably means from low to very low.

 

There are a variety of interpretations on this Forum (eg <10cfu to <100cfu)  but unfortunately most do not give the reference units, eg per cm2 or ? so not much use.

 

Some published data is in the 2nd/3rd files of this post. the expected values are "low" -

 

https://www.ifsqn.co...ing/#entry33629

Edited by Charles.C, 26 February 2019 - 10:08 AM.
corrected link