[quote=MMBACIU]Is true this situation:
The worst case for echipment is represented by the equipment with the larger surface product contact surface and the hardest- to -clen locations?
I can’t utilise this for my situation the" worst case" in cleaning validatin of drier - granulator echipment?
Thanks for help!
( I am new in this compartiment of validation and I true to understanding few necessity):)[/quote]
Mostly hardest- to Clean locations is supose the reactor, you have collect the sample difficult to cleaning.
Equipments shall be visually clean.
you have calculate the maximum allowable limit for Rinse/ equipment.
Acceptance limits for microbial contamination shall be based on the study
(25 cfu/swab for Bacterial Count ,should be absent for Fungal Count ,Pathogens ).
Acceptance limit for chemical contamination to be calculatethe swab limts .
cleaning samples collecting the two types
Swab sampling method (Direct Surface sampling):
Swab sampling method is selected as a direct measurement of residue or contaminant.
Rinse sampling method (Indirect sampling):
Rinse samples allow sampling of a large surface area. In addition, inaccessible area of equipment that cannot be routinely disassembled can be evaluated.
the top dish and shell connecting area to be collect the swab sample
10 x 10cms area.
manhole top side top dish area to be collect the swab sample 10 x 10cms area for analysis the chemical analysis.
• Maximum allowable carry over (MACO):
No product shall contain more than 10 ppm of a contaminating substance from a previous batch =.
= 10 ppm of previous product X Min. batch size of next product (in Kg)
•Limit for Swab = MACO X surface area for swab (in m 2)
Total shared surface area of set of equipment used (in m2)
Limit for Rinse / Equipment =MACO X Surface area of equipment (in m2)
Total surface area of set of equipment used (in m2)