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!
Best regards!
( I am new in this compartiment of validation and I true to understanding few necessity)
[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!
Best regards!
( 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)
= mg.
•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)
regards
jmtbrahma
thank you very much for help,
Best regards!
Mihaela Baciu
[quote=jmtbrahma]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)
= mg.
•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)
regards
jmtbrahma[/quote]
Absolutely Right,
Swab Recovery is the most important factor in cleaning validation…
Prasad
Aventis Pharma…