Dear Chales,
I'm looking for Verification template of these kinds of Critical limits (including Fail-safe testing):
CCP - Sterilisation of Milk
UHT - Milk white:
. Cap 7000:
- T ≥ 136.1 oC
- Q ≤ 7350 L/h
oPRP
'Sterilizing parameters of Internal surfaces of Filler:
• Sterile air temperature (T)
• Concentration of Peroxide ©
• Amount of Peroxide sprayed (V)
• H202 injection time (t injection)
• Drying time (t drying)
• Temperature for sterilizing valve C (T valve C)
•Time for sterilizing valve C (t valve C).
• T ≥ 280 oC
• C >= 33%
• V:
- V Aseptic chamber > 100 mL
- V Nito pipe > 18 mL
• t injection:
- t injection - Aseptic chamber: 18s <= t <=33s
- t injection - Nito pipe: t < 11s
• t drying time: >=20 mins
• T valve C >= 125 oC
• t valve C >= 13 mins
Hi Dat Hoang,
Thks for the details.
I'm not sure if you mean (A) Verification or (B) Validation ? eg -
(A) Product Sterilization Verification would involve sterility testing such as discussed at length here -
Commercial Sterility testing methods.pdf 581.35KB
16 downloads
(B) Critical/Action Limit Validation would imply something like -
(1) A Va Procedure for determining the sterilization parameters for UHT Milk (presumably in respect to T/ t).
(2) A Va Procedure for determining the sterilization parameters appropriate to internal surfaces of the "Filler" (I am not in the Milk business but I assume this item [somewhere] relates to the UHT Milk Process).
I'm guessing you are seeking (B) but please correct me if I'm wrong. So -
(a) I anticipate No.1 is standardized (eg like HTST) and available in UHT milk textbooks (IIRC from long memory, a UHT milk graph exists illustrating possible "critical" combinations).
(b) I speculate that No 2 may need access to the manufacturer of the specific Filler equipment.