6 replies to this topic

[Dat Hoang]

Dear all, I'm looking for a template protocol/report to test fail-safe function at defined Criticial limits of CCP/oPRP? Do you have such template to share? And can you tell me what info should this protocol/report have? Thanks in advance, Tom

[pHruit]

What type of failsafe function is it that you're looking to test?
The specifics of what you need to record could be very dependent on that.

Is this routine (e.g. daily) testing, or validation for a new install?

In principle this can be relatively simple - for example I have a pasteuriser with an autodivert if the temp falls below the critical limit, and there is a simple check recorded on the production form to confirm that this has triggered as part of the automatic test built into the startup cycle.

If it's something more complex then you'll just need to work out what the key parameters/observations are that prove it works in the intended way.

[Dat Hoang]

Thank you. Do you have a template?

What type of failsafe function is it that you're looking to test?
The specifics of what you need to record could be very dependent on that.

Is this routine (e.g. daily) testing, or validation for a new install?

In principle this can be relatively simple - for example I have a pasteuriser with an autodivert if the temp falls below the critical limit, and there is a simple check recorded on the production form to confirm that this has triggered as part of the automatic test built into the startup cycle.

If it's something more complex then you'll just need to work out what the key parameters/observations are that prove it works in the intended way.

[Charles.C]

Thank you. Do you have a template?

 

Hi Dat Hoang,

 

It may assist to get relevant feedback if you can answer some of the queries in Post 2.

[Dat Hoang]

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 

 

Edited by Dat Hoang, 06 August 2021 - 02:10 AM.

[Charles.C]

 

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.

[Ryan M.]

Validation can be found in the FDA's pasteurized milk ordinance.  You can also find some ways to test for those variables under the equipment testing methods in the same pasteurized milk ordinance.  Latest version is 2019.  2021 comes out early in 2022.

 

Take care to denote the differences between HTST and UHT equipment testing methodologies.

 

https://www.fda.gov/...model-documents