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Aseptic process validation

aseptic process validation

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#1 MA-Te'

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Posted 08 July 2014 - 08:51 AM

I am starting to work in food factory (fruit juce in aseptic carton). I would like to know how to validate aseptic process.

Hope some expert guys here can advise! Thank you in advance :spoton:



#2 Charles.C

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Posted 08 July 2014 - 11:00 AM

I am starting to work in food factory (fruit juce in aseptic carton). I would like to know how to validate aseptic process.

Hope some expert guys here can advise! Thank you in advance :spoton:

 

Dear MA-te,

 

A couple of generic viewpoints -

 

http://www.foodsafet...ptic-beverages/

 

http://www.fda.gov/F...e/ucm072557.htm

 

You may have to give more process details if require specific evaluations. :smile:

 

Rgds / Charles.C

 

@RRoss - :spoton:?  Feel free to amplify textually.


Kind Regards,

 

Charles.C


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#3 MA-Te'

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Posted 09 July 2014 - 09:12 AM

Dear Charles.C,

 

    Thank you very much for your information. I need information to support my basic knowledge of aseptic processing and concept to establish microorganism validation protocal. I searched additional information from many websites and found this document in below link.

Could you (other experties) please review and advise the reliable of this guideline.

Besides, if you have other websites related to aseptic process which may be useful to new commer for aseptic processing like me, please advise!!

 

http://www.iftps.org...on G_005_V1.pdf 

 

Product Group

Acid food: fruit juce i.e. orange juice

Low acid food: Coconut juice, Green Tea RTD

 

Simplyfied processing

 

Mixing --> UHT treatment by THE  --> Aseptic filling into aseptic carton (Tetra pak, SIG combibloc, Evergreen system)

 

Regards,

MA-Te'

  



#4 Tony-C

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Posted 09 July 2014 - 02:18 PM

I am starting to work in food factory (fruit juce in aseptic carton). I would like to know how to validate aseptic process.

Hope some expert guys here can advise! Thank you in advance :spoton:

 

Hi MA-Te,

 

For Process Validation you will need to consider:

Raw material quality
D value target organisms
Sterilising efficiency:
Logarithmic reduction of spores
In dairy spores of Bacillus subtilis or Bacillus stearothermophilus are generally used as test organisms to determine the sterilising effect of UHT equipment, since these strains – especially B. stearothermophilus – form fairly heatresistant spores.
F0 value
(Some people also look at B* and C* values)
“The fastest particle”
Assessing commercial sterility*

 

Attached File  Validation UHT_001.png   1.08MB   10 downloads

* Tetra Pak Guideline for Microbiological Evaluation of Commercially Sterile Products is useful if they are your packaging supplier.

Regards,

Tony



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#5 MA-Te'

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Posted 16 July 2014 - 08:37 AM

Thank you Tony! :silly:

 

   For residence time analysis and critical point location (e.g. the center of the slowest heating particles or the center of the tube), I have to revisit with Machine supplier like Tetra Pak or SIG Combiblock and request supporitng document from them right?

 

  Now, I am reviewing  the principle of thermal process establisment. Most of document on hand is related to canning process. This is normally starting from the following step.

1) Heat resistance (mircrobial)

2) Temperature distribution study ( cold spot ) and heat penetration study (F zero )

  I understand for the first step but have many enquiries for the seconde step. 

     - How to conduct tempertaure distribution study in closed system (aseptic process)  

     - Do we have to do experimental verification or can use the mathermatical modeling?

 

   I also apply to process authority trianing which will be conducted by our FDA in the next month. Hope this course will contirbute valuable knowlege for me.



#6 Charles.C

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Posted 16 July 2014 - 09:38 AM

Dear Ma-Te,

 

Apologies that i never noticed yr 2nd post.

Unfortunately aseptic packaging is not my area of expertise unlike Tony.

 

However from studying yr OP-attachment, it is clear that IFT article has somewhat re-invented terminologies as used typically in food sterilization which rather confuses the topic, eg LCR is unknown to me.

The most obvious lack in IFT document is that it is only a protocol, albeit an impressive one. It contains no numerical examples which are crucial for understanding in this topic.

 

The basic theory - application in this field are rather book size topics, eg the useful publications by Tetra Pak as mentioned by Tony, parts of which should be  locatable on the net plus there are also numerous Google Books on this subject. There are also many documents on thermal sterilization posted on this forum if you search a little, eg under thermal, lethality etc. For example can try these 2 threads -

 

http://www.ifsqn.com...d-c/#entry49798

http://www.ifsqn.com...ion/#entry48963

 

Rgds / Charles.C

 

added - PS - and one more -

 

http://www.ifsqn.com...indpost&p=71674

 

added - and one more

http://www.ifsqn.com...ge-2#entry71207

(and surrounding posts)


Kind Regards,

 

Charles.C


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#7 MA-Te'

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Posted 06 November 2014 - 03:42 AM

Hi all,

 

     I am serching support information to setting pasteurization condition for fruit juice by tubular heat exchanger.

     Could you please advise how to determine pasteurization value  and process time. Are there any equations for calculate? What is the reference temperature that shoud be used?

 

Thank you in advance.

MA-Te'

 

 

 

  



#8 Charles.C

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Posted 06 November 2014 - 07:16 AM

Dear Ma-te,

 

I moved the previous post from yr new topic (deleted) since the post appeared to be a continuation.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


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#9 Mike Green

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Posted 06 November 2014 - 08:55 AM

guessing you may already have seen this.... but just in case..........! Juice haccp

 

and also Attached File  FDA Recommended Pasteurization Time.pdf   195.28KB   67 downloads

 

 and also Attached File  NACMCF_Pasteurization_082704.pdf   333.21KB   59 downloads

 

Mike


Edited by Mike Green, 06 November 2014 - 08:57 AM.

I may sound like a complete idiot...but actually there are a couple of bits missing

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