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Explanation of the text of CFR - Title 21


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#1 Zeeshan

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Posted 02 January 2018 - 12:17 PM

Following are some excerpt from the below mentioned reference. Can somebody explain further what does it mean?

 

 

Reference: https://www.accessda...h.cfm?fr=113.40

 

(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a 3/4-inch (2 centimeters) diameter opening and equipped with a 1/16-inch (1.5 millimeters) or larger bleeder opening so located as to provide a full flow of steam past the length of the temperature-indicating device sensor. The bleeders for external wells shall emit steam continuously during the entire processing period. The temperature-indicating device--not the temperature recording device--shall be the reference instrument for indicating the processing temperature.

 

(i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process.

 


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#2 Charles.C

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Posted 03 January 2018 - 03:30 PM

Following are some excerpt from the below mentioned reference. Can somebody explain further what does it mean?

 

 

Reference: https://www.accessda...h.cfm?fr=113.40

 

(v) Each temperature-indicating device shall be installed where it can be accurately and easily read. The temperature-indicating device sensor shall be installed either within the retort shell or in external wells attached to the retort. External wells or pipes shall be connected to the retort through at least a 3/4-inch (2 centimeters) diameter opening and equipped with a 1/16-inch (1.5 millimeters) or larger bleeder opening so located as to provide a full flow of steam past the length of the temperature-indicating device sensor. The bleeders for external wells shall emit steam continuously during the entire processing period. The temperature-indicating device--not the temperature recording device--shall be the reference instrument for indicating the processing temperature.

 

(i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be measured and recorded at intervals of sufficient frequency to ensure that the weight of the product does not exceed the maximum for the given container size specified in the scheduled process.

 

Hi Zeeshan,

 

Nice to hear from you,

 

Re - 2nd query, asssuming  use of  "critical factor" is appropriate, I guess one (maximal interval time?) interpretation might be as that shown below -

 

(9) Critical factors. Critical factors specified in the scheduled process shall be measured and recorded on the processing record at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. The minimum headspace of containers, if specified in the scheduled process, shall be measured and recorded at intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process. The headspace of solder-tipped, lap seam (vent hole) cans may be measured by net weight determinations. When the product consistency is specified in the scheduled process, the consistency of the product shall be determined by objective measurements on the product taken from the filler before processing and recorded at intervals of sufficient frequency to ensure that the consistency is as specified in the scheduled process. Minimum closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, minimum net weight, and percent solids shall be as specified in the scheduled process for all products when deviations from such specifications may affect the scheduled process. All measurements and recordings of critical factors should be made at intervals not to exceed 15 minutes.

A statistical answer to yr 2nd query would presumably need some further assumptions, eg confidence levels.

 

Regarding 1st query, I guess it means exactly what it says, can you explain what you don't understand about the quotation ? eg Are you asking why 2 thermometers ?


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Kind Regards,

 

Charles.C


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#3 Zeeshan

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Posted 04 January 2018 - 07:41 AM

Dear Charles, Thanks for reply.

 

First query: The temperature-indicating device--not the temperature recording device--shall be the reference instrument for indicating the processing temperature. We assume our temperature indicating device as our control panel screen where temperature of water and product is "indicating" and second our "mercury-in-glass" thermometer which is indicating water bath temperature. and we assume temperature recording devices as two printers. One is printing time,temp,pressure graph and second is printing time, temp and F-value data. My questions are

1) whether our above assumptions is correct in the context of FDA text?

2) why temperature recording devices can not be considered as reference instruments?

 

Second query: maximum fill-in or drained weight. We assume it as hot water fill-in and drained weight (that is used as sterilization medium in retort chamber). Is my understanding is correct? if yes, i assume that this weight will be used as data for verification of facts such as whether minimum level of water was achieved for sterilization etc.

 

Hope i have made my questions more understandable! :)


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#4 Zeeshan

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Posted 04 January 2018 - 07:42 AM

Hi Zeeshan,

 

Nice to hear from you,

 

Thanks for greetings. I was also missing this forum since long.


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#5 Charles.C

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Posted 04 January 2018 - 05:32 PM

Dear Charles, Thanks for reply.

 

First query: The temperature-indicating device--not the temperature recording device--shall be the reference instrument for indicating the processing temperature. We assume our temperature indicating device as our control panel screen where temperature of water and product is "indicating" and second our "mercury-in-glass" thermometer which is indicating water bath temperature. and we assume temperature recording devices as two printers. One is printing time,temp,pressure graph and second is printing time, temp and F-value data. My questions are

1) whether our above assumptions is correct in the context of FDA text?

2) why temperature recording devices can not be considered as reference instruments?

 

Second query: maximum fill-in or drained weight. We assume it as hot water fill-in and drained weight (that is used as sterilization medium in retort chamber). Is my understanding is correct? if yes, i assume that this weight will be used as data for verification of facts such as whether minimum level of water was achieved for sterilization etc.

 

Hope i have made my questions more understandable! :)

 

Hi Zeeshan,

 

You probably need a qualified retort/FDA expert which unfortunately I am not. :smile: (other posters here may qualify ?).

 

I offer a few unqualified comments below. In addition to yr link, i also utilised a previous version since its text seemed a bit clearer albeit possibly superceded, (eg see the attachment in this post -

 

http://www.ifsqn.com...ans/#entry71207

 

Re yr queries -

 

(1) The only mention of "indicating"  i cud see in 2 refs was to a MIG thermometer.

(2) Maybe determined by "definition". eg see - Sec. 113.40 Equipment and procedures, subs a1,a2, Pgs 5-6/48 in the FDA pdf linked above.

 

For yr "2nd weight query" I would suspect the reference is to the product drained weight in the can. (eg study the text in my lower quote of  Post 2)


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Kind Regards,

 

Charles.C


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