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Is this document sufficient for Cleaning Validation?


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lindsaysheppard91

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Posted 15 January 2019 - 04:27 PM

Good afternoon,

 

I have some questions regarding "Cleaning Validation Tests". I am working at a company that did not have any kinds of programs. I created a "Weekly Cleaning Validation Test" for the company a month ago, and now that I have been learning more about these topics, I think it may be incorrect. Can someone please take a look for me and let me know if this is sufficient?  A little background- I work at a packaging manufacturer that makes plastic packaging. We do not have any food here, we just make the packaging. We also do not have any certifications yet, I am working on GMP certification and hopefully will have our first audit by March.

 

Thank you,

 

Lindsay



lindsaysheppard91

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Posted 15 January 2019 - 04:28 PM

Good afternoon,

 

I have some questions regarding "Cleaning Validation Tests". I am working at a company that did not have any kinds of programs. I created a "Weekly Cleaning Validation Test" for the company a month ago, and now that I have been learning more about these topics, I think it may be incorrect. Can someone please take a look for me and let me know if this is sufficient?  A little background- I work at a packaging manufacturer that makes plastic packaging. We do not have any food here, we just make the packaging. We also do not have any certifications yet, I am working on GMP certification and hopefully will have our first audit by March.

 

Thank you,

 

Lindsay

 

Sorry, I did not upload the file. Here it is!

Attached Files



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Scampi

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Posted 15 January 2019 - 04:43 PM

If sanitation is only done weekly, then the form makes sense

 

However, you should have a pre op check that is done daily, this helps catch issues that have happened to equipment (leaks, broken pieces, general cleanliness) prior to beginning the production day. YOu may find once doing this, that weekly cleaning may not be sufficient, or is just right


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lindsaysheppard91

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Posted 15 January 2019 - 04:44 PM

If sanitation is only done weekly, then the form makes sense

 

However, you should have a pre op check that is done daily, this helps catch issues that have happened to equipment (leaks, broken pieces, general cleanliness) prior to beginning the production day. YOu may find once doing this, that weekly cleaning may not be sufficient, or is just right

Yes, we have a pre-op check that is done daily. This is just a weekly ATP swab test. I was just making sure that the test areas were ok.



Scampi

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Posted 16 January 2019 - 05:49 PM

It looks sound to me


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MsMars

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Posted 16 January 2019 - 07:13 PM

Looks good to me as well.  What makes you think you are incorrect?



Charles.C

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Posted 16 January 2019 - 08:22 PM

The file seems to lack criteria for acceptability.


Kind Regards,

 

Charles.C


lindsaysheppard91

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Posted 16 January 2019 - 08:34 PM

The file seems to lack criteria for acceptability.

Hi Charles,

 

Can you give me an example please?



Charles.C

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Posted 16 January 2019 - 09:01 PM

Hi Charles,

 

Can you give me an example please?

 

Hi Lindsay,

 

So what kind of swabbing procedure do you intend to use, eg ATP, micro.analysis, protein ?


Kind Regards,

 

Charles.C


lindsaysheppard91

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Posted 16 January 2019 - 10:01 PM

Hi Lindsay,

 

So what kind of swabbing procedure do you intend to use, eg ATP, micro.analysis, protein ?

Hi Charles,

 

I use the Hygiena Rapid Protein Residue Test Swabs. I'm currently trying to convince my company to get a testing system that stores all the results in one device. 



Charles.C

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Posted 17 January 2019 - 01:02 AM

Hi Charles,

 

I use the Hygiena Rapid Protein Residue Test Swabs. I'm currently trying to convince my company to get a testing system that stores all the results in one device. 

 

Hi Lindsay,

 

No direct experience this tool but it looks straightforward to use.

 

Assuming you get a negative baseline result on a routinely just cleaned surface, this reading is presumably the criterion for acceptability.

 

I deduce you intend to test a given item max.one time per week

 

 I enclose a (suggested) slightly modified excel but other formats would no doubt be equally (or even more) acceptable to an auditor.

 

(I prefer to designate this activity Verification rather than Validation but I am not a SQF User and for them Validation may be appropriate. Up to You. :smile: )

 

Attached File  test - Verification of Cleaning Procedure.xlsx   10.94KB   132 downloads


Kind Regards,

 

Charles.C


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lindsaysheppard91

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Posted 17 January 2019 - 02:50 PM

Hi Lindsay,

 

No direct experience this tool but it looks straightforward to use.

 

Assuming you get a negative baseline result on a routinely just cleaned surface, this reading is presumably the criterion for acceptability.

 

I deduce you intend to test a given item max.one time per week

 

 I enclose a (suggested) slightly modified excel but other formats would no doubt be equally (or even more) acceptable to an auditor.

 

(I prefer to designate this activity Verification rather than Validation but I am not a SQF User and for them Validation may be appropriate. Up to You. :smile: )

 

attachicon.gif test - Verification of Cleaning Procedure.xlsx

Thank you SO much! I really appreciate the help!  We are not SQF, we are trying to get just the GMP cert as of now.

 

Thank you again!






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