10 replies to this topic

[Guy Spagnoli]

I work at a dry food packaging facility.  We package vegatables, fruits, rice, beans, milk powder and meats (All are Freeze Dried.)

 

Currently our program states that if a process has lagged longer than 12 hours, we would do a full sanitation and Swab test.

 

Does anyone out there experience the same thing and if so how long between stops and re-starts do you schedule Swab testing?

[Scampi]

Could you kindly clarify some?  Do you mean you would stop working at 12 hours to perform sanitation just because it's been 12 hours?  I worked in a cheese factory, sanitation 1 night/week ever

[Guy Spagnoli]

To replay and maybe make myself clearer.  We did full sanitation of a production room, did ATP swab testing and did the Pre-op checks and then the Production operational checks and everything was good.  We produced for X amount of time lets say of Corn.  We stop and are going to do corn in the morning which is 12 hours away so same product however a 12 hour time lag in the same room.

 

Would you do any testing as there has been a 12 hour in between production or what level of Sanitation would you do?

[kmalvetti2]

Is there a validation study done to prove that 12 hours in between cleaning was necessary? Or was 12 hours just a number that was chosen?

 

If you want to change your policy of 12 hours, have your cleaning company come in (if you have an Ecolab-type supplier) and help you validate your line for a longer processing cycle to ensure the change to a longer time between cleanings doesn't negatively effect product safety (and quality).

[kmalvetti2]

Just saw your reply to the first question - document & prove that this 12 hr. time between shut down and start up does not affect the cleanliness of the equipment or processing area. So if you're doing swabbing at start up in various critical areas and these are all coming up okay, I think you'd be fine.

[Guy Spagnoli]

We say that we will do full sanitation and ATP testing if there has been a lapse of production time of 12 hours.  Do any of you have time levels in production saying that if you are down for X amount of time then cleaning and testing must be performed prior to production?

[Guy Spagnoli]

The scenario here is a dry Organic Soy Protein powder that is being processed.  The shift has ended and being that they are going to run the same product first thing in the morning (which is 12 hours away) they want to just cover the machinery up and then just rinse the equipment off in the morning (without any Swab testing) and start production again.

 

Per our current SOP's, the time of 12 hours says wash, rinse, spray Organic solution, wait 10 minutes dry time, Swab test - good - proceed, fail - re-clean and retest.

 

I am wondering if anyone else out there is doing ATP testing and what time parameters do they have in place.  Are mine to stringent or?  Again, we are a dry product facility and do not spray wash our rooms down but rather use the three bucket process.

[Scampi]

I would trend you're results to date against the production schedule before changing anything, then I would do some investigative swabs using the set up you've described. If results are good then you can adjust your program. There is nothing to prevent you from trying different things to see if they can be cost effective and safe.

 

You won't really know the answers your seeking until you trend and swab a trial

[Chippy]

We are a low risk manufacturer and had to apply through our state Department of Agriculture for an extended run variance for one of our machines that is used daily, but not cleaned daily (ie: more than 12 hours). I would check with your inspector.

[Marshenko]

Well, he probably doesn't have regular inspection due to being covered under 21 CFR 111 - Dietary Supplements.  I could be wrong.

 

We are a low risk manufacturer and had to apply through our state Department of Agriculture for an extended run variance for one of our machines that is used daily, but not cleaned daily (ie: more than 12 hours). I would check with your inspector.

[012117]

Do you have data before the 12th hr or less? If none, collect the data first (wherein statistically you may have confidence), and use the analysis of your data for your recommendation. Until such time that you don't have anything to support the changes, retain the current SOP as recommended by Scampi.