11 replies to this topic

[apasquel]

I am creating a hazard analysis for the creation of bulk polyethylene liners but I am have a hard time coming up with the 'germ' aspect. The liners come off a sterile roll of film and have no human contact until converted bags are folded. From what I see, the major germs would come from human conduct and poor hygiene.  There is no food contact, no allergens in the process.  We have a clean room process, hairnets, uniform jackets, hand washing etc.

 

What would limits of biological be from human touch to a sterile plastic bag (dirty hands, coughing, hair..etc) or a folding table? 

 

[ncorliss]

What food industry will your product be servicing? For my company, we are a packaging supplier for several dairies in the US and Canada. We follow the guidelines for residual bacteria and coliform of the Pasteurized Milk Ordinance.

[apasquel]

Primarily liquid edible oils. However, many items may go into the liner fruit puree, icings, dairy, protein slurry...etc.

[ncorliss]

Unfortunately I do not know the fruit guidelines as well as the dairy, but there may be some FDA or codex alimentarius to provide some information. For dairy, and listed in the FDA's interstate milk shipper's list, you must follow the guideline's under the Pasteurized Milk Ordinance. It seems packaging can be a gray area in certain testing requirements. Has a customer required particular testing yet? Perhaps if the other food products don't require particular testing, you could follow the PMO to show your SQF program is performing some form of industry accepted testing.

[ncorliss]

To answer your original question a bit more. The PMO calculates the residual bacteria and coliform limits based on the size of the container / packaging. The FDA IMS listing has qualified laboratories that perform PMO related testing. One of them could point you in a proper direction.

[Charles.C]

I am creating a hazard analysis for the creation of bulk polyethylene liners but I am have a hard time coming up with the 'germ' aspect. The liners come off a sterile roll of film and have no human contact until converted bags are folded. From what I see, the major germs would come from human conduct and poor hygiene.  There is no food contact, no allergens in the process.  We have a clean room process, hairnets, uniform jackets, hand washing etc.

 

What would limits of biological be from human touch to a sterile plastic bag (dirty hands, coughing, hair..etc) or a folding table? 

 

Hi apasquel,

 

Is the context of yr OP with respect to presenting a hazard analysis or formulating a microbial specification ?

 

I presume the manufacturing stage is high temperature >> "sterile" product.

 

As per yr description i would hv anticipated no significant haccp  "B" hazards, ie control is via PRPs.

 

PS- i suppose the analysis might change somewhat if the liners were for food products for NASA.

[apasquel]

Thank you for the response. We have done a couple swabs (ATP) on the product tables and come up empty.  I believe we will use the Dairy standards to test.

We have had a couple customer audits and they appear to be satisfied with current sanitizing of the area along with swab testing. My issue is I don't have a set limit of what we are testing for.

[Charles.C]

Thank you for the response. We have done a couple swabs (ATP) on the product tables and come up empty.  I believe we will use the Dairy standards to test.

We have had a couple customer audits and they appear to be satisfied with current sanitizing of the area along with swab testing. My issue is I don't have a set limit of what we are testing for.

 

Hi apasquel,

 

Try this thread and work backwards from the links -

 

http://www.ifsqn.com...food-packaging/

 

PS - what are the Dairy micro. Standards ? I would imagine that the data from post2 is ultimately expressed per a unit area unless it's like the specs for a milk churn.

 

PPS - Is this what you mean ?

 

(Strictly speaking, HACCP would not regard a  total plate count value or a coliform value as significant health hazards. A question of objectives.)

 

6.      a.   The  residual  bacteria  count  of  multi-use  containers  and  closures  shall  be  conducted  as
outlined  in   Appendix  J.  The  residual  bacteria  count  of  multi-use  containers,  used  for  
packaging pasteurized milk and milk products, shall not exceed one (1) colony  per milliliter  
(1/mL)  of  capacity,  when  the  rinse  test  is  used,  or  fifty  (50)  colonies  per  fifty  (50)  square
centimeters (one (1) colony per square centimeter) of product-contact surface, when the swab
test is used, in three (3) out of four (4) samples taken at random on a given day.  Coliform
organisms shall be undetectable in all multi-use containers.
b.   The residual bacteria count of single-service containers and closures, used for packaging
pasteurized milk and milk products,  shall not exceed fifty (50) colonies  per container, or in
the case of dry product packaging, shall not exceed one (1) colony per milliliter (1/mL)  of
capacity  when the rinse test is used, except that in containers less than 100 mL the count shall
not exceed ten (10) colonies  or fifty (50) colonies per eight (8) square inches (one (1) colony
per square centimeter) of product-contact surface, when the swab test is used, in three (3) out
of  four  (4)  samples  taken  at  random  on  a  given  day.    Coliform  organisms  shall  be
undetectable in all single-service containers.

 

[Constantine_S]

Hi apasquel,

Do you have any microbial test of the air in process environment? There are germs expressed by personnel without any hand contact, e.g. Staphylococcus aureus expression while coughing. Also some industries are interested in air test results for mould and yeast, as they can contribute to food deterioration. So in addition to regulation requirements it's good to ask customers what are they key pathogens and then check whether these germs can survive of polymeric film.

P.S.: I don't know you process, but have you considered thermal-oxidative degradation of polyethylene? As for polystyrene film extruded from granules, I have considered such degradation with such toxic outcomes as styrene, benzene, formaldehyde.

 

Regards,

Constantine

[IzzyP]

Have you tried doing a "rinse out" ?

 

We use plastic pots & bottles, and the packaging providers in the UK do not routinely test for micro on their packaging, So I will take random pots / bottles to send to my lab, who will rinse with BPW or MRD (or whatever diluent your lab recommends) and plate onto the relevant agar to see what will grow.

[apasquel]

Our liners are for bulk packaging liquids.. they tend to be 275 gallons to 330 gallons of product which weight 2,500/lbs when filled. Can a rinse out be done on this size container at a testing lab?

[IzzyP]

Our liners are for bulk packaging liquids.. they tend to be 275 gallons to 330 gallons of product which weight 2,500/lbs when filled. Can a rinse out be done on this size container at a testing lab?

 

 

I would think so. My lab has in the past.