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Cleaning validation for equipment where wet cleaning is not applicable


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althene

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Posted 24 July 2008 - 10:08 AM

hi everyone!

i would just like to ask if anyone here knows how validation of cleaning could be done for food contact surfaces that could not employ wet cleaning. We only do vacuum cleaning for flourmill processing equipment and its kinda hard to validate through swabbing due to the high counts for micro.

could anyone suggest a validation process or possible way to check if its properly cleaned?

thanks. :biggrin:



vecdika

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Posted 24 July 2008 - 11:34 AM

Dear Althene,
Which one you mean that cleaning, disinfection, sterilization, sanitation or all of them shortly"hygiene" validation?
Best regards
vecdi Karacaoğlu
HACCP Eğitim


Edited by vecdika, 24 July 2008 - 11:36 AM.


wamamili

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Posted 24 July 2008 - 11:55 AM

Althene,
I am not quite sure but i think validation and verification are carried out against specified procedures or specifications as outlined. i dont know according to you what you intend your end results to be after cleaning. i dont know wether you need zero counts or agiven range counts at the end of cleaning.From this you can validate your cleaning procedure if you can achieve results.



GMO

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Posted 24 July 2008 - 03:00 PM

If your surface isn't food contact then the high micro counts won't matter as much.

I suppose you need to ask "why am I cleaning?" Are you cleaning to reduce the micro loading to a safer level? Probably not on the description of your process. Are you cleaning to reduce the risk of stored product insects? In which case you could validate it by your pest control findings or hygiene audits on the visible amount of debris built up over your chosen frequency of clean.



Charles.C

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Posted 24 July 2008 - 08:45 PM

Dear Althene,

As you probably know and in agreement with previous posts validation is generally interpreted something like this (drug industry example) -

Cleaning Validation.

This validation is used to show proof that the cleaning system consistently performs as expected and provides scientific data that consistently meets pre-determined specifications for the residuals.
The cleaning validation process must be written into protocols and standard operating procedures which are detailed and specific for the different pieces of equipment and instrumentation used by the facility for each type of drug product produced. Other protocols and SOP's are also required if cleaning is performed based on the type of product manufactured or process used (such as a batch or bulk process or shared versus dedicated equipment).
A final report on the cleaning validation system will attest that the studies and data prove that the process is in control and cleans as expected. This report will also detail when and why revalidation needs to take place. Call on VCI to help you clean up your cleaning validation backlog.


http://www.vcillc.com/what_is.html

The above demands that you specify the objective which is logical of course. Not my area but would hv assumed there are industry micro. guidelines for the surfaces involved ? Yr comment suggested you might be well over such limits :whistle: ?!

I remember a similar problem for cleaning equipment with respect to allergens. One of the official guides commented that it could be acceptable to routinely clean such that the equipment was visually "clean" if this could be correlated with a residue analysis. (My guess is that in this case some processors bypass the analysis and simply protect via labeling.)

Rgds / Charles.C

Kind Regards,

 

Charles.C


AS NUR

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Posted 25 July 2008 - 01:54 AM

hi everyone!

i would just like to ask if anyone here knows how validation of cleaning could be done for food contact surfaces that could not employ wet cleaning. We only do vacuum cleaning for flourmill processing equipment and its kinda hard to validate through swabbing due to the high counts for micro.

could anyone suggest a validation process or possible way to check if its properly cleaned?

thanks. :biggrin:


Dear Althene...

you have to make sure that cleaning methode is right... there is some standard for dry cleaning method:(source: Handbook of Hygiene control in the Food Industry)

Dry cleaning is applicable for dry food material contact surfaces where:

·

dry material remaining in the equipment as loose layers or dust covering does

not present any risk of degrading the quality of the dry material subsequently

produced;

·

possible cross-contamination of dry material during a production change to

another material presents no problem to the quality or safety of the dry

material subsequently produced;

·

dry material remaining in the equipment does not present any risk of

microbial growth occurring due to the prevailing moisture content, tempera-

ture and humidity conditions;

·

dry material is non-hygroscopic and non-sticky.

Dry cleaning procedures include the use of vacuum cleaners, brushes and

scrapers. However, procedures can also be applied in which the equipment is

rinsed with `neutral' agents such as salt and starch.

so.. if your area not meet with that standard.. i Think you have to apply wet cleaning too in frequent time...

Hope make you clear :thumbup:



althene

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Posted 30 July 2008 - 12:27 PM

thank you for everyone's expert advice...to give you an overview of the area, the flourmill equipments are equipments used to change grains to the flour that we use here at the plant since we are basically a noodle and biscuit factory.

as such, the flour in itself is not our finished product but would undergo further processing at the biscuit and noodles production areas but it is the final product of the flourmill plant.

Since the items we produce as finished products (biscuits and noodles) are both low in moisture and are usually do not have high micro counts, the standards we have set for food production are at 100 colonies. majority of the other production areas we have validated are all within limits due to the cleaning done is wet cleaning with equipment sanitation afterwards.

The flourmill department also have their own SSOPs. However, since only vacuum cleaning is done, it is expected that the counts would indeed be high. Does anybody know of a standard for direct food contact surfaces which only employ dry cleaning? Or should we set our own limits based on our production process.

There is also no change over of product at the flourmill area. Only soft flour is produced. It is also non-hygroscopic and non-sticky, and the machines are very much enclosed especially during the final stages.

Again, my thanks to everyone for the help.

I am also looking forward to other inputs with regards to how we would validate their cleaning.

cheers! :biggrin:



Charles.C

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Posted 30 July 2008 - 11:24 PM

Dear Althene,

The general topic you mention has certainly generated greatly variable suggestions for limits for wet cleaning systems, some of which are accumulated in this thread – http://www.ifsqn.com...?showtopic=9365

A similar logic for both wet and dry cleaning has been adopted by NZFA based on operational criteria, an extract follows for dry cleaning -
13.6.4 Cleaning frequency
13.6.4.1 The frequency of cleaning shall be determined from a microbiological evaluation of the types of raw materials used, the characteristics of the process and the nature of the food soils and the environmental residues.
13.6.4.2 Microbiological monitoring shall be carried out according to the principles set out in Section 13.4.1.
13.6.4.3 The numbers of micro-organisms on food contact surfaces should not exceed in-house base levels that have been established for the indicator organisms, see also Section 13.4.2.
And
13.4.1 General requirements
Microbiological monitoring of the processing environment and food contact surfaces of plant and equipment shall be carried out to verify the effectiveness of the cleaning programme.
13.4.1.1 Indicator organisms
a. The programme shall include the surveillance of aerobic plate counts using methods generally recommended for microbiological surveillance of the environment.
A reference database, compiled using the principles of microbiological monitoring outlined in IS8/IAS8: Appendix A, should be maintained from the quantitative data.
b. Rapid tests for hygiene evaluation, e.g. bioluminescence, may be routinely used provided the methods are adequately calibrated against quantitative aerobic plate count data.
13.4.1.2 Pathogens
The programme shall establish a specific pathogen profile where there is a likelihood for a particular environmental pathogen to create an adverse food safety outcome in a specific product, e.g. Listeria monocytogenes in cooked ready to eat foods.
13.4.2 Performance standards
The microbiological condition of any food contact surface during operations, as measured by the mean log10 count of the indicator organism(s), should not exceed the expected mean log10 count of similar indicator organism(s) on product.
The numbers of micro-organisms on food surfaces throughout a processing day will be influenced by cleaning programmes, incoming microbial loads on the food and the opportunities for growth during production. The objective of this standard is to minimise contamination of foods through redistribution of micro-organisms from food surfaces.

http://www.nzfsa.gov...tml/page-13.htm


The above approach conveniently reflects their believed variability and passes the responsibilty for evaluation back to the user. Not sure what level of agreement exists on this style as compared to specifying “just cleaned” surface data / limits which seem to hv an equal degree of variability also.
Personally, hv never had an auditor object to the use of in-house formats validated as “based on” appropriate (named) published refs like in the top thread. Obviously some practical data is also required. I guess this follows yr current method where 100 colonies refers to some area of surface.

An example of the practical implementation of a (presumably wet) pre-operational cleaning approach is given in ScheduleC in this link –

http://www.oqps.gov....i_20020234_en_2

I realise this still doesn’t answer yr specific request for “dry’ limits. Not seen any on the IT as yet. Maybe there are some other dry process people here ?

Rgds / Charles.C

added - I know it's not directly comparable however you might find this generic (dry) validation SOP for cleaning in the pharmacological business of some interest, particularly the closing section.

http://www.yvqm.com/.....40 sample.pdf


Kind Regards,

 

Charles.C


Charles Chew

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Posted 01 August 2008 - 08:56 AM

Hi Althene
I had just completed an ISO 22K pre-assessment audit for a flour mill a couple of days ago. As the presence of water is a big no! no! in any flour mills, you have no choice by to use vacuum cleaning instead. Because of the nature of end-product use, heat treatment is usually applied at high temperature and as such you can determine your risk assessment level in this area

Primarily you should be concern about Mycotoxins build-up from old grains and flours remaining in your system since the high temp. will destroy the vegetative cells but not the spores.


Cheers,
Charles Chew
www.naturalmajor.com

althene

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Posted 09 August 2008 - 09:20 AM

thank you for the tips and the links charles. i am currently looking into the links you had given and found it beneficial.

cheers!






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