17 replies to this topic

[Daube Matatia]

Hi,

 

I work in a manufacturing plant that produces bottled (packaged) water for retail sale.

We've identified a few CCPs whilst conducting our risk assessments, and reverse osmosis (RO) 

membrane filtration was identified as a CCP.

 

What is the best way to validate or monitor this as a CCP?

It's quite difficult to open up and inspect (unlike other filters) hence my dilemma here.

 

I can't seem to find literature anywhere else give guidance on this.

[Tony-C]

Hi Daube,

 

 

You do not say what the hazard is. If it is micro then monitoring/validation can be carried out for example by testing the water for TVC and Enteros before and after the RO filter. If the hazard is foreign bodies then is there a subsequent filter in the process?

 

Kind regards,

 

Tony

[Daube Matatia]

Hi Tony,

 

At the RO the risk identified was micro.

There is a subsequent 0.35 micron filter in the process and that

filter was identified also as a CCP for elimination/reduction of foreign matter.

 

We're currently using pour plate methods here on site for micro

testing and usually have results within 24-48 hours (incubation for TVC and Coliforms). 

 

Hence my enquiry on the validation methods as we may have significant

product sitting in quarantine awaiting micro clearance.

 

Thanks though, this gives me a few points to work through regarding methods  

of validating and monitoring at the RO.

 

Regards,

Daube

[Tony-C]

Hi Daube,

 

That is what I was thinking. You check and monitor the second 0.35 micron filter (FB hazard control) and do not need to inspect the RO filter membrane, that is monitored and validated by micro.

 

You should be able to get a rough idea of the RO membrane performance in real time by measuring total dissolved solids before and after.

 

Kind regards,

 

Tony

[Ryan M.]

I wonder if it really needs to be a CCP.  The determining factor would be the source water supplier/quality.  Is it municipal or well water?  If well water, is it treated?

 

I would say the process could be handled with PRP's and no CCP.  Even the micro testing would be under the PRP as a verification/validation tool.

[Daube Matatia]

We use a bore well as our source and treat the water using calcium hypochlorite.

We've not had any micro issues as well over the last  year or so that will be part of the consideration

when completing the risk assessment.

 

Appreciate the feedback..

[Athula61]

Hi Daube,

 

In our water bottling plant, we are purifying the source water (Sea Water) by reverse osmosis system where we identified the RO as a chemical CCP and not as a micro CCP. Our micro CCP is UV sterilization machine as well as we are doing ozonization to eradicate microorganisms. Chemical CCP at RO is controlled by monitoring the Electrical Conductivity (EC) and the TDS of the product water. I think the main purpose of the RO is to eliminate excessive salt concentration in the source water either sea water or brackish water.

 

Rgds.

 

Athula

 

 

Attached Files

•  Bottle Water Analysis.doc   62.5KB   156 downloads

[Tony-C]

Hi Daube,

 

In our water bottling plant, we are purifying the source water (Sea Water) by reverse osmosis system where we identified the RO as a chemical CCP and not as a micro CCP. Our micro CCP is UV sterilization machine as well as we are doing ozonization to eradicate microorganisms. Chemical CCP at RO is controlled by monitoring the Electrical Conductivity (EC) and the TDS of the product water. I think the main purpose of the RO is to eliminate excessive salt concentration in the source water either sea water or brackish water.

 

Rgds.

 

Athula

 

Hi Athula,

 

In your process that makes some sense as you have subsequent steps that remove the micro hazard. My question would be does the RO contribute to establishing a safe micro level? In some cases a combination of control measures achieves the desired effect.

 

Kind regards,

 

Tony

[Daube Matatia]

Thanks Athula,

 

In our case we do not have any subsequent micro reduction steps as yet as you

do hence we assessed the RO to be an effective micro reduction step based on the fact that hyper-filtration

has the ability to filter out particulate matter at diameters of 0.001microns or lower.

This also includes certain bacteria and viruses.

 

Rgds,

Daube

 

 

Attached Files

•  RADCLIFF%202004%20Filtration%20Spectrum.png   218.95KB   3 downloads

[jayakrish]

Hi

 

I would like to know how you arrived as RO as CCP - what sort of decision tree process used?  The water can get contaminated subsequent to RO process also. RO process verification will definitely take time. 

 

Krishnan, R

Food Safety Auditor

India

[Athula61]

I agree with Krishnan because even though the RO process could retain microorganisms up to certain extent (not completely), product water could be contaminated with microorganisms beyond the RO step. CCP for microorganisms should be established just before the filling of bottles.

[Charles.C]

Hi All,

 

Not my area of expertise but it appears that reverse osmosis has been designated as a CCP in various published works from a micro. POV.

 

It also seems to currently be regarded as offering considerable power to act as a microbial reduction technique.

 

The precise designation in current case may also relate to the overall process/defined hazards of interest.

 

Some Examples -

 

 water treatment systems,2015.pdf   275.69KB   199 downloads

 reverse osmosis, 2001.pdf   717.03KB   165 downloads

 reverse osmosis,2005.pdf   150KB   178 downloads

[Tony-C]

I agree with Krishnan because even though the RO process could retain microorganisms up to certain extent (not completely), product water could be contaminated with microorganisms beyond the RO step. CCP for microorganisms should be established just before the filling of bottles.

 

You cannot have a CCP where there is no control measure. 

 

Kind regards,

 

Tony

[Daube Matatia]

I agree with Krishnan because even though the RO process could retain microorganisms up to certain extent (not completely), product water could be contaminated with microorganisms beyond the RO step. CCP for microorganisms should be established just before the filling of bottles.

 

Hi

 

I would like to know how you arrived as RO as CCP - what sort of decision tree process used?  The water can get contaminated subsequent to RO process also. RO process verification will definitely take time. 

 

Krishnan, R

Food Safety Auditor

India

 

Hi Krishnan,

 

We arrived this decision since this is the only known micro reduction step pre-filling.

Ideally we'd like to have a subsequent reduction step as pointed out by Athula, unfortunately we don not have an additional control step (for now) prior to filling.

Hence the RO was deemed to be worthy of being considered a CCP.

 

My query was with the current process we have in place, what would be the best method of verification/monitoring of the RO step?

 

Daube

[AS NUR]

Hi,

 

I work in a manufacturing plant that produces bottled (packaged) water for retail sale.

We've identified a few CCPs whilst conducting our risk assessments, and reverse osmosis (RO) 

membrane filtration was identified as a CCP.

 

What is the best way to validate or monitor this as a CCP?

It's quite difficult to open up and inspect (unlike other filters) hence my dilemma here.

 

I can't seem to find literature anywhere else give guidance on this.

Hi..

 

As i know to validate your filter is you have should know what the size of the filter, so you have read the spect of the filter. if the size of filter less than micro size that you can prove your Filter is can be control measure for micro.

And to monitor you should check the leak, and the leak can indicated by diferential pressure between input and output.

 

Rgds

 

AS Nur

[Charles.C]

Hi Daube Matatia

 

Validation procedures for assessing the filtration performance in Bottled Water production are IMO likely to be local Regulatory-based.

I anticipate that yr supplier has such information to hand also.

Certified membrane filters (not necessarily RO-type), exist. See attachment bw3 below.

Compliance testing seems in more common use than Challenge tests. See bw1, bw2 below.

 

 bw1 - Bottled Water Code,Australia.pdf   787.58KB   85 downloads

 bw2 - Bottled Water, Process Requirements,Philippines.pdf   92.03KB   83 downloads

 bw3 - Bottled water filtration -Parker.pdf   4.74MB   113 downloads

 

PS - in contrast to the above, see this link -

 

http://www.fluidquip...tem-validation/

[FurFarmandFork]

RO should be sufficient as your micro control step, and preventing contamination post-RO is a combination of prerequisite programs, not a CCP. That's like having a CCP to prevent cross-contamination of cooked beef, it shouldn't be happening due to your prereqs.

 

Validation/verification could be done in any number of ways, there's a ton of water chemistry options out there that would help quickly validate whether the RO membranes failed. If it's a true RO, you should see a total dissolved solids drop from before to after the filter (filter manufacturer should give you a percentage or something), which can be verified instantaneously based on conductivity. You could even put in an in-line sensor and have it just alarm if TDS rose too high, eliminating operator error (but requiring verification of the in-line sensor at some frequency as well).

 

I don't have RO in my plant, but it seems like aquarium people are really into them for sensitive fish, and there's a lot of checking the function of these devices on those forums to keep fish healthy that feels a lot like CCP verification. I'd recommend looking at what they have to say to get an idea of how it could be done and then involve your RO manufacturer when determining the limits.

[Sean Archer]

Hi all.

 

The most simple way to validate effectiveness of RO against microorganisms is a size comparison study. Collect size information of expected pathogenic microorganisms in the water source and compare them against RO membrane size usually specified in manufacturer's documentation. However there's something strange with the process described above. The process involves a 0.35 micron filter that is going to reduce suspended particles and it is a subsequent to RO stage. As far as I know, microfiltration usually takes place before RO systems to reduce RO regeneration cycles and to help membranes last longer. That said I wouldn't look for a CCP at microfiltration unless it is the only counter measure for reducing foreign matter at a water bottling plant. Instead, I'd rather invest in RO and play on "combination of control measures" as in the RO case I could accomplish two tasks with one action. Microfiltration would be OPRP in this case but unfortunately, I still have to validate its effectiveness.

 

Kind regards,

Sean