18 replies to this topic

[Vishal D]

Hi,
We are monitoring the mold count in the food processing area.
Need the standrards & guidelines to control the same.
Can you pl help

Regards
Vishal

[FSSM]

Dear Vishal:

Check this attachment, might be helpful.

 Cleanroom_classifications_1.pdf   109.24KB   177 downloads

Regards,

FSSM

[Kamwenji Njuma]

Dear FSSM,

It got nice info.Thanks

Regards,
Jeremy

[Simon]

Hi Vishal,

Did the document FSSM provided help you? Let us know if you need further help.

Regards,
Simon

[sudarshan]

Dear Vishal:

Check this attachment, might be helpful.

 Cleanroom_classifications_1.pdf   109.24KB   177 downloads

Regards,

FSSM

Hi FSSM

Many thanks for the documents...but i think vishal question is counts of environment which not clean rooms. As per my knowledge their is no specific standards for the same ......if any one has ...please share those standards........& if i am wrong correct me

Many thanks once again

[FSSM]

Hi FSSM

Many thanks for the documents...but i think vishal question is counts of environment which not clean rooms. As per my knowledge their is no specific standards for the same ......if any one has ...please share those standards........& if i am wrong correct me

Many thanks once again

Dear sudarshan,

The classification of clean room also considers mold count, look to the document attached, search for mold.

Regards,

FSSM


 Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice.pdf   734.22KB   62 downloads

[sudarshan]

Dear sudarshan,

The classification of clean room also considers mold count, look to the document attached, search for mold.

Regards,

FSSM


 Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice.pdf   734.22KB   62 downloads

Hi FSSM

Many Thanks for documents

Please coorect me if i am wrong..

But I thought Clean rooms are those which has filters ....but where production area is without filters that environment count standard for Yeast & Mould is different or same...

Sudarshan

[FSSM]

Hi FSSM

Many Thanks for documents

Please coorect me if i am wrong..

But I thought Clean rooms are those which has filters ....but where production area is without filters that environment count standard for Yeast & Mould is different or same...

Sudarshan

Sudarshan,

To have controlled conditions of micriological load in the environment you need tools to help you, like filters, if not, then you can check the microbiological quality of air, but can´t do anything about it. It also depends on the design of your facilities, if you have open acces for air, then you have a lot or little (if no resources available) to do. The document is only a references of what Pharmaceutical Industry use, so you can get a parameter of what would be useful for food production.

Regards,

FSSM

Edited by FSSM, 19 April 2010 - 05:04 PM.

[sudarshan]

Sudarshan,

To have controlled conditions of micriological load in the environment you need tools to help you, like filters, if not, then you can check the microbiological quality of air, but can´t do anything about it. It also depends on the design of your facilities, if you have open acces for air, then you have a lot or little (if no resources available) to do. The document is only a references of what Pharmaceutical Industry use, so you can get a parameter of what would be useful for food production.

Regards,

FSSM

Hi FSSM

I agree with you.....we check the same microbiological quality......but how you can decide whatever count is within limit .........or needs to improve ...

improve means if filters are not their then some times the combination of formaldehyde & pottasium permanent use to control the micros (not in food stored area because may be chances of chemical deposition on food or food may be catch the smell of chemical )..


any standard is supporting this thing...anyone can help on this topic

your view is highly appreciated

Thanks

[FSSM]

Hi FSSM

I agree with you.....we check the same microbiological quality......but how you can decide whatever count is within limit .........or needs to improve ...

improve means if filters are not their then some times the combination of formaldehyde & pottasium permanent use to control the micros (not in food stored area because may be chances of chemical deposition on food or food may be catch the smell of chemical )..


any standard is supporting this thing...anyone can help on this topic

your view is highly appreciated

Thanks

Well, actually we are working in what you say, triying to stablish what is a good limit or when to improve.

Will let you know our decission.

Regards,

FSSM

[Sureshac]

Hi,
We are monitoring the mold count in the food processing area.
Need the standrards & guidelines to control the same.
Can you pl help

Regards
Vishal

whats ur company manufacturing???whats current bacterial,yeast and mold count now?do u hv any fumigation process in ur cleaning schedule????

[FSSM]

whats ur company manufacturing???whats current bacterial,yeast and mold count now?do u hv any fumigation process in ur cleaning schedule????

Warehousing of additives and ingredients only.

Plates were exposed for 10 minutes, see attachment for the data.

We clean floor daily, other surfaces are cleaned less frequently.

Regards,

FSSM

 Microbiological quality of air.xls   15.5KB   61 downloads

Edited by FSSM, 23 April 2010 - 04:09 PM.

[sudarshan]

Warehousing of additives and ingredients only.

Plates were exposed for 10 minutes, see attachment for the data.

We clean floor daily, other surfaces are cleaned less frequently.

Regards,

FSSM

 Microbiological quality of air.xls   15.5KB   61 downloads

Hi FSSM

I saw your results........which is yearly basis ..............as per my view it should be fortnightly or monthly ...when you establish the standard & my next question is how you differ yeast & mould count.....means can you use any special media which allows only yeast growth & not to mould & vice versa......

thanks

[FSSM]

Hi FSSM

I saw your results........which is yearly basis ..............as per my view it should be fortnightly or monthly ...when you establish the standard & my next question is how you differ yeast & mould count.....means can you use any special media which allows only yeast growth & not to mould & vice versa......

thanks

I´m not sure about the media used to differentiate yeast and moulds, but we do ask the external lab to do so. You may be right, a more frequent monitoring might be good, but I can´t do to much to control the environment, so it would be useless.

Regards,

FSSM

[sudarshan]

I´m not sure about the media used to differentiate yeast and moulds, but we do ask the external lab to do so. You may be right, a more frequent monitoring might be good, but I can´t do to much to control the environment, so it would be useless.

Regards,

FSSM

Hi FSSM

Nothing is useless.......

are you just monitor the environment count? ......or you take some corrective action on it when thing not in order.......

can your external lab give you any suggestion if when they found high count?

[FSSM]

Hi FSSM

Nothing is useless.......

are you just monitor the environment count? ......or you take some corrective action on it when thing not in order.......

can your external lab give you any suggestion if when they found high count?

Yeap, we just monitor, but we officially do not have a limit, so we are not having any actions against the results we have received to date.

We will try to reach to a conclusion in the next months, I´m sure we will have to take into consideration the comments from the external lab.

Regards,

FSSM

[sudarshan]

Yeap, we just monitor, but we officially do not have a limit, so we are not having any actions against the results we have received to date.

We will try to reach to a conclusion in the next months, I´m sure we will have to take into consideration the comments from the external lab.

Regards,

FSSM

Hi FSSM

If i will get something on it i will defiantly share with you & all.

[Gao Yu Qing]

Hi FSSM

I saw your results........which is yearly basis ..............as per my view it should be fortnightly or monthly ...when you establish the standard & my next question is how you differ yeast & mould count.....means can you use any special media which allows only yeast growth & not to mould & vice versa......

thanks

In regards to this, I don't know if theres neccessarily a media that's yeast or mold specific, but you can generally tell the two types of growth apart. Yeast forms little smooth blobs of colonies with distinct edges, while mold tends to spread, look fuzzy and put out fruiting bodies.

[sudarshan]

In regards to this, I don't know if theres neccessarily a media that's yeast or mold specific, but you can generally tell the two types of growth apart. Yeast forms little smooth blobs of colonies with distinct edges, while mold tends to spread, look fuzzy and put out fruiting bodies.

Hi Gao Yu Qing

As per my information no media can allow separate growth for yeast or mould ......

i know the colony characteristic of both .......but some times some mould inhibit the growth of other microorganisms

I am not sure but sodium propionate can differentiate the yeast & mould growth

Thanks for your comment