Cooling Process Validation for Cheesecake, Pie and Baked Custards
For something so "out of the norm" I'd do some microbiological modelling. In the UK there is a highly respected organisation called Campden BRI who can undertake that kind of modelling for you and there are presumably US organisations who can do something similar. Unfortunately if your product isn't one of the "one size fits all" group then it can be a challenge but you may find a combination of hurdle factors, e.g. the Aw being lower due to sugar content, slightly low pH, combined with the baking time may be enough but then it would be key if you redesigned your product some day, to, say, reduce sugar, that you then repeat the exercise.
Thank you so much for your response.
We'll do some research and see if we can find a counterpart in the U.S. The organization in the UK you mentioned looks like an AMAZING resource. A lot of the microbiological testing companies here in the U.S. seem to offer some of these services, but I haven't seen anything like the Member Interest Groups that Campden BRI offers.
We are a small manufacturing company with limited resources, so I am concerned that doing studies like you mention are not feasible for us, but we'll price them out and see. If anyone has any other "creative" suggestions that might fit the bill for a manufacturing company with limited resources, would love to know them.
Hi Rebecca1981
I've had great conversations with Covance about these types of studies, they should be able to help you: https://www.covance....alidations.html
Sorry I tried to post earlier but it didn't let me! One option is to get the Aw, pH etc figures and still contact Campden BRI to do the modelling. They will do work for you even if you're not a member, it's just a bit more expensive. It's still cheaper than challenge testing though.
Sorry I tried to post earlier but it didn't let me! One option is to get the Aw, pH etc figures and still contact Campden BRI to do the modelling. They will do work for you even if you're not a member, it's just a bit more expensive. It's still cheaper than challenge testing though.
GMO, thank you! Quick, ignorant question: Is there an argument for working with an organization in the U.S., or would Campden BRI be able to offer insight into ensuring regulatory compliance with FDA?
Hi rebecca,
The obvious query is how do you handle the lack of validation material so as to be able to commercialise these special products at the moment ?
Regarding Consultants, I fear you are going to be faced with some significant quotations for Literature research.
Do you not have any Bakery Trade Organisations in USA ? If so, such an approach may to be the quickest/most efficient/cheapest way to go.
FDA are an obvious alternative if you don't mind involving such legalistic connections.
Cooling validations have been discussed here several times and, as detailed in those threads, can often be non-consensus. IIRC there are some threads related to baking processes but I'm unsure if yr special situation is considered. You can find various alternatives to the data you mention in OP in the literature, as i expect you know. (it seems highly unlikely to me that AIB would suggest a 5.06 log reduction, why not 5 or 6 ?).
I predict that for a large Industry like Baking, the topic in yr OP has been encountered already in the Literature, and probably in the context of Regulatory issues also.
There is a highly detailed haccp plan for, afai can remember, "normal" cheesecake attached on this forum. But offhand, i don't recall if it included "Validation" material.
PS - as per GMO's comments there are some, long established, highly sophisticated modelling software facilities available in US for process stages but you will need some expertise to do it yourself. Whether any free options available I have no idea unfortunately.
GMO, thank you! Quick, ignorant question: Is there an argument for working with an organization in the U.S., or would Campden BRI be able to offer insight into ensuring regulatory compliance with FDA?
Yes there probably is that argument. While UK organisations can advise on US legislation (handy having mostly the same language) it may hold more weight with an FDA auditor if it's done in the US.
I like Charles' idea about Bakery Trade Associations but have to be honest the trade associations I've been part of wouldn't share this kind of information with competitors.
Another thought I had but it might not be cheaper is to see if you could get a University to help you. In the UK, you can quite often get "sandwich placement" students (students who spend their 3rd year in industry before returning for a 4th to University) or summer project students. Often the cost is relatively low and can sometimes be part funded by the institution. Knowing the different attitude to finance in the US though I'm not sure that would be the case for you.
As the OP knows, AIB is a bakery trade organization. They have a page where you can download kill step calculators for various bakery foods, and Cheesecake is one of them. So I would suspect that you could at least get some preliminary information on the cooling process. They do perform process research, so they could be someone to do that for you.
They are a non- profit organization, so even though it would not be free, it could be more reasonable. And they have credibility in the US.
http://www.aibonline...lculators.aspx
Martha
As the OP knows, AIB is a bakery trade organization. They have a page where you can download kill step calculators for various bakery foods, and Cheesecake is one of them. So I would suspect that you could at least get some preliminary information on the cooling process. They do perform process research, so they could be someone to do that for you.
They are a non- profit organization, so even though it would not be free, it could be more reasonable. And they have credibility in the US.
http://www.aibonline...lculators.aspx
Martha
You got the local knowledge I don't have! Obviously I know AIB but didn't know they did that. Great tip!