[mikethair]

Sounds expensive to me @ $3,000. Surely you can set up an accelerated stability test yourself? You would require an oven to maintain 45 C and monitor the products for 3 months with a range of basic tests.

In our company we do the accelerated stability test plus another set of samples for real time testing. Generally, in my opinion, it is not an excat science, but does identify problems with the product and packaging.

[mikethair]

Best place to start would be looking at the need and demand for these services in your area. Once identifying the lab services required, this would be a guide for equipment procurement and the type & size of premises required. 

You may also need to look at staffing, their availability, and cost.

[mikethair]

UPDATE: I pasteurized these bottles @ 60 C for 30 minutes. The TPC Bacteria = 100,000 CFU/mL was reduced down to 0 CFU/mL.

Seems to be a good approach. Will repeat the microbial tests just to be sure.

[mikethair]

Why not just use a blend of oils and leave the other gunk out?

Our most successful product is:

Simmondsia chinensis (Jojoba) seed oil, Sesamum indicum (Sesame) seed oil, Olea europaea (Olive) fruit oil, Cocos nucifera (Coconut) oil, Helianthus annuus (Sunflower) seed oil, Pelargonium graveolens (Geranium) oil, Salvia sclarea (Clary Sage) oil, Cananga odorata (Ylang Ylang) flower oil.

[mikethair]

Sorry again, I am making mistakes converting between units, plus updates to the ASEAN Guidelines which have also revised units

In response to @manuksh the ASEAN Guidelines state =< 500 cfu/g or cfu/ml in products for children under 3 years, eye area and mucous membranes, and =< 1000 cfu/g or cfu/ml.

Our results are ranging between TPC Bacteria = 100,000 CFU/mL down to 1,000 CFU/mL, which of course are problematic.

One solution “may” be pasteurising these hydrosols?

[mikethair]

Sorry, a typo in my original post…..it should be 500 CFU/cm2.

In response to @manuksh the ASEAN Guidelines state <500 CFU/g for products for children under 3 years, eye area and mucous membranes, and =< 1000 cfu/g for other products.

[mikethair]

You are correct @manuksh about the original question. My approach to this issue is one of compliance and customer safety. If I am facing a GMP inspector, and taking customer safety seriously, the safest route is to follow the manufacturers instructions for the test kit. It would be a weak argument on our side if we didn’t in the case of facing a customer compalint or GMP query. 

[mikethair]

Fairly common right across the industry…. some brands just push the envelope a bit harder than other.

I nice reminder…..thanks.

[mikethair]

As mentioned by @MarkBroussard   “You can purchase a small incubator from Schuelke & Mayr for use with their microbial test strips”….. exactly what we have done in our productio  facility. We use the microbial test strips for monitoring of low risk products (just to be 100% sure).

[mikethair]

The 2.7 % essential oil is far too high. In our shampoo for our own and other brands we use between 1.2 - 1.5% depending on the essential oils. You may also need to look at the balance between base, middle and top notes. Using mainly top notes, you will find that the fragrance will be lost before customers finish the bottle. We usually run a few test bottles over a couple of weeks to check for fragrance duration.

Some have sensitive scalps as suggested by @johnb, therefore I would suggest you calculate the allegen levels in your essential oil blend.

[mikethair]

Getting back to the question…. “make sure that my formulations are compliant with end application”…… @pbs is your main concern remaining within the prescribed allergen limits with any recipe you come up with?

[mikethair]

Yes @johnb and @DRBOB@VERDIENT.BIZ  we insist on CoA’s for all ingredients and these include heavy metals analysis.

Are you suggesting then that in the cosmetics industry generally that heavy metal testing of finished products (or a least some sort of periodic sampling) is not required?

[mikethair]

For a number of years, we have successfully produced a shampoo made from the following base:  Water (Aqua) Potassium Cocoate, Potassium Canolate, Potassium Ricate, and Mel (organic honey). The negative comments above are typical for this type of saponified oil shampoo, but we listen more to our customers.This product has sold well under our own brand plus a number of other brands we produce for (sells across all the major top-end department strores). Like any shampoo, one recipe does not suit all hair types.

@Microformulation you raise an interesting question re preservation. As confirmed by our UK Safety Assessor: “Normally shampoos and hand-washes would require a microbiological challenge test however because of the method of manufacture these too may have a high enough pH to make this unnecessary. ” Anyway, we regularly had these shampoo tested for TAMC and TY&MC and always negative, plus Preservative Efficacy Testing, and all returned 99.99% kill rate.

@MarkBroussard makes some useful suggestions, and we have already started down this track and are now in the middle of testing various recipes. Good results to-date.

With your current choice of oils, I would experiment with these as various types, percentages and combinations can greatly affect the final product.

[mikethair]

@David08848  we are making similar products as yourself, mainly saponified liquids and bar soap. We use essential oils exclusively….I have bad reactions to many synthetic fragrances for some reason. Usually, our liquid soap products have around 1.5% EO, or a bit less, depending on the EOs. This works for us. If you are using 3% (that’s high in my opinion) in your shaving product, perhaps the fragrances you are using have been adulterated?

Finding a good EO supplier has been a challenge, and in 2009 finally found one. We insist on full CoA’s including allergen levels. Many can’t or won’t provide this level of CoA’s, and I think this requirement sorts out the serious suppliers.  Works for us.

[mikethair]

Thanks @Perry ……some things to think about, plus your comments raise a few other queries.

I think the point on asterisks is very valid, and must admit have been guilty myself on this one.

Isn’t there a contradiction here:

“On saponification - The point of the ingredient list is to list the chemicals that are in the final product. If you put two ingredients in your formula and they chemically react to form a new ingredient, you should list the resulting ingredient. If the reaction isn’t complete you should list the two starting ingredients too. If the reaction is complete, then you can simply list the final ingredient.  So, for a saponification reaction you would list the oil, the base and the resulting soap.”
 
If we saponify coconut oil with KOH, then what is in the final product (assuming saponification is complete) is Potassium Cocoate. Why then do you state “So, for a saponification reaction you would list the oil, the base and the resulting soap”   but also say ” If you put two ingredients in your formula and they chemically react to form a new ingredient, you should list the resulting ingredient” ??

[mikethair]

Point take @Perry on INCI.  However, re your point:

  “The first ingredient should be Water. Aloe Vera Leaf juice is mostly water and you are supposed to list ingredients based on their composition not based on how much of the raw material you put in the formula.”

It looks as if a number of oils have been saponified here (listed as Sodium Cocoate etc etc., but if liquid I think it should be Potassium Cocoate). I assume that any water used here would be consumed in the saponification reaction and therefore not listed as “water.”

Generally, for these saponified liquid products, once the soap paste is produced,  the dilution is larger than the volume of the paste. If the Aloe Vera Leaf juice is made by dissolving powdered Aloe Vera in water, then shouldn’t this be listed as Aloe Vera Leaf juice first?

Also, your comment “The asterisks do not belong in the ingredient list. That doesn’t follow the proper INCI listing,” again, point taken. But this is a very common practice I see on many labels. Do you have an alternative suggestion?

@Perry your thoughts on this would be appreciated. Thanks.

[mikethair]

For a number of years we have been using:

 WARING 18″ HEAVY DUTY IMMERSION BLENDERS (MODEL: WSB65E)

Works well for us in our batches of around 75 L.

[mikethair]

Yes, agree @johnb and @MarkBroussard. Good thing is that we have good results on all the microbial tests to-date (zero fails), including the challenge tests. I will navigate through all of this, apply good science, and come up with a testing protocol that can be defended.

@MarkBroussard have had a win with the Schuelke & Mayr distributor and have ordered a box of these microbial test strips to try out. A quirk of this distributor, however, is that they ship from Europe via sea cargo which takes 3 months, reducing the 9-month shelf life to only 6 months.

[mikethair]

Yes @johnb I agree “..strongly in your interest to get an “approved” statement of what the requirements are..”   and that is exactly what I have done. 

The response to my question “Can you please provide clear details of the type of microbial testing regime that would be acceptable?”  was:

“Hi Dear Dr Mike Thair,
For the microbial testing, Indeed I did not mention it is not necessary, but indeed if we refer to the Annex 1 (as attached), it is a requirement.
It just left to your own risk assesment on how to conduct on microbial limit testing.
 
For example: What product most likely demonstrate haviest microbial proliferation during production, is that the cosmetics likely cause side effect on human if the viable count is more than the acceptance limit, the nature properties of the products: As if the product itself is a natural antimicrobial agent, etc..
 
For me personally as a auditor, I wouln’t be too rigid on the concept that every single batch of cosmetics have to do a thorough microbial limit test. It is always good to consider the necessary step and precautions to make sure the cosmetic product is safe and of quality
 
Hope it helps”

Currently, I’m in the process of unpackaging exactly what all this means.

[mikethair]

@Perry why do you say “….this isn’t a proper INCI ingredient list” ?

[mikethair]

Yes @MarkBroussard, exactly the line I am now pursuing. Has been difficult to source these types of strip tests here in Malaysia, and will certainly follow up any local agents for Schuelke & Mayr.

Thanks

[mikethair]

@johnb   over the past week I have used the shampoo in Australia and Malaysia and good in both locations. No sign of scum precipitation. The Malaysian supply is probably reasonably soft, but not the Oz water, although it would not be in the very “hard” water category.

[mikethair]

No @johnb did not type this out……used cut & paste !!!

Yes agreed @Bobzchemist it’s a “pretty” list, but having said that, am using this shampoo and it suits my hair well. I guess the “pretty” bit allows the brand to jack up the price.

Thanks for the comments……

[mikethair]

Suffered many years from dry skin, tried everything on the market and never really solved the problem. In 2006 started to experiment with various blends of oils and found the best was Jojoba, Sesame, Olive, Coconut, and Sunflower oil.  Worked well for me, and so turned it into a product which now has good sales.

[mikethair]

We make “natural” body wash via saponification of whole plant oils. Agreed, not from a “body wash tree,” but perhaps a bit closer to nature than some of the synthetic surfactants currently in use. For manufacturers like us, the use of the word “natural” differentiates us from the majority using synthetic surfactants.   I know the word “natural” is a red flag to you guys, and I understand that.

To the original question “…..they rarely foam and the testers have to pour so much to have a decent foam.”  Not a problem we have heard back from customers using our products made via saponification of whole plant oils. The secret is in the choice of oils. Our face wash is made from saponified extra virgin olive oil, and this does foam a bit less than the others, but is our biggest seller under our own brand and other brands we manufacture for. To-date have not had a single customer complaint.