[mikethair]

Why would you want to bring the pH down? We manufacture many liquid different types of liquid soap with high pH and it is not a problem.

[mikethair]

We have an intern at the moment. My advice is to be flexible. OK, she is working with our QC Manager across two labs and is doing some of the tests…. but at times she is helping out in production and other times in the labelling room. I have had her communicate with ingredients suppliers following up orders, and also research and contact potential suppliers for new ingredients.  Had her meet a German product supplier who was visiting, and problem solve a few issues.

No need to refresh your memory on stuff you have learnt. Industry is a different ball game.

Don’t make the mistake of a gal I interviewed recently for an internship. The only question she asked was if we paid interns an allowance.

Good luck with your internship.

[mikethair]

We are in Malaysia and use Mikrocount , so USA should not be an issue. They have distributors in most countries.

A good product I might add. Only thing is the shelf life is short, so best to make sure you local supplier can ship fairly quickly.

[mikethair]

For the tank we have purchased these:   https://soapequipment.com/Tanks/

Mixing is done with hand held Waring WSB65CK 18″  Heavy Duty Immersion Blender

[mikethair]

If the product is a wash-off then the pH 10-11 will not be a problem. It is a common pH for saponified oil soap washes and soap bars.

ISO 29621 (Second edition 2017-03) “Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products” covers the pH of formulations. It says “Liquid soaps with alkaline pH (pH 9,0 to pH 10,0) present an environment unfavourable for the growth of some microorganisms. Hair curl relaxers, due to their extreme pH (around 12), prevent the growth of virtually all microorganisms that would be likely to contaminate cosmetic products.”

However, we always carry out microbiol tests in our lab on every batch produced.

Hope this helps.

[mikethair]

For me, producing cosmetics is all about controlling variables, and there can be many.  “inside my home where I make them” is a difficult place to controll variables. Also, what do you have in terms of a QC system? What about your Batch Manufacturing Record? Without any of these in place you can waste a lot of time in trying to identify causes of an issue like this.

[mikethair]

@UsmanAli, not sure why you refer to a “soap base” when in fact there is no soap. We produce a range of liquid soap face washes. These sell well. Yes @Belassi they do have a high pH and this eliminates the need for preservatives. And no, with the correct selection of oils and careful saponification calculations, liquid soap WILL NOT dry out the skin. If they did, I would have been out of business years ago.

[mikethair]

When you say “home-based business,” in which country are located?

A lot will depend on the local cosmetics regulations. In Malaysia, where we are, nothing less than an audited GMP facility will be accepted. The other alternative is to produce illegally, which many do, but it does limit where you can sell.

[mikethair]

We use MIKROCOUNT DUO. We validate results with tests done by an external registered microbiol lab on a set basis, and all is good. You will need an incubator.

[mikethair]

But isn’t a “make diaper rash ointment” bordering on pharmaceuticals and not cosmetics?

[mikethair]

@natural76 if you don’t validate the microbial results somehow, you will never know.

[mikethair]

In response to your querey   @Gunther   our manufacturing facility is located in Malaysia. With my own brand I have zero intention of going down the path of bulk retail dispensers for all the reasons mentionded. Howevere, it was a query from one of the brands we manufacture for.

[mikethair]

We use MIKROCOUNT DUO. We validate results with tests done by an external registered microbiol lab on a set basis, and all is good. You will need an incubator.

[mikethair]

Another approach we now use as opposed to sending each batch out for testing is we use MIKROCOUNT DUO. We validate results with tests done by an external registered microbiol lab for every third batch, and all is good.

[mikethair]

Generally, agree with you @Bill_Toge. Do you know if the authorities in Europe have made any cosmetics compliance statements on this issue? What I observe recently is that the environmental issue of plastics waste is now starting to gain momentum. This is driving the bulk dispenser approach. 

[mikethair]

Our protocol is 40 C for three months , including packaging. At the same time we retain samples at ambient conditions. Over time these provide  Real Time stability.

[mikethair]

With respect @em88, I am meant to be running a profitable business, and that is 100% my responsibility.  This is nothing to do with the GMP inspectors. If we have absolutely zero ingredients requiring RH specified storage conditions, and if I as the factory owner decide that  “it is just useful to know the RH” and spend the money, then this does not imply an excuse for them to require third part calibration. Very simply, calibration is not required, it’s that simple.

And “just useful to know the RH” is helpful in determing staff comfort and efficiecy of AC’s. Calibrated equipment not necessary.

“If you keep bringing up excuses like this, we will end up saying nothing should be calibrated. ” Again @em88 we credit people with the intelligence of deciding (based on their particular production facility) if particular items of  equipment require calibration.

[mikethair]

Exactly correct @khoikhoa …. as stated above, we are in fact in compliance with ingredient strage conditions sated by suppliers.

And @em88 states,  ” why do you have hygrothermometers in the first place? You should have only thermometers.” The answer is that it is just useful to know the RH. This does not mean we need to state ranges and do calibrations.

[mikethair]

I agree @aperson   “the person who really knows whether or not that RH meter needs to be controlled, is the owner of the plant.  Not the inspector. “

And added to that, we are the ones that need to make a profit within the framework of the GMP Guidelines.

Interesting outcome.…I usually allow my QC Manager to deal with these guys when they visit our production facility for these audits. I drop in periodically to see how things are going. On one visit they were hammering her on the RH meter and calibration of these. I stopped the conversation and said something along the lines of “Stop. Deep breath guys. Now look around you…. we are not in a pharmaceutical/vaccine producing facility, we produce simple cosmetics. I now challenge you to check all the specs of our ingredients, and tell me how many specify RH storage conditions?”

We received the written report last week. This issues was not included. Case closed.

[mikethair]

Sure @em88 there are many products that have RH in the storage conditions. Fact is, I have checked every ingreidentwe have, and not one has storage conditions specified for humidity.

“why not have a good working environment for yourself and/or workers?” … agreed. But isnt this a bit outside of what should be a GMP focus? And according to the GMP inspectors “these Hygrothermometers need to be calibrated by a licenced company on an annual basis.”  For what purpose is my response.

Let’s stay focussed.

 

[mikethair]

I’m originally from Perth, and appreciate your isolation. I’d give labfriend.com.au a try. I now live on an island where we have cosmetics manufacturing facility, and find labfriend very useful. Have made some siginifant purchases. Top grade equipment, good prices.

[mikethair]

Why not saponify an oil, for example extra virgin olive oil, and leave out all the other stuff?

 We do this and it is a huge success for our own brand and the other OEM brands we manufacture for.

[mikethair]

Thanks @Belassi  @em88 @”DRBOB@VERDIENT.BIZ”     confirms my toughts. OK, will go into battle with these GMP compliance guys.

I guess on the positive side, they found such piddly items and nothing too significant, so that must be good. They also mentioned that we need to have our AC’s calibrated…. crikey!!!

[mikethair]

Thanks for your comments @em88   In response:

Why do you need GMP if you are not making anything special?

All cosmetics production requires GMP in Malaysia, where we are located.

It is strange that you don’t have  any ingredient that does not specify the storage condition including RH. 

Temperature, yes. Its just a fact, I have gone through our ingredients store checking every label, plus the CoAs, and non stipulate RH.

What common ingredients would, in your view, stipulate RH storage conditions?

Calibration is mandatory for any equipment you declare.

Why calibrate for a parameter that is not stipulated for any ingrerdients?

[mikethair]

In response to @Belassi  @tanelise  once you make a purchase there is no interest from Chinese brands in service, warranty issues, or replacement parts. I must be a slow learner, the same happened with our Chinese autoclave. Nothing but trouble from day 1, plus I found out later that the company did not provide the appropriate Government safety certificate for pressure vessels of this type. Therefore the entire transaction was illegal and left us open to prosecution. Chucked it into the rubbish, and have putchased a European made Autoclave.