[mikethair]

Hi @DAS yes I agree we should maintain our standards. We had an interesting exhange with the RO water supplier as follows:

Our email to them was as follows:

“Our Quality Manager has alerted me to the microbiol test for the RO water delivery we received on Tuesday 15 September. From the attached photo you will see that the result is between 1 CFU/cm2 and 5 CFU/cm2. Usually, we would expect 1 or less than 1 CFU/cm2 . We have our own RO system, and the result is always ND (no bacteria detected). Our previous suppliers result was always  1 or less than 1 CFU/cm2 .”

Their reply (from chemist):

“From the information provided, what I understand is:

1 CFU/cm2 = 1000 CFU/ml (per 1 ml sample)

5 CFU/cm2 = 10,000 CFU/ml (per 1 ml sample)

 So in this case, your QC is <1 MPN/100 ml (per 100 ml sample).

 

Your QC show <1 MPN/100 ml sample which is interpreted as no detection.

The only difference is the unit (MPN) because of different testing method, but still your result per 100 ml sample is no detection. If in 100 ml sample has no detection, same goes to 1 ml of sample, no detection. So there should be no problem with your QC result.”

I have since found out that their own QC takes samples from the plant tap, not from a filled 18L bottle that is supplied to us. In my opinion this testing eliminates the possibility that the 18L bottles may be contaminated.

If, with our own testing from other suppliers we have also had results of 1 or less than 1 CFU/cm2, then I would expect the same from this supplier. I have missed anything? I’m not a water quality expert.

Thanks.

[mikethair]

@Sibech without going too far into GMP requirements you have already identified a few critical issues.

Addition areas are, in my opinion, layout and design of production area to minimise the risk of cross contamination and errors during all aspects of manufacture, filling and packaging. 

The weighing of starting materials should be carried out in a separate purpose designed weighing area.

The list goes on….

[mikethair]

In reality, if you check Lush ingredients they are not so “natural” (whatever that means).

@Perry that would require a massive reconstruction for a visit by inspectors. I doubt it very much.

@Sibech not sure if I agree with you. Some of what I observe would require a microbial regime

So, from my side as the owner of a GMP cosmetics facility, still non the wiser. As @em88 says “WTF??? Are you kidding me, why are they still in the market with this? ”   My thoughts exactly. Even without any microbial risks, this place would never be accepted under any GMP regime.

Mark Constantine, the Lush founder, was originally making stuff for Anita Roddick (The Body Shop). After some time, the Body Shop then paid £11 million for the rights of Mark Constantine’s recipes. So this guy has been around for a while and knows the cosmetics business. 

[mikethair]

Our GMP certified production facility is located in a very humid environment. We have never had any issues with bacteria and fungi. The reasons are simple.  Smooth surfaces (walls and floors) with good quality painted surfaces. We use epoxy paint on the floor.  Regular cleaning, and a VERY strict hygiene and gowning up regime. We do not use disinfectants on the floors and walls.

We do not use tiled surfaces. In my humble opinion they invite bacteria and fungi because of the gaps, and are difficult to keep clean.

[mikethair]

@Normasegovia55    I can only relate our experience and that of customers. For some years now we have produced a face oil formulation under our own brand plus a few Private Label brands. These formulations include essential oils. We do not make too many any claims about wrinkles etc. We see some plumping and smoothing of the skin, and that’s about it. However, across all brands, the formulation has been very successful and sells well.

My advice, do a lot of research and select your oils carefully. And don’t over promise on the benefits.

[mikethair]

The ISO 29621 Second edition 2017-03 provides some definitive answers on this issue. Quoting from this document:

“Alkaline pH may also create a hostile environment and may in some products be used as part of their preservative system. Liquid soaps with alkaline pH (pH 9,0 to pH 10,0) present an environment unfavourable for the growth of some microorganisms (see Reference [11]). 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 (see Reference [12]).
The reason for this is that the extreme pH, either acidic or alkaline, makes it necessary for microorganisms to expend energy on maintenance of intracellular pH rather than growth. When pH is used in combination with chelating agents, glycols, antioxidants, water activity and high surfactant levels, an environment can be created which will not support microbial growth.”

Works for us. Of course every new product we produce is Challenge Tested, and each batch manufactured is tested in our microbial lab before release.

[mikethair]

My entire life (I’m now pushing 70) I have stayed away from synthetic fragrance. You won’t find them in my home or work environment.

We produce body wash, face wash, shampoo, soap. The function of these products is to cleanse and not much else. In our opinion EOs provide a more pleasant fragrance sensation. Our customers agree. Many appreciate something different to synthetic fragrances.

Yes, EO’s are pricy. At the end of the day it really depends where you position your product and your brand message.

[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.