RE: (was:FDA Requirements) MSDS, C of A, QC

[Guest guest]

Thanks for the summary!!

Sherry

[Guest guest]

Sherry,

A C of A is a Certificate of Analysis. This is just a listing of the test

specifications for a product and the results for that specific batch of

product. Form many personal care products the QC specifications include

form, color, odor, Sp. G., pH and Viscosity. FCO is generally TMS-To Match

Standard. The other three you will need separate pieces of test equipment to

establish the specs and to test the products. A pycnometer is used to

establish the Specific Gravity of a product and costs about $100. A pH meter

can vary in cost depending on the features. You can obtain a serviceable

unit for about $100-$150. A viscometer is a very expensive piece of

equipment and can cost from $800-$5000.

When you make your acceptable experimental batch of product that you want

all future batches to emulate then you will save 8-16 ounces of it in a

glass jar and label it as your standard. All subsequent batches will be

compared to the test results that you measured from your standard. You

typically set the results wide enough to be acceptable for a range of

variations in the physical parameters. I.e., if your ideal pH is 6.5 you

could set the acceptable range as 6.0-7.0. Then when you make a batch if the

pH is 6.8 or 6.2 it is still acceptable. FCO is very subjective; that's why

the standard is TMS. If it matches in your opinion then that is all that

matters.

Young

KY Labs

Innovators of Fine Personal Care Products

www.kylabs.com

(was:FDA Requirements) MSDS, C of A, QC

,

>>What you should do to protect yourself is have a copy of the MSDS of each

>>material that you work with in your business.

Does this mean " each material " = each ingredient i use for a formulation?

>>Have a copy of the C of A for each of the materials used in your

manufacturing process.

>>Establish QC specifications for each product that you make and show that

you have tested

>>each batch against those specifications.

What is the C of A? And, is there a file and/or guidelines as to setting up

these QC specifications to help us in our " just starting " process?

Thanks!

Sherry