Deactivation of sex hormone

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

How to de activate sex hormones like Levonorgesteral and ethinylestradiol in manufacturing area.

Suppose deactivation of hormone on used garmentes .

please guide.

2

Dear Him_che,
Steroidal hormones like Levonorgesteral and ethinylestradiol in manufacturing area and in garments can be destroyed using 10% Sodium Hypochlorite solution.
The purpose of Sodium Hypochlorite [Chlorine bleach], is to oxidise and to break down the more complex steroidal ring to a simpler form, which will be easily removable and more water soluble.
Even we follow, the above explained procedure for our steroidal formulation facility manufacturing, Levonorgesteral , Norethindrone and ethinylestradiol Tablets.

3

Thanks T. Arun sir

I want to know that any guidline or standard procedure on de activation of sex hormone

if any, please povide link

Himansu Khandhedia

Famy Care Ltd.
India

4

Dear Himanshu,
Chlorine bleach is the usual approach for deactivating steroidal substances.
As such, there is no regulatory guideline for this procedure.
For concentration of bleach , perform a laboratory study.

5

Any one have document ?