All disinfectants are manufactured as per schedule ‘O’ of The Drugs and Cosmetics Rules 1945 and their standards and characteristics are as enunciated below.
Disinfectants are classified into two major groups:
Class BLACK: BLACK DISINFECTANT FLUIDS:-
These shall be homogenous dark brown solution of coal tar acids or similar derived from petroleum with or without hydrocarbons and/or other phenolic compounds and their derivatives and a suitable emulsifier.
Class WHITE: WHITE DISINFECTANT FLUIDS:-
These shall be finely dispersed homogenous white to off-white emulsions consisting of coal tar acids or similar acids derived from petroleum, with or without hydrocarbons and/or other phenolic compounds and their derivatives.
Each of the above classes of disinfectant fluids shall be graded on the basis of the minimum requirements in respect of Rideal Walker Coefficient (RWC). The grading is as follows.
TYPE : Each of the above grades and classes of disinfectants are grouped into 2 types on the basis of their range of temperature in which they will be stable.
|Type||Stability Range (Temperature)|
|Normal||15 °C to 45 °C|
|Winter||5 °C to 30 °C|
All the disinfectants (all classes, all grades and types) comply with the following requirements.
1- STABILITY AFTER DILUTION:-
The disinfectant fluids shall be miscible with artificial hard water (black fluids) and with artificial sea water (white fluids) in all proportions from 1% to 5% by volume to give emulsion which shall not break or show more than traces of separation of either top or bottom oil where kept for 6 hours at 15 °C to 45 °C for Type (1) Normal and 5 °C to 30 °C for Type (2) Winter.
2- GERMICIDAL VALUE:-
All the disinfectants shall have determined Rideal Walker Coefficient (RWC).
They should be storable in mild steel, tinned mild steel containers. Galvanized iron containers are not suitable for their storage.
All the disinfectant containers shall have the following details on their labels invariably.
1] Name of the product
2] Name and full address of the manufacturer
3] Grade, Type, Class and RWC of the product
4] Batch No, Date of Manufacture and Expiry date
5] Quantity present in the container
6] Drug Manufacturing Licence No.
7] Indications and Directions for use and
8] Bar Code