I intend to start a small manufacturing unit producing disinfectants and alcoholic hand sanitzers.
What type of clean room is required for this as per drug control department. No information could be obtained from Drugs control web sites. Will clean room is enough for formulating room and packaging room. Or is it required for entire area. My manufacturing area will be 2500 sft.
Of which 20 ft x 15ft is the formulating ( mixing room), another 20 ft x 15 ft s for liquid filling area.
The bottles are fiilled in the filling room and then exists into a 15x10 ft packaging area, from where packed finished products are stored in another room. As per Drugs control requirement which are the rooms mentioned above require clean room and which Class is required.
Please refer first schedule of the Drug & cosmetics Act 1940 and Schedule “O” (second part) in the Rules- 1945 for the standards to be followed for “Disinfectants”. Now, very recently due to COVID-19, Govt. of India has from 13 March 2020 has notified masks and hand sanitizers under Essestial commodities Act 1955 to regulate their production, Quality, Distribution and logistics. Schedule-II of The Drug & cosmetics Act 1940 & Rules thereunder 1945 specify GMP requirements of plant and equipmant for manufacturing of cosmetics.
Also please refer Second schedule as well as Schedule “K” of the Drugs & cosmetics Act 1940 and Rules thereunder1945 for the same.