Disinfectant Requirements for Aseptic Area | Pharmadocx Consultants

Disinfectants to be used for Aseptic Sterile area shall be filtered through bacteria retaining filter and kept in sterile containers till used.
In clean areas all exposed surfaces shall be smooth, impervious and unbroken to minimise the shedding or accumulation of particles or microorganisms and to permit the repeated application of cleaning agents and disinfectants, where used. Use of water for cleaning shall be restricted and controlled. Routinely used disinfectants are suitable for sanitising the different areas. Records of sanitation shall be maintained.
The sanitation of clean areas is particularly important. They shall be cleaned frequently and thoroughly in accordance with an approved written programme. Where disinfectants are used, more than one type shall be
employed. Monitoring shall be regularly undertaken to detect contamination or the presence of an organism against which the cleaning procedure is ineffective. Interactions between different cleaning materials shall be
validated. Appropriate cleaning validation shall be carried out to ensure disinfectant residuals can be detected and are removed by the cleaning process.
Disinfectants and detergents shall be monitored for microbial contamination; dilutions shall be kept in previously cleaned containers and shall only be stored for defined periods unless sterilised. Disinfectants and
detergents used in Grade A and B areas shall be sterile before use.
A disinfectant programme shall also include a sporicidal agent since many common disinfectants are ineffective against spores. The effectiveness of cleaning and disinfectant procedures shall be demonstrated.
Our company Pharmadocx Consultant helps in establishing pharmaceutical plants, GMP Certification and also obtaining Drugs manufacturing license like Form 25, Form 28 etc.
Pharmadocx FDA Consultant
Sonipat Office -
Opposite Dewan Mill, Old DC Road, Sonipat-131001
M:- 9896133556
Delhi Office –
G-12, Pearls Best Heights-1, Netaji Subhash Place, Delhi-110034
Ph:- M:-8708385761