Home / Production / SOP for preparation of disinfectant solution

SOP for preparation of disinfectant solution

  • Objective:
  • To lay down a procedure for preparation of disinfectant solution.
  • Scope
  • This SOP is applicable for preparation of disinfectant solution at dry powder Injectable facility.
  • Responsibility
  • Officers /above –(Production Injectable) is responsible for preparation of disinfectant solution.
  • Accountability
  • Production Head shall be responsible for the compliance of the SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • S.S. : Stainless Steel
  • WFI : Water for Injection
  • IPA  : Isopropyl alcohol
  •  Procedure
  • Issuance of bulk containers of disinfectant solution:
  •  Issue the bulk containers of specific disinfectant solutions from warehouse as per the sanitizing schedule on material requisition slip.
  • Transfer the issued quantity of disinfectant solution containers to the compactor.
  • From compactor disinfectant solution containers are taken to equipment wash and sterilization room for disinfectant preparation as per the disinfectant schedule for aseptic area, controlled area and uncontrolled area.
  • Preparation of disinfectant and Iso propyl alcohol for aseptic area
  • Surface disinfectant and spray disinfectant:
  • As per the disinfectant rotation schedule the amount of spray and surface disinfectant solution is taken from compactor to equipment wash and sterilization room (on weekly basis).
  • Disinfectant solution and WFI is filtered and collected in Cooling zone as per SOP. Disinfactant solution is filtered on the weekly basis and WFI is filtered on the daily basis. Transfer requirement quantity of WFI from collection tank in SS bucket. Add required quantity of concentrated disinfectant solution to SS bucket.
  • Mix the contents gently by shaking the bucket.
  • Record the preparation details in format for cleaning and sanitization record of aseptic area.
  • Note: Cidex is to be used undiluted therefore No such dilutions to be prepared for Cidex solution.
  • Note: Fumigation solution to be prepared as per criterion give in Sop for fumigation of Aseptic area.
  • Preparation of Isopropyl alcohol:
  • As per the weekly requirement the amount of Isopropyl alcohol is taken from compactor to equipment wash and sterilization room.
  • Isopropyl alcohol is filtered and collected in cooling zone as per SOP.
  • Transfer requirement quantity of WFI from collection tank in SS bucket.
  • Add required quantity of Isopropyl alcohol to SS bucket.
  • Mix the contents gently by shaking the bucket.
  • Record the preparation details in format for cleaning and sanitization record of aseptic area.
  • Preparation of disinfectant solution and Isopropyl alcohol  for Controlled area and uncontrolled area
  • As per the disinfectant rotation schedule the amount of disinfectant solution & isopropyl alcohol solution is taken from compactor to equipment wash and sterilization room on daily basis.
  • Transfer requirement quantity of WFI from collection tank in SS bucket.
  • Add required quantity of concentrated disinfectant solution to SS bucket.
  • Mix the contents gently by shaking the bucket.
  • Record the preparation details of solution prepared for cleaning and sanitization of uncontrolled area in format for cleaning and sanitization record of uncontrolled area.
  • Record the preparation details of solution prepared for cleaning and sanitization of controlled area in format for cleaning and sanitization record of controlled area.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –   Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

 

 

About Pharma Editor

Check Also

Tablets In Pharma Industry

Tablets In Pharma Industry NOTE- The provisions of this monograph do not necessarily apply to …