SOPs

Procedure for handling of Microbiology Area

STANDARD OPERATING PROCEDURE

Title:Procedure for handling of Microbiology Area
Department
:
Quality Control-Microbiology
  •     OBJECTIVE  
    • To lay down a procedure for handling of microbiology area.
  • SCOPE
    • This SOP is applicable for handling of microbiology area.
  • RESPONSIBILITY
    • Officer / Executive-QCM – responsible for Implementation of SOP.
  • ACCOUNTABILITY
    • Manager – Quality Control
    • Manager – Quality Assurance
  • PROCEDURE
  • Cleaning of Microbiology Area:
    • Put any leftover waste on floor to waste bin.
    • All the waste bins in microbiology lab should be cleaned on daily basis.
    • Clean the area with disinfectant solution.
    • Weekly clean the doors, walls, glasses and monthly clean the ceiling with disinfectant solution like dettol, savlon,  70L% IPA.
  •  Handling in Microbiology lab and MLT Room:
    • Remove the factory slippers outside microbiology lab.
    • Cap, Masks, Apron should be used in microbiology lab.
    • Put wastes after analysis in waste bin.
    • Always kept used glassware’s in tray containing 70% IPA.
    • Follow aseptic handling during testing to avoid external contamination.
    • Keep the LAF bench clean after use with 70% IPA.
    • Get the area clean immediately after use.
  •     Sterility Room:
    •  Transfer sterilized test units & other articles through pass box to sterile area.
    • Remove factory clothes in air lock -2 & clean the hands with IPA 70%.
    • Use sterilized dress kept in air lock-2 prior to entering sterility test room.
    • Open the door of sterility room using elbows & enter in sterile area.
    • Switch on the LAF & allow running 30 minutes prior to testing & continued.
    • Transfer the articles from pass box to LAF bench.
    • Conduct the sterility test as per SOP No.
    • Put wastes after analysis in waste bin.
    • Used glass wares shall be kept in tray containing IPA 70%.
    • Follow aseptic handling during testing to avoid external contamination.
    • Keep the LAF bench clean after use.
    • Get the area clean immediately after use.
  •     ABBREVIATION
    •    SOP      –  Standard operating procedure
    •    IPA       –  Iso Propyl Alcohol
    •   LAF        – laminar Air Flow
    •    MLT       – Microbial Limit Test
    •    UV         – Ultra Violet

 

  •     FORMAT

Nil.

 

  •   DISTRIBUTION LIST
Sr. No.Copy No.Department
Quality Assurance
Quality Control-Microbiology
VP – Plant & Operations

 

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube