SOP Sterile Garment Cabinet operation, cleaning and maintenance

SOP Sterile Garment Cabinet

  • Objective

To lay down the procedure for the routine operation, cleaning and maintenance of the Sterile Garment Cabinet (SGC).

  •  Scope

This SOP is applicable operation cleaning and maintenance of the Sterile Garment Cabinet present in Microbiology Laboratory of (Pharmaceutical Company Name).

  • Responsibility
    • Chemist or above of QC laboratory.
    • Head – Microbiology Section.
  • Accountability
    • Head – Quality Control.
  • Abbreviations and Definitions

SOP                             : Standard operating procedure

No.                              : Number

QC                              : Quality Control

QA                              : Quality Assurance

SGC                            : Sterile Garment Cabinet

  • Procedure
    • Operation:
      • Plug the cord of the SGC to the MAINS.
      • Switch ON the MAINS.
      • The following buttons are present on the front panel of all the CRP’S SGC.
  • Press the UNIDIRECTIONAL FLOW ON button for Blower to turn ON.
  • Press the FLUORESCENT LIGHT ON button for light to turn ON.
  • Leave the LAF ON for some time and then hang the sterile garments inside the SGC using a sterile hanger.
  • After closing the door switch ‘ON’ the GERMICIDAL LIGHT and leave it in ON condition.
  • Switch ‘OFF’ the GERMICIDAL LIGHT before opening the door.
  • Take the garments and then close the door and again switch on the GERMICIDAL LIGHT.
  • Cleaning:
    • Clean the inner walls, grill and hangers of SGC before and after placing any sterile garments with the help of a lint free cloth soaked in disinfectant solution.
  • Maintenance:
    • Clean the inner and outer surface of SGC with the help of a lint free cloth soaked in disinfectant solution.
    • Once in a month check the intensity of UV lamp by using LUX meter.
    • Replace UV lamp of the SGC after 2000 hrs. of burning.
  • Forms and Records (Annexures)
    • Not applicable
  • Distribution
    • Master copy       –        Quality Assurance
    • Controlled copies  –       Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
  • History:
Date Revision Number
Reason for Revision
00   NEW SOP

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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