Drugsformulations

STANDARD OPERATING PROCEDURE
Title	:	Procedure for preparation of disinfectant & cleaning of microbiology laboratory

• OBJECTIVE

• • To lay down a procedure for preparation of disinfectant & cleaning of microbiology laboratory.
• SCOPE

• • This SOP is applicable for disinfectant & cleaning of microbiology laboratory.
• RESPONSIBILITY

• • Officer / Executive-QCM – responsible for Implementation of SOP.

• ACCOUNTABILITY

• • Manager – Quality Control

• PROCEDURE

Safety Precaution:

• • Use proper safety apparel such as gowns, rubber hand gloves and safety goggles during preparation and use of disinfectant.
  • While preparing disinfectant solutions always add disinfectant to the water and not water to disinfectant.
  • Prepare quantities of disinfectant solutions sufficient for one-day use.
• Disinfectant solutions:

• • Dettol 2.5%
  • Savlon 2.5 %
  • Virosil 20%

• Procedure for preparation of disinfectant solution:         

• • Dettol (For 1 lit) 2.5%

• • Take 500 ml of purified water in suitable sterile container.  Add 25 ml of Dettol and mix. Make-up the volume to 1000 ml with purified water.
• Savlon (for 1 lit) 2.5%

• • Take 500 ml of purified water in suitable sterile container. Add 25 ml of Savlon and mix. Make-up the volume to 1000 ml with purified water.
• IPA (for 1 Liter) 70%

• •   Take 300 ml of purified water in suitable sterile container. Add 700 ml of IPA & make-up to 1000 ml. Mix well.
• Virosil 20%

• •  Prepare the virosil solution as per manufacturer direction. Use the solution within 14 days.

 

• General instructions:

• • Before start of day work perform the cleaning operation in classified and non classified area daily.
• Classified Area:

• • Microbiology Testing Area and Airlocks
  • Sterility Testing Area and Airlocks.
  • Incubation area.
  • Media Preparation Area.
• Non classified area:

• • Wash and destruction area.
• Cleaning of Classified Area:

• • Cleaning of classified area shall be done in following order.

• • Sterility room → Airlock –4 → Airlock – 3→Airlock – 2 and then Airlock-1

• •  All disinfectant solutions shall be prepared freshly.

• •  Use sterile non-shedding dusters for cleaning of classified area.

• •  Rotate the disinfectant solution weekly.

• • Record the preparation of disinfectant .
• Daily cleaning procedure:

• •   Clean the classified area in the following order

• • Ceiling and fixtures→ Walls→ Top and side surface of LAF Bench →Floors.

• • Cleaning of Ceiling, fixtures, walls, top and side surface of LAF Bench shall be done with non shedding dusters.

• • Cleaning of floor shall be done using a nylon brush / non-shedding duster.

• • Subsequently mop the floor using non-shedding wiping mops dipped in the disinfectant.
• Cleaning of Non Classified Area:

• • All disinfectant solutions shall be prepared freshly

• • Rotate the disinfectant solution weekly

• • Record the preparation of disinfectant .
• Daily cleaning procedure:

• • Clean the floor using a nylon brush / non-shedding duster

• •  Subsequently mop the floor using non-shedding wiping mops dipped in the disinfectant

• • Maintain records in Cleaning record of Non Classified Area .
• Frequency:

• •  Ceiling and fixture – Weekly

• • Walls  – Weekly

• •   Floor – Daily

• • LAF  – Daily
•   ABBREVIATION

• •    SOP      –  Standard operating procedure

• •     IPA       –  Iso Propyl Alcohol

• •    WFI      –  Water for Injection
• FORMAT

Sr. No.	Title	Format No.
	Micro Lab cleaning record
	Format for disinfectant preparation & filtration record
	Isopropyl Alcohol Status Label
	Sanitization Schedule for week in month

 DISTRIBUTION LIST

Sr. No.	Copy No.	Department
		Quality Assurance
		Quality Control-Microbiology