Laboratory cleaning is the vital part a pharmaceutical factory. Here Microbiology, Quality Control, Product Development Laboratory cleaning procedure has been clearly defined.
Purpose
To ensure proper cleaning and sanitizing of Quality Assurance Department in order to prevent contamination.
Scope
This SOP applies for cleaning and sanitizing of Quality Assurance Department of XX Pharmaceuticals Limited.
Definitions
Disinfectants
The specific substances which are used on the nonliving objects/ surface of the objects to kill the selective microorganism which are present on the objects/ surface of the objects. It’s not essential to kill all type of microorganism especially bacterial spores [non-resistant bacteria].
All type of Disinfectants are less effective than sterilization which kills all type of living organism. Antimicrobial agents like antibiotics are different from Disinfectants which [antibiotics] kill microorganism within the body.
Antiseptics
The specific substances which are used on the living objects/ surface of the objects to kill the selective microorganism which are present on the living objects/ surface of the objects.
Cleaning agents
The specific substances which are found generally in liquid but not limited to, use to remove dust, dirt, stains, bad smells, and clutter on the specific surfaces. The cleaning agents are used in beauty, health, to avoid shame, to absence of offensive odor, prevent spreading of dirt, contaminants to oneself and surroundings. It can kill bacteria and clean it.
Responsibilities:
The roles and responsibility is as follows
Cleaner/Lab. Attendant
Preparation of Cleaning & disinfectants solution, Cleaning & Disinfection
Microbiologist
Monitor of cleaning & disinfection
Asst. Manager, Microbiology/QC/PD
Ensure of Laboratory cleaning, disinfection and application of sound technical information.
Head Quality Assurance
Take initiative to approve of this SOP
Procedure
Instructions
- Use gloves to handle the disinfectants, cleaning solution and wastage materials.
- Wear gloves, mask, specific Footwear and suitable garments before entrance into Microbiology Testing area.
- Disinfect the outer surface of the apparatus before transfer into Microbiology Testing area.
Preparation of Cleaning agents & Sanitizer :
Preparation of 5% Savlon/Dettol Solution:
Dilute 50 ml of Dettol/ Savlon Liquid to 1000 ml with Purified Water.
Preparation of 250 to 300 ppm Chlorine Solution:
Dilute 6 ml of Chlotec (Chlorine solution) Solution to 1000 ml Purified Water.
Preparation of Detergent Solution:
Dissolve 10 g detergent powder in Purified Water & dilute to 1000 ml with same solvent.
Cleaning and Sanitizing Microbiology Laboratory
Cleaning and Sanitization of Grade D Area.
(Media Destruction Room, Media Preparation Room, Washing area, Media Store Room, Microbiology Office, D Corridor, D Dress Off)
Floor Cleaning & Disinfection:
- Enter into the specific area for cleaning.
- Remove the dust particles, papers or any others dirt or dirty materials from the floor with the help of properly cleaned Vacuum Cleaner.
- Sink the properly cleaned mop into the specific bucket contains detergent solution.
- Clean the selective area at twice with the help of mop properly.
- Wash the mop with tap water initially and finally with Purified water.
- Wipe again the selective surfaces with cleaned wetted mop.
- Wash the mop to clean it properly with purified water.
- Sink the mop into the specific bucket containing Dettol/Savlon solution or Chlorine solution
- Wipe all the selective area with Dettol/Savlon properly.
- Rinse the mop properly with Purified Water.
- Wipe all the selective surfaces with the cleaned mop.
- Use tap water to clean the mop initially and finally clean with purified water
- Use 70% IPA to sink the mop then dry it.
- Keep the mop at closed condition in the designated place for the next time use after proper dry.
Walls, glasses, tables, doors, doorknobs, switches:
- Place the circular cut sponges in bucket containing previous prepared detergent solution.
- Use sponges previously wetted with detergents solution to wipe down the walls, glasses, tables, doors, doorknobs, etc.
- Wipe all surfaces with Purified water instead of detergents.
- Use wetted cloth with 5% Dettol/Savlon solution or 250 to 300 ppm chlorine to wipe down all the surfaces.
- Wash the cleaning tools with tap water & finally with purified water.
- Dry it & keep at designated place for the next use.
- Use detergent once in a week.
- Use Dettol/Savlon solution and Chlorine solution in alternative week in one after another.
Cleaning and Sanitization of Grade C & B Area:
[Sterility Test Room, Microbial Limit Test Room, C Dress on & Off, B Dress on]- Previously mention steps to be Follow for Floor cleaning and Disinfection & Walls, glasses, tables, doors, doorknobs.
- Wipe all surfaces with 70% IPA wetted sponges.
- Minimize and control the traffic in the Sterility Test room and Microbial Count Room.
Cleaning and Sanitization of Laminar Air Flow workstation
- Remove used flask, used samples or any other dirty materials from the workstation.
- Wipe whole surface of the workstation with the help of 70% IPA.
Cleaning and Sanitizing at Product Development Laboratory
Cleaning and Sanitization of Grade D Area:
[Dispensing area, manufacturing rooms, In Process check rooms & Material staging and WIP room, D Corridor, D Dress Off]Floor Cleaning & Disinfection:
- Enter into the specific area for cleaning.
- Remove dust particles, papers or any others dirt or dirty materials from the floor with the help of cleaned Vacuum Cleaner.
- Sink cleaned mop into specific bucket containing detergent solution.
- Clean all area at twice with the mop appropriately.
- Wash mop with tap water initially & finally with Purified water.
- Wipe again all the respective surfaces with cleaned wetted mop.
- Wash the mop again with purified water.
- Sink the mop into the specific bucket containing 5% Savlon/Dettol solution.
- Disinfectant all area with the mop properly.
- Rinse the mop with purified water.
- Wipe all surfaces with the cleaned mop.
- Clean the mop with potable water initially and finally with purified water
- Keep it at closed condition in the designated place for the next time use.
- Use 5% Dettol solution for first and third week of the month.
- Use 5% Savlon solution for second and fourth week of the month.
Walls, glasses, tables, doors, doorknobs, switches:
- Place sponges in their respective bucket
- Use wall sponges wetted with detergents solution to wipe down the walls, glasses, tables, doors, doorknobs, switches etc.
- Use to wipe all of the surfaces with Purified water instead of detergents.
- Use the towels wetted with 5% Dettol/Savlon solution to wipe down all the surfaces.
- Take towels in other bucket and sponges to the down up area and leave them there.
- Wash all the used cleaning tools with tap water & finally with purified water.
- Dry cleaning tools and keep at designated place for the next time use.
- Use detergent once in a week.
- Use 5% Savlon and Dettol solution in alternative week in one after another.
Cleaning and sanitization of others area.
[Analytical room, E corridor, change rooms, Managers and officers room]
Floor Cleaning & Disinfection:
- Enter the specific area for cleaning.
- Remove the dust particles, papers or any others dirt or dirty materials from the floor with the help of Vacuum Cleaner.
- Sink the cleaned mop into the specific bucket containing potable water.
- Clean the designated area at twice with the mop properly.
- Wash the mop with Purified water.
- Wipe again all surfaces with properly cleaned wetted mop.
- Wash with detergent solution twice a week.
- Wash with 5% Dettol /Savlon solution once a week.
- Sink the mop into potable water first initially and finally into purified water for cleaning.
- Keep the mop at closed condition in the designated place for the next time use.
- Use 5% Dettol solution for first and third week of the month.
- Use Savlon solution for second and fourth week of the month.
Walls, doors, doorknobs, glasses, tables, switches:
- Place the sponges in their respective bucket.
- Use properly wetted sponges with potable water to wipe down the walls, glasses, doors, doorknobs, tables, switches etc.
- Use to wipe all surfaces with Purified water.
- Wash all used cleaning tools with potable water and finally with purified water.
- Dry it and keep at designated place for the next use.
- Clean twice a week.
- Use detergent once in a week.
Cleaning and Sanitizing Quality Control Laboratory:
Floor, Wall and Others Area:
- Empty the dust bins, clean them & keep them at specific place.
- Clean all tables & reagent racks with the help of dry mopping.
- Brush the floor of twice daily and then mop with wet mop using liquid soap.
- Disinfect with prescribed disinfectant solution (2% Savlon & 1% Dettol by weekly rotation). Drain 2% Savlon & 1% Dettol solution through the sink after cleaning & then clean the sink with detergent.
- Clean doors, windows & glass pans with glass cleaning agent. Sponge may be used for the purpose.
- In case of spillage occur, stop the activity. Clean the spillage and resume the activity.
- Clean all the instruments with a cotton duster.
- Once in a week clean all the fixtures and all the racks in chemical stores with dry mopping.
- Clean the walls, celling, with vacuum cleaner or with moist duster.
- After cleaning the area, check the cleanliness of the area and maintain the cleaning record Savlon and Dettol solution in alternative week.
Cleaning and Sanitizing Record:
Note down cleaning & Sanitization record in Annexure-I, Laboratory Cleaning & Sanitizing Record.