Production

Cleaning & sanitization of classified/clean area

Shiv Kumar

Cleaning & sanitization of classified/clean area

 PURPOSE:

To lay down the procedure for sanitizing the clean rooms in normal operation and during various interruptions to make the clean area free from microbial & particle load.

SCOPE: This SOP will be applicable for cleaning & sanitization of  classified clean area manufacturing, filling, air lock system, autoclave room  of

REFERENCE(S) & ATTACHMENTS:

References

USP <1072> Disinfectants and Antiseptics

Attachments

Attachment-I:  Classified/clean cleaning & sanitization Record

RESPONSIBILITY:

Concern Department Person

For preparation of Sanitization Solution.

Production  Person

To ensure the sanitization process.

To Maintained the record.

Production Head

To ensure the compliance of SOP.

Quality Assurance Persons

To verify that all the instructions are followed properly as per the given SOP..

To ensure implement of the SOP.

DEFINITION & ABBREVIATION(S):

Clean Area :Clean area is the area in which defined environmental control of particulate & microbial contamination, constructed & used in such a way to reduce the introduction, generation & retentions of contaminants within the area.

Abbreviations

IPA : Iso Propyl Alcohol

µ  : Micron

PROCEDURE:

Cleaning materials

Lint Free cloth, water for injection, Sterile Gloves, safety goggles, Stainless steel Bucket, Stainless  steel Mug, Cleaning wipers  & Disinfectants solution  like 2.5% v/v Dettol, 2.5% v/v Savlon, 70% v/v IPA solution, 5%v/v Silvicide/Virosil.

Precaution

Do not use the disinfectant in the manufacturing area during the batch manufacturing process.

Cleaning of clean area to be performed with three bucket system.

Cleaning shall always proceed from the more  critical area to  less critical area.

Freshly prepared disinfectant shall be used for sanitization and shall be prepared as per SOP & should be use within a day.

Non particle shedding cleaning tools shall be used.

Use safety goggles during cleaning .

Disinfectant shall not be sprayed towards HEPA filters or electrical components.

Cleaning shall be avoided during production process.

Cleaning Frequency

Doors, Frames & glass Panel

Ensure that door, frame & glass panes are mopped with  70% IPA  (v/v) solution using a dry lint free cloth, start wiping from the top and cover the side edges of the door also.

Ensure that the handles and key holes are disinfected with IPA70% v/v solution and wipe it with dry lint free cloth.

Ensure that the door closures are cleaned with a dry lint free cloth.

Frequency: Twice in a day or whenever necessary.

Work stations (Tables, Chairs & Telephone)

Work stations (Tables, Chairs & Telephone) shall be disinfected with IPA 70% v/v solution wipe & clean with a dry lint free cloth.

Frequency: Once a shift or whenever necessary.

Pass Box

The pass box shall be cleaned with lint free cloth dipped in disinfectant solution Ensure that all corners, hinges and glass panes are cleaned.

Frequency: Once in a day or whenever necessary.

Floor

Ensure that all fallen objects, debris are removed with lint free cloth prior to cleaning.

Clean the floor of each room by taking filtered WFI in one bucket, disinfectant solution in second bucket & third bucket empty for squeezing the solution.

Clean the floor surface by applying straight & long strokes with long handle mop from inner side (back side) to outer side (door) of room towards change room.

Frequency: Once in a shift or whenever necessary.

Floor Drain

  • Remove the top lid of the floor drain.
  • Pour sufficient disinfectant into the trap cup until it overflows with the disinfectant.
  • Place the top lid & hold the drain without process at least 20 minutes.

Frequency: Once in a day.

Change Room

Clean & mop the change room

Frequency: Once in a shift or whenever necessary.

Ceiling

Clean ceiling of each room by taking filtered WFI in bucket with long handled smart mop followed by sanitizing with disinfectant solution with overlapping unidirectional strokes.

Frequency:  Twice in a week.

Walls 

Clean ceiling of each room by taking filtered WFI in bucket with long handled smart mop followed by sanitizing with disinfectant solution with overlapping unidirectional strokes.

Frequency:  Twice in a week.

Stainless steel garment cubicle

Stainless steel cabinet  shall be disinfected with IPA 70% v/v solution and wiped clean with a dry lint free cloth.

Frequency: Internally & externally once in a day and  whenever necessary.

Stainless steel ladder

Solution preparation unit stainless steel ladder shall be cleaned with hot water for injection  and wiped with dry lint free cloth. Same shall be documented in cleaning record as a part of floor.

Frequency: Internally & externally once in a day and  whenever necessary.

Disinfectant Schedule for mopping of floors & walls.

Monday: Savlon 2.5 % v/v

Tuesday :Savlon 2.5 % v/v

Wednesday : Dettol 2.5 % v/v

Thursday : Silvicide/virosil 5.0 % v/v

Friday :Savlon 2.5 % v/v

Saturday :Dettol 2.5 % v/v

Sunday : Silvicide/virosil 5.0 % v/v

 Attachment-I

 Classified/clean area cleaning and sanitization record

Date/Sanitizing agent / Area Name

Sr. No. /Area Details /Walls, ceiling, tube lights ( Timings -From /To) /Done by

SS Furniture & fixtures ( Timings -From /To) /Done by

Glass, handles, racks, doors ( Timings -From /To) /Done by

Floors ( Timings -From /To) /Done by

Drains ( Timings -From /To) /Done by