Cleaning and Sanitization of Production Area

In this post Standard Operating Procedure of Cleaning and Sanitization of Production Area) in Pharmaceuticals is describe.  

1.0 OBJECTIVE:

To lay down the procedure for Cleaning and Sanitization of Production Area.

2.0 SCOPE:

This procedure is applicable for Cleaning and Sanitization of Production Area.

3.0 RESPONSIBILITY :

Officer / Executive / Assistant Manager

Head Production: To ensure execution & compliance.

Head QA: To ensure the compliance.

4.0 PROCEDURE :

4.1 Safety Precautions:

4.1.1 Use proper safety apparel such as gowns, hand gloves and safety goggles (if required) during preparation and use of cleaning and disinfectant solution.

4.2 Preparation of Cleaning and Disinfectant solutions:

Cleaning solutions-

1.0 % v/v Teepol.

1 N Sodium Hydroxide (for enteric coating).

Disinfectant solution-

2.5 % v/v Savlon.

2.5 % v/v Dettol.

70 % v/v Iso-Propyl Alcohol.

4.2.1 Prepare quantities of disinfectant and cleaning solutions as below.

1.0 % v/v Teepol (For 1 litre)-

Take 10 ml of teepol and make-up to 1000 ml with purified water. Mix well and use within a day.

1N Sodium Hydroxide-

Take 40 gm Sodium Hydroxide & add 1000 ml Purified water to make 1N Sodium Hydroxide solution. Mix well and use within a day.

2.5 % v/v Savlon (For 1 Liter)-

Take 25 ml of Savlon & make-up to 1000 ml purified water. Mix well & use within a day.

2.5 % v/v Dettol (For 1 Liter)-

Take 25 ml of Dettol and make-up to 1000 ml with Purified water. Mix well and use within a day.

70% v/v IPA-

4.2.2 Take 14 kg of IPA & add 7.68 kg purified water to make 70 % v/v IPA and prepare as per requirement and use within 48 hours.

4.2.3 Maintain record in “Cleaning and Sanitization Solution Preparation Register’’ as per Annexure–I and “Cleaning aid consumption record” as per

Annexure –II

Note: Destroy the left over qty. of disinfectant and cleaning solution (if any) by putting in drain of wash area after validity.

4.3 Cleaning of Ceiling / AHU grill / dust collector pipe:

4.3.1 Frequency: Once in a week or product change over whichever is earlier.

4.3.2 Climb on a ladder to clean the ceiling.

4.3.3 Wipe out the entire ceiling surfaces with dry lint free cloth followed by wet cloth dipped in purified water. Wipe out again with a dry lint free cloth.

4.3.4 Wipe the grill thoroughly from the outside with wet lint free cloth dipped in purified water, then wipe again with a dry lint free cloth.

4.3.5 Wipe the outer side and inside of dust collector pipe present in production area with dry cloth

to remove the adhered material.

Note: Dismantle the dust collector pipe, the butterfly valve of the pipe and clean with purified water using nylon scrubber during product changeover or same product run for a week in respective area.

Use a safety goggles to prevent dust falling into the eyes.

4.4 Cleaning of Walls / electrical fixtures / windows / doors:

Frequency: Once in a week or product change over which is earlier.

4.4.1 Wipe the wall surface with a wet cloth dipped in purified water to remove all adhering material.

4.4.2 Wipe out entire wall surface thoroughly with a dry lint free cloth.

4.4.3 Remove dust from panel frames, electrical switch, glass frame, flameproof light and switchboard with a clean dry cloth.

4.4.4 Wipe the entire glass panels, windows, and doors with a cloth dipped in purified water.

4.4.5 Sprinkle few drops of Colin (cleaning agent) over glass panel of windows and doors. Wipe it out with a lint free cloth.

4.4.6 Wipe the door closure thoroughly with wet lint free cloth dipped in purified water to remove adhering material.

4.4.7 Remove the door seals (Side and Bottom) and clean with wet lint free cloth dipped in purified water to remove adhering material.

Note: Wipe all the cables with lint free cloth dipped with purified water once in week

4.5 Waste Bin Frequency :

1) Before initiation of the first shift,

2) At the end of day activity and

3) During batch change over

Remove the waste from waste bin in to the poly-bag and send to scrap yard. In case of any powder in poly-bag rinse with water and send to scrap area with scrap label. After removal of waste from bin, clean the bin inside and outside.

4.6 Floor Frequency

1) Before initiation of the first shift,

2) At the end of day activity and

3) During batch change over

Clean the floor with the help of vacuum cleaner/Device of the respective area (if applicable) followed by cleaning by scrubber machine or manual as per the area accessibility.

4.7 Cleaning of change room

4.7.1 Wipe the wall surface with a wet cloth dipped in purified water to remove all adhering material at the beginning of 1st shift

4.7.2 Clean the lockers with dry lint free cloth and clean the cross over bench with dry lint free cloth then disinfectant solution.

4.7.3 Clean the ceiling of the change room with dry lint free cloth then followed with wet cloth once in a week.

4.7.4 Clean the floor at the beginning and end of the shift daily or whenever required with the help of floor mopping machine or as per area accessibility.

4.8 Cleaning of SS tables , SS chair, SS cabinet, SS lockers

Daily cleans the SS tables, SS chair, SS cabinet, SS lockers and drawers twice daily and whenever necessary with dry lint free cloth.

4.9 Cleaned by scrubber machine:

4.9.1 Frequency:

1) Before initiation of the first shift,

2) At the end of day activity and

3) During batch change over

4.9.2 Fill required quantity of prepared teepol solution(1% v/v) into the scrubber machine.

4.9.3 Clean the entire floor by using a scrubber machine.

4.9.4 Remove the above cleaning solution from the scrubber machine into the drainage of the washing area. Clean the scrubber machine.

4.9.5 Fill the required quantity of purified water in it and clean the entire floor by using a

scrubber machine.

4.9.6 Fill required quantity of prepared Savlon / Dettol solution (2.5% v/v ) in scrubber machine and disinfect the entire floor.

4.9.7 Drain the unused disinfectant solution from the scrubber machine into the drainage of the washing area.

4.9.8 Clean the scrubber machine and keep it in the washing area.

Note: Ensure that the pallets are moved aside so as to facilitate the proper cleaning of the floor beneath.

4.10 Manual cleaning and sanitization:

4.10.1 Frequency:

1) Before initiation of the first shift,

2) At the end of day activity and

3) During batch change over

4.10.2 Fill required quantity of teepol solution (1% v/v) in cleaning trolley.

4.10.3 Dip a clean mopper in above solution, squeeze and then wipe out the floor thoroughly and use the required quantity of purified water from cleaning trolley for rinsing the mop.

4.10.4 Again dip that mop in the purified water, squeeze and wipe out the floor

previously cleaned by cleaning solution.

4.10.5 Fill required quantity of savlon/dettol solution (2.5% v/v) in cleaning trolley.

4.10.6 Dip a clean cloth in solution prepared, squeeze and wipe to disinfect the entire floor.

4.10.7 Repeat the procedure of dipping and squeezing the cloth in the disinfectant and wipe to clean the entire floor.

4.10.8 Drain the left over quantity of cleaning solution, dirty water and disinfectant solution into the drainage of the washing area.

4.10.9 Clean the mopper with purified water and store it in washing area.

4.10.10 Clean the used buckets/cleaning trolley with purified water and keep it in Janitor Room/Washing area.

4.11 Precautions:

4.11.1 Use disinfectant savlon/dettol in every alternate day.

4.11.2 In case of weekly off / holiday the disinfectant solution of penultimate day shall be utilized.

4.11.3 Use fresh solution for cleaning in each area.

4.11.4 Record the cleaning and sanitization activity of area as per Annexure –III.

5.0 ANNEXURE (S) :

ANNEXURE –I: Cleaning and sanitization solution preparation register.

ANNEXURE –II: Cleaning / Sanitization agent consumption record.

ANNEXURE-III: Area Cleaning and Sanitization Record.

6.0 REFERENCE (S):

SOP: Preparation, approval, distribution control, revision and

Destruction of Standard Operating Procedure (SOP).

7.0 ABBREVIATION (S) / DEFINITION (S):

IPA: Iso-Propyl Alcohol.

v/v : volume / volume

w/w : weight / weight

ml : Mililiter

gm : Gram

Kg : Kilogram

SS : Stainless steel