Production

Operation, cleaning & precaution of three bucket system

Operation, cleaning & precaution of three bucket system

PURPOSE : To lay down the procedure for operation, cleaning & precaution of three bucket system.

SCOPE :                                

This procedure is applicable for operation, cleaning & precaution of three bucket system used for mopping & cleaning for aseptic area of SVP section.

References

USP <1072> Disinfectants and Antiseptics

WHO Annexure: VI

Attachments

Reference SOP attachment (): Equipment/Machine Log Book

RESPONSIBILITY

Operator

Operator shall be responsible for operation, cleaning, usage & storage of cleaning tools of three bucket trolley.

Production  Person

Production officer/chemist/executive shall be responsible for verifying the operation. Cleaning, usage & storage of cleaning tools.

Responsible to take corrective action if any deviation performed in cleaning.

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.

Abbreviations

SS: Stainless Steel

IPA  : Iso Propyl Alcohol

µ : Micron

WFI : Water For injection

PROCEDURE

Description:

Clean room or clean area is simply an area that is clean simply in terms of both particle counts (as defined in the international clean room standard ISO 14644) and microbial counts (as defined in the second clean room standard for bio contamination control, ISO 14698). One important step towards achieving microbial control within a clean room is the use of defined cleaning techniques such as two bucket or three bucket system.

In this system three stainless steel square bucket with ss lid, of capacity approx.10 liter mounts on the movable SS trolley. These trolley moves with the aid of castor wheel.

Operation of three bucket mopping system

The cleaning technique used for clean room should be defined & standardized.

With the technique for cleaning & disinfection of clean room is the “two bucket” or “three bucket” is recommended.

These technique involve using a bucket of disinfectant & water (purified water & WFI).

In three bucket mopping system three ss buckets of 10 liters capacity are kept on ss trolley.

First bucket contain disinfectant solution to clean the area.

Second bucket contain fresh purified water to squeeze the dirty mop.

Third bucket contain fresh WFI for final rinsing of mop.

For mopping dip smart mop in the disinfectant solution containing bucket no.1 & mop the Floor from inside corner to outside & walls from upside to down side.

Rinse the dirty mop in second bucket containing purified water, with squeeze handle to remove excessive dirty solution.

Again rinse the  smart mop with fresh WFI contain in bucket third.

Squeeze the mop in bucket no. 3 to remove excess WFI.

Again dip smart mop in disinfectant solution & clean floor surface in long straight strokes.

Continue follow the same order & clean classified/clean area from inner room to outer room.

Cleaning of three bucket mopping system & storage of cleaning tools

After cleaning transfer three bucket mopping trolley in unit preparation area.

Squeeze water and disinfectant solution soaked in mop.

Clean smart mop with fresh WFI, three four time & squeeze to remove excess solution until all the dirt from the mop removed.

Drain out all dirty solution & remain over disinfectant solution from buckets of mopping trolley.

Wash all three buckets with teepol & fresh WFI & finally with IPA 70% v/v solution.

Clean all mopes brushes with 70% v/v solution & transfer to disinfectant room.

Three bucket mopping trolley & vacuum cleaner shall be clean immediately after use & properly covered with polybag & “CLEANED “ status label in the  area.

No equipment washing activity will performed in case uncleaned cleaning tools in washing area.

Precautions

 Clean room cleaning is often regarded as time consuming, inconvenient or troublesome.

Utmost care to be taken during performing of clean room cleaning & this process need to be carried out as efficiently as possible.

While at the same time ensuring that the quality should not be reduced.

Before performing the task the related person (operator as well as chemist) should give proper training to operate the equipment & to avoid the contamination & for personal safety.

The operator should wear mask, goggles & hand gloves before performing the operation to avoid any harmful effect of disinfectant on body.

Strictly adhere the validated cleaning, operating procedure & instructions for effectively cleaning process.

Incorrect cleaning, handling of mop or trolley system can quickly lead to insufficiently wetted floor or ineffective cleaning & safe disinfection will not be achieved.

The mopping trolley should be move in slow motion in clean area to avoid particle generation during movement.

The mopping trolley, mopper should not be rusted, mopper should not release fibers.

Daily use freshly prepared purified water & WFI for cleaning.

Operators & chemist belonging to cleaning should follow all instruction for clean area practice and behavior.

REVISION HISTORY

New SOP