Three-bucket mopping trolley

Three-bucket mopping trolley

To provide a written procedure for the operation, cleaning & precaution of three bucket mopping trolleys.

DEFINITIONS

Aseptic Area: a room or special area within the clean room designed, constructed, serviced & used with the intention of preventing microbial contamination of the product during production because it can’t support the growth of micro-organisms.

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

ABBREVIATIONS

SVP:           Small Volume Parenteral

PW:       Purified Water

WFI:       Water For injection

ISO:       International Organization of Standardization

EHS:       Environment Health & Safety

IPA:       Isopropyl Alcohol

RESPONSIBILITY

Originating department designee shall be responsible:

• Preparation of the SOPs.
• To follow the procedure & contents of SOP.
• Execution & updation of required documents as per SOP.

The Head of Originating department shall be responsible for:

• To provide the training of SOP to the concerned personnel.
• Responsible for implementation & compliance of procedures mentioned in the SOP.

The Quality Assurance department shall be responsible for:

• To verify the procedure/instructions are followed as per the given SOP.
• To verify that all the relevant records are maintained as per the defined SOP.

Head – Quality Assurance shall be accountable for:

• To approve new or revised SOP.
• For compliance & implementation of the defined system. 

The plant Head shall be accountable for:

• To approve new or revised SOP.
• For compliance & implementation of the defined system.

PROCEDURE:

SAFETY/PRECAUTION/EHS   

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

Utmost care to be taken during the performing of cleanroom cleaning & this process needs to be carried out as efficiently as possible.

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

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

Strictly adhere to the validated cleaning procedure for effective cleaning procedure.

Incorrect cleaning or handling of the mop will lead to an insufficiently wetted floor & safe disinfection will not be achieved.

The mopping trolley should move in slow motion to avoid any particle generation during movement.

The mopping trolley, mopper should not be rusted & mopper should not be fiber releasing.

Daily use freshly prepared purified water & WFI for cleaning.

Operators/chemists should follow all instructions for clean room behavior.

Brief Description

A clean room or clean area is simply an area that is clean simply in terms of both particle counts (as defined in the international cleanroom standard ISO 14644) and microbial counts (as defined in the second clean room standard for bio-contamination control, ISO14698). 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 systems.

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

                                                                 (Figure: 1)

Operation of three bucket trolley system

The cleaning technique used for cleaning & disinfection of clean rooms should be defined & standardized.

With the technique of clean room disinfection three bucket trolley system is recommended.

These techniques involve using a bucket of disinfectant & water (PW & WFI).

In three bucket mopping system, 3 square ss buckets of 10 liters capacity are kept on ss trolley.

The first bucket contains the disinfectant solution to clean the area.

The second bucket contains fresh purified water to squeeze the dirty mop.

The third bucket contains fresh WFI for the final rinse of the mop.

For mopping dip the smart mop in a disinfectant solution containing bucket no. 1 & mop the walls from upside to downside & floor from the inside corner to the outside.

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

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

Squeeze the mop in a third bucket to remove excessive WFI.

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

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

Cleaning of three bucket trolley system & storage of cleaning tools

 After mopping transfer three bucket mopping system to unit preparation area.

 First squeeze, all water & disinfectant soaked in mop.

Clean smart mop 3-4 times with fresh WFI & squeeze to remove excess solution until all the              dirt removed from mop.

 Drain out all dirty solution & remain over disinfectant solution in bucket of mopping trolley.

Wash all three buckets with Teepol & fresh purified water & finally rinse with WFI.

Finally clean with IPA 70% v/v solution & covered with poly bag by mentioning “CLEANED”              status label.

No equipment washing activity will be performed if uncleaned equipment will be there in unit              preparation room.

After cleaning transfer all cleaning tools to mfg. & filling area through dynamic pass box for              further processing. 

REFERENCE(S)

USP <1072> Disinfectants and Antiseptics FDA and schedule M

WHO TRS 961 Annexure 6

Attachment – Three bucket system usage logbook