Standard Operating Procedure for cleaning of dispensing and sampling room

1. Purpose:

To lay down a procedure for cleaning of dispensing and sampling room.

2. Scope

The scope of this SOP is applicable for cleaning of dispensing and sampling room in the warehouse at [company name].

3. Responsibility

Warehouse and Quality Control (QC) Person: cleaning of dispensing and sampling room as per SOP

Warehouse supervisor: To monitor cleaning of dispensing and sampling room.

Head Warehouse: Effective implementation of SOP

4. Definitions

PPE: Personnel Protective Equipment

PDE: Permitted Daily Exposure

5. Procedure

5.1 Product to product changeover/ major cleaning:

• Use PPE such as hand gloves, nose mask while cleaning of dispensing and sampling room.

• Once the sampling and dispensing is completed, remove the product/ material containers from the area before cleaning of dispensing or sampling the room.

• Required tools such as lint free duster, mop, scrubber, vacuum cleaner shall be used for area cleaning activity.

• De-dust the ceiling, supply and return of AHU grills, wall surface, using dry mop, lint free duster or vacuum cleaner using Scissor Lift or ladder as per requirement.

• After cleaning of above parts, clean the inner and external surface of Reverse Laminar Air Flow (RLAF) shall be cleaned with dry lint free duster or vacuum cleaner.

• Weighing balance shall be cleaned with wet lint free duster soaked in potable quality water and dry using dry lint free duster.

• Collect the spilled material (solid materials) from floor, under the balance and surrounding the weighing balance shall be cleaned using vacuum cleaner.

• Clean the room door and door closure using wet lint free duster soaked in potable quality water and dry it using dry lint free duster.

• Clean the fenders, Stainless Steel (SS) table, chair, storage cabinets, trolley, pallet, and other accessories using wet duster soaked in potable quality water and dry using dry lint free duster.

• Clean the storage cabinets used to store the clean utensils using wet duster soaked in potable quality water and dry using dry lint free duster.

• Clean the outer surfaces of light fixture using of wet lint free duster soaked in potable quality water and dry it using dry lint free duster.

• Clean the outer surface of cables, electrical switches, GPS clock, computer, printer, and other similar accessories and with the help of dry lint free duster. As per the suitability of cleaning, use wet duster soaked in potable quality water.

• The inner and outer surface of RLAF shall be cleaned with wet lint free dusters soaked in purified water. Scrubber (preferably single use nylon) shall be used to remove adhered materials to the surfaces if any. The RLAF shall be dried using compressed air or lint free duster.

• The RLAF filter grills shall be cleaned using wet lint free dusters soaked n purified water. Avoid sprinkling of water on RLAF filters grills.

• The riser filter covers shall be cleaned using vacuum cleaner or using lint free duster soaked in potable quality water and dry using dry lint free duster.

• Clean the floor using vacuum cleaner with scrubber machine using potable quality water and followed by clean using disinfectant solution.

• Major cleaning shall be done once the dedicated riser filter and pre filter installed that are applicable for low PDE (≤10 mcg/day) product.

• Major cleaning shall be performed when previous product and next product API is different. Major cleaning is also applicable after completion of dispensing activity and removing of the riser filter and pre filter of low PDE product.

• After completion of cleaning activity, vacuum cleaner outer surface to be cleaned using wet lint free duster soaked in potable quality water.

• Used single use cleaning accessories such as dusters, scrubber shall be discarded in waste bin.

• After completion of cleaning activity, the waste shall be transferred to scrap disposal area.

• Make entries in the Cleaning logbook after completion of cleaning the activity.

• Disinfectant solution shall be prepared as per the disinfectant use schedule as per respective SOP.

• The area under the weighing balance shall be cleaned by using mop that can be reach to the inner most surface.

• After cleaning is done, mop should be transferred to the wash area.

• Mop cloth shall be removed from the rod. Clean the mop cloth using potable quality water, squeeze it and allow it to air dry.

• The rod of the mop shall be cleaned using the wet duster soaked in potable quality water. Dry it using lint free clean duster. Store the mops to its dedicated place.

• Hand gloves shall be removed after completion of cleaning of dispensing or sampling area. Gown shall be changed before dispensing or sampling activity.

• Once the cleaning of dispensing or sampling room is done, make entries in respective area cleaning log book.

5.2 Batch to batch change cover or minor cleaning also called as batch to batch change over (same product):

• De-dust the area using vacuum cleaner to remove powder from the area and under the weighing balance platform.

• Clean the inner and outer surface of RLAF using vacuum cleaner and dry lint free duster.

Note: vacuum cleaner used in the dispensing area shall have HEPA filter.

6. Frequency

Major cleaning/ product to product change over: Between dispensing of two different API products, after preventive maintenance or breakdown maintenance.

Minor cleaning/ batch to batch change over: Between dispensing of different batch having API, after.

7. Formats

7.1 Dispensing/ Sampling Room Cleaning Checklist

1. Previous Product Name:

2. Previous Batch No:

3. Room Id.:

4. Cleaning Type:

5. Date:

6. Cleaning start time:

7. Cleaning end time:

Checkpoint for Major Cleaning:

• Change the Status Board

• Transfer unclean utensil in washroom for cleaning

• Clean the Ceiling, Wall and Grill

• Clean the Doors & Glass Window

• Clean the Hand Disinfectant Bowl

• Clean the Printer, Computer

• Clean Electric Fixture

• Clean SS Table, Chair and Cupboard

• Clean SS Box & Other Accessories

• Clean SS Trolley & Pallet

• Clean the fender

• Clean the weighing balance

• Clean the waste bin

• Clean outer body of vacuum cleaner

• Clean the outer surface of Riser Filter

• Clean the RLAF

o Dust from inner and outer surface of RLAF shall be cleaned with vacuum cleaner / clean lint free duster.

o Outer and inner surface of RLAF cleaned with moist lint free duster of purified water.

o RLAF shall be dried with compressed air or clean lint free duster.

• RLAF: Critical Checkpoints after Major Cleaning

• Clean the Floor

• Attach the cleaned label with relevant details

Check point for Minor Cleaning

• Change the status board

• Transfer unclean utensil in washroom for cleaning

• Clean the RLAF

• Clean the weighing balance

• Clean the Floor

Read about sampling of pharmaceutical products and related materials