1.0 PURPOSE:
2.0 SCOPE:
This procedure for operation and cleaning of dispensing booth and accessories is applicable to warehouse department at (Company name).
3.0 REFERENCE:
4.0 DEFINITION:
Not Applicable.
5.0 RESPONSIBILITY:
5.1 Warehouse personnel is responsible to perform the operation and cleaning of dispensing booth and accessories.
5.2 Warehouse Officer / Executive is responsible for execution of the procedure.
5.3 Head-Warehouse is responsible to ensure the compliance of the procedure.
6.0 PROCEDURE:
6.1 Ensure following points before entry to the dispensing booth:
6.1.1 Check and ensure the differential pressure of men entry is within the specified limit and record the same in Annexure-II.
6.1.2 Ensure the temperature and relative humidity are as per prescribed limit and record the details before starting the activity in BMR.
6.1.3 If the readings are not found within the limit, inform to engineering department for further corrective action.
6.1.4 Ensure that dispensing room and dispensing booth are cleaned.
6.1.5 Follow secondary gowning procedure for entry and exit from the Dispensing/Sampling Areas of Warehouse.
6.2 Operating procedure for dispensing booth:
6.2.1 Switch “ON” the power supply of dispensing booth before 15 minutes of starting the dispensing activity and record the RLAF start time as per Annexure-II.
6.2.2 Record the differential pressure of RLAF before starting the dispensing activity as per Annexure-II.
6.2.3 Differential pressure limit of RLAF shall be as under:
6.2.3.1 Pre filter between 4-6 mm of water
6.2.3.2 Intermediate filter between 4-8 mm of water
6.2.3.3 HEPA filter between 7-17 mm of water
6.2.4 If the readings are not found within the limit then inform to engineering department for further action.
6.2.5 Ensure that the weighing scales are calibrated.
6.2.6 Ensure the containers are cleaned before transfer to the dispensing area.
6.2.7 Open the container of the material to be dispensed under the RLAF and dispense the material inside the safe zone marking.
6.2.8 Dispense the excipients first, then API followed by ‘B’ type cleaning and at the end dispense the colour.
6.2.9 Record the details in ‘Dispensing Booth Operation and Cleaning Log’ as per Annexure-I.
6.2.10 Open the containers/packs/bags carefully and dispense the material as per dispensing procedure.
6.2.11 Tie the polybag of the dispensed material and close the containers/packs/bags of remaining materials under the dispensing booth after completion of dispensing activity.
6.2.12 Transfer the dispensed materials to production through pass box and remove the containers/packs/bags of leftover materials through dynamic pass box to warehouse.
6.2.13 Record the above activities in log book as per Annexure-I.
6.2.14 Switch OFF the RLAF and record the OFF time as per Annexure-II.
6.3 Procedure for cleaning of dispensing booth:
6.3.1 Type ‘B’ cleaning is applicable in below conditions:
6.3.1.1 Between dispensing of excipients and API.
6.3.1.2 Between dispensing of different APIs or different colours in a single product batch.
6.3.1.3 After dispensing of API if colour to be dispensed.
6.3.1.4 Between dispensing of same product with different batch number.
6.3.2 Type ‘A’ cleaning is applicable in below conditions:
6.3.2.1 Between product changeover.
6.3.2.2 After completion of dispensing activity of the particular day.
6.3.2.3 Post maintenance work in the dispensing booth.
6.3.2.4 After fumigation.
6.3.2.5 After ‘B’ type cleaning if the equipment is idle for more than 48 hours then perform ‘A’ type cleaning.
6.3.3 Procedure for type ‘B’ cleaning:
6.3.3.1 Clean the S.S furniture, weighing balance platform and filter grills by using clean and dry lint free cloth.
6.3.3.2 RLAF shall not be switched OFF during type ‘B’ cleaning.
6.3.3.3 Record the cleaning activities as per Annexure-I.
6.3.3.4 Visually inspect and ensure for cleanliness and if the cleaning is not satisfactory then perform re-cleaning.
6.3.3.5 Validity of ‘B’ type cleaning is 48 hours.
6.3.4 Procedure for type ‘A’ cleaning:
6.3.4.1 Ensure all the materials are removed from the dispensing area.
6.3.4.2 Switch OFF all electrical supplies of dispensing booth (RLAF) and weighing scales.
6.3.4.3 Clean the powder on the table, floor, weighing scale, filter grill, inside and outside walls of the dispensing booth by using vacuum cleaner and lint free cloth.
6.3.4.4 Clean the dispensing booth until the traces of previous batches are removed.
6.3.4.5 Wipe the dispensing booth and surface of the booth with 70% IPA solution.
6.3.4.6 Finally clean the surface using purified water and sanitize with the recommended disinfectant solution as per schedule.
6.3.4.7 Record the cleaning activities in ‘Dispensing Booth Operation and Cleaning Log’ as per Annexure-I.
6.3.4.8 Visually inspect and ensure for cleanliness and if the cleaning is not satisfactory then perform re-cleaning.
6.3.4.9 If cleaning is found satisfactory then affix ‘CLEANED’ status label.
6.3.4.10 Validity of ‘A’ type cleaning is 06 (six) days and if the equipment is not used within 06 days then ‘A’ type cleaning shall be performed before use.
6.4 Cleaning procedure for dispensing accessories:
6.4.1 Following accessories are used for dispensing raw materials:
6.4.1.1 SS Scoops, SS Spoons; Spatula (if any) and SS Jugs etc.
6.4.1.2 Accessories (scoops, spatula, spoons etc.) used for dispensing of excipients must be cleaned between dispensing of different excipients with lint free cloth.
6.4.1.3 Use dedicated scoops for dispensing of different APIs and colours and finally clean the scoops once the dispensing activity is completed.
6.4.2 After completion of dispensing activity, cover all the used accessories in a polybag; affix ‘TO BE CLEANED’ label.
6.4.3 Open the valve of the purified water supply and flush water before its usage for the cleaning activity.
6.4.4 Clean the accessories properly with purified water and visually inspect for proper cleanliness; if the cleaning is not satisfactory then perform re-cleaning.
6.4.5 After completion of cleaning activity, dry the cleaned accessories with compressed air/lint free cloth, put in a polybag after completion of cleaning activity.
6.4.6 Newly introduced dispensing accessories must be cleaned prior to use.
6.4.7 Clean the accessories properly and dry with compressed air or lint free cloth; put in a polybag after completion of cleaning activity.
6.4.8 Put the cleaned accessories in polybag or wrap in stretch films; affix ‘CLEANED’ label.
6.4.9 Use the cleaned SS accessories within 06 (six) days after cleaning and if the accessories are not used within 06 days then rinse with purified water prior to use.
7.0 ABBREVIATIONS:
SOP – Standard Operating Procedure
RLAF – Reverse Laminar Air Flow
API – Active Pharmaceutical Ingredient
SS – Stainless Steel
IPA – Isopropyl Alcohol
8.0 ENCLOSURES:
Annexure-I: Dispensing Booth Operation and Cleaning Log
Annexure-II: Differential Pressure Record
Also read: SOP for dispensing of raw materials
Also read: SOP for dispensing of packaging materials