- OBJECTIVE:
To lay down the procedure for cleaning of dispensing booth and room (RM/PM).
- SCOPE:
This SOP is applicable for the procedure for cleaning of dispensing booth and room (RM/PM)at {Company Name} {Location}.
- RESPONSIBILITY:
- WH Executive/Designee – is responsible for ensuring compliance with the SOP.
- Head Warehouse – is responsible for compliance of the SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- Cleaning Tools and Equipment shall be used as per SOP for Cleaning and Sanitization.
- The disinfectant shall be used and changed as per the disinfectant schedule provided in the SOP.
- CLEANING OF DISPENSING BOOTH AND ROOM:
- Type-A Cleaning: Type-A Cleaning is applicable in case of following instances,
- · In between dispensing of two excipients.
- Type -B Cleaning: Type-B Cleaning is applicable in case of following instances,
· In between the Product to product change over.
· In-between dispensing of colour/flavoured material.
· After cleaning LAF Prefilters.
· After preventive maintenance of equipment and AHU, Area maintenance activity of the dispensing area.
Type –A Cleaning Procedure:
- Before cleaning the LAF, ensure that all the dispensing tools, containers and Raw material of the previous material were removed.
- LAF and balance should be in running condition during cleaning operation.
- Clean the visible powder inside the dispensing booth by using vacuum cleaner/lint free cloth.
- Clean LAF grills by using vacuum cleaner and lint free cloth.
- After completion of cleaning ensure no traces of the previous material are found inside the LAF.
- Record the cleaning activity as “Type-A Cleaning”.
- Type –B Cleaning Procedure:
- Before cleaning the LAF, ensure that all the dispensing tools, containers and Raw material of the previous material were removed.
- Switch Off the LAF and balances.
- Clean the entire dispensing booth, grills, balance, side panels, workbench, perforated protective screens, Electrical coils and along with the accessories thoroughly by using vacuum cleaner.
- Wipe the entire inner surface of safe working zone including filter grills with dry lint free cloth followed by 70% IPA.
- Clean the side view glass with Window shine solution followed by dry lint free cloth.
- Dry mop the balance platform with clean lint free cloth.
- Clean the balance platform with 70% IPA.Windows/Glasses/Waste bin, S.S. railings shall be cleaned by Window shine/All clean.
- Wall fittings shall be cleaned by Window shine/All clean.
- Cleaning of the floor shall be done by dry moping/Vacuum Cleaner and double bucket wet moping system/floor scrubbing with scrubber drier machine.
- The double bucket wet moping system shall be done as per SOP.Record the cleaning activity as “Type-B Cleaning”.
- Dispensing booth return air filters shall be cleaned once in 15 days or as and when the manometer/ magnehelic gauge reading reaches the alert level by engineering department as per the SOP.
- Perform cleaning as per instructions provided in ‘Type-B Cleaning’ procedure.
- Record the cleaning activity as “Type-B Cleaning”.
- REFERENCES:
- Not Applicable
- ANNEXURES:
- Not Applicable
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Warehouse
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| LAF | : | Laminar Air Flow |
| IPA | : | Iso Propyl Alcohol. |
| QA | : | Quality Assurance |
| AHU | : | Air handling unit |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be written Manual |
Frequently Asked Questions ?
Q: What is the procedure for cleaning the dispensing booth and room under Type-A Cleaning?
A: Type-A Cleaning applies in scenarios such as between dispensing two excipients. The procedure involves ensuring all dispensing tools and materials from the previous substance are removed, cleaning visible powder inside the booth using a vacuum cleaner or lint-free cloth, cleaning LAF grills, and ensuring no traces of the previous material remain inside the LAF. This cleaning activity should be recorded as “Type-A Cleaning.”
Q: What is involved in the Type-B Cleaning Procedure for the dispensing booth?
A: Type-B Cleaning is applicable for instances such as product-to-product changeover, dispensing of color/flavored material, after cleaning LAF Prefilters, and after maintenance activities. The procedure includes thorough cleaning of the dispensing booth, grills, balance, side panels, workbench, and accessories using a vacuum cleaner, wiping inner surfaces with 70% IPA, cleaning glass surfaces with Window shine solution, dry mopping the balance platform, cleaning with 70% IPA, and cleaning other areas such as windows, walls, and floor as per SOP. This cleaning activity should be recorded as “Type-B Cleaning.”
Q: How often should dispensing booth return air filters be cleaned?
A: Dispensing booth return air filters should be cleaned once every 15 days or when the manometer/magnehelic gauge reading reaches the alert level as per the SOP.
Q: What action should be taken after cleaning the dispensing booth return air filters?
A: After cleaning the dispensing booth return air filters, cleaning should be performed as per the instructions provided in the Type-B Cleaning procedure, and the activity should be recorded as “Type-B Cleaning.”