- OBJECTIVE:
- To lay down the procedure for operation of dispensing booth for the raw and packaging material.
- SCOPE:
- This SOP is applicable for the operation of dispensing booth for the raw and packaging material at {Company Name} {Location}.
- RESPONSIBILITY:
- WH Executive/Designee – shall be responsible to follow the procedure as per SOP.
- Head Warehouse – is responsible for compliance of the SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- OPERATION OF LAF:
- The dispensing booth and room should be cleaned prior to the start of dispensing activity daily.
- Verify the Preventive Maintenance Status of LAF.
- Ensure the cleanliness of side panels, grills and balance wherever applicable.
- Ensure minimum items should be stored under the LAF as required for dispensing.
- Ensure AHU of dispensing room is switched “ON” at least 30 minutes prior to commencement of the operations.
- Do not open the container inner pack outside the safe working zone.
- Switch on the LAF station, and light switches of Dispensing booth wherever applicable.
- Wait for 15 minutes after switching on the LAF station to stabilize the system prior to start the dispensing activity and record the LAF switched on time in the Format.
- Check the 10.0µ, 5.0µ & HEPA (0.3µ) filter pressure differentials indication level and record the filter pressure differentials.
- Limits of LAF:
10 µ (Pre Filter) – 1 to 4 mm of WC
5.0 µ (Fine Filter) – 4 to 10 mm of WC
0.3 µ (HEPA) – 10 to 25 mm of WC
- In case of any power failure/LAF breakdown, stop the activity and inform to the Engineering Department, after rectification once again take Line Clearance from IPQA and start the Dispensing.
- After ensuring required environment conditions and Differential Pressure of Dispensing area/LAF are within the specified limits.
- The Warehouse Executive/Designee shall ensure that the material, which is going for dispensing, shall be placed at respective designated area.
- Run the LAF station till dispensing is completed, and then switch “OFF” LAF station and record in the Format.
- REFERENCES:
Not Applicable
- ANNEXURES:
| ANNEXURE NO. | TITLE OF ANNEXURE |
| Annexure-I | Usage and cleaning record of Dispensing Booth & Room in Warehouse |
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 |
| QA | : | Quality Assurance |
| LAF | : | Laminar Air Flow |
| AHU | : | Air handling unit |
| WC | : | Water Content |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Annexure-I
USAGE AND CLEANING RECORD OF DISPENSING BOOTH & ROOM IN WAREHOUSE
Frequently Asked Question?
1. What are the key steps involved in preparing the LAF for dispensing activity?
Answer: The key steps include:
- Cleaning the dispensing booth and room
- Verifying the LAF’s preventive maintenance status
- Ensuring cleanliness of side panels, grills, and balance
- Minimizing items stored under the LAF
- Switching on the dispensing room’s AHU 30 minutes prior
- Waiting 15 minutes after switching on the LAF to stabilize
2. What are the acceptable pressure differential ranges for the LAF filters?
Answer:
- 10 µ (Pre Filter): 1 to 4 mm of WC
- 5.0 µ (Fine Filter): 4 to 10 mm of WC
- 0.3 µ (HEPA): 10 to 25 mm of WC
3. What actions should be taken in case of a power failure or LAF breakdown?
Answer:
- Stop dispensing activity immediately
- Inform the Engineering Department for rectification
- Obtain line clearance from IPQA before restarting
- Ensure environmental conditions and pressure differentials are within limits before restarting
4. Who is responsible for ensuring materials are placed in the designated area for dispensing?
Answer:
- The Warehouse Executive/Designee
5. When should the LAF station be switched off?
Answer:
- After dispensing is completed