- OBJECTIVE:
- To lay down the procedure for cleaning of Isolator. Make: Bectochem.
- SCOPE:
- This SOP is applicable for the procedure for cleaning of Isolator in warehouse department 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:
- PRE-CHECKS:
- Switch off the isolator before starting the cleaning.
- Ensure the catch pot is connected to the isolator and it should be open.
- Before cleaning of isolator all HEPA filters in isolator should be closed.
- CLEANING:
- Take wastage outside from the isolator through the continuous liner port.
- Before starting the cleaning activity ensure the catch pot is connected to the isolator.
- Connect the Catch pot to the isolator drain end points with the help of clamps.
- Ensure the catch pot and isolator waste water drain valves are open before starting the cleaning.
- Spray the potable water with the help of spray gun provided inside the chamber through the glove port until all particles are removed.
- Remove the potable water connection and connect to purified water connection. Finally rinse the inside chamber by spraying purified water.
- Spray the compressed air to the entire chamber until water drops are removed.
- Spray 70% v/v IPA solution and then wipe the entire chamber with lint free cloth.
- Spray 70 % v/v IPA solution to the parent drum interior surface and wipe.
- Remove the catch pot from the isolator and transfer to the wash area.
- Connect the compressed air pressure pipe and water hose pipe to the catch pot for draining purposes.
- Apply the air pressure and drain the entire water into the drain point.
- Clean the catch pot with water followed by disinfectant solution.
- Enter the cleaning details in the annexure.
- PRE-CHECKS:
Note: Clean the scoops/spatula as per the above procedure and put the cleaned label.
- Isolator hand gloves shall be cleaned first by potable water followed by purified water. The hand gloves shall be disinfected by 70%v/v IPA solution.
Note: Check the glove for any damage/torn. Discard if any found
- The water drained after cleaning of Isolator shall be collected in catch pot. The same shall be neutralize as per the current version of the SOP.
- 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:
| PGH | : | Pharmaguidehub |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| IPA | : | Iso propyl alcohol |
| HEPA | : | High efficiency particulate air |
| QA | : | Quality Assurance |
- 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 Question?
Q: What are the key pre-cleaning checks required?
A:
- Isolator must be switched off.
- Catch pot must be connected and open.
- All HEPA filters must be closed.
Q: Describe the steps involved in cleaning the Isolator.
A:
- Remove waste through the continuous liner port.
- Connect the catch pot to the isolator drain points.
- Open waste water drain valves.
- Spray the chamber with potable water, then purified water, to remove particles.
- Use compressed air to remove water drops.
- Spray and wipe the chamber and parent drum interior with 70% v/v IPA solution.
- Clean and drain the catch pot.
- Clean scoops/spatula and label them.
- Clean and disinfect isolator hand gloves.
- Collect and neutralize drained water according to the current SOP.
Q: What happens if a glove is damaged or torn?
A: The damaged glove must be discarded and replaced.