PROCEDURE FOR CLEANING OF DISPENSING /SAMPLING ISOLATOR (MAKE: BECTOCHEM)

• 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.

Note: Clean the scoops/spatula as per the above procedure and put the cleaned label.

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/procedure-for-cleaning-of-dispensing-sampling-isolator-make-bectochem/

• 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:

• REVISION HISTORY:              

CHANGE HISTORY LOG

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.

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/procedure-for-cleaning-of-dispensing-sampling-isolator-make-bectochem/