PROCEDURE FOR DISPENSING OF ACTIVE MATERIAL IN ISOLATOR

• OBJECTIVE:

• To lay down the procedure for active material dispensing in Isolator.

• SCOPE:

This SOP is applicable for the active material dispensing in the Isolator in the 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:
    • Check the cleanliness of the area and the equipment, scoops, container etc.
    • Close all the doors and ensure the isolator leakages if any.
    • Ensure that the isolator compressed air is in ON mode.
    • Ensure the catch pot is connected to the isolator.
    • Ensure the dispensing accessories (like scissors, cable ties, cutters, poly bags, scoops, spatula, SS container,) are kept in the isolator.
    • Use separate cleaned scoops for dispensing of each active material.
    • Ensure that the required environmental conditions & room differentials pressure are as per requirements.
    • Before starting the dispensing check for the balance calibration status.
  • DISPENSING PROCEDURE:
    • After receiving the indent through Batch Manufacturing Record from Production department, check for the availability of approved materials and quantity. And take the line clearance as per the line clearance check list.
    • Calculate the quantity of API to be dispensed as per calculation given in respective BMR & take the COA of relevant API. Then fill in the required quantities and Lot No. in the Batch Manufacturing Record. Dispense the API on FIFO basis.
    • Keep the required materials into the isolator room PASS BOX. Ensure that every container/package is having Approved label.
    • Take the line clearance from QA for dispensing activity.QA personnel shall verify the calculation quantity of API to be dispensed as per calculation given in respective BMR.
    • Production personnel shall verify the Approved Status of Material, Name of Material, Material Code, Lot Number and Qty as per respective BMR before starting of the dispensing.
    • Personnel involved in dispensing activity shall enter into the dispensing room after proper Gowning.
    • Start the isolator as per current version of SOP and record the pressure differential of the isolator before starting the dispensing activity.
    • Dispensing personnel shall bring the material for dispensing from isolator room pass box to isolator drum lifting area.
    • Material shall be taken into the dispensing chamber through the drum loading chamber as per the procedure mentioned in the SOP.
    • The material shall be dispensed as per the Batch Manufacturing Record.
    • In case material is required to dispense in multiple API cleaning shall be done in between two API’S as per the SOP.
    • Dispense the required quantity of material into pre weighed poly bag, tie with cable tie. and transfer into SS container in presence of Production personnel.
    • Collect the dispensed/sampled material from the pass box chamber.
    • Record the gross weight and Net weight in BMR and concerned stores and production personnel shall sign off all cells in the dispensing sheets of the BMR.
    • Fill the Material Issue Tags for each material, store personnel sign on the material issue tags at the dispensed by column, and Production personnel shall verify the dispensed material with respect to all the details on the Material Issue Tag and sign at the received by column on the Material Issue Tags. In case of material dispensed in a poly bag place the material issue tag in-between double lined poly bag.
    • In case of any product required for handling of materials under nitrogen environment, open the regulator valve and purge the nitrogen gas in the isolator. Close the regulator valve immediately after completion of the activity.
    • Transfer the dispensed material into the “Dispensed Material Hold”. Area PASS BOX and place the BMR pages pertaining to dispensing activity and lock the PASSBOX.
    • Leftover materials in the original pack shall be sent back to the respective storage area through the PASSBOX after labelling the container as ‘LOOSE MATERIAL’
• All the loose drums to be sealed with tamper proof cable ties.
• All loose bags to be tied tightly with tamper proof cable ties.
  • Switch off the isolator and exit from the isolator room.
  • After Dispensing of every Batch, Reconcile the API Lot. No. wise and record the details in Format separately for each lot. And update the stock details
  • Stores personnel shall enter the quantity against the respective batch/lot numbers, update the issue entry/inventory transfer to production. The acceptable variation limit for all the materials is ±1% on received quantity.

Note: Empty containers/bags shall be sent to scrap yard after defacing the container labels.

• Record the isolator usage details in respective logbook.
• REFERENCES:

Not Applicable

• ANNEXURES: 

Not Applicable

ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:

• Controlled Copy No. 01  :    Head Quality Assurance
• Controlled Copy No. 02  :    Head Warehouse
• Controlled Copy No. 03  :    Head Production
• Master Copy                    :    Quality Assurance Department
• ABBREVIATIONS:

• REVISION HISTORY:              

CHANGE HISTORY LOG

Frequently Asked Question ?

• Q: What should be checked for cleanliness before starting dispensing?
• A: The area, equipment, scoops, containers, etc., should all be clean.
• Q: How can you ensure no isolator leaks exist?
• A: Close all doors and visually inspect for any leaks.
• Q: What should the status of the compressed air and catch pot be?
• A: Compressed air should be on, and the catch pot should be connected to the isolator.
• Q: Are there specific dispensing accessories required?
• A: Yes, scissors, cable ties, cutters, poly bags, scoops, spatulas, and SS containers should be kept inside.
• Q: How are scoops used to avoid cross-contamination?
• A: Separate, cleaned scoops should be used for each active material.
• Q: What environmental conditions and pressure differentials are important?
• A: Ensure they meet the required specifications before starting dispensing.
• Q: How is balance calibration verified before dispensing?
• A: Check the balance calibration status to ensure accuracy.

• Q: How do you ensure availability of approved materials and quantity?
• A: Check BMR, take line clearance, and calculate needed API based on BMR.
• Q: How is FIFO dispensing ensured, and what information is recorded?
• A: Dispense the API on a first-in, first-out basis, recording required quantities and lot numbers in the BMR.
• Q: How are materials transferred into the isolator, and how is approval obtained?
• A: Place materials in the pass box, ensure approved labels, take line clearance from QA, and verify material details with production personnel.
• Q: What gowning procedures are followed before entering the dispensing room?
• A: Proper gowning is required before access.
• Q: How is the isolator started, and what pressure is recorded?
• A: Start the isolator as per SOP and record the differential pressure before dispensing.
• Q: How is material transferred from the pass box to the dispensing chamber?
• A: Follow the SOP procedure for drum loading through the designated area.
• Q: How is dispensing done, and what cleaning occurs between different APIs?
• A: Dispense as per BMR. If dispensing multiple APIs, clean in between as per SOP.
• Q: How is dispensed material weighed, recorded, and transferred?
• A: Dispense into a pre-weighed poly bag, tie it, transfer it to an SS container, record gross and net weights in BMR, and obtain signatures.
• Q: How are dispensed materials documented and transferred to the “Dispensed Material Hold” area?
• A: Fill Material Issue Tags, transfer material to the pass box, place relevant BMR pages in the pass box, and lock it.
• Q: How are leftover materials handled and labeled?
• A: Return them to storage through the pass box, labeled as “LOOSE MATERIAL,” with specific sealing procedures for drums and bags.
• Q: What are the final steps after dispensing, and what records are kept?
• A: Switch off the isolator, exit the room, reconcile API lot numbers, update stock details, record isolator usage in the logbook, and dispose of emptied containers/bags after defacing labels.