SOPs

PROCEDURE FOR CLEANING & STORAGE OF FBD FINGER BAG

1) OBJECTIVE

To define the procedure for cleaning & Storage of FBD Finger Bag

2) SCOPE

This SOP is applicable for the cleaning & Storage of FBD Finger Bag  available in the Production Department of ACME LIFE SCIENCE Baddi

3) RESPONSIBILITY

Production officer as well as QA Officer

4) ACCOUNTABILITY

Production Manager

5) REFERENCES

In House

6) ANNEXURE

ANNEXURES  I: FBD Bag Issuance, Usage, Cleaning & Receipt Record

7) PROCEDURE

7.1 Cleaning Procedure

7.1.1 Upon completion of the drying operation, remove the bowl from the FBD.

7.1.2 Shake the bag & ensure the complete removal of adhered material from the finger bag.

7.1.3 Bring down the finger bag and remove the finger bag. Check the bag for its integrity.

7.1.4 Collect the potable water in a cleaned container. Take a sufficient quantity of water so that the finger bag dipped completely.

  • Soak the finger bag in the container containing potable water for 10 minutes.

7.1.6 Fall over/down the bag and scrub the bag using nylon scrubber till complete removal of adhered material.

7.1.7 Drain out the water in the container.

7.1.8 Refill the container with hot water (temp. should not be less than 80°C) and allow the finger bag to soak for further 10 minutes.

7.1.9 Fall over and down the bag in the container and drain out the water.

7.1.10 Ensure the complete removal of adhered material from the finger bag.

7.1.11 Dip the finger bag into the container containing freshly collected purified water.

7.1.12 Soak the finger bags for 05 minutes. Drain out the water.

7.1.13 Remove the finger bag and squeeze it to remove the excess water.

7.1.14 Assemble the finger bag with FBD ring and dry the finger bag at 60°C inlet temperature for 45 minutes.(Ensure that FBD cleanness when assembling finger bag with FBD ring. )

7.1.15 Bring down the bag and check for dryness. If required then re-dry the bag for a further 15
minutes at 60°C inlet temperature.

7.1.16 Remove the dried finger bag from FBD.

7.1.17 Put the dried finger bag in a cleaned double polybag and tie it.

7.1.18 Insert the duly filled and signed “Cleaned” label between the first and second polybag.

7.1.19 Transfer the bag to the bag storage area and stored it in the dedicated container.

7.1.20 Record the details in FBD Bag Issuance, Usage, Cleaning & Receipt Record.

                  FBD BAG ISSUANCE, USAGE, CLEANING & RECEIPT RECORD

FBD BAG ID NO:

Name of ProductBatch No.Issued onUsed onCleaned onReturned onBag Integrity (OK/Not OK)Checkd
By
Verified ByRemarks
Before useAfter use

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube