SOP Title: Inward, Handling and Cleaning of FBD Finger Bag
- Objective:
To lay down a procedure for Inward, Handling and Cleaning of FBD Finger Bags.
- Scope:
This SOP is applicable to Finger bags used in FBD for drying purpose.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the Inward, Handling and Cleaning of FBD Finger bag.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Quality Control Department: To collect the Sampling Intimation Slip and to perform the analysis.
- Purchase Department: To share a copy of the Purchase Order to the Production department.
- Accountability:
Head, Production.
Head, QA.
- Procedure:
- Definition:
- Production Associate: Executive or operator of Production Department trained to perform duties as per this SOP.
- QA Associate: Executive of QA department trained to perform duties as per this SOP.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batch of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases,
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Do not scrub the bag with metallic wire brush to remove the adhered material. | |
| 5.2.2 | Check the integrity of finger bag before and after use. | |
| 5.2.3 | Dry the finger bag properly before storage. | |
| 5.3 | Inwarding | |
| 5.3.1 | On receiving the new finger bag, physically check the bags for any damage. | |
| 5.3.2 | Refer the received finger bag against the Specification and Purchase Order as received from the Purchase Department. In case of any discrepancy, consult the Purchase Department. | |
| 5.3.3 | Upon ensuring the steps 5.3.1 and 5.3.2 accept the finger bag. | |
| 5.3.4 | Issue the ‘Finger Bag Code’ from the production department and mark it in the finger bag. | |
| 5.3.5 | The finger bag code will be the first two alphabets of the product code for which the finger bag been purchased.
Eg: One Finger bag has been purchased for the product whose product code is ‘XYZ’, then the Finger bag code will be ‘XY-01’.Where as the number ‘01’ represents the number of finger bags purchased. |
|
| 5.3.6 | Enter the details in the ‘Inventory record of the Finger bag’ as per Annexure . | |
| 5.4 | Handling | |
| 5.4.1 | Wash and dry the new finger bag received as per Type- B cleaning procedure mentioned in this SOP. | |
| 5.4.2 | Send the Rinse / Swab sample of the finger bags for Microbiological testing. | |
| 5.4.3 | Collect the Swab/Rinse sample result from Quality Assurance department. If the result is complying, Store the finger bag in the designated place. | |
| 5.4.4 | Whenever required, Issue the dedicated finger bag for the respective product use and enter the details as per Annexure. | |
| 5.4.5 | Transfer the Issued finger bag to the FBD by means of trolley. Care should be taken not to damage the finger bag. | |
| 5.5 | TYPE A Cleaning | |
| 5.5.1 | Dry clean the outer portion of the FBD with dry clean duster. Physically check the integrity of the finger bag. | |
| 5.5.2 | Fix the Finger bag as per SOP. | |
| 5.6 | Type B Cleaning: | |
| 5.6.1 | Dry clean the outer portion of the FBD with dry clean duster. | |
| 5.6.2 | Remove any excess material adhered to the surface by Vacuum cleaner or dry duster. | |
| 5.6.3 | Wash the finger bag from inside and outside using potable water to remove the adhered powder. | |
| 5.6.4 | Scrub the finger bag with nylon scrubber/ nylon brush. | |
| 5.6.5 | If the product is sticky to the finger bag, then soak the finger bags in hot water about 10-15 minutes. Then wash the finger bag with potable water till product residue is completely removed | |
| 5.6.6 | Visually check the cleanliness and finally rinse with sufficient quantity of purified water. | |
| 5.6.7 | Keep the finger bag in hanging position to remove water. Then dry the finger bag in clean tray dryer / dry by FBD about 70°C (without material). | |
| 5.6.8 | Ensure the drying and cleanliness keep the cleaned FBD bag in poly bag in dedicated container with proper label. | |
| 5.6.9 | Record the usage details in Annexure. |
- Abbreviation:
| Abbreviation | Expansion |
| Eg. | Example |
| FBD | Fluid Bed Dryer |
| QA | Quality Assurance |
| QCD | Quality Control Department |
*Note – Ready to use SOP available in “DOWNLOAD” Section.