SOP Inspection, Usage Assignment and Storage of Fluid Bed Dryer (FBD) and Fluid Bed Processor (FBP) Finger Bags.
1. OBJECTIVE 1.1. This Standard Operating Procedure (SOP) describes the procedure for inspection, usages assignment and storage of the FBD and FBP finger bags.
2. SCOPE 2.1. This SOP is applicable to all the existing and purchases of new FBD and FBP finger bags. 2.1.1. P/PR/FBD/001 2.1.2. P/PR/FBD/002 2.1.3. P/PR/FBP/001 2.1.4. P/PR/FBP/002 2.1.5. P/PR/FBP/003 2.1.6. P/PR/FBP/004 3. RESPONSIBILITY 3.1. Production Department: Request of new FBD/FBP bags, inspection of new bags received as per given specification issue and recollect and cleaning as per relevant SOP. 3.2. Commercial Department: Procurement of FBD/ FBP finger bags. 3.3. QA: Approval of inspection report.
4. PROCEDURE
4.1. Procure the finger bag as per specification mentioned in annexure –I.
4.2. Receipt of new FBD/FBP finger bags.
4.2.1. On receipt of FBD/FBP finger bags, log the same into receipt record (Register No. PRP/R/057).
4.2.2. For FBD ID P/PR/FBD/001 (120 Kg) and FBD ID P/PR/FBD/002 (100 Kg) FBD bag shall be numbered serially such as 01, 02, 03 …
4.2.3. For FBP ID P/PR/FBP/001 shall be numbered as FBP-01; FBP-02; FBP-03……
4.2.4. For FBD ID P/PR/FBP/002 and FBD ID P/PR/FBP/003 FBD bags shall be numbered as FBD-01; FBD-02; FBD-03……
4.2.5. For FBP ID P/PR/FBP/004 shall be numbered as FBPP-01; FBPP-02; FBPP-03……
4.2.6. Enter the details in FBD finger bag register (Register No.: PRP/R/057).
4.3. Inspection of new finger bag:
4.3.1. Check the visible integrity at the seam and body; dimensions and record in the inspection report.
4.3.2. For other specification verify the certificate from the manufacturer against the set standard if it complied record the same in format (Format No. PRP/F/078, Format No. PRP/F/087, Format No. PRP/F/088 and Format No. PRP/F/093).
4.3.3. If the specification is not complied with the set standard replace the finger bag as per required.
4.4. Before introducing for routine use clean the new FBD/FBP finger bag as per SOP No.:SOP/PTN/PR/126 and SOP No.:SOP/PTN/PR/127 for washing and drying of FBD bag.
4.5. FBD bags shall be dedicated for each product and record for same shall be maintained (refer annexure-II).
4.6. After use clean and dry the finger bag and check visually for any damage.
4.7. If damage is found discard the finger bag and subsequently enter details in finger bag usage record.
4.8. Keep the finger bag in polyethylene bag label it as cleaned (Format no. PRP/F/081). Keep the bag in plastic container in change part room. Label the container.
4.9. The cleaning validity is 75 days from the date of cleaning. After the validity period, clean the FBD/FBP finger bag before use.
5. FREQUENCY
5.1. Procurement of FBD finger bags - As and when required.
5.2. FBD/FBP finger bag shall be used up to 5 years from its receipt.
6. ACCEPTANCE CRITERIA
6.1. FBD / FBP finger bag should comply with specification.
7. RELATED DOCUMENTS
7.1. SOP no.: SOP/PTN/PR/126 – Operation of washer extractor.
7.2. SOP no.: SOP/PTN/PR/127 – Operation of drying tumbler.
7.3. Format no.: PRP/F/081 - Cleaned label.
7.4. Format no.: PRP/F/009 - To be recleaned.
8. REFERENCES
8.1. Nil.
9. RECORDS
9.1. Format No.: PRP/F/078–FBD finger bag inspection report.(For FBD ID No.: P/PR/FBD/001 and P/PR/FBD/002)
9.2. Format No.: PRP/F/087–FBD finger bag inspection report.(For FBP ID No.: P/PR/FBP/001)
9.3. Format No.: PRP/F/088–FBD finger bag inspection report.(For FBD ID No.: P/PR/FBP/002 and P/PR/FBP/003).
9.4. Format No.: PRP/F/093–FBD finger bag inspection report.(For FBP ID No.: P/PR/FBP/004)
9.5. Register No.: PRP/R/057 – FBD finger bag register.
9.6. Annexure I : FBD finger bag specification.
9.7. Annexure II : FBD finger bag list.
10. REVISION RECORD
Version Reason for Revision Effective Date
00 New SOP. Aug 22, 2009
01 Inclusion of new FBP ID No. and its specification and format.