1.1 To lay down a procedure for indent, receipt, usage and specifications of Fluid Bed Drier Filter Bag.
- Technical assistant – To follow the SOP.
- Executive – To comply the SOP.
What is Fluid Bed Drier :
Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment used extensively in the pharmaceutical industries to reduce the moisture content of pharmaceutical powder and granules. The equipment works on a principle of fluidization of the feed materials.
In fluidization process, hot air is introduced at high pressure through a perforated bed of moist solid particulate. The wet solids are lifted from the bottom and suspended in a stream of air (fluidized state). Heat transfer is accomplished by direct contact between the wet solid and hot gases.
3.1.1 Production personnel to indent the new FBD filter bag as and when required.
3.1.2 The indent is raised as per the specification of the particular FBD bag and with product name.
3.2.1 The engineering stores personnel shall receive the FBD filter bag along with the party’s COA, regarding filter cloth used in FBD bag manufacturing and inform the production personnel about the receipt.
3.2.2 After receiving the information about the receipt from engineering stores, the production personnel shall check the party’s COA as per the specification.
3.2.3 The production personnel shall record the receipt and initiate for joint inspection of the FBD filter bag visually for absence of holes, foreign particles, fibres, stitching quality, bag diameter, finger diameter, finger length and number of fingers by the production personnel and QA personnel.
3.2.4 Record the receipt and inspection of FBD filter bag.
3.2.5 After inspection, transfer the FBD filter bag to the washing area for washing, followed by drying.
3.2.6 After drying store the cleaned FBD filter bag in a polythene bag and close the polythene bag after affixing CLEANED label and kept in HDPE container labelled with the corresponding product name.
3.2.7 Store the HDPE containers, which contained cleaned FBD filter bag in change parts room.
Note: Do not store more than one FBD filter bag in a polythene bag.
3.3.1 Record the details of FBD filter bag usage, integrity checking (visually), cleaning and discarded dates.
1. Check the integrity of the FBD filter bag before and after use.
2. Incase of any damage to the FBD filter bag, discard that FBD filter bag.
Specification is given for 150 kg Capacity with Alliance Company and different capacities of FBD Filter bags is available with different companies and their specification can vary accordingly. The below details are given for reference purpose.
4.1 FBD : Fluid Bed Drier
4.2 QC : Quality Control
4.3 HDPE : High Density Poly Ethylene
5.1 Destruction procedure for tableting tools, processing aids and change parts.
6.1 Receipt and Inspection Report of FBD Filter Bags.
6.2 FBD Filter Bag Usage Record.
This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing department.
8.0 SOP Revision History record
|Revision No.||Details for Revision(s) with Change Control No.||Effective Date (Sign. / Date)|