Design Qualification of Bin Blender

Qualification is the process of planning, conducting, and recording tests on equipment and systems that will be used in a validated process to ensure that they will work as expected. The bin blender’s (200 L) performance qualification for minimal (20%) and maximum (70%) occupancy capacities, as well as blend uniformity at various blending time intervals.

Bin Blender Design Qualification Steps:

1. Objective
2. Scope
3. Responsibility (Client and manufacturer)
4. URS (User Requirement Specification)
5. Machine description
6. Technical specification 
7. Technical specifications of the sub-components/bought-out items, and their make, model & quantity, and backup records/ brochures
8. Details of Utilities
9. Identification of components for calibration
10. Material of construction of all components
11. P & ID diagrams for reference & approval
12. Equipment orientation with room layout
13. Brief process description
14. Safety features and alarms
15. FAT procedure
16. Change control procedure
17. Qualification Document report approval
18. Appendix

1.0 OBJECTIVE:

To design, engineer, and supply the Blender Bin (Model: RP/BUK/1200Ltrs.) as per cGMP and cGEP guidelines and to provide assurance that the machine is manufactured as per the complies with the Scope of Supply.

To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document are the same at utmost transparency. The validation procedure is set for the complete satisfaction of the customer & building the confidence of the user about the machine.

2.0 SCOPE:

The scope of this qualification document is limited to the Design Qualification of Blender Bin (Model: RP/BUK/1200Ltrs.) This qualification document is part of a validation activity for the Blender Bin (Model: RP/BUK/1200Ltrs.)

The scope of this qualification document does not include support utilities.

The Blender Bin shall be used for Mixing/Blending powders/granules. to be used in the Pharmaceutical formulation and also as an in-process container.

3.0 RESPONSIBILITIES:

CLIENT

1. To provide the URS for the equipment.
2. To perform the Factory Acceptance Test (FAT).

 MANUFACTURER:            

1. To design, engineer, and give all technical data relevant to the equipment’s design qualification, i.e.

• Machine overview,
• P&ID drawing,
• Equipment orientation with layout,
• Specifications of the sub-components/bought-out items, and their make,  model & quantity, and backup records/ brochures,
• Details of Utilities,
• Identification of components for calibration
• Material of construction of all components
• Brief process description
• Safety features and alarms
• Pre-installation requirements

2. To make it easier for the client to perform the factory acceptance test of the equipment at their workplace or location.

3. To ensure the safe delivery of the equipment/ machine to the user site.

4. To ensure that no unauthorized and/or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, the Change control procedure shall be followed and documented.

5. To ensure the proper installation and commissioning of the equipment.

4.0     USER REQUIREMENTS SPECIFICATION (URS):

5.0 MACHINE DESCRIPTION: 

5.1 Process Equipment Description

The purpose of the container Blender is to mix various substances in dry powder and / Or granular form. Mixing can be achieved by selecting a suitable RPM and suitable time periods depending on the product characteristic. The following setting can be done in the VFD:-

1. RPM setting
2. Soft start
3. Soft stop

The complete machine can be divided into the following sub-sections:

• Drive shaft with bearing housing
• Speed reduction system consisting of Brake Motor & Worm & Worm Wheel reduction gearbox Gear – Pinion arrangement.
• Container holding arm.
• Hydraulic power pack & cylinder.
• Main electric panel (housing PLC, VFD) & safety railing with operating panel (having MMI, Push buttons).

6.0 TECHNICAL SPECIFICATIONS:

• Blender Bin – SS 316L x 3mm Thk.
• Lid – Hinged with Gasket 350dia., SS 316L
• Butterfly Valve – SS 316L with Gasket, 190dia.
• Trolley – SS 304  2” dia x 10G. Pipe and 610mm dia x 10G Pipe ht: 775 mm with wheels.
• Trolley Castor wheels – SS 304  Bracket, PU PU-coated nylon wheels 6” x 2” W,  2 Fixed & 2 swivel types.
• Gaskets & Valve Seat – Food Grade Silicon.

6.1 Operating Control Panel

Not Applicable.

6.2 Main Electric Panel

Not Applicable.

6.3 Spares

1. Butterfly  Valve  Seat (190 dia)  1No.
2. Butterfly Valve Flange Gasket (190 dia) 2Nos.
3. Castor wheel 6”dia x 2” (w) Swivel 2Nos.
4. Castor wheel 6”dia x 2” (w) Fixed 2Nos.
5. “O” ring for 350dia Lid 2Nos.

7.0   TECHNICAL  SPECIFICATIONS  OF  COMPONENTS & SUB –

COMPONENTS USED / BOUGHT OUTS 

8.0 MATERIAL OF CONSTRUCTION

1. Bin                  SS 316L
2. Trolley                SS304.
3. Castor wheel     PU Coated Nylon.
4. Gasket                Food Grade Silicon

9.0 P & ID DIAGRAM FOR REFERENCE & APPROVAL

Attached as annexure – DQ/ANX/IV  (Drg. MAC – BUK – 4251-01.

Approval status: APPROVED/ NOT APPROVED

Any change in the approved diagram:    Yes/ No. 

If yes, the reason for change ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

10.0 EQUIPMENT ORIENTATION WITH ROOM LAYOUT:

Attached as annexure-……….

Approval status: APPROVED/ NOT APPROVED

Any change in the approved orientation layout:          Yes/ No. 

If yes, the reason for change …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

11.0 BRIEF PROCESS DESCRIPTION

 See Blender Brief Process Description   

12.0 SAFETY FEATURES:

 NOT APPLICABLE

Related Search: PQ Of Generation Of Purified Water

13.0 FAT PROCEDURE:

Factory Acceptance Test Procedure shall be as follows:

After the completion of the erection work of the machine, the client shall be informed to perform the factory acceptance test (FAT).

Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below: 

1. Test criteria
2. Design Verification Checklist
3. Deficiency & Corrective Action Report
4. Final report

14.0 CHANGE CONTROL PROCEDURE:

Change in the agreed design shall be addressed through the well-defined Change control procedure.

15.0 DESIGN QUALIFICATION REPORT APPROVAL

15.1        Summary:

15.2        Certification:

16.0   APPENDIX

16.1 LIST OF ABBREVIATIONS 

16.2        REFERENCE DOCUMENTS

1. Manufactures Brochure (s) / Manual (s). (Title and Location).

To be supplied with the Installation qualification documents