Multimill Design Qualifications In Pharma

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Design Qualification (DQ) is the recorded assurance that the planned design of the facilities, systems, and equipment is suitable for the intended purpose and complies with regulatory and procedural requirements. Following are details about Multimill Design Qualifications.

Multimill Design Qualifications Content:

Objective
Scope
Responsibility (Client and manufacturer)
URS (User Requirement Specification)
Machine description
Technical specification
Details of Utilities
Identification of components for calibration
Material of construction of all components
P & ID diagrams for reference & approval
Equipment orientation with room layout
Brief process description
Safety features and alarms
FAT procedure
Change control procedure
Qualification Document report approval
Appendix

1.0 OBJECTIVE:

To design, engineer, and supply the MultiMill (Model: 3 HP) as per GMP guidelines and to provide assurance that the machine is manufactured as per the URS and 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 Promtech Multi Mill – 3 HP in Pharmaceuticals. This qualification document is part of a validation activity for the Promtech Multi Mill – 3 HP.

Qualification of support utilities is not within the scope of this qualification document.

The equipment shall be used for milling & grinding of different powders to be used in the formulation. The equipment shall operate in a dust-free environment and conditions as per the GMP requirements.

3.0 RESPONSIBILITIES:

CLIENT:

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

MANUFACTURER:

To design, engineer, and provide the complete technical details of the equipment pertaining to its design qualification viz.

(i) Machine overview,
(ii) P&ID drawing,
(iii) Equipment orientation with layout,
(iv) Specifications of the sub-components/bought-out items, and their make, model & quantity, and backup records/ brochures,
(v) Details of Utilities,
(vi) Identification of components for calibration
(vii) Material of construction of all components
(viii) Brief process description
(ix) Safety features and alarms
(x) Pre-installation requirements

To facilitate the client for the Factory acceptance test of the machine at their works/ site.
To confirm the safe delivery of the equipment to the user site.
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.
To ensure the proper installation and commissioning of the equipment.

4.0 USER REQUIREMENTS SPECIFICATION (URS):

DESCRIPTION SPECIFICATIONS

Equipment Promtech Multi Mill – 3 HP

Specification Flameproof construction as per Purchase Order.

Capacity 100 – 150 Kgs.

Model: The equipment should be a GMP model as per the drawing submitted, with contract-specific SS316 L parts.
Ease of cleanability.
Process Equipment should be able to perform milling operations.

Material of construction: Conical Shell, Beater/Shaft & Blades, Screen, Top Flange, and Bottom Flange should be made up of SS 316L & all other non-contact components are of SS 304.
The exterior is easy to clean, disinfect, and non-corrosive.
Material test certificates are to be provided.

DESCRIPTION SPECIFICATIONS

Calibration: All components that require calibration shall be identified and calibrated – (NA).
Calibration certificates are to be provided at the time of Installation qualification – (NA).
Test certificates/calibration charts of sensors & control instruments to be provided – (NA).
Qualifications/ Documentation.
The manufacturer shall complete and provide the documents pertaining to Design, Installation, and Operation Qualification, and detailed functional specifications including the control system with screen design of the operating terminal.
Information on purchased/bought-out parts.
Safety features
Adequate safety features for men and materials shall be provided along with the equipment.
Flameproof motors and controls.
Control system The equipment shall be controlled through FLP, Local Push Button Station.
Electrical system.
The electrical system of the equipment shall be housed as per the GMP with adequate safety

5.0 MACHINE DESCRIPTION:

5.1 Process Equipment Description

The purpose of Multi Mill is to put substances in powdery form (bulk materials).

The multi-mill operates on the working principle of variable force swing the beaters having both knife & impact edges rotating within a selected screen to get the desired size reduction.

The material is to be charged into the hopper, it moves into the periphery of the screen with the help of the knife & impact edges the material passes through the screen radially & tangentially, thus avoiding the choking of the material in the chamber & rise in temperature. The processed material gets collected in the collection container below the screen chamber.

6.0 TECHNICAL SPECIFICATIONS:

Description Specifications Remarks -NO.

1 Equipment Description
1.1 Equipment Name Multi-mill
1.2 Specification Flameproof with dust-free charging arrangement Non-Flameproof with Charging Hopper arrangement
1.3 Capacity 150 Kg/hr @ # 80 100 – 150 Kgs./hr.
1.4 Model GMP
1.5 Overall Dimensions Pl. specify 1700HX880LX775W
1.6 Weight Pl. specify 200 Kgs. Approx.
1.7 Speed (R.P.M.) 1440 1440 or 1430

2 Utility Requirement

2.1 Vacuum N.A. N.A.

3 Electrical Requirement
3.1 Power Supply 3 Phase 440V A.C.
3.2 Total Electrical Loads Pl. specify 3 HP / 2.2 kW An

A. Electrical Panel
3.3 Control Panel Flp starter inside SS-304 enclosure – 180 Grit finish – 16SWG NonFlp DOL starter inside SS-304 enclosure – 180 Grit finish – 16SWG
3.4 Panel Size Pl specify 1 Ft X 1.5 Ft. Approx
3.5 Location Equipment Mounted Floor Mounted with 4 Nos. Castor PU Wheels.

B. Switch gears
3.6 Contactors Flameproof Equipment India Ltd. N.A.
3.7 Relay Starter with Single Phase Preventer N.A.

C. Motor Details
3.9 Make Crompton (High-efficiency class-II motor with Class ‘F’ insulation & CE mark) Crompton MAKE Non-FLP motor
3.10 Type Flameproof Non-FLP.
3.11 Mounting Flange mounting YES
3.12 HP/KW Pl. specify 3 HP / 2.2 kW
3.13 RPM 1440 1400 or 1430
3.14 Phase 3 Phase

4. Material Of Construction MOC Gauge thickness4.1 Contact Parts ( Beater, hopper, conical shell) SS-316 L 16 SWG
4.2 Clamps, Ring, etc. SS-304 Wing Nut, 18 Swg.
4.3 Control Panel SS-304 16 SWG
4.4 Beater blades SS-316 L SS-316 L, 5 to 6 mm thick.
4.5 Bolts & nuts SS-304 (dome/flush type) Dome Type
4.6 Gasket Silicon Food Grade
4.7 Inspection Windows (2Nos) 150mm dia covered with silicon cap N.A.

5.0 Surface Finish Inside Outside

5.1 Contact parts 0.35 Ra 0.85 Ra
5.2 Non Contact parts 0.85 Ra 0.85 Ra

6.0 Instrumentation Make Specification

7.0 Mechanical

 N.A.     N.A.    N.A.

8.0 PU wheels with locking brackets.
9.0 Discharge spout at 1050mm elevation & 350 mm apart from the column to insert IPC.
10.0 Charging neck 150 mm diameter & 50 mm projection.

7.0 DETAILS OF UTILITIES

DESCRIPTION SPECIFICATIONS

Electrical
Phase 3 Phase
Voltage 440V
Frequency 50 Hz

8.0 MATERIAL OF CONSTRUCTION

COMPONENT DESCRIPTION MOC

Conical Shell SS 316 L
Support Column SS 304
Beater – Shaft & Blades SS 316 L
Hopper SS 316 L
Screen SS 316 L
Top Flange SS 316 L
Bottom Flange SS 316 L
Clamps & Rings SS 304
Control Panel Housing SS 304

9.0 P&ID DIAGRAM FOR REFERENCE & APPROVAL

NOT APPLICABLE

Attached as annexure-……….

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:

`NOT APPLICABLE`

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

11.1    Purpose of Multi Mill.

The purpose of Multi Mill is to put substances in powdery form (bulk materials).

The multi-mill operates on the working principle of variable force swing the beaters having both knife & impact edges rotating within a selected screen to get the desired size reduction.

12.0 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:

Test criteria
Design Verification Checklist
Deficiency & Corrective Action Report
Pre-installation requirements
Final report

13.0 DESIGN QUALIFICATION REPORT APPROVAL

13.1 Summary:

13.2 Certification:

14.0 APPENDIX

14.1 LIST OF ABBREVIATIONS

GMP Good Manufacturing Practices
GEP Good Engineering Practices
AISI American Iron & Steel Institute
WIP Wash In Place
MS Mild steel
FLP Flame Proof
SS Stainless Steel
CFM Cubic Feet Per Minute
KW Kilo Watt
DQ Design Qualification
HMI/MMI Human/Man-Machine Interface
FAT Factory acceptance test

14.2 REFERENCE DOCUMENTS

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

To be supplied with the Installation qualification documents

Instruction and maintenance manual
Material of construction certificates
Test certificates of all motors
Purchase Order Attached (Yes / No). If no, state the Location.

Yes – Attached (P.O. No. XX dated: XX.XX.2XXX ) with DQ Document

Remarks (if any) :

14.3 ANNEXURE LIST

DESCRIPTION ANNEXURE NO.

FAT Report DQ/ANX/I
Equipment Brochure DQ/ANX/II
Purchase Order DQ/ANX/III
Scope of Supply
DQ/ANX/IV

Multimill Design Qualifications in Pharma