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DQ of CONTA BLENDER 400/200/50Ltrs

TABLE OF CONTENT

  • Objective
  • Scope
  • Responsibilities
  • Machine description
  • Operating control panel
  • Main electric Panel
  • Program of Bin Blender
    • Program
    • Data Program
  • Spares
  • Technical Specifications of Components & Sub-Components used/ bought outs
  • Details of Utilities
  • Identification of component for calibration
  • Material of construction
  • Enclosures
  • Safety features and alarms
  • FAT procedure
  • Change control procedure
  • Design qualification report
  • List of Abbreviations 
  • OBJECTIVE

To design, engineer, and supply the Conta Blender 400/200/50 Ltrs (Model: BLD/NFLP/400-200-50) and to provide assurance that the machine is manufactured as per the URS and it complies with the Scope of Supply.

To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.

  • SCOPE

The scope of this qualification document is limited to the Design Qualification of Conta Blender 400/200/50Ltrs(Model: BLD/NFLP/400-200-50) . This qualification document is part of a validation activity for the Conta Blender 400/200/50Ltrs (Model: BLD/NFLP/400-200-50)

  • RESPONSIBILITIES
    • CLIENT

To check and approve the design qualification.

  • MANUFACTURER
    1. To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
  • Machine overview
  • General arrangement 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
  • Safety features and alarms
    1. To facilitate the client for the Factory acceptance test of the machine at their works/ site.
    2. To confirm the safe delivery of the equipment to the user site.
    3. To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
    4. To ensure the proper installation and commissioning of the equipment.
  • MACHINE DESCRIPTION

The Blender is designed to mix/Blend different ingredients in dry Granules/power form in Blender Bin. Blender bin consisting of unmixed dry mass is clamped in bin holding arm .Bin holding arm is fixed on moving trolley. Trolley can be move up and down with the help of Hydraulic cylinder with chain and pulley arrangement. Hydraulic cylinders, Trolley, chain and pulley arrangement is housed inside the mast. Mast base is fixed on the floor and top is supported on the ceiling. Safety railing of SS304 with interlock is provided for safety of the operator. All the gaskets are of food grade silicone.

Product mass in the Bin can be rotated at preset RPM and preset time for the following:

  • RPM setting
  • Soft start
  • Soft stop.

Complete equipment can be divided in the following sub sections:

  • Mast consisting of Hydraulic cylinder, Guide Rollers and chain-pulley assembly.
  • Bin Holding arm.
  • Main panel consisting of Hydraulic power pack and hydraulic circuit, Electrical power panel, PLC (optional) and VFD.
  • Operating panel consisting of push button, MMI (optional) and limit switch for safety railing.
  • Bins (50/200/400 l) having butterfly valve at the discharge end, housed in SS 304 trolleys with PU caster wheel.
  • Operating control panel
    1. The Non-flame proof and Flame proof control panels are made of SS304 sheet. It is located and mounted on the wall and on the safety railing pillar. Operating panel consist of
      • MMI (E-300)
      • Emergency switch
      • Limit switch for safety railing interlock.
  • Main Electric panel

The main Non-Flame proof Electrical power panel along with Hydraulic power pack is housed inside M S powder coated panel and is located in service/Technical area.

Main power panel consists of

  • VFD & brake resister
  • PLC
  • Electrical power circuit
  • Main ON/OFF switch. 
  • Programme of conta blender

PLC: Fx 1N 24 MR with extra module Fx 1N 1 DABD, Mitsubishi make   (14 DI+10DO)

MMI: E-300 Mitsubishi make.

VFD: FRE E540 –(2.2) KW, 400V, Mitsubishi make.

  • Program
    • Blender is programmed for manual and auto mode. Lifting & lowering is manual, rotational RPM &timing is automatic.
    • RPM of the Blender can be pre set and different RPM can be stored.
    • Acceleration (Soft start) and Deceleration (Soft stop) time can be set per the requirement.
    • Mixing /Rotation time can be pre set.
    • Different products with different rotation time and RPM can be programmed.
    • Inter locking is done for the rotation height/ position.
    • Programming is done for the blender to stop at the right position i.e. vertical position, repeatedly after every mixing cycle.
    • Display of actual RPM of the Bin on MMI with the help of Fx 1N 1 DABD analog output module.
  • Data program
    • Date
    • Product name
    • Batch no.
    • Operator name.
    • Batch size.
  • Standard blending time.
  • Print interval.
  • Mixing, 3 level pass word

Print port is available for connecting to the printer.

Data can be stored in PC through software program like SCADA.

  • Spares
    • Hydraulic Flexible Hose Pipe – 3/8”BSP   2 Nos.
    • Coil for 2-way solenoid valve, 24V DC 2 Nos.
    • Hydraulic Cylinder Seal Kit  1 Set.
    • Guide roller with 6205zz bearing   8 Nos
  • TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB –COMPONENTS USED / BOUGHT OUTS 
S.No. DESCRIPTION SPECIFICATIONS
1.                  Equipment Description
a Name Conta Blender
b Specification Non Flame proof construction
c Capacity 400/200/50Ltrs (Bin Qty. = 3,3 and4 respec. )
d RPM 5-16
e Model BLD/NFLP/400-200-50
f Overall dimensions 225x225x3080 (WxDxH)
g Foundation Bolts (bottom) Pin type Anchor Bolt (M12 x 6”) with SS 304 dome nut
h Foundation Bolts (top) Pin type Anchor Bolt (M12 x 4”) with

SS 304 dome nut

i Mast center to Bin center 1040mm
j Minimum height of the bin holding arm from the ground 500 mm
2.                  Power Pack
a Type Hydraulic
b Model Solenoid operated, Single station, Double acting
c Make RP Make
3.                  Power pack Motor
a Type TEFC, Non-Flame proof, Squirrel cage, three phase induction motor.
B Model Flange Mounted,
c Capacity 1.5HP x 1415 RPM
d Make Crompton Greaves
4.                  Hydraulic Cylinder
Dimensions :-
a Bore  65 (dia)mm
b Rod  35(dia)mm
c Stroke  300mm
d Stop Tube  100 mm
5.                  Worm Reduction Gear Box
a Type Worm Reduction Gear Box
b Make Bonfliglio
c Reduction Ratio 10:1
d Location LHS / RHS
e Qty 02 nos.
6.                  Drive Motors
a Type  Non Flame Proof, 3 phase induction
b Make Bharat Bijlee
c Model Flange Mounted,
d Capacity 2HP
e Location LHS / RHS
f Qty 02 nos.
7.                  Variable Frequency Drive
a Type E-Series, 400 V class AC drive
b Model FR-E 540-2.2 K
c Capacity 2.2 K
d Make Mitsubishi
8.                  Pressure Gauge
a Type 2 ½” (dia) , Glycerin filled
b Range 0 – 280kg/cm2
c Mounting Bottom mnt. , ¼”BSP
d Make Shreeji
9.                  Programmable logical cont
a Model No Fx 1N 1DABD FX IN 24 MR
b Make Mitsubishi
10.              Man Machine Interface
a Model No E-300
b Make Mitsubishi
11.              Limit Switch
a CAT No. NLL1
b Qty. 02 Nos.
c Make Bhartia Cutler
d Location Upper / Lower
12.              Proximity Switch
a Model EGT18X80  AP  024 –2000L
b Make Tekknic Euchner
13.              Emergency Switch
a Qty. 01 No.
b Location Control Panel

 

  • DETAILS OF UTILITIES
 DESCRIPTION SPECIFICATIONS
Electrical
Phase 3 Phase
Voltage 415V
Frequency 50 Hz

 

  • IDENTIFICATION OF COMPONENT FOR CALIBRATION

In the Conta Blender, following are the components, which needs calibration.

  1. Pressure Gauge (to measure Oil pressure of the power pack)
  • MATERIAL OF CONSTRUCTION
S. NO. COMPONENT DESCRIPTION MOC
1 Bin 400 Ltrs. (Qty.  3) SS 316
2 Bin 200 Ltrs. (Qty.  3) SS 316
3 Bin 50 Ltrs.  (Qty.  4) SS 316
4 Control Panel SS 304,
5 Mast Structure MS,
6 Mast cladding SS 304,
7 Container/Bin holding Arm SS 316 L
8 Main Panel MS, (Powder coated)

 

 

  • ENCLOSURES
S. No. Description Drawing No
1 General arrangement drawing of              Conta blender BLD-3402

 

  • SAFETY FEATURES AND ALARMS
    • MCB, Relay provided in the Main Panel

If power pack motor is overloaded to draw more current than the limit, the circuit will trip.

  • Locking rod & bush arrangement is provided at the foot of the mast.

To prevent accidental mast swiveling while lifting & lowering the load.

  • Pilot operated check valve (C I 10 S) on hydraulic cylinder

In case of hydraulic leakage during operation, check valve does not allow the load / Arm to come down.

  • FAT PROCEDURE

Factory Acceptance Test Procedure shall be as follows:

After the completion of erection work of the machine, 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 Check list
  3. Deficiency & Corrective Action report
  4. Pre-installation requirements
  5. Final report
  • CHANGE CONTROL PROCEDURE

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

  • DESIGN QUALIFICATION REPORT 

18.0      LIST OF ABBREVIATIONS  

cGMP current Good Manufacturing Practices
GEP Good Engineering practices
MS Mild steel
NFLP Non Flame Proof
SS Stainless Steel
KW Kilo Watt
DQ Design Qualification
FAT Factory acceptance test
LFT Lift
VFD Variable frequency drive
RPM Revolution per minute
MMI Man machine interface
SCADA Supervisory control & data acquisition
MCB Miniature circuit breaker

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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