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DESIGN QUALIFICATION OF BIN WASHING & DRYING SYSTEM

TABLE OF CONTENT

  • Objective
  • Scope
  • Responsibilities
  • Machine description
  • Operating control panel
  • Main electric Panel
  • 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
  • Change control procedure
  • Design qualification report
  • List of Abbreviations 
  • OBJECTIVE
  • To design, engineer, and supply the Bin Washing & Drying System 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 Bin Washing & Drying System. This qualification document is part of a validation activity for the Bin Washing & Drying System.
  • RESPONSIBILITIES
    • CLIENT
      • To check and approve the design qualification.
    • MANUFACTURER
      • 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
      • To confirm the safe delivery of the equipment to the user site.
      • 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.
      • To ensure the proper installation and commissioning of the equipment. 
  • MACHINE DESCRIPTION

Bin Washing & Drying System is automatic system with services like portable water, purified water, hot water, and boiler steam.

  • The basic operation cycle will be:-
    • Portable water pre wash from inside and outside.
    • Hot water washes from inside and outside.
    • Soap water wash from inside and outside.
    • Portable water washes from inside and outside.
    • Hot water washes from inside and outside.
    • Purified water rinse from outside.
    • Filtered hot air drying at 80 0
  • System is having chamber to accommodate 1000/400/200/50 Ltrs. SS bunkers.
  • Water tank of 500 Ltrs. Capacity with level sensors have been provided to store portable water.
  • Jacketed Hot Water tank of 1500 Ltrs. Capacity has been provided. Heating media to be used is steam at 3 bar pressure.
  • Operating control panel
    • The Non-flame proof and Flame proof control panel are made of SS304 sheet. It is located and mounted on the wall and on the safety railing pillar. Operating panel consist of
      • MMI
      • Emergency switch
  • 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

  • PLC
  • Electrical power circuit
  • Main ON/OFF switch. 
  • TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS 
Description Specification
1.          Equipment Description
Name Bin Washing & Drying System
Specification Non Flame proof construction
Capacity 1200/600/400/200/50 Ltrs.
Foundation Bolts

(Bottom)

Pin type Anchor Bolt

(M12x6”) with SS 304 dome nut

Hot Water Tank Jacketed, SS 304
Portable Water Tank SS 304
MOC Contact Parts : SS 316

Non-Contact Parts : SS 304

2.      SS High Pressure Pump
Type Impeller Type
P max. 16 Bar
Power Rating 4 KW
Capacity 5 m3 / hr at 16 bar
Water consumption 5 Cu.m/hr
Make Grundfos
3.               Spray Ball
 Type Rokon spray ball
Model D 28984
Make Spraying system Inc.
Mounting ½” BSP
4.      Pneumatic Cylinder
Make Festo
5.      Washing Nozzles
Type Manifold
Make Spraying system Inc.
Size 25 mm
Qty. 17 Nos.
6.      Control Valve
Make Spraying system Inc.
Size 25 mm & 38 mm
MOC SS 316 with Sanitary fitting
7.      Pneumatic Actuator
Purpose Overall control circuit of control valve
8.      Hot air Blower
Power Rating 2.2 KW
MOC Ms / GI
Capacity 2500 m3 / hr.
9.      Hot air exhaust
Power Rating 2.2 KW
MOC Ms / GI
Capacity 2700 m3 / hr.
10.  Washing and Drying chamber
Type Double walled, insulated
MOC SS 304
View Glass Toughen Glass
Door Interlocks For safety purpose
Drain At the bottom of the chamber and connected to main drain
11.  Programmable logical controller
Make Mitsubishi
12.  Man Machine Interface
Make Mitsubishi
13.  Diaphargm Valve
Make Sunders
MOC SS 316
Capacity / Size / Qty. 16 bar / 25 ESC 62 / 03 Nos..
14.  Solenoid valve
Make Festo
MOC Aluminium
Capacity 10 bar
Size MFH – 3 – ¼
Qty. 03 Nos.
15.  Level controller
Qty. 02 Nos.
Location Portable & Hot water tank
16.  temp. indicator cum controller
Qty. 01 No.
Range 0 – 100 0C
17.  Solenoid operated Ball Valve
Make Abcon
Size 25 NB
MOC SS 304
Capacity 3 bar
18.  Bypass valve
Make audco
Size 25 MB
MOC SS 304
Capacity 3 bar
19.  Pre – filter
Make Technopack
Dimensions 610 X 610 X 300
Capacity 2500 cfm
20.  Hepa Filter
Make Technopack
Dimensions 610 X 610 X 300
Capacity 2500 cfm
Rating 0.3 µ
21.  Drain
Make Forbes Marshal
MOC SS 304
  • DETAILS OF UTILITIES
 DESCRIPTION SPECIFICATIONS
Electrical 3 Phase / 415V / 50 Hz / 4 KW
Steam 3 bar
Purified / Potable water To be provided
  • IDENTIFICATION OF COMPONENT FOR CALIBRATION

In the Bin washing & Drying system, following are the components, which needs calibration.

  • Controller cum Indicator
  • Pneumatic actuator
  • MATERIAL OF CONSTRUCTION
Sr. No. COMPONENT DESCRIPTION MOC
1 Non return valve SS 316
2 High Pressure pump SS 304
3 Diaphragm valve SS 316
4 Sol. Operated Ball valve SS 304
  • ENCLOSURES 
Sr. No. Description Drawing No
1 General arrangement drawing of Bin Washing & Drying System
  •  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 door.

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

  • CHANGE CONTROL PROCEDURE

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

  • DESIGN QUALIFICATION REPORT: 
  • 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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