DESIGN QUALIFICATION OF BIN WASHING & DRYING SYSTEM

BIN WASHING & DRYING SYSTEM

MACHINE DESCRIPTION

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

The basic operation cycle will be as follows:-

    • Portable water pre-wash from inside and outside.
    • Hot water washes from inside and outside.
    • Soap water washes 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 C

The system has having chamber to accommodate 1000/400/200/50 Ltrs. SS bunkers.

Water tank of 500 Ltrs. Capacity with level sensors has been provided to store portable water.

They have a jacketed Hot Water tank of 1500 Ltrs. Capacity has been provided. The heating media to be used is steam at 3 bar pressure.

Operating control panel

The Non-flame proof and Flameproof control panels are made of SS304 sheet. It is located and mounted on the wall and the safety railing pillar. The operating panel consists of an MMI and an emergency switch.

Main Electric panel

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

The main power panel consists of PLC, an Electrical power circuit, Main ON/OFF switch. 

DESIGN QUALIFICATION 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 components 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 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. 

TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS 

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, the following are the components, which need 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 the power pack motor is overloaded to draw more current than the limit, the circuit will trip.

A 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

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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