PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

DESIGN QUALIFICATION

PROTOCOL CUM REPORT

FOR

VIBRO SIFTER 30”

DATE OF QUALIFICATION
SUPERSEDE PROTOCOL No. NIL
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

PRTOCOL CONTENTS

S. No. TITLE PAGE No.

1.0 Protocol Pre-Approval 3

2.0 Objective 4

3.0 Scope 4

4.0 Responsibility 5

5.0 Project Requirements

6.0 Brief Equipment Description 6

7.0 Equipment Specification 7

8.0 Critical Variables to be Met 7

8.1 Process/Product Parameters 7

8.2 Utility Requirement/Location Suitability 7

8.3 Technical Specification/Key Design Features 8

8.4 Material of Construction 9

8.5 Safety 10

8.6 Vendor Selection 10

9.0 Document to be Attached 11

10.0 Review (Inclusive of Follow Up Action, If Any) 11

11.0 Any Change Made Against the Formally Agreed Parameter 11

12.0 Recommendation 11

13.0 Abbreviations 12

14.0 Reviewed by 13
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

1.0 PROTOCOL PRE-APPROVAL:

INITIATED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

2.0 OBJECTIVE:
 To prepare the Design Qualification document for Vibro Sifter on basis of URS and information
given by Supplier.
 To ensure that all Critical Aspects of Process/Product Requirement, cGMP and Safety have been
considered in designing the equipment and are properly documented.

3.0 SCOPE:
 The Scope of this Qualification Document is limited to the Design Qualification of Vibro Sifter 30”
(Make: Elicon Pharma) for …………………….
 The Vibro Sifter is a Standalone unit with plug in type electrical connections for operation and is on
castor wheel. Hence, may be moved as per requirement to other area of operation which shall not
change the performance of equipment.
 The equipment shall be operated under the dust free environment and conditions as per the cGMP
requirements.
 The drawings and P & IDs provided by Vendor shall be verified during Design Qualification.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments, shall be
responsible for the overall compliance of this Protocol cum Report:
DEPARTMENTS RESPONSIBILITIES
 Preparation, Review and Approval of the Protocol cum Report.
 Assist in the verification of Critical Process Parameters, Drawings as per the
Specification.
Quality Assurance  Co-ordination with Production and Engineering to carryout Design
Qualification.
 Monitoring of Design Qualification Activity.
 Review of Design Qualification Protocol cum Report after Execution.
 Review of Design Qualification Protocol cum Report.
 Assist in the verification of Critical Process Parameters, Drawings as per the
Production
Specification.
 Review of Design Qualification Protocol cum Report after Execution.
 Review of Design Qualification Protocol cum Report.
 Assist in the Preparation of the Protocol cum Report.
 To co-ordinate and support the Activity.
 To assist in Verification of Critical Process Parameter, Drawings as per the
Specification i.e.
 GA Drawing
 Specification of the sub-components/bought out items, their Make,
Engineering
Model, Quantity and backup records/brochures.
 Details of utilities Required.
 Identification of components for calibration
 Material of construction of Product Contact Parts
 Brief Process Description
 Safety Features and Alarms
 Review of Design Qualification Protocol cum Report after Execution.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

5.0 PROJECT REQUIREMENTS:

To confirm that safe delivery of the equipment from the supplier site. To ensure that no un-authorized or
unrecorded design modification 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.

6.0 BRIEF EQUIPMENT DESCRIPTION:

Vibro sifter is an efficient & compact unit self contained & mounted on castor wheels. Vibro sifter have
circular unitary vibrating screen used for gradation of material & its proven records over the rotary or
longitudinal movement used in the conventional type of sieving machine, both in term of output &
uniform grading of materials. Specially designed motor with eccentric weights imparts vibratory motion
to the hopper, which have a screen in between them. Material finer than the screen mesh pass through
the screen & are collected in the bottom hopper. Coarse material is retained on top of the screen. The
amplitude of vibration can be varied from minimum to maximum by adjusting the eccentric weights to
suit the process requirement in base minimum time. The machine is generally as per enclosed specs &
consists of:
1. Motor: It is fitted with top & bottom eccentric weights designed as per required centrifugal force.
This whole assembly is covered by SS plate. The motor is flanged mounted & is fixed on the
mounting plate by hex. Bolts. The top weights are fixed on the output shaft over the mounting plate.
2. Spring: the eight number chrome plated spring are fixed on the base flange at equi- distance. These
springs are provided with the ends of the springs. The springs are then screwed on at both the bolts at
one end to the base & on the mounting plate at the top. These rugged springs amplify the vibration &
restrict them from being transmitted to the floor.
3. Hopper: It is a cylindrical, flanged body with an inverted cone at the bottom. This is placed over the
mounting plate. The bottom flange is used for clamping to the base plate with a rubber gasket in
between the hopper & plate. Hopper is provided with an outlet, tangential to the periphery for
discharge of sieved material. The top flange is to provide for holding the charging/ intermediated
hopper with a sieve in between them. It is fabricated from stainless steel sheet and works for loading
the materials for sifting.
4. Screen: based on the product size required a suitable screen is clamped in between the two hopper.
Finer mesh sieves can be or with back up cross support to ensure longevity of sieve. This is
recommended for sieves finer than 150 meshes.
5. Discharge port: To collect the processed materials.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

6. Conical shape top lid: It is provided with charging port. Screen is fitted in between the hopper &
top lid.

7.0 EQUIPMENT SPECIFICATION:

Equipment Specifications are based on User Requirement Specification prepared by ……….. The
manufacturer of equipment ensures complies with User Requirement Specification.

8.0 CRITICAL VARIABLES TO BE MET:

8.1 PROCESS/PRODUCT PARAMETERS:

CRITICAL VARIABLES ACCEPTANCE CRITERIA REFERENCE

Application: The Vibro Sifter should be able for sifting of Process Requirement
The Vibro Sifter shall be able for raw material, APIs, Excipients during the
sifting of raw material, APIs, manufacturing process.
Excipients during the
manufacturing process.
Working: Vibro Sifter should capable of sifting the Process Requirement
Working of Vibro Sifter various drugs, raw material, excipients with
desired uniformity as per product requirement.
Electrical Control Panel The system should have Electrical Control Design Requirement
Panel.

8.2 UTILITY REQUIREMENTS/LOCATION SUITABILITY:

CRITICAL VARIABLES ACCEPTANCE CRITERIA REFERENCE

Electrical Supply The electrical system of the equipment shall be cGMP Requirement
housed as per the cGMP and cGEP standards,
with adequate safety.

Room Condition Temperature and RH requirement as per Process Requirement

requirement of product
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

8.3 TECHNICAL SPECIFICATIONS/KEY DESIGN FEATURES:

S.NO. NAME OF THE COMPONENT TECHNICAL SPECIFICATION
1. Model cGMP
2. All contact parts SS316
3. All non-contact parts SS304
4. Capacity Std.
5. Dimension 1300 (W) x 800 (D) x 1250 (H) in mm
6. Charging height Approx.: 1350 mm,
7. Discharging height Approx.: 780 mm,
As per your specifications and purchase order.
8. Electric motor Make : Vikrant
Type : Vibratory
H.P : 0.5 HP
RPM : 1440
Volt : 415± 10V
Amp : 1.2
9. Screen Diameter 750 mm
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

8.4 MATERIAL OF CONSTRUCTION:

MACHINE PARTS ACCEPTANCE CRITERIA REFERENCE

Top Lid AISI 316 L GMP Requirement

Top Deck AISI 316 L GMP Requirement

Bottom Deck AISI 316 L GMP Requirement

Mesh AISI 316 L GMP Requirement

Base AISI 304 GMP Requirement

‘C’ - Clamp AISI 304 GMP Requirement

Gasket White Food Grade GMP Requirement

Spring AISI 304 Design Requirement

Motor Mounting Plate MS Design Requirement

Motor STD Design Requirement

Castor Wheel Polyurethane (PU) GMP Requirement

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

8.5 SAFETY:

CRITICAL VARIABLES ACCEPTANCE CRITERIA REFERENCE

MCB MCB is provided so that when there is an overload Safety Requirement
in current or any short circuit then the MCB trips
Mechanical Guard Mechanical guard for all rotating parts. Safety Requirement
Joints Welding of joints without any welding burrs Safety Requirement

Metal Parts All the metal parts should be Safety Requirement

Properly grind without any sharp edges.
Leveling And Balancing Equipment should be properly balanced & leveled Safety Requirement
Electrical Wiring And Electrical wiring should be as per approved Safety Requirement
Earthing drawings. Single external Earthing to control
machine (panel and motors) and operator should be
provided
Noise Level Below 80 db GMP & Safety
Requirement

Emergency Switch Provided easy access position GMP & Safety

Requirement

8.6 VENDOR SELECTION:

CRITICAL VARIABLES ACCEPTANCE CRITERIA REFERENCE
Selection of Vendor for supplying Selection of Vendor is done on the basis of Process Requirement
the Vibro Sifter review of vendor. Criteria for review
should include vendor background
(general/financial), technical knowhow,
quality standards, inspection of site,
costing, feedback from market (customers
already using the equipment)

Reference: (1) User Requirement Specifications (URS).

(2) Design & Functional Specifications provided by Vendor.

Verified
(Quality Assurance)
Sign/Date: ……………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

9.0 DOCUMENTS TO BE ATTACHED:

 Technical details for Equipment Requirement with Engineering Drawings.
 Approved Design and Specifications.
 Any other relevant documents.

10.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

11.0 ANY CHANGES MADE AGAINST FORMALLY AGREED PARAMETERS:

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

12.0 RECOMMENDATION:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

13.0 ABBREVIATIONS:
AISI : American Iron Steel Institute
cGMP : Current Good Manufacturing Practice
DQ : Design Qualification
GA : General Arrangement
GB : General Block
mm : Millimeter
MOC : Material of Construction
P & ID : Piping and Instrumentation Diagram
QA : Quality Assurance
SS : Stainless Steel
STD : Standard
URS : User requirement specification.
VSF : Vibro Sifter
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

DESIGN QUALIFICATION PROTOCOL CUM REPORT FOR VIBRO SIFTER

14.0 REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(ENGINEERING)

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)