DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.

:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

DESIGN QUALIFICATION
PROTOCOL CUM REPORT
FOR
DYNAMIC GARMENT CABINET

DATE OF QUALIFICATION

SUPERSEDE PROTOCOL No. NIL

 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

PROTOCOL 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 REQUIRMENT 6

6.0 BRIEF PROCESS DESCRIPTION 6

7.0 EQUIPMENT SPECIFICATION 6

8.0 CRITICAL VARIABLES TO BE MET 7

7.1 PROCESS/PRODUCT PARAMETERS 7

7.2 UTILITY REQUIREMENT/LOCATION SUITABILITY 7

7.3 TECHNICAL SPECIFICATION/KEY DESIGN FEATURES 8-10

7.4 MOC 10

7.5 SAFETY 11

7.6 VENDOR SELECTION 12

9.0 DOCUMENT TO BE ATTACHED 12

10.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) 13

11.0 ANY CHANGE MADE AGAINST THE FORMALLY AGREED 13

PARAMETER
12.0 RECOMMENDATION 13

13.0 ABBREVIATIONS 14

14.0 REVIEWED BY 15
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

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)
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

2.0 OBJECTIVE:
 To prepare the Design Qualification protocol for Dynamic Garment storage Cabinet 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 Dynamic
Garment Cabinet (Make: Chempharm Industries India Pvt Ltd.) for FFS Line
 The equipment shall be operated under the dust free environment and conditions as per the cGMP
requirements.
 The drawing provided by Vendor shall be verified during Design Qualification.
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

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, Approval and Compilation of Design Qualification 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.
 Reviewed 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.
 Reviewed 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, Model,
Engineering
Quantity and backup records/brochures.
 Details of utilities Required.
 Identification of components for calibration.
 Material of construction of Garment Contact Parts.
 Brief Process Description
 Safety Features and Alarms
 Reviewed of Design Qualification Protocol cum Report after Execution.
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

5.0 PROJECT REQUIRMENT:

 To confirm the safe delivery of the Equipment from the supplier Site. To ensure that no
Unauthorized and / 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.
The Dynamic Garment Cabinet &, its associated components are designed in accordance with cGMP
principles

6.0 BRIEF PROCESS DESCRIPTION:

Dynamic Garment storage cabinet are used to maintain Class 100 through HEPA filter having an efficiency
of 99.99% down to 0.3µ, with a velocity of 90±20 % FPM , at its face to remove dust and atmosphere
contaminants from air and maintain Garments in Class 100 environment.
Dynamic Garments Cabinet consists of HEPA filters with an efficiency of 99.99% down to 0.3µ with
permitted pressure drop. The system is equipped with a motor blower assembly and Pre-filter to suck air
from atmosphere and to pass it through HEPA filter.

7.0 EQUIPMENT SPECIFICATION:

Equipment Specifications are based on User Requirement Specification prepared. 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: Dynamic Garment storage Cabinet unit should Process Requirement

Dynamic Garment storage Cabinet meet the requirement to provide a clean
unit is capable of delivering environment for sterilized Garments.
sufficient air volumes and to avoid
the cross-contamination under the
HEPA filters.
Working: To provide a clean environment for Garments. Process Requirement
Working of Garment Cabinet.
Electrical Control Panel The system should have Electrical Control Design Requirement
Panel.
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

8.2 UTILITY REQUIREMENTS/LOCATION SUITABILITY:

Critical Variables Acceptance Criteria Reference

Utility connections should be available as per the manufacturer’s specification.

Electrical Supply Single Phase cGMP Requirement
3 Wire Line Up To The Panel Board
Terminal.
Voltage- 220 - 230 V
Frequency- 50 -60 Hz
Power required -350 watt
Room Condition Should be able to meet the requirement of Process Requirement
clean environment.

8.3 TECHNICAL SPECIFICATIONS/KEY DESIGN FEATURES:

PARAMETERS ACCEPTANCE CRITERIA REFERENCE

Body
Manufacturer Chempharm Industries India. Ltd. Design Requirement
Model CP-GSC-3’ x 1.5 ’ x 7’ Design Requirement
Flow Vertical Design Requirement
Type 100 % Exhaust Dynamic Garment Cabinet Design Requirement
Overall Dimension 1050 X 450 X 2105 mm Design Requirement
Capacity 190 CFM Design Requirement
Static Pressure 30 mm of water Design Requirement
MOC SS 304 Sheet of 1.0 mm thickness Design Requirement
Surface Finish Hair Line Finish Design Requirement
Door Double Wall Sandwitch Doors—Double Door Design Requirement
Door Hinge SS 304 ,06 Nos. Design Requirement
Door’s Glass 125X 875 X5 mm – 4 Nos. Design Requirement
Blower Assembly
Make Air Scanner Design Requirement
MOC of Blower Housing SS Design Requirement
MOC of impeller Aluminium Design Requirement
RPM 1350 RPM Design Requirement
Motor Capacity 1/3 HP - single phase Design Requirement
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

PARAMETERS ACCEPTANCE CRITERIA REFERENCE

HEPA Filter
Make Chempharm Industries India. Ltd. Design Requirement
Type Minipleat Design Requirement
Size 313 X 783 X 69 mm Design Requirement
Quantity 01 No. Design Requirement
Media Micro Fiber Glass Design Requirement
Efficiency 99.99% down to 0.3µ , Design Requirement
Filter class H-14 Design Requirement
Exhaust Pre-filter
Make Chempharm Industries India. Ltd. Design Requirement
Size 176 X 196 X 20 mm Design Requirement
Quantity 02 No. Design Requirement
Type Box type Design Requirement
Efficiency 90% Down to 5µ Design Requirement

Media Al Expended+3HDPE+Al Expended Design Requirement

Fresh air filter
Make Chempharm Industries India. Ltd. Design Requirement
Size 270 X 510 X 50 mm Design Requirement
Quantity 01 No. Design Requirement
Type Box type Design Requirement
Efficiency 90% Down to 5µ Design Requirement

Media Al Expended+3HDPE+Al Expended Design Requirement

Magnehelic Gauge
Make Dwyer Design Requirement
Range HEPA filter: 0-50 mm of water column Design Requirement
Accessories
Make Philips Design Requirement
UV Light
Watt 15 W Design Requirement
Quantity 1 No. Design Requirement
Hour meter Make Nishant
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

PARAMETERS ACCEPTANCE CRITERIA REFERENCE

Quantity 1 No. Design Requirement
Make Roma Design Requirement
Switch Qty. 03 Nos.
voltage 5/15 Amp.
Make Philips Design Requirement
Tube Light
Watt 14 W Design Requirement
Quantity 1 No. Design Requirement
PAO Port SS Design Requirement
Door Handle With Lock STD. – 01 No. Design Requirement
Levelling Screw SS – 04 Nos. Design Requirement
Indicator Make : Laptron Design Requirement
Hanging Hook Set SS --- 03 NOS. Design Requirement
Hanging pipe SS (19 mm dia) Design Requirement

Electrical Supply
Power Supply 220-230 V AC/ 50-60 Hz Design Requirement
Power Consumption 350 Watts Design Requirement

8.4 MOC:
COMPONENTS ACCEPTANCE CRITERIA REFERENCE
Body SS304 Design Requirement
Dore Hinge SS304 Design Requirement
Blower SS Design Requirement
HEPA Micro Fiber Glass Design Requirement
Fresh Air & Exhaust Filter Al Expended+3HDPE+Al Expended Design Requirement
PAO Port SS Design Requirement
Switch SS Design Requirement
Indicator STD Design Requirement
Hanging Hook Set SS Design Requirement
Hanging pipe SS Design Requirement
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

8.5 SAFETY:
CRITICAL VARIABLES ACCEPTANCE CRITERIA REFERENCE

Joints Welding of joints without any welding burrs Safety Requirement

Metal Parts All the metal parts should be properly grind Safety Requirement
without any sharp edges.
Leveling and balancing Equipment should be properly balanced & Safety Requirement
leveled
Electrical wiring and earthing Electrical wiring should be as per approved Safety Requirement
drawings. Single external Earthing to control
machine (panel and motors) and operator should
be provided
Emergency Switch Provided easy access position. GMP & Safety
Requirement

Verified By
(Quality Assurance)
Sign/Date: ……………
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

8.6 VENDOR SELECTION:

Critical Variables Acceptance Criteria Reference
Selection of Vendor for Selection of Vendor is done on the basis of Process Requirement
supplying the Dynamic Garment review of vendor. Criteria for review should
Cabinet 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.

9.0 DOCUMENTS TO BE ATTACHED:

 Technical Specifications for Equipment
 Approved Engineering Drawings Design
 Minutes of meeting held with the supplier, if any.
 Purchase Order Copy.
 Any other relevant documents.
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

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

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11.0 ANY CHANGES MADE AGAINST FORMALLY AGREED PARAMETERS:

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12.0 RECOMMENDATION:
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 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

13.0 ABBREVIATIONS:
% : Percent
µ : Micron
AC : Alternate current
cGMP : Current Good Manufacturing Practice
CQA : Corporate Quality Assurance
DQ : design qualification
EU : European Union
FFS : Form Fill Seal
FPM : Feet per minute
GA : General Arrangement
HEPA : High Efficiency Particulate Air
HP : Horse Power
Hz : Horse Power
IB : Injection block
ID. : Identification
Ltd. : Limited
mm : Millimeter
MOC : Material of Construction
Nos. : Number
PAO : Poly Alpha olefin
Pvt. : Private
QA : Quality Assurance
RPM : Rotation per minute
SS : Stainless Steel
SSG : Sterile storage cabinet
STD. : Standard
URS : User Requirement Specification.
UV : Ultra Violet
V : voltage
W : Watt
 DESIGN QUALIFICATION PROTOCOL CUM REPORT PROTOCOL No.:
FOR
DYNAMIC GARMENT CABINET

PHARMA DEVILS

14.0 REVIEWED BY:

INITIATED BY:
DESIGNATION NAME SIGNATURE DATE

HEAD
(ENGINEERING)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)