Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.

Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 1 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
TABLE OF CONTENT
1. Objective
2. Scope
3. Responsibilities
4. Machine description
5. Technical specifications
6. Technical specification of component / bought-outs
7. Material of construction for product contact parts
8. Surface area calculation for capsule and product contact part
9. Brief process description
10. Safety
11. Capacity vis a vis requirement given in URS
12. Utility consumption
13. Lubrication procedure
14. Limitation of equipment
15. Change control procedure
16. Design qualification report approval
17. Appendix

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 2 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
1.

OBJECTIVE
To design, engineer, and supply Air Displacement Unit as per cGMP & cGEP guidelines
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 specification and the tolerances
prescribed there in the document.

2.

SCOPE
The scope of this qualification document is limited to the Design Qualification of ACG Pam
Pharma Technologies Pvt. Ltd. make Model: ADU 100. This qualification document is part
of a validation activity for the ACG Pam Pharma Technologies Pvt. Ltd.
Qualification of support utilities is not within the scope of this qualification document.
The equipment shall be used for continuous removal of powder from Automatic Capsule
Filling Machine. The equipment shall operate as per the GMP requirements.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 3 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
3.

RESPONSIBILITIES
CUSTOMER
1. To provide the URS for the equipment.
2. To perform the Factory Acceptance Test (FAT).
MANUFACTURER
1. To design, engineer and provide the complete technical details of the
equipment pertaining to its design qualification viz.
i. Machine overview
ii. Specifications of the sub-components / bought out
iii.Details of Utilities,
iv. Material of construction of major components
v. Brief operational description
vi. Safety
2. To facilitate the client for the Factory acceptance test of the machine at their
works/ site.
3. To confirm the safe delivery of the equipment to the user site.
4. 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.
5. To ensure the proper installation and commissioning of the equipment.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 4 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
4. MACHINE DESCRIPTION
Sr. No.

Description
The ADU 100 machine comprises,

A cylindrical Chamber called the dust collector provided with cover. A rubber seal
ring is provided between the chamber and the cover to prevent leakage and loss of
vacuums.

ii

A filter bag enclosed inside the Chamber, where sucked powder gets deposited. A
vertical rod called shaker is connected to the filter bag at the bottom and is used for
dedusting of the filter bag. The filter bag is connected to a ring on top and clamped
with a hose clip.

iii

The cylindrical Chamber is mounted on a structure and is held with the help of 2
toggle clamps. The structure is provided with a handle and 4 wheels for easy
manoeuvrability. An aluminum impeller enclosed between an Impeller Housing and
casing.

iv

The suction side of Impeller Housing is connected to the cylindrical Chamber by a

Hose pipe. An electric Motor mounted on the impeller housing. The motor is directly
mounted on the impeller housing. The impeller assembly consisting of the impeller,
housing and casing and motor is mounted on the structure.

A DOL starter for starting and stopping the motor is mounted on the back side of the
structure. The ADU 100 machine is connected to the the AF machine by a hose pipe
which is connected to the cover of chamber. The hose pipe end connections are
provided with rubber Hose Adapters to ensure an air tight joint.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 5 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
5.

TECHNICAL SPECIFICATIONS
Sr. No.
i

Description
Output :
Vacuum developed 500 mm of water (maximum)

ii

Air flow
2800 LPM.

iii

Overall dimensions
915 mm X 600 mm X 1483 mm approx.

iv

Equipment weight
150 kg approx.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 6 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
6.

TECHNICAL SPECIFICATIONS OF COMPONENTS / BOUGHT OUTS

Sr. No.
Description
1. Main structure with handle
i
Material
ii
Surface Finish
2. Dust collector with cover
i
Position
ii
Manufacturer
iii
Specification
iv
Material
v
Surface Finish of frame
3. Filter bag
i
Position
ii
Manufacturer
iii
Specification
iv
Air permeability at W C 10M
v
Material
4. Impeller housing
i
Position
ii
Manufacturer
iii
Specification
iv
Material

Specifications
Stainless Steel , SS 304
320 grit Mirror finish
Above main structure.
ACG-Pam
Powder collector.
SS 316
320 grit Mirror finish
Inside dust collector.
RP Trading
5 micron
4 to 9 cc / sec / cm2
Synthetic fabric
Inside structure.
ACG-Pam
Provide suction inside dust collector.
Aluminum casting

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 7 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
5. Motor
i
ii
iii
iv

Position
Manufacturer
Type
Protection

Above blower casing.

Hindustan Motor Mfg.Co.
1.5 Kw , 2.0 Hp , 2860 Rpm , 3.10 Amp , 3 Ph.
IP55

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 8 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
7.

MATERIAL OF CONSTRUCTION FOR PRODUCT CONTACT PARTS

Sr. No.
Component Description
1
Dust collector and cover (Drum)
2
Filter bag

MOC
SS 316
Synthetic fabric

Surface Finish
Mirror Finish.
NA

8. SURFACE AREA CALCULATION FOR CAPSULE AND PRODUCT CONTACT

PARTS
Sr. No.

Component Description

MOC

Surface Finish

Area cm2

Dust collector and cover (Drum) SS 316

Mirror Finish.

6973.86

Filter bag.

NA

5579

Synthetic fabric

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 9 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
9.

BRIEF PROCESS DESCRIPTION

Sr. No.

Description
The machine consists of an Impeller enclosed in an Impeller Housing with a suction
and exhaust port. As the impeller rotates at high speed a partial vacuum is created in
the impeller Housing. Atmospheric air is sucked in from the suction port and
exhausted from the exhaust port. The ADU is basically a vacuum cleaner, the suction
side of which is used for sucking dedusted powder. The powder gets collected in the
stainless steel drum mounted on the structure.

10.

SAFETY

Sr. No.

Description

Only trained personnel may operate the machine.

ii

During installation, disassembly, maintenance and cleaning, the main switch of the
equipment must be switched off and protected against unintended operation, by
disconnection from the main supply.

iii

Only qualified personnel may remove the covers.

iv

Isolate from the main power source before any covers or doors on the machine is
removed or opened.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 10 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
11.

CAPACITY VIS A VIS REQUIREMENT GIVEN IN URS

Sr. No.

Description

Air flow: 2800 LPM (without Hepa Filter and EU7)

ii

Vacuum: 500 mm of water (without Hepa Filter and EU7)

12.

UTILITY CONSUMPTION

Sr. No.

Description

Electrical Power :- 1.5 kW.

ii

Electrical power consumption :- 1.5 kW X 0.9 X 1

= 1.35 Kwh / hr. Max.

Considering 60 % normal utilisation.

iii

Electrical power consumption:- 1.5 kW X 0.9 X 0.6 = 0.81 Kwh / hr. Min.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 11 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
13.

LUBRICATION PROCEDURE
The ADU 100 machine does not need specific lubrication schedule.

14.

LIMITATION OF EQUIPMENT
Using very fine powder will lead to frequent clogging of the chocking of the same.

15.

CHANGE CONTROL PROCEDURE

Change in the agreed design shall be addressed through official letter or email from
authorised person of the customer.

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 12 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
16.

DESIGN QUALIFICATION REPORT APPROVAL

16.1

Summary

16.2

Certification

Comment Section:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD.

Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.
Job name: Air Displacement Unit: Model ADU 100

JODHPUR.

Date:...................
Page No 13 of 13
Sr. No.: 2062
_____________________________________________________________________________
DESIGN QUALIFICATION FOR LINE MACHINE
17.

APPENDIX
List of abbreviations

CGMP

current Good Manufacturing Practices

Kg

Kilogram

cGEP

Current Good Engineering practices

cm

Centimetre

AISI

American Iron & Steel Institute

hp

horsepower

SS

Stainless Steel

ph

Phase

CFM

Cubic Feet Per Minute

rpm

Rotation per minute

KW

Kilo Watt

IP

Industrial protection

DQ

Design Qualification

o/p

output

HEPA

High Efficiency Particulate Air Filter

Voltage

MMI

Man Machine Interface

Hz

Hertz

MOC

Material of Construction

um

Micron

URS

User requirement specification

ppm

Part per million

FAT

Factory Acceptance test

lpm

Litre per minute

PLC

Programmable logic control

ANX

Annexure

MCB

Miniature circuit breaker

spm

Strokes per minute

CPU

Central processing unit

gms

grams

mm

Millimetre

hr

Hour

Comment Section:
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_______________________________________________________________________________
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