DQ FOR ADU 100

Customer Name : M / s. UMALAXMI ORGANICS PVT. LTD. JODHPUR.Manufacturer: ACG Pam Pharma Technologies Pvt. Ltd.Job name: Air Displacement Unit: Model ADU 100

Date:................... Page No 1 of 13Sr. 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:

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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:

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3. RESPONSIBILITIES

CUSTOMER1. To provide the URS for the equipment.2. To perform the Factory Acceptance Test (FAT).

MANUFACTURER1. 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:

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4. MACHINE DESCRIPTION

Sr. No. DescriptionThe ADU 100 machine comprises,

i 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.

v 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:

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5. TECHNICAL SPECIFICATIONS

Sr. No. Description

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

ii Air flow 2800 LPM.

iii Overall dimensions915 mm X 600 mm X 1483 mm approx.

iv Equipment weight150 kg approx.

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6. TECHNICAL SPECIFICATIONS OF COMPONENTS / BOUGHT OUTS

Sr. No. Description Specifications1. Main structure with handle

i Material Stainless Steel , SS 304ii Surface Finish 320 grit Mirror finish

2. Dust collector with coveri Position Above main structure.ii Manufacturer ACG-Pam iii Specification Powder collector.iv Material SS 316 v Surface Finish of frame 320 grit Mirror finish

3. Filter bagi Position Inside dust collector.ii Manufacturer RP Tradingiii Specification 5 microniv Air permeability at W C 10M 4 to 9 cc / sec / cm2

v Material Synthetic fabric4. Impeller housing

i Position Inside structure.ii Manufacturer ACG-Pam iii Specification Provide suction inside dust collector.iv Material Aluminum casting

Comment Section:

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5. Motor i Position Above blower casing.ii Manufacturer Hindustan Motor Mfg.Co.iii Type 1.5 Kw , 2.0 Hp , 2860 Rpm , 3.10 Amp , 3 Ph.iv Protection IP55

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7. MATERIAL OF CONSTRUCTION FOR PRODUCT CONTACT PARTS

Sr. No. Component Description MOC Surface Finish1 Dust collector and cover (Drum) SS 316 Mirror Finish.2 Filter bag Synthetic fabric NA

8. SURFACE AREA CALCULATION FOR CAPSULE AND PRODUCT CONTACT PARTS

Sr. No. Component Description MOC Surface Finish Area cm2

1 Dust collector and cover (Drum) SS 316 Mirror Finish. 6973.86

2 Filter bag. Synthetic fabric NA 5579

Comment Section:

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9. BRIEF PROCESS DESCRIPTION

Sr. No. DescriptionThe 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. Descriptioni 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:

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11. CAPACITY VIS A VIS REQUIREMENT GIVEN IN URS

Sr. No. Descriptioni 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. Descriptioni 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.

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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.

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16. DESIGN QUALIFICATION REPORT APPROVAL

16.1 Summary

16.2 Certification

Comment Section:

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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 V 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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Documents

DQ FOR ADU 100