DESIGN QUALIFICATION AUTOMATIC CAPSULE FILLING

MACHINE
Table of content

1. Objective
2. Scope
3. Responsibility (Client and manufacturer)
4. URS (User Requirement Specification)
5. Machine description
6. Technical specification
7. Technical specifications of the sub-components / bought out items
8. Details of Utilities
9. Identification of components for calibration
10. Material of construction of components
11. Surface area calculations for capsule and product contact parts
12. Equipment dimensional details with tolerances
13. Brief process description
14. Capacity vis a vis requirement given in URS
15. Utility consumption
16. Lubrication procedure
17. Limitation of equipment
18. Change control procedure
19. Design qualification document report approval
  OBJECTIVE
To design, engineer, and supply the Automatic capsule filling machine as per cGMP and 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, are the same at utmost transparency. Validation procedure is set for complete satisfaction of the customer
& building confidence of the user about the machine.

 SCOPE
The scope of this qualification document is limited to the Design Qualification Automatic capsule filling
machine . This qualification document is part of a validation activity of Automatic capsule filling machine.
Qualification of support utilities is not within the scope of this qualification document. The equipment shall be used
for filling powder or pellet or tablets in capsules. The equipment shall operate under dust free environment and
conditions as per the GMP requirements.

RESPONSIBILITIES
CLIENT

1. To provide the URS for the equipment.

MANUFACTURER

1. To design, engineer and provide the complete technical details of the equipment pertaining to its design
qualification viz.

 Machine overview
 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 major components
 Brief operational description
 Safety features and alarms
 Pre-installation requirements

2. To confirm the safe delivery of the equipment to the user site.

3. 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.
4. To ensure the proper installation and commissioning of the equipment.

 MACHINE DESCRIPTION
 Equipment Description
The basic Automatic capsule filling machine consists of the following sub-assemblies

 Structure Assembly
 This houses the main drive motor, powder drive motor, pneumatic and vacuum piping, all drive elements and
electrical control cabinet. The structure is enclosed on all four sides by removable covers. Removing the
hand wheel side cover exposes the filter regulator lubricator unit of compressed air system, the pressure
 switch, main drive motor clutch. Removing the cover below the exit chute exposes the cam switch box, drive
mechanism. When the cover located below the empty capsule loading area is removed, electrical control
panel is exposed.
 Drive Assembly
 This consists of the main motor, drive shaft, gears, cams, cam followers, bearings, housings and brackets.
Rotary indexing motion is given to the turret, dosing disc and a reciprocating motion is given to various
sections that move vertically by specially designed cams.
 Turret Assembly
 The turret is a cylindrical disc. It has 8 pairs of cap & body bush holder plates with the cap plate located
above the body plate. Each pair are radially equidistant around the turret center. The turret also houses
pneumatic cylinder and cams for providing motion to the cap and body bush holder plates. The cap & body
bush holder plates hold cap & body bushes of different sizes as per requirement.
 Empty capsule loader assembly
 This consists of a capsule hopper, magazine, rectifier block, horizontal finger assembly, vertical finger
assembly and vacuum block. The hopper has a baffle plate to regulate the flow of capsules in the hopper. The
magazine is mounted on a shaft. The vertical finger assembly and the capsule releasing fingers are fitted on
the magazine. A handle is provided to start or stop the release of capsules to the rectifier block. The released
capsules are pushed by the horizontal finger assembly. A vacuum block located below the body bush holder
plate moves up & down. The magazine has four different sizes of holes depending on the change part
ordered. The rectifier block has four different sizes of slots corresponding to the size of capsules. Similarly
the horizontal and vertical finger assemblies have different fingers depending on the capsule size.
 Powder filling Device
 This consists of a hopper, stirrer, feed tube, powder level sensing device, powder tub. The powder hopper is a
stainless steel container fitted with an acrylic window. A powder stirrer is mounted centrally in the hopper
and driven by a separate motor. At the delivery end of the hopper, adjustable gate is provided to control the
rate of powder flow and to facilitate the removal of powder at the end of shift. The powder level in the
powder tub is sensed by a capacitive type proximity switch.
 Tamping station
 The product to be filled is fed from the hopper to the dosing disc. Due to the centrifugal force of the dosing
chamber drive, the product is carried to the outer edges of the dosing disc to the tamping plungers. The
product is then compressed five times before being transferred into the capsule. Four different sizes of dosing
discs are made with their hole position corresponding to the size of capsule.
 Pin plate assembly
 This consists of a plate on which various segments of pins for different applications are fitted. At no.5
unopened capsules are collected in a box which are ejected out by pins. Similarly at station 6,7 & 8 there are
pins for closing of capsules, ejecting the capsules from the exit chute and cleaning of the capsule bushes.
 Electrical control assembly
 The electrical control panel is mounted inside the structure of the machine. The mains ON / OFF switch is on
the cover of the machine. The Drive ON / OFF, Control ON, Speed regulator and the Emergency OFF
switches are mounted on the pendant of the machine. Inching facility is provided for easy checking of
various settings on the machine.
 The display screen of the PLC has various selector keys for performing various operations.
 The control cabinet inside the structure houses the AC drive, the PLC, MCB’s, contactors, overload relays.
 Pellet filling attachment
 This is an optional attachment that can be fitted at station 3. It is a gravimetric type of filling.
 It consists of a Hopper, reservoir and dose chamber assembly. The hopper is a stainless steel container with
an acrylic window. A manually operated gate is provided at the bottom of the hopper. The hopper is mounted
on top of the reservoir. A capacitive type proximity switch is mounted at the bottom of the reservoir. The
reservoir is supported on a guide block. The dose chamber assembly consists of guide block, fixed jaw,
movable jaws, slide plate top, slide plate bottom, movable jaw & fix jaw. The volume of the dose to be
 controlled is by the two movable jaws. The slide plate top & slide plate bottom move radially in & out by the
reciprocating shaft through a bell crank lever. When the top plate moves backwards, the reservoir is
connected through the apertures in the top slide plate to the adjustable cavities in dose container and thus all
the cavities are filled by pellets. The bottom of the dose container is blocked by the slide plate bottom during
this metering phase. When the turret indexes and brings the empty capsule bodies under the guide block, the
top slide plate moves forward to close the entry of pellets to the adjustable cavities in the dose container. At
the same time the slide plate bottom moves forward to open the bottom side of the dose container to transfer
the metered dose to the capsule bodies.
 PLC Description
 The main function of a PLC is to translate the instructions into the digital codes needed to operate the device
or machine. The main function of this PLC system is to collect data from field instrumentation & display the
information on the operator station. The instruments are connected to the system equipment. The collected
data will be utilised by the PLC for process control. The user interface, based in an industrial type MMI, will
assist the operator to supervise and control the process. Based on the displayed information the operator, by
means of the user interface, can provide commands to the PLC. The PLC then executes the operator
instructions. A Mitsubishi Family Fx2N PLC has been chosen as the Central Processing Unit (CPU).

 TECHNICAL SPECIFICATIONS
 Output :Upto 6,000 capsules / hour for powder filling and Upto 5000 capsules / hour for pellet filling.
 Capsule size : # 00 to # 5
 Overall dimensions : 1000 mm X 1000 mm X 1750 mm approx.
 Equipment weight : 1000 kg approx.
 TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT
OUTS

Sr. No. DESCRIPTION SPECIFICATIONS

1. Structure

Mild Steel, Painted, Enclosed on all sides

Material
by SS 304 covers

Structure covers SS 304, 120-140 grit finish outside

2. Top cover assembly

Position Above top plate

Manufacturer
Sr. No. DESCRIPTION SPECIFICATIONS

Specification Enclosure with acrylic doors

Aluminium anodised, Phoenix Mecanno

Material of support frame
make

Surface Finish Satin finish

3. Drive assembly

Below the top plate for performing various

Position
operations

Manufacturer

Specification Drive assembly

Material Alloy Steel

Timer belt HTD 8 mm pitch

Timer pulley En 19

Cams En 36

Bearings

4. Turret Assembly

Position
Cylindrical disc above Machine top,
Sr. No. DESCRIPTION SPECIFICATIONS

holding cap & body bush holders.

Manufacturer

Specification Turret assembly

Material Aluminium casting

Surface finish Electroless nickel plated

5. Loader Assembly

Above machine top plate to load empty

Position
capsules in bushes.

Manufacturer

Specification Loader assembly

Material Aluminium / Half hard brass / SS 316 L

Black hard anodised / electroless nickel

Surface finish
plated / mirror polished

6. Powder filling Device

Above machine top plate to provide powder for

Position
filling operation.
Sr. No. DESCRIPTION SPECIFICATIONS

Manufacturer

Specification Powder filling device

Material SS316 L / Polycarbonate

Surface finish Mirror polished

6.1 Pellet filling Device

Above machine top plate to provide pellets for

Position
filling operation.

Manufacturer

Specification pellets filling device

Material SS 316 L / Polycarbonate

Surface finish Mirror polished

7. Pin plate assembly

Above machine top plate to perform

various operations like closing,
Position
ejection,bush cleaning, removing
unopened capsules.

Manufacturer
Sr. No. DESCRIPTION SPECIFICATIONS

Specification Pin Plate assembly

Material Alloy steel / SS316 L

Surface finish Electroless nickel plated / mirror polished

8. Limit switches

Specification Door safety switches 1NO + 1NC

Position Aluminium plate of top cover assembly

Manufacturer Essen

Model no. MBC 1

9.Proximity switches (capacitive)

Specification Powder low level switch

Position Powder tub

Manufacturer IFM

Model no. KG5010

Sensing range 10 mm
Sr. No. DESCRIPTION SPECIFICATIONS

10.Proximity switches (inductive)

Specification To provide signals for various operations.

Position Cam switch box

Manufacturer TAP

Model no. GLP-12APS

Sensing range 1 mm

11.Filter regulator

Specification To provide filtered air at a set pressure

Position Inside structure

Manufacturer Airmatic

Model no. B13-023 / PB / RK

Accuracy 5 microns

12.Vacuum valve

ON / OFF valve for vacuum for capsule

Specification
loading
Sr. No. DESCRIPTION SPECIFICATIONS

Position Inside structure

Manufacturer Univer

Model no. AG-3232

Range 610 Torr- 0.5 Torr

13. Pressure switch

Specification Air pressure switch

Position Inside structure

Manufacturer Indfoss

Model no. Indfoss PR SW IPS 100

Range 0-100 psi

14. Pressure Gauge

Specification For Operating Air Pressure 0-10 bar

Position On FRL unit inside structure

Manufacturer M/s. Uday

Sr. No. DESCRIPTION SPECIFICATIONS

Model No. Dia 40 mm

Accuracy ± 2%

15. Vacuum Gauge

Specification Vacuum Gauge

Range 0 to -30” Hg

Position On structure

Manufacturer Manometer

Model No. Dia. 63 mm

16. Main motor

Position Inside structure

Manufacturer Bharat Bijlee

1.5 HP, 3ph AC Brake motor Frame 100L

Type
750 rpm

Protection Class IP 54

17. Powder stirrer motor

Sr. No. DESCRIPTION SPECIFICATIONS

Position Inside structure

Manufacturer Hindustan( custom built)

0.25 hp 3 ph, AC motor Frame 63, 1500

Type
rpm

Protection Class IP54

18. Gear box for powder stirrer motor

Inside structure coupled to powder stirrer

Position
motor

Manufacturer Shanti

SA112, 30:1 FL-63 I/P – horizontal, O/P -

Specification
Vertical

19. Machine mount

Position Below structure

Manufacturer Avmac

Specification NAV 08 M16 x 1.5

20. Pneumatic Cylinder

Sr. No. DESCRIPTION SPECIFICATIONS

Position Inside turret well, Exit chute

Manufacturer Rexroth, Festo

Compact cylinder 20 mm dia 4 mm stroke,

Specification
DG 6-10, Part no. 3620

Operating pressure 6 bar

21. Solenoid valve

Position On pneumatic panel inside structure

Manufacturer Festo

Specification Single solenoid MFH-3-1/8

Single solenoid MFH-3-1/8 SEU -11121

Operating pressure 6 bar

22. Lubricator

Position On pneumatic panel

Manufacturer Airmatic

Specification Upto 12 kg / cm2 max.

Sr. No. DESCRIPTION SPECIFICATIONS

Model no. ML-10-02

23. Chain

Position Drive assembly, Cam switch box

Manufacturer Rollon

Specification 3/8″ pitch

24. Filter bag of ADU 100

Position Inside drum

Manufacturer RP

Filter quality 5 microns

Filter material Synthetic fibre

Filter area 5579 cm2

25 PLC

CPU Make Mitsubishi

Model Fx 2N-32-MT
Sr. No. DESCRIPTION SPECIFICATIONS

PLC Input / Output 16 Input / 16 Output

26. MMI

Make E – 300

Position On pendant control box

Manufacturer Beijer

Keyboard RS-232, RS 422 Port

Serial interface 320 x 240 Pixels

Supply Voltage +24 VDC, +/- 20%

 DETAILS OF UTILITIES
DESCRIPTION SPECIFICATIONS

1 Electrical

Phase 3 Phase

Voltage 415 V

Frequency 50 Hz
Power (only machine) 2 kW

Power (with vacuum pump, air compressor and ADU100) 8 kW

2 Compressed Air

Consumption (pneumatic parts)

Flow pressure 6 bar (Kg)

Quality oil, water & dust free

Residual moisture content < 5.5 g / m3

Particle size 0.1 um

Residual Oil < 1 ppm

Max. Consumption 225 lpm

Power (Air compressor motor) 2.2 kW

3 Vacuum requirement

Vacuum pump

Flow 575 lpm

Pressure 26 inches of Hg
Power ( Vacuum pump motor) 1.5 kW

4 Air Displacement Unit

Flow 2800 lpm

Maximum vacuum 500 mm of water

Power ( ADU100 motor) 1.5 kW

 IDENTIFICATION OF COMPONENT FOR CALIBRATION

 In the Capsule filling machine, following items need calibration. They shall be calibrated during / before
installation of the equipment at the site:
 Following are the components:

1. Pressure Measurement (Operating Air Pressure gauge)

2. Vacuum measurement ( vacuum gauge)

 MATERIAL OF CONSTRUCTION FOR PRODUCT CONTACT PARTS

Sr. No Component Description MOC Surface Finish

1. Capsule Hopper SS 316 L Mirror polished

2. Magazine Aluminium Hard anodized

3 Cap bush SS 316 L Mirror polished

4 Body bush SS 316 L Mirror polished

5 Powder hopper SS 316 L Mirror polished

6 Powder tube SS 316 L Mirror polished

7 Powder tub SS 316 L Mirror polished

8 Dosing disc SS 316 L Mirror polished

9 Tamping pins SS 316 L Mirror polished

10 Closing plate SS 316 L Mirror polished

11 Exit chute SS 316 L Mirror polished

12 Grommets Silicon ——————

 SURFACE AREA CALCULATION FOR CAPSULE AND PRODUCT CONTACT PARTS

Sr. No Component Description MOC Surface Finish Area cm2

1. Capsule Hopper SS 316 L Mirror polished 1500

2. Magazine Aluminium Hard anodised 100.4

3 Cap bush SS 316 L Mirror polished 36.1

4 Body bush SS 316 L Mirror polished 75

5 Powder hopper SS 316 L Mirror polished 2174

6 Powder tube SS 316 L Mirror polished 282.7

7 Powder tub SS 316 L Mirror polished 740.9

8 Dosing disc SS 316 L Mirror polished 564.1

9 Tamping pins SS 316 L Mirror polished 68

10 Closing plate & pins SS 316 L Mirror polished 339.2

11 Exit chute with cover SS 316 L Mirror polished 1297.2

 BRIEF PROCESS DESCRIPTION

 The various operations of capsule filling takes place at eight stations of the turret.
 At station 1, capsules are loaded in the bushes. The cap bush holder plate and body bush holder plates are
exactly above one another. The capsules are rectified, i.e. Cap up and body down position and loaded in the
bushes. They are separated by vacuum.
 At station 2, the cap bush holder plate is lifted partially & body bush holder plate is “in” position.
 At station 3, the body bush holder plate is fully out and the cap bush holder plate is partially up. This station
is made for pellet filling or tablet filling.
 Station 4 is meant for powder filling operation.
 At station 5, unopened capsules are ejected out.
 Station 6 is for closing operation of capsules.
 Station 7 is for ejection of capsules and
 Station 8 is for cleaning of the bushes.

 CAPACITY VIS A VIS REQUIREMENT GIVEN IN URS

 Powder filling:
 Speed of machine 108 strokes per minute,
 No. of capsules in one bush segment 1
 Output per hour = 108 x 1 x 60 = 6480 capsules / hour
 Pellet filling:
 Speed of machine 85 strokes per minute,
 No. of capsules in one bush segment 1
 Output per hour = 85 x1 x 60 = 5100 capsules / hour
 Powder filling, Pellet filling outputs are theoretical based on standard powders, pellets. The actual outputs
depend on the actual formulation, type and mesh of pellets.
 UTILITY CONSUMPTION
 Electrical power
 A)Main motor = 1.1 kW
 Powder feeder motor = 0.18 kW
 Total kW = 2.0 kW (rounded off) for machine only
 Electrical power consumed = 2 x 0.9 x 1 = 1.8 kWh / hr Max.
 Considering 60% normal utilisation Electrical power consumed = 2 x 0.9 x 0.6 = 1.08 kWh / hr Min for
machine only
 Vacuum pump motor = 1.5 kW
 ADU100 motor = 1.5 kW
 Air compressor motor = 2.2 kW
  Total kW = 8.0 kW for machine with vacuum pump, ADU100 and air compressor.
 Electrical power consumed = 8 x 0.9 x 1 = 7.2 kWh / hr.
 Max onsidering 60% normal utilisation Electrical power consumed = 2 x 0.9 x 0.6 = 4.32 kWh / hr Min. for
machine with ADU, vacuum pump and air compressor.
 Compressed air consumption :144 lpm
 LUBRICATION PROCEDURE
 Regular and proper lubrication is essential to prevent premature wear and break downs. Only recommended
lubricants should be used. Recommended lubricants and their equivalents are given in table below.
 All lubricating oils must be changed, for the first time, after 200 hours of operation. The subsequent oil
changes should be as given in Table. Whenever oil change is undertaken original oil should be drained out
completely before refilling. The sumps and strainers should be cleaned whenever the oil is
replaced. Greasing to the drive parts is to be done
 Turret well is filled with food grade grease. This is a must as it is in the pharma zone of the machine.
 Loader shafts and pin plate shafts have linear up and down motion for giving motion to magazine, closing
pins, ejection pins, bush cleaning pins and unopen capsule ejection pins. These shafts are guided in housings
fitted with bearings. Special wiper seals are provided on top of the housings to prevent the oil traces to come
out. However due to continuous operation and if seals are worn out over a period of time there are chances of
oil traces to come out from these portions.
 Lubricants are used at different locations as recommended in the table below.
 LUBRICANT

FREQUENCY OF
APPLICA- CHANGE EQUIPMENT
INDICA-
TION TYPE QTY. TO BE USED
TION
FIRST / LATER

Visual
White check
Turret (Turret
200 / 200 PTFE
(Inside the cover
hours (Food 250gms Manually
cover)
grade)
removed)

Oil
SAE 30
Vacuum 200 / 1500 1.8
Pump hours litres Oil level
Non Bellow pump
(Capsule indicator
food
separation)
grade)

Oil
200 / 1500 SAE 90 0.3 Oil level
Gear Box hours litres indicator Bellow pump
(Non
food
 grade)

 LIMITATION OF EQUIPMENT

1. The speed of the machine has to be reduced for pellet filling and tablet filling operations.
2. It is not possible to fill odd shaped tablets due to feeding problem of tablets.
3. Two tablets of same size only can be filled.

 Change in the agreed design shall be addressed through the well-defined Change control procedure.
 CHANGE CONTROL PROCEDURE
 DESIGN QUALIFICATION REPORT APPROVAL
 APPENDIX
 LIST OF ABBREVIATIONS
CGMP current Good Manufacturing Practices

cGEP Current Good Engineering practices

AISI American Iron & Steel Institute

SS Stainless Steel

CFM Cubic Feet Per Minute

KW Kilo Watt

DQ Design Qualification

MMI Man Machine Interface

MOC Material of Construction

 REFERENCE DOCUMENTS
 1. Manufactures Brochure (s) / Manual (s). (Title and Location).
To be supplied with the Installation qualification documents

1. Instruction & Maintenance manual

2. Calibration certificates

3. Material of construction certificates

4. Instruction manual for PLC

5. Test certificates of motors

6. Certificates of boughtout items.

 ANNEXURE LIST

SR. NO. DESCRIPTION ANNEXURE NO.

1 URS

2 Purchase Order