TABLE OF CONTENT
- Responsibility (Client and manufacturer)
- URS (User Requirement Specification)
- Machine description
- Technical specification
- Technical specifications of the sub-components / bought out items
- Details of Utilities
- Identification of components for calibration
- Material of construction of components
- Surface area calculations for capsule and product contact parts
- Equipment dimensional details with tolerances
- Brief process description
- Capacity vis a vis requirement given in URS
- Utility consumption
- Lubrication procedure
- Limitation of equipment
- Change control procedure
- Design qualification document report approval
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.
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.
- To provide the URS for the equipment.
- 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
- To confirm the safe delivery of the equipment to the user site.
- 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.
- 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
|Material||Mild Steel, Painted, Enclosed on all sides by SS 304 covers|
|Structure covers||SS 304, 120-140 grit finish outside|
|2. Top cover assembly|
|Position||Above top plate|
|Specification||Enclosure with acrylic doors|
|Material of support frame||Aluminium anodised, Phoenix Mecanno make|
|Surface Finish||Satin finish|
|3. Drive assembly|
|Position||Below the top plate for performing various operations|
|Timer belt||HTD 8 mm pitch|
|Timer pulley||En 19|
|4. Turret Assembly|
|Position||Cylindrical disc above Machine top, holding cap & body bush holders.|
|Surface finish||Electroless nickel plated|
|5. Loader Assembly|
|Position||Above machine top plate to load empty capsules in bushes.|
|Material||Aluminium / Half hard brass / SS 316 L|
|Surface finish||Black hard anodised / electroless nickel plated / mirror polished|
|6. Powder filling Device|
|Position||Above machine top plate to provide powder for filling operation.|
|Specification||Powder filling device|
|Material||SS316 L / Polycarbonate|
|Surface finish||Mirror polished|
|6.1 Pellet filling Device|
|Position||Above machine top plate to provide pellets for filling operation.|
|Specification||pellets filling device|
|Material||SS 316 L / Polycarbonate|
|Surface finish||Mirror polished|
|7. Pin plate assembly|
|Position||Above machine top plate to perform various operations like closing, ejection,bush cleaning, removing unopened capsules.|
|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|
|Model no.||MBC 1|
|9.Proximity switches (capacitive)|
|Specification||Powder low level switch|
|Sensing range||10 mm|
|10.Proximity switches (inductive)|
|Specification||To provide signals for various operations.|
|Position||Cam switch box|
|Sensing range||1 mm|
|Specification||To provide filtered air at a set pressure|
|Model no.||B13-023 / PB / RK|
|Specification||ON / OFF valve for vacuum for capsule loading|
|Range||610 Torr- 0.5 Torr|
|13. Pressure switch|
|Specification||Air pressure switch|
|Model no.||Indfoss PR SW IPS 100|
|14. Pressure Gauge|
|Specification||For Operating Air Pressure 0-10 bar|
|Position||On FRL unit inside structure|
|Model No.||Dia 40 mm|
|15. Vacuum Gauge|
|Range||0 to -30” Hg|
|Model No.||Dia. 63 mm|
|16. Main motor|
|Type||1.5 HP, 3ph AC Brake motor Frame 100L 750 rpm|
|Protection Class||IP 54|
|17. Powder stirrer motor|
|Manufacturer||Hindustan( custom built)|
|Type||0.25 hp 3 ph, AC motor Frame 63, 1500 rpm|
|18. Gear box for powder stirrer motor|
|Position||Inside structure coupled to powder stirrer motor|
|Specification||SA112, 30:1 FL-63 I/P – horizontal, O/P -Vertical|
|19. Machine mount|
|Specification||NAV 08 M16 x 1.5|
|20. Pneumatic Cylinder|
|Position||Inside turret well, Exit chute|
|Specification||Compact cylinder 20 mm dia 4 mm stroke, DG 6-10, Part no. 3620|
|Operating pressure||6 bar|
|21. Solenoid valve|
|Position||On pneumatic panel inside structure|
|Specification||Single solenoid MFH-3-1/8|
|Single solenoid MFH-3-1/8 SEU -11121|
|Operating pressure||6 bar|
|Position||On pneumatic panel|
|Specification||Upto 12 kg / cm2 max.|
|Position||Drive assembly, Cam switch box|
|24. Filter bag of ADU 100|
|Filter quality||5 microns|
|Filter material||Synthetic fibre|
|Filter area||5579 cm2|
|PLC Input / Output||16 Input / 16 Output|
|Make||E – 300|
|Position||On pendant control box|
|Keyboard||RS-232, RS 422 Port|
|Serial interface||320 x 240 Pixels|
|Supply Voltage||+24 VDC, +/- 20%|
- DETAILS OF UTILITIES
|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|
|Pressure||26 inches of Hg|
|Power ( Vacuum pump motor)||1.5 kW|
|4 Air Displacement Unit|
|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:
- Pressure Measurement (Operating Air Pressure gauge)
- 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|
|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|
- 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|
|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.
|APPLICA-TION||FREQUENCY OF CHANGE
FIRST / LATER
TO BE USED
(Inside the cover)
|200 / 200
|Vacuum Pump (Capsule separation)
|200 / 1500
Non food grade)
|Oil level indicator||Bellow pump|
|200 / 1500
(Non food grade)
- LIMITATION OF EQUIPMENT
- The speed of the machine has to be reduced for pellet filling and tablet filling operations.
- It is not possible to fill odd shaped tablets due to feeding problem of tablets.
- 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
- LIST OF ABBREVIATIONS
|CGMP||current Good Manufacturing Practices|
|cGEP||Current Good Engineering practices|
|AISI||American Iron & Steel Institute|
|CFM||Cubic Feet Per Minute|
|MMI||Man Machine Interface|
|MOC||Material of Construction|
- REFERENCE DOCUMENTS
- 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.|
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube