Tablet Compression Machine IQ (Installation Qualification)

Tablet Compression Machine IQ (Installation Qualification)

TABLE OF CONTENTS

APPROVAL

• The validation team comprising of a representative from each of the following departments shall be responsible for the overall compliance with this protocol:
• RESPONSIBILITY: –  
• Standard Operating Procedure have been identified and listed.
• The equipment operation has been verified for its intended use.
• No unauthorized or unrecorded modifications have taken place.
• All critical components have been identified and calibrated.
• All supporting utilities are properly connected.
• The system meets the current Good Manufacturer’s Practice (cGMP) requirements.
• The system is installed according to the manufacturer’s recommendations.
• The system meets the Design Specification / URS.
• The purpose of this protocol is to provide an outline for the inspection of equipment for static attributes to verify that:
• OBJECTIVE: –
• Engineering Department
• Production Department
• Quality Assurance Department
• The Production and Engineering shall be responsible for checking the installation and recording installation data as per the procedures outlined in this protocol.
• Engineering Personnel shall be responsible for verifying the data recorded in the Installation Qualification Protocol.
• Quality Assurance Department shall be responsible for the final review of the qualification documents and its compliance to meet the acceptance criteria of the Installation Qualification protocol.
• EQUIPMENT DETAILS:

• EQUIPMENT LOCATION 
• Facility :Tablets Manufacturing Facility
• Area :Tablets manufacturing Area
• Room Name:Tablet Compression Room
• Room ID No. :
• DOCUMENTATION:- 

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

• PREREQUISITE OF Tablet Compression Machine IQ: –
• Machine should be open in front of validation Team.
• Ensure the cleanliness of the area.
• Check the correctness of location of the equipment to be installed with respect to layout.
• Check for correctness of mounting of equipment with respect to manufactures recommendation.
• Ensure the Electric connections required for installation.
• Ensure the other supporting utilities required for Installation.

Tablet Compression Machine IQ Procedure:

• Instructions:

• Check the installation of equipment :
• To verify the location of installation as per the equipment layout.
• To verify the proper assembly of the components as per the equipment drawings and  record the installation location and verification of assembly.
• To check the leveling and alignment as per the procedure and record the observation.

• Identify the critical components of equipment and verify that the components are complying as per desired specifications and record the observations.
• Check the MOC of the component and record the observation of the MOC.
• Identify the utility supplies required for equipment operation and verify that utilities are as per the specification and record the observatio.
• Identify the critical instruments supplied with the equipment or installed on the utility supply line. Verify that instruments are as per the desired specifications. Review the calibration status of the instruments & record the status.
• List the available drawing and record the Ref. No. for their location / availability.
• Identify the SOPs and assign SOP Numbers, record the SOP Title and Number.
• Record the deviation (if any)
• SYSTEM DESCRIPTION:
• The major components of the equipment are identified us:-

• Powder Feeding unit.
• Powder transfer unit
• Compression unit
• Hydraulic power pack assembly
• Discharge unit
• The Compression machine 26 station D tooling, a single rotary high speed tablet press, is a machine in incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor and rejection / sampling port.
• Powder feeding unit has S.S. 316 Hopper of capacity 20 Ltrs. rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which control the flow of the powder between the hopper and the feeding assembly. The hopper consists of an agitator, which enhanced the powder flow. A barrel –type powder level sensor is mounted on a bracket and fixed against the sight glass of the hopper.
• Powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the force feeder, the force feeder has two counter rotating paddles of S.S. 316, driven by reduction gearbox and variable frequency AC drive motor. The tail over die is an essential feature of the high – speed tablet press. The function of the tail over die is to keep the filled die covered until the last moment before the upper punch enters the die.
• Drive unit has main motor of 5HP drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm shaft.
• Turret is a three piece structure having the center die tablet of S.S. 316 and upper and lower piece of cast iron of SG 400/15. The upper piece holds the upper punches, which rests on the upper cam tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower cam tracks and Dozer.
• Compression unit comprises upper main pressure roll assembly having a roll centre, pressure roll and pressure roll pin. The roll centre holds the pressure roll and is locked by using external circlips upper punch penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness assembly is responsible in deciding the tablet thickness.
• Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight adjusting head through a dozer adjusting screw with the help of dial.
• Hydraulic power pack assembly system control the safety overload mechanism, which governs the maximum pressure, level, at which particular tablets are being made. The oil reservoir for this system is located in front LH corner within lower cabinet. It can be accessed by removing the lower side guard (LH). The oil level in the reservoir should be checked regularly through the oil level indicator.
• Tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die so as to avoid tablet-chipping problem. As soon as the tablet is ejected out it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. Tablet discharge chute is made S.S. 316 with acrylic cover. Tablets slide out through this chute to the container.
• Auto lubrication system provided for the lubrication of all critical pinpoints like roll pins, it comprises of a lubrication tank, a motorized pump, distribution manifold and pipelines. This pump operates on timer set in the PLC. It should be noted that the ON time should be less then the OFF time, to prevent the oil flooding. The dozing of oil respective critical points can be throttled through the distribution manifold.
• Lower punch lubrication system helps mainly for smooth and easy ejection of tablets. In addition the tablet gets a clean, smooth surface at the web. The lower punch has an extractor groove below the tip for the lubrication support, which may be a lubrication felt or woolen thread winding. In order to avoid lubricant, the scraper mechanism is built in. the stripper oil is collected in a collecting tray. The scraper keeps the external diameter of the die plate and lower punch guide clean. From the collecting tray the oil is transported downward through a funnel and a hose line and returned back into the tank.
• The working principle of compaction force control is whenever the powder is compressed to from a tablet an impact is generated. The oil in the hydraulic cylinder absorbs this impact. The load cell, which is mounted between the upper roll lever and the hydraulic cylinder, senses the load received. The value is transferred to the data control screen through the transducer and the PLC. The data control screen displays the individual force of all 26 punches.
• PROCEDURE :

• Tablet Compression Machine IQ (Installation) Check List: 

• Checklist for Inspection of Tablet Compression Machine IQ:

• Leveling and alignment of Machine during Tablet Compression Machine IQ
  :

• Method for checking the Leveling of the Equipment:
• – Using Spirit Level Indicator

• Place the spirit level indicator at different points on the machine frame.
• Acceptance Criteria:
• The air bubble of the spirit level indicator shall be observed in the center.
• – Using Water Level Indicator:
• Place transparent tube filled with water of suitable length at various corners. Compare the levels of water and align the equipment.
• Acceptance Criteria:
• The water level at both the locations should match with the edges of those locations, if required should be repeated for other edges of the equipment on same plane.
• Method for checking the Alignment:
• Dial Indicator Method:

• Place the dial indicator on the coupling.
• Rotate the shaft slowly by hand.
• Observe the indicator reading on both sides’ rotation of the shaft.
• Acceptance Criteria:
• The total indicator reading should not be more than 0.305 mm.
• Straight Edge Method:
• Place the straight edge along the circumferences of both driver and driven pulleys simultaneously.

• Shift the motor base so as to adjust the gap between the straight edge and the circumferences of both the pulleys
• Check the gap with filler gauge.
• Acceptance Criteria:

The gap between the straight edge and pulleys should not be more than 1.0 mm

• Material of Construction of contact Part:

• Method for checking Material of Construction (MOC) of Stainless Steel (SS) material (Molybdenum Test):
• Put 1 drop of electrolyte solution of the Molybdenum test kit on clean metal surface, which is to be tested.
• Switch ON the detector and touch the metal tip of the detector on metal surface and carbon point in electrolyte.
• Do not pass the current for more than 3 to 4 seconds.
• If the red color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 316
• If the solution remains colorless or green color appears then it can be concluded that the material of construction of the part being tested is S.S. 304.
• If the Black color appears and is stable for more than 2 seconds then it can be concluded that material of construction of the part being tested is S.S. 302.
• Certificate for Motors:

• Drawings:

• List of Identified of Standard Operating Procedures:

• Checklist for Supporting Utilities:

• Identification of Critical Instruments for Calibration:

• DEVIATION DETAILS(If Any):
• Description of deviation and date observed
• CHANGE CONTROL (If Any)

• REVALIDATION CRITERIA for Tablet Compression Machine IQ:Installation Qualification to be re-qualified on
• Replacement of major component of the equipment with a new component
• Any major modification in the existing equipment
• Transfer/Shifting of the equipment from one location to another.
• ACCEPTANCE CRITERIA for Tablet Compression Machine IQ :
• Installation Qualification shall be considered acceptable when all the conditions specified in various checklist have been met.
• SUMMARY:
• The acceptance criteria of the protocol and Specific check points  are checked and verified as per above mentioned instillation checklist and found that all the parameter met the specification.

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