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Qualification of tablet compression machine

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Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam

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Qualification of tablet compression machine

  1. 1. QUALIFICATION OF TABLET COMPRESSION MACHINE Prepared By, Mr. Pritam P. Kolge M.Pharm First Year (SemII) Department of Pharmaceutical Quality Assurance Bharati Vidyapeeth College of Pharmacy, Kolhapur 6/29/2020 1 Guided By, Dr. Mrs. N.M.Bhatia Professor and Head, Department of Pharmaceutical Quality Assurance
  2. 2. CONTENT Introduction Design Qualification Installation Qualification Operational Qualification Performance Qualification Case Study Conclusion Reference 6/29/2020 2
  3. 3. INTRODUCTION 6/29/2020 3 Qualification an ideal step for equipment validation is the action undertaken to demonstrate the intended use and performance of the utilities and equipment. The individual steps of qualification such as design, installation, operational and performance qualification were done in order to qualify the equipment. Blue print of equipment validation was also included. The compression parameters such as compression force, turret rpm and feeder rpm were studied. The process capability of the equipment was studied by observing the weight of 20 tablets, disintegration time, friability, individual weight variation, thickness and hardness. These parameters were studied at three different speeds and the best results were obtained at the optimum speed (40 rpm).
  4. 4. Design Qualification  Providing documented evidence that the design of the facility and equipment meet the requirements of the user specification and GMP.  The purpose of the Design Qualification (DQ) is to define the functional specifications of the system and document the vendor selection process.  Documentation and verification of procedures required to fulfill the protocol.  Execution of protocol and data collection, interpretation and review of data for accuracy, completeness and cGMP compliance.  Approval of original protocol formats, approval for the final summaries and system qualification statement. 6/29/2020 4
  5. 5. Installation Qualification (IQ):  The information required for an IQ evaluation is • Equipment identification, • Required documentation, • Equipment utility requirements, • Major component specifications, • Component material, • Lubricants and equipment safety features. 6/29/2020 5
  6. 6.  Equipment Identification: Record the equipment identification numbers, along with the following information: ▪ Model number ▪ Serial number ▪ Company assigned equipment number and ▪ Location of the equipment  Required Documentation: Record the equipment manufacturer's operation and maintenance manual and drawings. Record the SOP that cover the setup, operation and cleaning of the tablet press.  Equipment Utility Requirements: Compare the manufacturer's specified volts (V) and amps (A) requirements to their conditions at the time of qualification testing and record. Also record the location of the power supply source. 6/29/2020 6
  7. 7.  Major Component Specifications: The component specifications section of the protocol verifies that the tablet press components purchased were delivered and installed.  Component material: Record the material of each component that contacts the product.  Lubricants: Record the lubricants used to operate the tablet press and indicate if they make contact with the product.  Equipment Safety Features: The objective of testing equipment safety features is to verify that the safety features on the tablet press function according to the manufacturer's specifications. This test is performed with the tablet press empty. Verify that all of the guards are present and record the results. 6/29/2020 7
  8. 8. Operational Qualification (OQ):  An OQ evaluation should establish that the equipment can operate within specified tolerances and limits. The mechanical ranges of the tablet press are challenged, along with the basic tablet press operations. The tablet press will be validated for its operating ability. Information required for the OQ evaluation is: • calibration of the instruments used to control the tablet press • equipment control functions (switches and push buttons) • equipment operation (cam tracks, upper punches, lower punches, feed frames, take off bars, rotor head direction, tablet press speed).  Calibration requirements Verify that all the critical instruments on the equipment have been logged into the calibration system, have calibration procedures in place and are in calibration at the time of qualification testing. Record all information for calibrated instruments used to control the tablet press.  Equipment Control Functions The objective of testing equipment control functions is to verify that the switches and push buttons on the tablet press operate per the manufacturer's specifications. The tests will be performed with the tablet press empty. Operate each control and verify its proper position. 6/29/2020 8
  9. 9.  Equipment Operation:  A) Cam Tracks Test The objective of the cam track test is to verify that the upper and lower cam tracks make contact with the upper punches according to the manufacturer's specification. • Install the punches and verify that the cams are contacting the punch head angles on the both the sides of the double-sided cams.  B) Upper Punch Test The objective of the upper punch test is to verify that the upper punch penetration is according to the manufacturer's specification. A vernier caliper is required for this test, which is performed as follows: • Attach a piece of tape to mark the depth of penetration of an upper punch when it is set to a standard depth. • Remove the upper punch and use a calibrated vernier caliper to measure the depth of penetration into the die. Record the results and instrument used to measure the depth. 6/29/2020 9
  10. 10.  C) Lower Punch Test The objective of the lower punch test is to verify that the lower punch height is set according to the manufacturer's specification. A dial indicator test is required. Measure the height of the lower punch above the die with a dial indicator and record the results and the instrument used to measure the height.  D) Take Off Bar Test The objective of the take-off bar test is to verify that the take-off bars do not make contact with the lower punches. Turn the tablet press by hand and verify that the takeoff bars do not make contact with the lower punches. Record the results.  E) Feed Frame Test The objective of the feed frame test is to verify that the feed frame distance above the rotor head is according to the manufacturer's specification. Feeler gauge test: Measure the clearance between the feed frame and the motor head with a feeler gauge and record the results and the instrument used to measure the clearance. 6/29/2020 10
  11. 11.  F) Tablet Press Rotation Direction The objective of the rotation direction test is to verify that the rotor head rotates in the proper direction. The tests will be performed with the tablet press empty. Press the start switch and observe the direction of the rotation of the rotor head as viewed from front of the press and record the results.  G) Tablet Press Speed The objective of the speed test is to verify that the measured speeds are within ± 10 % of the manufacturer's specification of a minimum of 9 rpm and a maximum of 36 rpm. This test will be performed with the press empty. A stop watch is required for this test. Measure the speed of the rotor head with a calibrated stopwatch. Verify that the measured speeds are within ± 10 % of the manufacturer's specification and record the results and the instrument used to measure the speed. 6/29/2020 11
  12. 12. 6/29/2020 12 Take off Bar Feed Frame Dial Indicator Feeler Gauge
  13. 13. Performance Qualification: 6/29/2020 13  The blend/dummy material is unloaded into the hoppers on the both sides and the compression machine is operated at low speed (20RPM) as per operating instructions. Then the machine is set to run for 20 minutes continuously after adjusting the following parameters. 1. Individual tablet weight variation 2. Weight of 20 tablets 3. Hardness 4. Thickness 5. Disintegration time 6. Friability
  14. 14. 6/29/2020 14  Then the experiment was repeated at both medium (40RPM) and high speed (60RPM) with same set of parameters and the parameters were checked at different speeds (low, medium and high rpm).  Sampling Plan Collect 100 tablets for every 05 minutes.
  15. 15. Case Study- sticking issues in tablet production  The problem The Italian division of Novartis approached I Holland Company and local agent Vis Viva with a sticking issue on an antiepileptic drug in the form of a coated tablet. Novartis reported a strong sticking/picking problem causing the press to be stopped several times during manufacture for cleaning and maintenance of the punches, which resulted in production downtime. Sticking and picking halted production These two problems can be caused by various factors related to the physicochemical properties of the formulation components, the surface characteristics of punch face, as well as factors related to the machinery and the environment, for example, compression force and speed, temperature and humidity. It has a negative effect on tablet appearance and often results in the removal of tablet tooling from production for regular cleaning and maintenance, as experienced by Novartis. 6/29/2020 15
  16. 16. 6/29/2020 16 Picking was another problem encountered by the company — this is when compressed granule that has adhered to the detail on the punch face, results in ‘picking out’ of parts from the tablet face.
  17. 17.  The Solution The selected anti-stick coating was used on the punches and applied to the tooling by using an electron beam process. This is one of the smoothest and most defect-free methods of applying a PVD coating as it does not create droplets during the atomization process. The atomic particles are attracted to the tooling leaving an even surface which is far less susceptible to breakaway defects. From the first trial of the new design and tooling using PharmaCote CN+, improvements were seen and all sticking/picking issues were instantly resolved resulting in a 25% increase in production. This was achieved over a five-day working week, with reduced hours, resulting in a full day’s production time saved. Before the implementation of the new tablet design and tool coating, four batches of the tablet were produced during a 6-day working week. This included the extra time required for cleaning and maintenance due to the original sticking/picking problem. Once I Holland’s improvements were adopted, a further batch was produced in the same time-period with a total of five batches manufactured without the need to stop production. As a result of this outcome, Novartis is now looking at further products to be analyzed to improve production and reduce down-time. 6/29/2020 17
  18. 18. CONCLUSION  The parameters studied under the compression process are such as compression force, turret rpm and feeder rpm. These are set at three different speeds and analyzed on both sides to assess the exact parameters.  The samples were collected from both the sides (LHS, RHS) to qualify the two press stations and the observations made from the results were found to be in specified limits as per the ICH specifications  From this we conclude that the equipment is successfully qualified and can be used for production of further batches.  The result is considerable variation in the way pharmaceutical companies approach the qualification of laboratory equipment and requirements. 6/29/2020 18
  19. 19. REFERENCES  EQUIPMENT QUALIFICATION AND VALIDATION OF TABLET COMPRESSION MACHINE, WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, Volume 2, Issue 6, 5412-5418., ISSN 2278 – 4357, P.Ramasubramaniyan, N.Sharanya, et.al.  A REVIEW ON QUALIFICATION OF AUTOCLAVE, RMG, FBD, CONE BLENDER, TABLET COMPRESSION MACHINE, Journal of Global Trends in Pharmaceutical Sciences, Volume 5, Issue 1, pp-1450-1459, January-March 2014, ISSN: 2230-7346, B.Venkateswara Reddy, B.Rasmitha Reddy et al.  I HOLLAND TABLETING SCIENCE, tablettingscience.com 6/29/2020 19
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