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Importance of Equipment Validation

Equipment validation is checking the equipment, recording and documenting all the values related to the installation, operation, performance, and process qualifications and finally, these values are compared with the standard values given by the producer. It is also known as the equipment qualification. The aim of this report is to present a step-by-step procedure for the validation of a new rotary press machine to bring it to a validated state from its installation. The method used for the validation is investigated in different relevant works of literature, and guidelines such as Good Manufacturing Practices (GMP), Current Good Manufacturing Practices(cGMP) provided by Food and Drug Administration (FDA) are strictly followed to help in the preparation of a reliable testing method.

Validation is recorded proof that imparts certainty of a desirable outcome by performing certain tests which follow approved procedures. It is implemented on such processes and types of equipment that affect the quality of the product. It ensures that the process or equipment will uniformly produce the same product with the same quality, standards of which are already specified. It proves that the product is safe to use, efficient, ethical, unadulterated, and potent (Kuschel et al., 2021). The term validation has its roots in the term “valid” which means justifiable. Food and Drug administration suggested it in the 1970s to check, assure, and enhance the quality of medications.

Increased production, decrease in alterations and rejections, decrease in costs, reduction in failures and complaints related to processes, avoidance of testing the final product, More dependable use of new machinery, improved maintenance, awareness about the procedures, may serve as a proof in case of any investigation (Varela et al., 2019).

It is reported evidence that shows that the equipment works accurately and gives correct results according to the standards. The basic principle underlying the equipment validation is that the design, creation, maintenance, and adjustments of the equipment are such that it executes the desired functioning. This process is important because equipment covers the major part of the functioning of pharmaceutical industries (Peddapatla et al., 2021).

At first, the procurement is initiated by submitting the documents as required and the user requirement specification (URS). A change request form (CR) is required by the facility to carry out the validation procedure. With the approval of the management, a validation project (VP) performance request is issued. If the request is approved, the validation process is initiated and it can be verified that the conditions provided in the cGMP and the URS are fulfilled. All the stages of the validation are examined and recorded according to the pharmaceutical firm (Zimmermann& Thommes, 2021).  

Steps In Equipment Validation: It consists of several steps. These are:

  • Design Qualification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Process Qualification

ASPECTS OF VALIDATION: There are three aspects: Pre-validation aspect, Process validation aspect, and Validation maintenance aspect.

Pre- Validation Aspect:  It consists of Design Qualification and Installation Qualification.

Design Qualification (DQ):  A recorded verification of the equipment design and facilities of production. The maintenance of clarity from the initiation about all the pre-requisite conditions for the system is the major part. All the aspects related to the quality of the equipment must be contemplated fully at this stage (Moondra et al., 2018).It includes the statements about the working and operation of the equipment with the conditions present in the URS and cGMP guidelines.

Aspects of Validation

If the design is qualified, it is concluded that the design follows- URS requirements, Functional requirements, Tender requirements, Purchase requirements, and Qualification of the vendor. The URS contains the demands of the user or customer such as instrument size and occupation of space, usefulness, and strength, speed of operation, must produce low pollution related to air and noise, presence of extra parts of the machine, and low-cost servicing and maintenance (Pazhayattil et al, 2020) 

Installation Qualifications (IQ): It confirms the compliance of all the conditions of installation and calibration of the instrument. It includes receiving the correct design, the intactness without any damage in the parts, measuring gauges, and associated spare parts, according to that specified in the URS. The location or site of work and the surrounding conditions where the equipment is installed are also documented and matched with the standards to ensure that the conditions are suitable for the instrument to work properly. This document includes information about production and supply, details about the equipment such as model, name, serial number, and color, and the date on which it is installed and calibrated (Vanhoorne & Vervaet, 2020).

Process Validation Aspect: It includes operational qualification and Performance Qualification.

Operational Qualifications (OQ): It confirms that the equipment installed will work accurately under the present conditions of its environment which is provided according to the specifications. The instrument operates according to the criteria already assigned and assures the recording of the testing results. All the conditions of working should demonstrate compliance with the URS specifications. There are simulators that work on electricity and standards that examine whether the working of the equipment is correct as per the requirement. The documents required for Operational Validation include the final and verified operations (test of functioning), calibration details, test of the stability of the system, and Standard Operating Procedures (Lindboe, 2021).

Performance Qualifications (PQ): It confirms that the equipment is working uniformly according to the given specifications in the URS document and the production standards. The procedure for Performance Qualifications is carried out in a controlled environment which is the same as routine functioning conditions. It is carried out on weekly basis. The Performance Qualification is also called testing for system suitability. The testing is more frequent than testing for Operational Qualification. As each part of the equipment is tested for stability which contributes to its frequency. Its report includes the report of performance qualification, stability testing of process, a record of product acceptance means reviews of the clients, regular testing outcomes, and re-validation report (if there is a modification in the system and the equipment) (Gallo-Molina et al., 2022).

Validation Maintenance Aspect: It includes Maintenance Qualifications.

Maintenance qualification (MQ):  It means performing a review of the system and the instrument periodically and is documented appropriately. It assures the system and the equipment integrity. It helps to confirm that the equipment is not adversely affecting the product’s quality, safety, identity, and strength. It makes sure that the product is pure and not contaminated or there is no change in the structure of the product. The regular servicing of the equipment and repairing is carried out as a part of Maintenance Qualification. The necessary document involves servicing records and information about the contract of maintenance (Martin et al., 2021).

Pre- Validation Aspect

A new rotary tablet press is considered. The model is NP- 155. The major, as well as minor components of the tablet press were studied, and then a validation procedure was explored from installation to the performance and finally providing it a validated state by documenting each of the values obtained by different tests (Murray, 2020).

NP-155 is created to reduce the costs of production as its single turret cycle produces two tablets, the requirement for electricity to be the same, overall doubling the number of tablets produced (Rozbroj, et al., 2018).

Parts of the Rotary Press Np- 155:

It is an electric, high-speed rotary tablet press. The press is driven by a motor that produces 2500 to 3500 tablets in a minute. There is a cam system from which the powder used to make the tablet is fed in the dies with the help of the vacuum created naturally while the lower punches are brought down. It helps to fill the powder accurately in the dies. This is the unique characteristic designed in this model. The weight of powder in each tablet can be controlled by the weight adjusting cam. The higher compression forces are produced for gears and drive systems which are needed for certain types of tablets (Wünsch et al., 2020).  The turret of the press contains interlocked guards. The interlocked guards are the safety devices that are used to turn off or discontinue the power supply to the press. When the guards are closed, the power is cut off, all the parts of the press in motion are stopped and the press comes in a switched-off state. The guarding system prevents operational error by the worker and stopping to do any harmful and unapproved operations with the turret, avoids any hazardous situation by instantly cutting off power, ultimately protecting the worker (Gallo-Molina et al., 2022).  The other features of the tablet press are:

  1. Dual vacuum system to keep the area of compression clean.
  2. Continuous lubrication of the head of the punch and cams to avoid the wearing of the parts.
  3. Pushbuttons and lower punch retainers which are self-adapting.
  4. Enhancer for powder flow which allows filling the dies consistently (Peddapatla et al., 2022).

Installation Qualification: The electrical aids must follow all guidelines and codes. Relevant details which are required here are- identification details of the press, specifications of the major components, details about the material of components, features for maintaining safety (guards), required documents, and the utility requirements of the press.

Identification of the Equipment: contains the recording of the identification number of the press, Serial number of the press, model number, equipment number provided by the company, and site of equipment (Ramírez-Aragón et al., 2018).

Documentation required:  It includes the producer’s manual of functioning and maintenance and the drawings, the standard Operating Procedures related to the installation, operation, and cleanliness of the press.

Utility Requirements: The producer’s details about the volts and amps (V and A) are to be compared with the actual values at the time of testing and are documented and compared. The location of the source for the supply of power is also recorded (Muzzio, 2022).

Specifications of Major Components:  These details record that all the components of the press were provided with the equipment and installed.

Material of the Components: It includes the material which comes with the contact of the product.

Process Validation Aspect

Lubricants: Details of the type of lubricant used and record if the product comes in contact with the lubricant.

Features for Safety:  The safety features are tested, documented, and compared with the specifications given by the producer. The test is carried out on an empty press not filled by the material of the tablet. This is done to check whether all guards are fixed (Du et al., 2018).

OPERATIONAL QUALIFICATION:  It is done to prove that the press is successfully functioning under the specified limits. The machine is operated till it reaches its mechanical limits.

Information needed: The instruments used in the press and their calibration details, parts for controlling such as push buttons and switches, parts for controlling the operation of the press such as punches, both upper and lower, take-off bars, cam tracks, feed frames, speed of the press, the direction of the rotor head (Gibson, 2018).

Calibration details: The instruments are verified to have gained access to the equipment’s calibration system, undergoing their calibration process, and finished being calibrated at this time. All the details are recorded.

Parts for controlling: To confirm that the pushbuttons and switches work according to the producer’s specifications. The press is empty while performing the test for it. Each part is operated and checked for its appropriateness of position.

Cam Tracks Testing: The basic reason behind testing cam tracks I to confirm that the upper punches remain in the contact with the upper and lower cam tracks as per the specifications given.

Procedure- punches installed and checked whether the angles of the punch head are contacting with the cams on both of its sides. Full cam track is contacted (Rolón et al., 2022).

Upper Punch Testing: Testing is done to check the penetration of the upper punch follows the manufacturing standards. Using vernier caliper test is done:

The penetration by an upper punch is marked by a tape, then the upper punch is removed and a vernier caliper which is already calibrated is used to gauge the penetration. The results are documented.

Lower Punch Testing: To confirm the height of the lower punch. For this, a dial indicator test is performed. The dial indicator will gauge the height of the lower punch when it is away from the die and results documented (Muzzio, 2022).

 Feed Frame Testing: To measure and confirm the distance between the feed frame and the rotor head. For this, a Feeler gauge test is to be performed. Measurement by Feeler gauge is done to measure the distance between the motor head and the feed frame.  

Take Off Bar Testing: To ensure that there is no contact between the take-off bar and the lower punches. The test is done by turning the press by hand.

Rotation Direction testing:  To confirm the rotation of the rotor head in the appropriate direction. The press is empty while doing this test. The start switch is on and the direction of rotation is observed and recorded (Vanhoorne & Vervaet, 2020).

 Tablet Press Speed testing:  To check whether the speed is +/- 10% of the rpm. The press is empty A stopwatch is used for measurement (Pazhayattil et al., 2019).

Validation Maintenance Aspect

PERFORMANCE QUALIFICATION: The test for weight and hardness is done to check that the tablets formed are consistent in terms of the weight and hardness range given by the provider. For this test, a hardness and thickness gauge is used on the placebo. Firstly, 5 tablets were checked at the initiation, at 10 min, 20 min, and 30 min and the result was recorded.

  1. The validation process takes a longer time to be completed for new installations therefore, more time should be allocated.
  2. All the aspects of validation were successfully recorded, and the documentation was signed.
  3. Reviewing the documentation will allow studying the deviations so that the press could be better operated in the future (Dühlmeyer, 2019).
  4. Important points to consider:
  • The guidelines and the standard criteria should be written with caution.
  • The possible problems can be predicted before.
  • It should be done in association with other continuing actions so that the resources will be obtained whenever needed. The process of validation cannot be done in isolation.
  • The cooperation of suppliers is necessary for the process to be completed successfully.

More standards are required as there is innovation in the construction of the machines and new parts with new features are added (Koutchma, 2022).

Conclusion:

The process of validation of new equipment which is a 45-station tablet compression machine has been done successfully. The new features included in the model to increase the efficiency of production were included such as the generation of natural vacuum and auto- lubrication of the punch heads, enhancer for the powder flow. All the stages were followed and each component or part of the rotary press was tested for its efficiency. All the results were recorded on time and the necessary documentation was carried out. The observations were made which will be helpful for future validation. All the processes of qualification that is, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, and Process Qualification were thoroughly carried out with the help of the standard tests and gauges. These values can be compared with the standard values which are given by the equipment manufacturer and hence can be validated.

 References

Du, M., Song, F., Li, K., Collins, T., & Moriarty, K. (2018, March). Qualification Methodology for Advanced Rotary Shouldered Threaded Connections. In IADC/SPE Drilling Conference and Exhibition. OnePetro.

Dühlmeyer, K. P. (2019). A novel method for determination of the filling level within the feed frame of a rotary tablet press (Doctoral dissertation, Staats-und Universitätsbibliothek Hamburg Carl von Ossietzky).

Gallo-Molina, J. P., Cogoni, G., Peeters, E., Ambati, S. R., & Nopens, I. (2022). A hybrid model for multipoint real time potency observation in continuous direct compression manufacturing operations. International Journal of Pharmaceutics, 613, 121385.

Gibson, M. (2018). Manufacturing and Process Controls. Pharmaceutical Quality by Design: A Practical Approach, 281.

Koutchma, T. (2022). Overview of other novel processes and validation approaches. In Validation of Food Preservation Processes Based on Novel Technologies (pp. 215-240). Academic Press.

Kuschel, M., Fitschen, J., Hoffmann, M., von Kameke, A., Schlüter, M., & Wucherpfennig, T. (2021). Validation of novel lattice boltzmann large eddy simulations (lb les) for equipment characterization in biopharma. Processes, 9(6), 950.

Lindboe, W. G. (2021). Validation of solid dosage finished goods. In Handbook of Validation in Pharmaceutical Processes (pp. 669-686). CRC Press.

Martin, N. L., Schomberg, A. K., Finke, J. H., Abraham, T. G. M., Kwade, A., & Herrmann, C. (2021). Process Modeling and Simulation of Tableting—An Agent-Based Simulation Methodology for Direct Compression. Pharmaceutics, 13(7), 996.

Moondra, S., Raval, N., Kuche, K., Maheshwari, R., Tekade, M., & Tekade, R. K. (2018). Sterilization of Pharmaceuticals: Technology, Equipment, and Validation. In Dosage Form Design Parameters (pp. 467-519). Academic Press.

Murray, F. (2020). Considerations for Tablet Compression with Multi-Tip Tooling.

Muzzio, F. J. (2022). Outlookdwhat comes next in continuous manufacturing (and in advanced pharmaceutical manufacturing). How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems, 397.

Muzzio, F. J. (2022). Outlookdwhat comes next in continuous manufacturing (and in advanced pharmaceutical manufacturing). How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems, 397.

Pazhayattil, A. B., Sayeed-Desta, N., Fredro-Kumbaradzi, E., & Collins, J. Solid Oral Dose Process Validation.

Pazhayattil, A., Sayeed-Desta, N., Fredro-Kumbaradzi, E., Ingram, M., & Collins, J. (2019). Stage 1B: Scale-Up and Technology Transfer. In Solid Oral Dose Process Validation, Volume Two (pp. 37-55). Springer, Cham.

Peddapatla, R. V., Sheridan, G., Slevin, C., Swaminathan, S., Browning, I., O’Reilly, C., ... & Crean, A. M. (2021). Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale. Pharmaceutics, 13(7), 1033.

Peddapatla, R. V., Slevin, C., Sheridan, G., Beirne, C., Swaminathan, S., Browning, I., ... & Crean, A. M. (2022). Modelling the Compaction Step of a Platform Direct Compression Process. Pharmaceutics, 14(4), 695.

Ramírez-Aragón, C., Alba-Elías, F., González-Marcos, A., & Ordieres-Meré, J. (2018). Segregation in the tank of a rotary tablet press machine using experimental and discrete element methods. Powder Technology, 328, 452-469.

Rolón, E. S., Futran, M., & Randolph, W. (2022). Continuous manufacturing process development case study. In How to Design and Implement Powder-To-tablet Continuous Manufacturing Systems (pp. 319-381). Academic Press.

Rozbroj, J., Necas, J., Zurovec, D., Hlosta, J., Gelnar, D., & Zegzulka, J. (2018). Simulation of material flow through a sample divider. Advances in Science and Technology. Research Journal, 12(1).

Vanhoorne, V., & Vervaet, C. (2020). Recent progress in continuous manufacturing of oral solid dosage forms. International Journal of Pharmaceutics, 579, 119194.

Vanhoorne, V., & Vervaet, C. (2020). Recent progress in continuous manufacturing of oral solid dosage forms. International Journal of Pharmaceutics, 579, 119194.

Varela, S., Valbuena, O., Armentia, J., Larrucea, F., Manso, V., & Santos, M. (2019, July). Material saving by a combination of rotary forging and conventional processes: Hybrid forging for net-shape gear. In AIP Conference Proceedings (Vol. 2113, No. 1, p. 040015). AIP Publishing LLC.

Wünsch, I., Friesen, I., Puckhaber, D., Schlegel, T., & Finke, J. H. (2020). Scaling tableting processes from compaction simulator to rotary presses—Mind the sub-processes. Pharmaceutics, 12(4), 310.

Zimmermann, M., & Thommes, M. (2021). Residence time and mixing capacity of a rotary tablet press feed frame. Drug development and industrial pharmacy, 47(5), 790-798.

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