【Weekly Topic】Production Technology: Pilot Testing Assessment for Projects?

The best way to evaluate the results of pilot tests is to determine whether all indicators of the product meet the requirements set by the enterprise’s specified standards or **standards. After producing products that meet the customer’s requirements, these products are delivered to the customers for use, who can then provide feedback on their usage! The end of a pilot scale trial is a process of continuously improving equipment operation, process control, and technical upgrades based on data; it cannot be determined by a single evaluation.

Pilot testing is a smaller-scale trial conducted prior to large-scale production. Before finalizing a project, laboratory tests must be carried out first； The second step is the “pilot test”, which involves scaling up based on the results obtained in the laboratory ； The third step is “pilot testing,” which involves scaling up further based on the results of the laboratory tests. Once pilot production is successful, mass production can generally proceed. Evaluation during the pilot stage:
(1) Process validation (process flow, process route, single-board process, whole-machine process, packaging process, logistics process) ； 　　(2) Verification of tooling (assembly tooling, testing tooling, production equipment) 　　(3) Verification of the production testing environment, testing procedures, and work procedures, along with the establishment of corresponding inspection protocols ； 　　(4) Structural verification ； 　　(5) Product data verification (verification of design documents such as BOM, PCB, SCH, etc., as well as production-related process documents) 　　(6) Product reliability verification ； 　　(7) Verification of material availability ； 　　(8) Verify issues remaining from research and development ； 　　(9) Issues identified during the pilot-scale testing process must be reported promptly and accurately, and their resolutions must be documented to create a closed-loop system ； 　　(10) Production transition review: The person in charge of the pilot production gathers information on various issues that arose during the pilot phase, such as testing problems, tooling issues, production environment concerns, process-related problems, material issues, planning problems, and documentation-related issues, as well as the solutions adopted, to prepare a summary report on the pilot production. They then organize a review meeting with judges including product development managers, in order to reach a final judgment on whether the product meets the requirements for mass production ； 　　(11) When the product does not meet the conditions for moving on to mass production, the review panel decides whether to initiate a new round of pilot testing ； 　　(12) The production process documents required for mass production include work instructions, standard working hours and capacity tables, special SMT soldering requirements and precautions, inspection specifications, and so on.

How should pilot plant test results be evaluated, or what are the requirements for the evaluation criteria for such results? It’s simple – it mainly depends on your product and what requirements exist in industry standards or **regulations**; evaluations are carried out accordingly. The criteria for assessing the test results are the same, and these may include factors such as quality, as well as consumption of water, electricity, gas, etc., along with indicators related to logistical balance such as pressure, temperature, and flow rate.

In the development of new products, after the initial prototype is completed, a pilot production phase must be gone through before the product can be manufactured and sold in bulk. “\"Pilot testing\" refers to intermediate tests; it is a concept that originated in the former Soviet Union. In the product development processes in Europe and the United States, it is referred to as the \"validation\" stage, with some experts using the term \"pilot\" to describe it. Pilot testing is an important stage in the new product development process, and this stage should account for more than 1/3 of the entire development cycle. As small-batch prototyping and β testing are required, this is the phase that involves the most labor and materials, as well as the stage that entails the greatest number of departments within the company and has the most complex processes. The main tasks to be accomplished during the pilot production phase are as follows: First, the new product must be brought to the desired quality level. The primary means of achieving this is through laboratory tests, trial production, and beta testing, which help identify and rectify any specification or design flaws in the new product. Secondly, during the pilot production phase, it is necessary to ensure that the new product is manufacturable, meaning that it can be put into mass production immediately after the research and development process is completed. This requires that during the small-batch trial production phase in the pilot stage, the validation of the manufacturing process for the new product, the preparation of process equipment and testing equipment for mass production, and even the full validation and readiness of the order fulfillment process for the new product be completed. Third, during the pilot production phase, preparations must be made for the mass sale and after-sales service of the new product. Tasks involved in building a pilot-scale production system: To carry out the above tasks, it is first necessary to develop the capabilities required for pilot-scale production, such as testing new products, ensuring the quality of new materials, process design, product data management, and so on ； Second, it is necessary to establish a well-structured pilot-scale business process system to ensure that the complex pilot processes are carried out in an orderly manner and to accelerate the pilot process. The pilot-scale production process must be integrated into the new product development process, and parallel operation should be pursued as much as possible, rather than a sequential approach of development followed by pilot production, in order to accelerate the time it takes for new products to reach the market. It is precisely because they lack a proper pilot-scale production system that many companies experience a low success rate in developing new products, or face long development cycles, with the new products failing to remain stable. It is also difficult for companies to develop their own pilot-scale systems on their own, as there is a lack of experts with practical experience to guide them, and no good books or materials are available.

In fact, many products do not require pilot testing; design for large-scale production can be carried out directly. There are many successful projects around us

This post was last edited by sun-rock on 2011-7-31 09:19. Reply 1# sun-rock: The intermediate experimental phase involves further studying the patterns of changes in the conditions of various chemical reactions in devices of a certain scale, as well as addressing problems that cannot be solved or identified in the laboratory. Although the nature of chemical reactions does not change due to differences in experimental scale, the optimal conditions for each step of the chemical reaction may vary depending on external factors such as the scale of the experiment and the equipment used. Therefore, pilot-scale scaling is very important. 8 n5 7 p$ k5 s0 Z0 ? At what stage of the experiment is pilot testing carried out? At least the following conditions must be met: % n4 B- H2 W# ^2 M" b3 Z9 k' F! k 1. The yield in pilot tests is stable, and the product quality is reliable. 7 R3 H' {6 U- p, Z4 ~8 y v 2: The manufacturing conditions have been determined, and the analysis and testing methods for the products, intermediates, and principles have also been established. ) W+ N3 c1 ^3 F% J& l 3. For some equipment, corrosion resistance tests on the pipe materials have been conducted, and the necessary general equipment is available. 4. Material balance was performed. Preliminary methods exist for dealing with the issues of waste water, waste gas, and solid waste. 5. The specifications and unit consumption amounts for the raw materials have been specified. 6. Requirements for safe production have been put forward. ! |8 M7 n4 p( V! | 2 E7 C1 A2 ?+ _: p& n/ c3 S) e The methods for pilot-scale scaling up include: 1. Empirical scaling**: This involves relying on experience to determine the characteristics of the reactor through gradual scaling up (pilot plant – intermediate scale plant – medium-scale plant – large-scale plant). It is also the main method used in current drug synthesis. 2. Similar scaling**: It mainly involves using the principle of similarity for scaling. This method has certain limitations and is only applicable to the amplification of physical processes. And it is not applicable to the scale-up of chemical processes. 3. Mathematical simulation casting: It is a form of casting that makes use of computer technology, and it represents the direction for future development. In addition, the development of micro intermediate devices is also progressing rapidly; that is, micro intermediate devices are being used to replace larger ones in order to provide accurate design data for industrial applications. Its advantages are low cost and fast construction. The tasks at the pilot-scale production stage 6 _& N0 V9 O( L/ o0 v- Y 4 D# Y. { ] k; _' c9 n mainly include the following ten points. In practice, it is possible to determine which tasks are more important based on different circumstances, and to carry out the work in an organized and planned manner. $ U1 M9 f" W4 H, y. n & l/ `; ~8 t' a l3 s3 g1 {% H, S 1、Final determination of the process route and the operating methods for individual reactions. Especially when the originally selected route and unit reaction method reveal significant problems that are difficult to resolve during the pilot-scale scaling up phase, other routes should be selected and pilot-scale scaling up should be carried out using the new routes. 2. Selection of equipment material and model. Special attention should be paid to the selection of material for equipment that comes into contact with corrosive substances. 3. Investigation of mixer type and mixing speed. Many of these reactions are heterogeneous, and they have large heat effects. During pilot tests, due to the small volume of the material, mixing is effective and heat and mass transfer issues are not significant. However, when scaling up to pilot plant scale, it is necessary to take into account the properties of the material and the characteristics of the reaction, paying attention to the influence of mixing patterns and speed on the reaction, in order to select an appropriate mixer and determine the suitable mixing speed. 8 ~2 D |" S5 e1 g' E 4, further study of reaction conditions. The optimal reaction conditions obtained at the laboratory stage may not fully meet the requirements of pilot-scale scaling. Therefore, in-depth studies should be conducted on the main influencing factors, such as feeding rate, mixing efficiency, the heat transfer area and coefficient of the reactor, as well as the refrigerant, in order to understand how these factors change in pilot-scale systems. More suitable reaction conditions are obtained. 5. Determination of the process flow and operating methods. It is necessary to consider meeting the requirements of industrial production for the reaction and post-treatment procedures. Pay special attention to shortening processes, simplifying operations, and improving labor productivity. Thereby finally determining the production process flow and operating methods. * \3 J! ~4 t( {" u2 B& f- o ; M+ j' b4 U( f; p 6、Conduct material balance calculations. Once the reaction conditions and operating procedures for each step have been determined, a material balance should be conducted for those reactions with low yields, numerous by-products, and significant generation of waste. The accuracy that must be achieved in material balance is that the total weight of the reaction products and other by-products equals the sum of the amounts of each material fed in before the reaction takes place. In order to address the weak points. Provide data for tapping potential energy savings, improving efficiency, recovering and comprehensively utilizing by-products, as well as preventing and controlling waste. Research on analytical methods should be conducted for chemical components for which no such methods exist. 7. Determination of the physical properties and chemical engineering constants of raw materials and intermediates. To address the issues in production processes and safety measures, it is necessary to determine the properties and chemical constants of certain materials, such as specific heat, viscosity, and explosion limits. 8. Formulation of quality standards for raw material intermediates. If the quality standards in the pilot tests are not sufficient, they should be revised and improved based on the pilot-scale experiments. . B4 j% P* a+ Q8 Q* B" w6 R* h+ f+ i 2 P& Z9 B2 }0 k& { 9. Determination of consumption quotas, raw material costs, labor hours, and production cycles, etc. Based on the summary report of the pilot-scale research, infrastructure design can be carried out, and a procurement plan for model equipment can be formulated. Design and manufacture of non-standard equipment, as well as construction of production workshop buildings and installation of equipment in accordance with the construction drawings. All production equipment and auxiliary equipment have been installed. If the trial production is successful and stable during the short-term trial phase, a process specification can be developed for full-scale production.