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In the field of pharmaceutical research and development, Jiangsu Aikon Biopharmaceutical R&D Co., Ltd. plays a leading role. We specialize in the research, development, import, and export of pharmaceutical intermediates, molecular building blocks, and laboratory reagents, committed to providing high-quality and efficient products and services for researchers. Our diverse product line, with standard packaging ranging from milligrams to kilograms, can meet the needs of various research projects. Whether you are conducting scientific experiments, custom synthesis, or process research, we can provide suitable products and solutions.

Pilot Scale-up and Production Process Regulations:

The purpose of pilot scale-up is to verify, review, and refine the reaction conditions determined by laboratory processes, as well as to study the structure, materials, installation, and workshop layout of selected industrial production equipment, providing data for formal production, including material quantities and consumption.

(I) Research Content of Pilot Scale-up

1. Overview

Process: In the production process, the sequence and conditions directly related to chemical synthesis reactions or biosynthetic pathways (such as ingredient ratios, temperature, reaction time, stirring methods, post-treatment methods, and refining conditions) are collectively referred to as process conditions. Other processes are considered auxiliary processes.

2. Importance of Pilot Scale-up

After the process route is determined, each step of the chemical synthesis reaction or biosynthetic reaction will not change significantly due to differences in small-scale, pilot-scale, and large-scale production conditions. However, the optimal process conditions for each step may need adjustment depending on external factors such as scale and equipment.

3. Research on Pilot Scale-up

1) Review of Production Process Routes

Generally, the methods and production process routes for unit reactions should be selected during the laboratory stage. During pilot scale-up, the focus is on determining specific operational processes and conditions to suit industrial production. However, if significant issues arise during pilot scale-up that are difficult to overcome, the laboratory process route must be reviewed and its process adjusted.

2) Selection of Equipment Materials and Types

At the start of pilot scale-up, the materials and types of all required equipment should be considered and evaluated for suitability, particularly the selection of materials for equipment that comes into contact with corrosive substances.

3) Evaluation of Stirrer Type and Stirring Speed

In the laboratory, due to the small volume of materials, stirring efficiency is high, and issues of heat and mass transfer are not prominent. However, during pilot scale-up, the impact of stirring efficiency makes heat and mass transfer issues significantly apparent. Therefore, during pilot scale-up, it is essential to study the type of stirrer based on material properties and reaction characteristics, and to evaluate the effect of stirring speed on reaction patterns, especially in solid-liquid heterogeneous reactions, to select a stirrer type and appropriate stirring speed that meet the reaction requirements.

4) Further Study of Reaction Conditions

The optimal reaction conditions obtained during the laboratory stage may not meet the requirements of pilot scale-up. In-depth experimental studies should be conducted on key influencing factors, such as the feeding rate in exothermic reactions, the heat transfer area and coefficient of the reaction vessel, and the use of refrigerants, to understand their variations in the pilot setup and obtain more suitable reaction conditions.

5) Determination of Process Flow and Operational Methods

During pilot scale-up, due to the increase in material handling, it is necessary to consider how to adapt reaction and post-treatment operations to industrial production requirements, with particular attention to shortening steps and simplifying operations.

6) Quality Control of Raw Materials and Intermediates

① Measurement of physical properties and chemical parameters of raw materials and intermediates.

② Establishment of quality standards for raw materials and intermediates.

(II) Material Balance

Material balance is one of the most fundamental and important aspects of chemical engineering calculations. It also serves as the basis for energy balance. Through material balance, the production process can be deeply analyzed, providing a quantitative understanding of the entire production process. This allows for the determination of raw material consumption rates, reveals material utilization, assesses whether product yields have reached optimal values, identifies potential equipment capacity, and checks if the capacities of various equipment are matched.

(1) Theoretical Basis of Material Balance

Material balance: It studies the changes in input and output materials and their composition within a system, i.e., material equilibrium. The system refers to the scope of the material balance, which can be a single device or multiple devices, a unit operation, or the entire chemical process.

The theoretical basis of material balance is the law of conservation of mass: Input material to the reactor - Output material from the reactor - Conversion in the reactor = Accumulation in the reactor.

In chemical reaction systems, material conversion follows chemical reaction laws, and quantitative relationships can be determined based on chemical reaction equations.

(2) Determining the Calculation Basis for Material Balance and Annual Equipment Operating Time

1) Basis for Material Balance

Commonly used bases include: ① Per batch operation, suitable for material balance of batch-operated equipment, standard, or custom equipment. ② Per unit time, suitable for material balance of continuously operated equipment. ③ Per kilogram of product, to determine the consumption rates of raw materials.

2) Annual Equipment Operating Time: The normal operating days for workshop equipment per year are generally calculated as 330 days, with the remaining 36 days reserved for workshop maintenance.

(3) Collecting Relevant Calculation Data and Material Balance Steps

1) Collecting relevant calculation data: Reactant ratios, concentrations, purity, or composition of raw materials, semi-finished products, finished products, and by-products; workshop overall yield, stage yield, conversion rate.

2) Conversion rate: For a specific component, the ratio of the amount of material consumed by the reaction to the amount of material fed into the reaction is referred to as the conversion rate of that component, usually expressed as a percentage.

3) Selectivity: The proportion of the main product among various main and by-products.

(4) Workshop Overall Yield: The workshop overall yield is the product of the yields of each step.

(5) Steps for Material Calculation

1) Collect basic data necessary for calculation.

2) List chemical reaction equations, including main and side reactions; draw a process flow diagram based on given conditions.

3) Select the basis for material calculation.

4) Perform material balance calculations.

5) Prepare material balance tables: ① Input and output material balance table; ② Waste discharge table; ③ Calculate raw material consumption rates (kg).

(III) Production Process Regulations

A product can be produced using several different process routes, but one of them is the most reasonable, economical, and capable of ensuring product quality under specific conditions. Documenting the details of this production process constitutes the production process regulations.

Production process regulations are important documents guiding production, the basic basis for organizing and managing production, and the core confidential information of a factory or enterprise. Advanced production process regulations are collective creations of engineering technicians, operators, and management personnel, belonging to the category of intellectual property. They should be actively patented to protect the legitimate interests of inventors and the enterprise.

(1) Main Functions of Production Process Regulations: ① Production process regulations are guiding documents for organizing industrial production. Production planning and scheduling can only be arranged based on these regulations to maintain coordination between various production links and complete tasks as planned. ② Production process regulations also serve as the basis for production preparations. ③ They are fundamental technical conditions for building and expanding production workshops or factories.

(2) Original Data and Basic Content for Formulating Production Process Regulations

To formulate production process regulations, the following original data and basic content are required:

1) Product introduction: Description of product specifications, pharmacological effects, etc., including name (trade name, chemical name, English name); chemical structure, molecular formula, molecular weight; properties (physicochemical characteristics); quality standards and testing methods (identification methods, accurate quantitative analysis methods, impurity testing methods, and maximum impurity limits); pharmacological effects, side effects (adverse reactions), uses (indications, dosage); packaging and storage.

2) Chemical reaction process: Describe the main reaction, side reactions, and auxiliary reactions (e.g., catalyst preparation, by-product treatment, recycling, etc.) step by step for chemical synthesis or biosynthesis, including reaction principles. Also include methods for controlling reaction endpoints and rapid testing methods.

3) Production process flow: Using chemical reactions in the production process as the center, describe physical and chemical processes such as cooling, heating, filtration, distillation, extraction, separation, neutralization, and refining in a diagrammatic form.

4) Equipment list: Position name, equipment name, specifications, quantity (capacity, performance), material, motor capacity, etc.

5) Equipment flow and maintenance: Equipment flow diagrams use schematic representations to show the connections between various equipment in the production process.

6) Operating time and production cycle: Record the step names and operating times for each position.

7) Quality standards for raw materials and intermediates: List by position name, raw material name, molecular formula, molecular weight, specifications, etc.

8) Production process: Ingredient ratios; process operations; main process conditions and explanations; intermediates and their physicochemical properties during production, and reaction endpoint control; post-treatment methods and yields.

9) Technical and economic indicators: Production capacity (annual, monthly); intermediate and finished product yields, step yields, and overall product yield, yield calculation methods; labor productivity and cost; consumption rates of raw materials and intermediates.

10) Technical safety, fire prevention, and explosion prevention.

11) Usage and safety precautions for main equipment.

12) Testing methods for finished products, intermediates, and raw materials.

13) Comprehensive utilization of resources and waste treatment.

14) Appendix (relevant constants and calculation formulas, etc.)

Choosing Jiangsu Aikon Biopharmaceutical R&D Co., Ltd. means choosing a professional, reliable, and efficient partner. We look forward to working with you to advance progress and development in the field of pharmaceutical research and development!