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Distribution system

Pharmaceutical water is a raw material in the pharmaceutical production process and participates in the entire production process. Used for processes such as ingredient preparation, cleaning, disinfection, and washing, water production equipment, storage tanks, distribution systems, and point of use pipelines are important components of the system; Water production equipment is designed to produce water that meets the standards of the pharmacopoeia. Practice has shown that the storage and distribution system itself has no sanitary function, and the pollution risk of pharmaceutical water systems is more likely to occur in the storage and distribution system. The goal of the system is to ensure that the water quality of production process water meets the standards.

Design Concept

  • Continuous water flow
  • Smooth and flat surface of pipelines in contact with water to prevent microbial growth
  • Pipeline slope
  • Regularly clean or disinfect
  • 3D dead angle control, No stagnation
  • Maintain positive pressure in the loop
  • High temperature or low temperature
  • Suitable design, installation, and maintenance system

Control system

  • Risk of red rust particles caused by high temperature
  • Insufficient polishing of the system, risk of residue
  • Risk of detachment of spray ball iron filings
  • Unqualified welding quality and residual risk

Process control

  • The water quality produced by the water production equipment must comply the quality requirements of the pharmacopoeia
  • Dynamic stable equilibrium design of data statistical analysis system
  • The long-term operation of the entire water system requires stable water quality that complies the requirements of the pharmacopoeia

Process control

1.Using 3D modeling methods, modular design, reasonable pipeline layout, compact structure, reserved operating and maintenance space.
2.Automatically generate a material list with traceable specifications and models to avoid material shortage risks and ensure project progress.
3.Performing 3D model previews can identify risks in the early stages of a project, ensuring high predictability and flexibility during project execution. This ensures that the project meets optimal production operating standards, improves production efficiency, and simplifies production operations.

Implementation goals for pharmaceutical water systems

Realize the storage and distribution of pharmaceutical water. Minimize the microbial load of the system and the potential risk of contamination during operation. After running online for a certain period of time, the system can be thoroughly cleaned and sterilized to avoid the risk of cross contamination. The cleaning and sterilization process can be verified, the process temperature and time can be recorded, and the production process parameter data can be truly recorded and stored, printed, and traceable.

System engineering design

  • (URS) URS
  • System selection
  • Determination of main equipment parameters
  • Common system design issues and considerations
  • Comparison between pure steam sterilization and superheated water sterilization
  • Automatic control design
  • Pipeline design

URS analysis

  • Clarify basic information (such as water usage in the workshop, water usage at point of use, and water usage parameters, and whether there is a possibility of increasing water usage in the future)
  • Clarify the user's production water usage mode (whether it is continuous production or batch production)
  • Clarify the production capacity of the preparation system and the effective volume of the storage tank (evaluate the 24-hour workshop water usage to ensure stable and balanced operation of the system, determine the production capacity of the water production equipment, the capacity of the storage tank, and the capacity of the distribution system)
  • Clarify the system sanitary method (hot water sterilization, pasteurization, pure steam sterilization, or ozone disinfection)
  • Clarify the selection of system allocation forms - hot cycle, cold cycle, single cycle, etc. (depending on the actual situation of workshop water use, etc.)
  • Selection of cold water usage point design method (whether series or parallel design)

System plan

  • Point of use requirment
  • Pressure
  • Water consumption
  • Instantaneous water consumption/peak water consumption (instantaneous quantity determines pump flow rate and pipe diameter, peak quantity determines preparation and storage size)
  • Temperature
  • Is there a possibility of increasing water consumption in the future

Microorganism control

  • Turnover rate (storage tank)
  • Flow velocity (turbulent high shear force), 1m/S
  • Temperature
  • The preparation system should not be frequently turned on/off
  • Mismatch between water production and usage
  • Selection too large or too small
  • Waste time and cost