EVERHEAL:Pharmaceutical water storage and distribution systems

Discover the crucial rules for creating pharmaceutical water storage and distribution systems that meet industry standards and regulations for quality and safety. Get expert insights on designing pharmaceutical water systems.

 

Creating pharmaceutical water storage and distribution systems that meet industry standards and regulations for quality and safety is essential for pharmaceutical companies to ensure the integrity of their products. These systems play a crucial role in ensuring that the water used in pharmaceutical manufacturing processes is of the highest quality and free from contaminants that could compromise the safety of the final product.

 

General principles for the design of pharmaceutical water storage and distribution systems

ISPE requires that the optimal design of any water storage and distribution system must meet the following three requirements: 

1.Maintain water quality within acceptable limits; 
2.Deliver water to the point of use at the required flow rate and temperature; 
3.Minimize capital investment and operating costs.

There are several key rules that pharmaceutical companies must follow when designing and implementing water storage and distribution systems. First and foremost, the systems must be designed to meet the specific needs of the pharmaceutical industry, taking into account the requirements of regulatory agencies such as the FDA and EMA.

 

Measures to Control Microbial Growth

Reasonable operating temperature (15-20℃ or 70℃-85℃) 
Continuous turbulence 
Appropriate slope 
Smooth and clean surface with minimal bacterial growth and accumulation 
Frequent drainage, flushing or disinfection
Ensure that the system is leak-free Maintain system positive pressure 
Control dead corners and flow rate.

 

One of the most important rules for creating pharmaceutical water systems is to ensure that the water used in the manufacturing process meets the standards set forth by the United States Pharmacopeia (USP) and the European Pharmacopoeia. These standards define the quality criteria for pharmaceutical-grade water, including limits for microbial contamination, endotoxin levels, and chemical impurities.

 

Storage

The storage system is used to adjust the relationship between peak flow demand and usage so that the two are reasonably matched. Storage capacity: It must meet the needs of users and keep the turnover rate at 1-5. 
The water flow in the storage tank is a low-velocity area, and artificial "dead corners" should be reduced as much as possible, such as opening holes in the tank wall to install sensors. 
And the surface roughness of the inner wall of the tank is Ra≤0.6μm. Vertical storage tanks should be used as much as possible to facilitate cleaning and emptying. 
The storage tank must be equipped with a hydrophobic ventilation filter (respirator) to reduce the inhalation of microorganisms and particles, as well as a spray ball, pressure sensor, temperature sensor, bursting disc, and liquid level sensor. The storage tank also needs to have appropriate strength and safety measures to prevent overpressure and deflated tanks.

 

 

Distribution System Function 1

  Return water flow control: After purified water comes out of the purified water tank, it is pumped to various points of use in the workshop to increase the pressure. The flow rate must meet the workshop process water requirements. The return water end is equipped with a flow detection.

When the water consumption in the workshop increases and the return water flow rate is lower than the set flow rate, the PLC sends a signal, and the inverter increases the output frequency, so that the speed of the delivery pump increases, and the return water flow rate is maintained at the set flow value. When the water consumption at the water point decreases, the speed of the delivery pump decreases, and the return water flow rate remains at the set flow value. Finally, it returns to the storage tank.

 Purified water return water temperature control: The long-distance transportation of purified water in the pipeline will increase the water temperature in the pipeline, which is not conducive to the control of microorganisms. The temperature of purified water storage and transportation can be controlled through the heat exchanger; the temperature sensor at the return water end controls the pneumatic control valve to adjust the refrigerant water flow entering the shell of the heat exchanger, so that the purified water is always maintained below the set temperature.

 

 

Distribution System Function 2

 Return water temperature control for injection water: The long-distance transportation of injection water in the pipeline will cause the water temperature in the pipeline to drop, which is not conducive to the control of microorganisms.  The storage and transportation temperature of injection water can be controlled through the heat exchanger; the temperature sensor at the return water end controls the pneumatic regulating valve to adjust the steam flow entering the shell side of the heat exchanger, so that the injection water is always maintained above the set temperature.  

Water quality control: The return water conductivity (or TOC) is monitored online by a conductivity sensor or TOC (optional). When the return water conductivity or TOC (optional) value exceeds the set value, the return water pneumatic diaphragm valve is automatically closed, and the discharge pneumatic diaphragm valve is opened to discharge unqualified water, and an audible and visual alarm is issued.      

 

 

Distribution System Functions 3

Liquid level control ： The liquid level sensor is used to monitor the liquid level in the pure water tank. Once it exceeds the set range (a total of 4 liquid levels are set), the system will respond accordingly.

 

 

Distribution System Functions  4

Purified water pasteurization function: After starting the disinfection program, first close the water inlet valve on the top of the storage tank, and then use the liquid level sensor to detect the liquid level in the storage tank. If it is higher than the set value, the discharge valve will automatically open to drain to the set disinfection liquid level. Then enter the heating program, and circulate the heating of the entire distribution network through the heat exchanger.  The heat exchanger uses a temperature sensor and an automatic regulating valve to adjust the water temperature. It is heated to above 80°C and enters the insulation program.

The insulation program lasts for two hours. After the disinfection is completed, close the steam passage valve, open the refrigerant water passage valve, and use the automatic regulating valve to adjust the refrigerant water flow to cool the pure water in the pipeline, and finally discharge it. Superheated water sterilization function for injection water: After starting the sterilization program, first close the water inlet valve and the respirator valve on the top of the storage tank, and then use the liquid level sensor to detect the liquid level in the storage tank. If it is higher than the set value, the discharge valve will automatically open to drain to the set disinfection liquid level.

 Then the heating program begins, and the entire distribution network is heated in a cycle through the heat exchanger. The heat exchanger adjusts the water temperature through a temperature sensor and an automatic regulating valve. The water is heated to 122°C and then enters the insulation program. The insulation program lasts for half an hour. After the sterilization is completed, the steam passage valve is closed and the steam is discharged after cooling.

 

 

Distribution System Functions 5

Maintaining system positive pressure The return water pressure transmitter displays the system return water pressure. The pressure in the pipeline can be adjusted by adjusting the opening of the return water valve to maintain positive pressure in the entire pipeline system to prevent siphoning. This pressure value needs to be obtained through a trial run. This system uses a three-level password system to prevent unauthorized operations. The password levels are described in detail in the Software Design Specification (SDS). Data Access The system has a password protection function. When no password is entered, all data can be browsed. When a value needs to be changed, a password of the corresponding level is required (refer to the HMI operation manual).

 

 

Use A Pipe

1. Materials: The construction materials should be able to withstand temperature, pressure and chemical corrosion, and 304 stainless steel and 316L stainless steel are usually used. Most valves use diaphragm valves, U-bends are connected to two-way valves or T-type valves.

2. Connection: The pipeline adopts a circular connection, and the pipeline length is controlled within 400 meters. Hot melt automatic welding is the first choice, and sanitary clamps can also be used for connection. Pay attention to the drainage angle when installing the valve.

3. 3D: The blind pipe ends of the pipeline must meet the 3D requirements.

4. Slope: 0.5%--1%

5. Sampling: Each use point can be sampled 6. Cooling with injection water

Injection water cooling

Tube-in-tube heat exchanger

 

 

Pipe Installing

Pipeline installation process:

1. Cutting: Cutting includes four processes: cutting, flattening, burr removal, and weld cleaning.

2. Spot welding

3. Argon filling protection

4. Orbital automatic welding Welding sample

5. Endoscope inspection:

6. Pipeline installation

7. Pressure test 8. Cleaning and passivation

 

In addition to meeting these quality standards, pharmaceutical water systems must also be designed to prevent microbial growth and ensure the integrity of the water throughout the distribution process. This includes implementing proper sanitization procedures, monitoring the water quality regularly, and maintaining the system in a state of control.

 

Another important rule for creating pharmaceutical water systems is to ensure that the system is designed to minimize the risk of contamination from external sources. This means implementing measures such as using stainless steel piping, installing UV sterilization units, and implementing air filtration systems to prevent airborne contaminants from entering the water supply.

 

Furthermore, pharmaceutical companies must ensure that their water storage and distribution systems are validated, meaning that they have been proven to consistently produce water that meets the required quality standards. This validation process involves testing the system under a variety of conditions to ensure that it can consistently produce water of the required quality.

 

Overall, creating pharmaceutical water storage and distribution systems that meet industry standards and regulations requires careful planning, attention to detail, and a thorough understanding of the specific requirements of the pharmaceutical industry. By following these crucial rules and seeking expert insights on designing pharmaceutical water systems, companies can ensure the quality and safety of their products and maintain compliance with regulatory standards.