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Pre charge pilot gas back pressure valve (pharmaceutical...)

NegotiableUpdate on 05/18
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Overview

The pre charge pilot gas back pressure valve is designed specifically for working conditions where there is no gas source on site and the pressure is consistently stable and controlled. Its core function is to ensure precise control of the pressure in continuous flow reactions, adapt to small flow precision control in continuous flow reactions, meet the needs of batch continuous production, ensure reaction continuity, and ensure consistency in the quality of each batch of reaction products

Product Details

Technical parameters of PRESSREG pre charge pilot gas back pressure valve (pharmaceutical continuous flow reaction)


1、 Basic performance parameters

parameter name
Specification Range
Remarks (Suitable for pharmaceutical continuous flow reaction conditions)
Nominal diameter (DN)
DN3 - DN20(6mm - 20mm)
Specially designed for on-site gas free conditions, covering scenarios such as pharmaceutical laboratories, continuous flow reaction production lines, and liquid preparation systems, with customizable special diameters; Adapt to continuous flow reaction with small flow precision control, meet the needs of batch continuous production, and ensure reaction continuity
Set pressure range
Conventional 0.001-10MPa, precision type can reach 20MPa
The pressure control accuracy is ± 0.1KPa, with no pressure hysteresis. Its core function is to ensure precise control of the pressure in the continuous flow reaction of pharmaceuticals; Pre filled pilot gas structure, no on-site gas source required, can maintain pressure stability for a long time, avoiding the impact of reaction pressure fluctuations on product quality
Medium temperature range
Normal temperature type 0 ℃~80 ℃, high temperature type up to 200 ℃ (suitable for sterilization conditions)
Suitable for the temperature of commonly used media in pharmaceutical continuous flow reactions, the high-temperature type can be matched with post reaction wet heat sterilization and dry heat sterilization conditions to avoid medium denaturation caused by high temperature, while maintaining stable pressure throughout the reaction process to ensure smooth continuous flow reactions
Work pressure difference
0.01MPa-0.03MPa (adjustable)
Extremely low pressure loss, avoiding medium retention in the valve body and reducing the risk of drug cross contamination; Suitable for pharmaceutical continuous flow reactions with low viscosity and clean media, ensuring smooth and continuous transportation of the media, and maintaining pressure stability with a pre filled pilot gas structure
Circulation capacity (Cv value)
0.01 - 5.2
According to the batch adaptation of pharmaceutical continuous flow reactions, small flow rate is suitable for laboratory continuous flow reactions, and medium flow rate is suitable for production line continuous flow reactions. The flow is smooth without turbulence, avoiding medium foaming and deterioration, while maintaining stable reaction pressure
leakage rate
≤ 1 × 10 ⁻⁷ Pa · m ³/s (super zero leakage level)
The sealing level reaches VI level+, which meets the cleanliness requirements and prevents medium leakage from polluting the environment and drugs; Pre filled pilot gas sealing structure, stable sealing can be achieved without on-site gas source, ensuring precise and non fluctuating continuous flow reaction pressure
Adjust response time
≤ 0.8s (manual pilot type)
Pre charge pilot gas control responds quickly, adapts to the uninterrupted production needs of pharmaceutical continuous flow reactions, regulates smoothly without pressure fluctuations, and ensures precise control of the pressure of continuous flow reactions, ensuring consistency in the quality of each batch of reaction products

2、 Structure and pharmaceutical grade special material parameters (core focus)

Component Name
Optional pharmaceutical grade specialty materials
Special material characteristics and adaptation to pharmaceutical continuous flow reaction conditions
valve body
316L stainless steel, Hastelloy HC276, PTFE, PFA
1. 316L stainless steel: meets GMP standards, is easy to clean, and is suitable for continuous flow reactions of conventional drugs; 2. HC276: resistant to strong corrosion, suitable for continuous flow reaction of acid-base pharmaceutical excipients; 3. PFA/PTFE: No adsorption, no pollution, suitable for continuous flow reaction of high-purity drugs and biological agents, avoiding loss of drug components, and maintaining pressure stability with pre filled structure
Valve core/seat
316L stainless steel, PTFE, PFA (same as valve body)
Same origin matching with valve body material, convenient for CIP/SIP cleaning and sterilization; Surface polishing accuracy Ra ≤ 0.4 μ m, avoiding residual chemicals and eliminating cross contamination; Structural adaptation pre filled pilot gas design ensures precise and stable continuous flow reaction pressure
diaphragm
PTFE, PFA, 316L stainless steel membrane
1. PFA/PTFE membrane: odorless, non dissolving, suitable for continuous flow reactions of high-purity drugs and biological agents; 2. 316L membrane: resistant to high temperature and sterilization, suitable for wet heat sterilization and high-temperature continuous flow reaction conditions, stable sealing performance without leakage, and pressure stability control achieved with pre filled pilot gas
sealing element
PTFE、PFA、 Food grade FKM (non soluble)
Compliant with FDA and GMP standards, with no dissolution or odor, suitable for various pharmaceutical continuous flow reaction media; Resistant to high temperature and sterilization, capable of withstanding wet and hot sterilization at 121 ℃, with reliable sealing performance, preventing leakage and pollution, and ensuring pressure stability of the pre filled pilot gas structure
structural form
Pre charged pilot gas type
Specially designed for on-site working conditions without gas source, the pre filled pilot gas integrated structure can achieve pressure stability without the need for additional gas source; Easy installation, reducing dead corners in pipeline connections; Accurate and stable pressure regulation ensures precise control of the pressure for continuous flow reactions

3、 Connection and installation parameters (adapted to continuous flow reactions in pharmaceutical cleanrooms)

parameter name
Specification Range
Remarks (Suitable for pharmaceutical continuous flow reaction conditions)
connection method
Sanitary grade quick installation (clamp), NPT thread, sanitary grade flange
Meets pharmaceutical cleanliness requirements, quick connect for easy disassembly, cleaning, sterilization, and no dead corners in pipelines; Both threaded and flange connections are treated with anti-corrosion measures to prevent impurities from falling off and contaminating the medicine solution; Adapt to the layout of continuous flow reaction pipelines to ensure the continuous transportation of media, and cooperate with the pre filling structure to maintain pressure stability
Installation direction
Horizontal installation (with anti retention design)
Install according to the flow direction of the medium to avoid the retention of medication; Horizontal installation adopts anti retention structure to eliminate dead corners in pipelines, adapts to the continuous flow reaction layout of clean workshops, facilitates equipment maintenance and cleaning, and ensures the stable pressure control effect of the pre filled pilot gas structure
ambient temperature
10℃~60℃
Adapt to the constant temperature environment of pharmaceutical clean rooms, avoid valve body deformation and sealing failure caused by temperature differences, and prevent affecting the stability of pre filled pilot gas pressure; Stay away from high-temperature areas of sterilization equipment to ensure stable pressure throughout the continuous flow reaction and stable operation of the equipment
Protection level
IP66 (standard), IP67 (optional)
Dustproof, waterproof, and anti cleaning spray, suitable for regular cleaning conditions in clean workshops; Smooth surface and easy to wipe, without dust accumulation or dead corners; The protective structure does not affect the pre charge pilot pneumatic pressure control performance, ensuring uninterrupted continuous flow reaction

4、 Control and adaptation parameters

parameter name
Specification Range
Remarks (Suitable for pharmaceutical continuous flow reaction conditions)
Control method
Pre charge pilot air control (default, no air source requirement)
Specially designed for on-site working conditions without gas source, pre filled pilot gas control does not require additional gas source and can maintain pressure stability for a long time; Remote control supports 4-20mA signals, suitable for pharmaceutical continuous flow reaction automation production lines; Can be linked with PLC system to accurately control continuous flow reaction pressure, ensuring reaction continuity
Adaptation medium
Medicinal solutions, purified water, injection water, acid-base excipients, organic solvents, biologics, etc. (dedicated for continuous flow reactions)
Adapt special materials according to the characteristics of the medium, without adsorption, dissolution, or residue, in compliance with GMP requirements; Adapt to continuous flow reaction with low viscosity and clean media, avoid valve core jamming, ensure smooth continuous medium transportation, and cooperate with pre filled pilot gas structure to maintain stable reaction pressure
Adapt to the industry
Chemical pharmaceuticals, biopharmaceuticals, formulation production, traditional Chinese medicine extraction, aseptic pharmaceuticals, laboratory continuous flow reactions, etc
Specially designed for working conditions where there is no gas source on site and stable pressure is required, the core is adapted to pharmaceutical continuous flow reactions, and can be customized according to specific working conditions, such as sterile continuous flow reactions adapted to zero leakage, and biological continuous flow reactions adapted to non adsorption special materials, ensuring precise control of reaction pressure

5、 Other parameters (exclusive to pharmaceutical continuous flow reactions)


parameter name
Specification Range
Remarks (Suitable for pharmaceutical continuous flow reaction conditions)
service life
≥ 10000 hours (normal operating conditions)
Adapting to the uninterrupted production needs of pharmaceutical continuous flow reactions, resistant to frequent cleaning and sterilization, and with a stable and durable pre filled lead gas structure; Vulnerable parts can be replaced separately and comply with GMP standards, making replacement convenient and avoiding contamination of the clean room and interruption of continuous flow reactions during maintenance
warranty period
1.5 years (complete machine warranty, extended warranty for pharmaceutical grade special materials)
The warranty period of pharmaceutical grade special materials (PTFE/PFA/HC276) can be extended to 2 years, and additional warranty support is provided for the pre filled pilot gas structure; Provide GMP compliance testing reports and after-sales technical support to meet the maintenance needs of pharmaceutical continuous flow reaction workshops, ensuring uninterrupted reactions
delivery cycle
Standard pharmaceuticals ≤ 30 days
Response to urgent orders within 48 hours, material testing reports, and pre filled pilot gas debugging instructions to shorten the landing cycle of continuous flow reaction projects
定制能力
Full dimensional customization of special material matching, pressure, diameter, connection method, cleaning and sterilization adaptation (suitable for continuous flow reaction without gas source)
Customization can be made based on the medium characteristics, cleanliness level, sterilization method, and pressure requirements of pharmaceutical continuous flow reactions, with a focus on optimizing the pre filled pilot gas structure to ensure stable pressure under no gas source conditions on site, accurately controlling the continuous flow reaction pressure, and meeting GMP compliance requirements


















Note: This technical parameter is based on the standard specification of PRESSREG pre filled pilot gas back pressure valve. This valve is designed specifically for working conditions where there is no gas source on site, the pressure remains stable, and stable pressure control is required. Its core function is to ensure precise control of the pressure in pharmaceutical continuous flow reactions; The specific materials and parameters can be customized and adjusted according to the customer's continuous flow reaction conditions (such as sterility level, medium characteristics, pressure requirements). For details, please consult the manufacturer for targeted compliance solutions.