Marya Pharmaceutical Equipment Mixes Water Preparation System for Injection Manufacturer & Supplier

Customization: Available
Application: Biotechnology Industry, Chemical industry, Clinical Diagnosis, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry
Capacity: 20000 L/hr

Product Description

Basic Specifications
Model NO.
MY-PS
Certification
CE, FDA, GMP, ISO
Control System
Fully Automatic
Treatment Process
Filtration, Ultrafiltration
Core Components Warranty
1 Year
Tank Material
Stainless Steel 316L
Temperature Resistance
150℃
Working Volume
2 ~ 15000L
Weighing Accuracy
3%
Power Supply
380V 50Hz
Protection Level
IP65
Temp. Control
-10~150℃ ±0.2℃
Stirring Speed
0~450rpm ±3.0%
Pressure Range
-0.01MPa~0.06MPa ±0.01MPa
Origin
China
Package
Wooden Box (3500.00kg)
Pharmaceutical Aseptic Preparation System

1. Description of the preparation system:

The preparation system is a type of pharmaceutical equipment used to mix and dispense liquids by adding an API to a solvent such as water for injection and then formulating it into a pharmaceutical agent that meets the desired concentration after stirring, heating, sterilization, and filtration.

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Production Steps: Detailed production steps involve precise mixing, temperature control, and high-efficiency filtration to ensure the final product meets pharmaceutical standards.
Preparation System Production Steps

2. Classification of the preparation system:

💧
CIP Station System: Used to assist in the on-line cleaning of tanks and pipelines of various preparation and bioreactor systems.
CIP station system
Technical Design Details
  • 🔹 Compliance: Material and structure meet EU PED and FDA certification requirements.
  • 🔹 Tank Quality: Stainless steel 316L tanks (2L to 15000L) with internal Ra < 0.4μm and electrolytic polishing.
  • 🔹 Safety Devices: Equipped with rupture discs or safety valves and pressure indicators for maximum personnel safety.
  • 🔹 Thermal Control: Sterile double-barreled plate heat exchangers for precise WFI cooling.
  • 🔹 Stirring System: Magnetic stirrer driven by electromagnetic coupling or mechanical frequency conversion stirring.
  • 🔹 Advanced Filtration: Sterilizing-grade PES liquid filters resistant to pH 1-14 and temperatures up to 150ºC.
Product Parameters
Component Name Technical Parameters
Working volume2 ~ 15000L
Stirring speed accuracy0 ~ 450rpm ±3.0%
Temperature control accuracy-10 ~ 150ºC ±0.2ºC
Pressure control accuracy-0.01Mpa ~ 0.06Mpa ±0.01MPa
Weighing control accuracy3‰
Power supply380V 50Hz (Other voltages customizable)
Protection levelIP65
Full System Overview
Frequently Asked Questions (FAQ)
Q1: What materials are used for the preparation tanks? A: The tanks are constructed using high-quality Stainless Steel 316L, featuring internal electrolytic polishing with an Ra value of less than 0.4μm to ensure a sterile and easy-to-clean environment.
Q2: Does the system comply with international pharmaceutical standards? A: Yes, our aseptic preparation systems are designed and manufactured to meet stringent FDA, GMP, and EU PED certification requirements.
Q3: What is the capacity range for these preparation systems? A: We provide flexible solutions with working volumes ranging from 2L for small-scale operations up to 15,000L for large industrial pharmaceutical production.
Q4: How does the system handle cleaning and sterilization? A: Every sterile tank is equipped with rotating spray balls for Cleaning in Place (CIP). The design avoids hard-to-clean "dead spots," and all components support high-temperature sterilization.
Q5: Can this system be used for biological products like vaccines? A: Yes, our biological preparation systems are specifically designed for vaccines, antibodies, blood products, and recombinant proteins, as well as culture medium preparation.
Q6: What kind of temperature control accuracy can be expected? A: The system provides highly precise temperature management with an accuracy of ±0.2℃ within a range of -10℃ to 150℃, controlled via probes at the bottom of the tank.

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