Marya Pharmaceutical Sterile Drug Preparation System with CIP Cleaning Manufacturer

1 / 5

Marya Pharmaceutical Sterile Drug Preparation System with CIP Cleaning Manufacturer

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

Send Inquiry

Product Description

Basic Information

CertificationCE, FDA, GMP, ISO

Control SystemFully Automatic

Treatment ProcessFiltration, Ultrafiltration

Warranty1 Year

Power Supply380V 50Hz

Tank MaterialStainless Steel 316L

Sealing LevelIP65

Temp. Accuracy±0.2℃

Stirring Speed0~450rpm ±3.0%

OriginChina

Product Description

Pharmaceutical Preparation System is a precision drug preparation equipment designed for the mixing and dispensing of liquid pharmaceuticals. It enables the controlled addition of active pharmaceutical ingredients into solvents such as Water for Injection (WFI), followed by homogenization through stirring, heating, sterilization, and filtration processes to achieve the desired drug concentration.

This system is widely used in both sterile and non-sterile pharmaceutical manufacturing, including applications in biopharmaceutical production, large-volume parenteral (LVP) solutions, and other critical drug formulation processes.

Classification

1. General Formulation System

For small-molecule chemical prep (e.g., aqueous injections, lyophilized powder injections).

2. Complex Formulation System

Handles advanced processes: suspensions, emulsions, liposomes, microspheres.

3. Biological Formulation System

For biotech products (antibodies/vaccines/blood products/recombinant proteins) & auxiliary liquids.

Core Advantages

1Modular Design - Cost-Saving & Efficient

Pre-tested modular equipment reduces installation costs, accelerates delivery, and ensures flexibility.

2Fully Automated Operation - Smart & Compliant

1-click CIP/SIP with auto-detection for cleaning/sterilization completion.
Computerized features: Recipe management, e-signature, e-records, and audit trail for full automation.

3Process Control & Real-Time Monitoring

Critical parameter control (temp, DO, pH) with auto-alerts for deviations to ensure drug quality.

43D Simulation & Ergonomic Layout

Pre-production 3D modeling optimizes piping, valve, and instrument placement for user-friendly operation.

Design Features

Premium Material

316L stainless steel tanks (2L-12,000L) with electrolytic polishing (Ra<0.4µm), compliant with EU PED & FDA standards.

Sterility Assurance

Sterile ventilation/exhaust filters and CIP spray balls for aseptic operations.

Safety Systems

Integrated safety devices (burst disc/safety valve) for equipment and personnel protection.

Efficient Mixing

Magnetic stirrer (bottom) or mechanical stirrer (top) with variable frequency speed regulation.

Product Parameters

Name	Parameters
Working volume	2~15000L
Material	304, 316L, 904L, TA2
Stirring type	Upper mechanical, lower magnetic stirring
Stirring speed control accuracy	Speed range 0~450rpm ±3.0%
Temperature control accuracy	Range -10~150ºC ±0.2ºC
Pressure control accuracy	Range -0.01Mpa~0.06Mpa ±0.01MPa
Weighing control accuracy	3‰
Power supply	380V 50Hz
Sealing and protection levels	IP65

Workshop & Quality Control

Certificates & Categories

Project Cases & Packaging

Frequently Asked Questions (FAQ)

Q1: What materials are used for the pharmaceutical tanks?

A: The system uses premium 316L stainless steel for tanks, ensuring compliance with FDA and EU PED standards. Inner surfaces are electrolytically polished to Ra < 0.4µm.

Q2: How accurate is the temperature control system?

A: The system provides high-precision temperature control within a range of -10 to 150℃ with an accuracy of ±0.2℃.

Q3: Does the system support automated cleaning and sterilization?

A: Yes, it features a 1-click CIP (Clean-in-Place) and SIP (Sterilize-in-Place) operation with automatic detection for completion.

Q4: What types of stirring mechanisms are available?

A: We offer both upper mechanical stirring and lower magnetic stirring, both equipped with variable frequency speed regulation.

Q5: Is the system compliant with digital record standards?

A: Yes, the computerized control system includes features like recipe management, electronic signatures, electronic records, and audit trails for full compliance.

Q6: What is the range of working volumes available?

A: The preparation systems can be customized for working volumes ranging from 2L up to 15,000L.