Sterile Manufacturing Vessel

Description

Sterile Manufacturing Vessel (SMV) is a specialized piece of equipment used in the pharmaceutical, biopharmaceutical, and biotech industries to produce sterile solutions, such as injectable drugs, large-volume parenterals (LVPs), small-volume parenterals (SVPs), inhalers, and other aseptic preparations. These vessels are designed to maintain a completely enclosed, hygienic environment that prevents microbial contamination, ensuring compliance with strict regulatory standards like USFDA, WHO, cGMP, and ASME BPE guidelines.

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Salient Features of Sterile Manufacturing Vessel

Design as per ASME code.
No stagnant point, internal surfaces are 0.28 Ra finish.
All contact parts/surfaces made out of SS 316/SS 316L quality.
If required, Load cell/capacitance type level indicator will be provided to measure the volume inside the tank.

Spray ball for CIP/SIP system.
Steam/Electrical heating, Flush bottom valve.
The vessel will be jacketed, insulated and cladded by SS 304 sheet.
Electro polished from inside.

Working Principle of Sterile Manufacturing Vessel

Jacketed Mixing Vessel (double jacketed vessel) including jacketed steam boiler is uses for mixing liquid and slightly solid materials. Jacketed Mixer assembly equipped with series of paddles types blades, pitched or flat blade of appropriate shape. In Mixer two consecutive blades move in opposite direction which creates laminar thinning of the material and facilitates uniform mixing. Paddle type blades mounted on scrapping arms and welded to hollow shaft have independent drive. Bottom support to the shaft called piyot provided for firmness of shaft during rotations. Paddles mounted on internal shaft creates relative movement of the material. For discharge of material different types of valves can be offered as per user requirements.

Technical Specification of Sterile Manufacturing Vessel

Description	Specification
Capacity	5 Liters to 20000 Liters
Power Supply	0.5 H. P. to 75 H. P.
Power Voltage	440 volts, 3 phase, 50 hertz
Gearbox	Helical type / similar
Stirrer Type	Pitch Type Stirrer
Stirrer MOC	Stainless Steel 304/316/316L
Stirrer RPM	150 RPM adjustable through VFD
Stirrer Mounting Orientation	Top Mounted
No. of blades	Two
Shaft Diameter	Suitable Diameter

* Power voltage can be adjusted as per customer’s domestic power voltage requirements.
* Rights of technical improvements & modification reserved.
* Illustrations & dimensions are shown for information purpose only.

Types of Preparation Vessel

Sterile Manufacturing Vessel

Sterile Preparation Vessel

Injectable Preparation Vessel

Jacketed Mixing Vessel

WFI Storage Tank

Oral Liquid Preparation Vessel

Applications of Preparation Vessel

Advantages of Sterile Manufacturing Vessel

Superior Sterility & Contamination Control

Excellent Temperature Control

Regulatory Compliance & Validation

Easy Cleaning & Maintenance

Product Integrity & Safety

Key Features of Sterile Manufacturing Vessel

Construction: Typically made from high-grade stainless steel (e.g., SS 316L) with electropolished surfaces for easy cleaning and corrosion resistance. The vessel often features a dish-shaped top and bottom for efficient mixing and drainage.

Enclosure and Agitation: Fully enclosed with an agitator (e.g., magnetic stirrer or standard stirrer with variable speed control) mounted on the top dome to ensure uniform mixing without introducing contaminants.

Jackets and Insulation: Equipped with heating/cooling jackets for temperature control, insulation for energy efficiency, and cladding (e.g., SS 304 sheets) for protection.

Sterilization and Cleaning: Supports Clean-In-Place (CIP) and Sterilize-In-Place (SIP) systems using pure steam, allowing automated cleaning and sterilization without disassembly. Nitrogen blanketing or sparging is used to displace oxygen and prevent microbial growth.

Filtration and Transfer: Integrated with sterile filters (e.g., 0.22–0.45 micron) for product transfer to holding tanks or filling lines via pumps or positive nitrogen pressure.

Monitoring and Controls: Includes sensors for pH, temperature, conductivity, dissolved oxygen (DO), and load cells for precise level/weight control. Often paired with PLC/HMI systems for automation, data logging, and traceability.

Capacity Range: Commonly available from 2 liters to 20,000 liters, customizable for batch sizes.

FAQ for Sterile Manufacturing Vessel

What is a Sterile Manufacturing Vessel?

A Sterile Manufacturing Vessel (SMV) is a specialized jacketed mixing vessel used in the pharmaceutical, biopharmaceutical, and biotech industries to produce sterile solutions. It is designed for manufacturing injectable drugs, large-volume parenterals (LVPs), small-volume parenterals (SVPs), inhalers, and other aseptic preparations. The vessel maintains a completely enclosed, hygienic environment to prevent microbial contamination and complies with USFDA, WHO, cGMP, and ASME BPE standards.

How does the Sterile Manufacturing Vessel work?

The vessel operates as a double-jacketed system with a top-mounted pitch-type stirrer (adjustable via VFD) for uniform mixing of liquids and semi-solids. Heating or cooling is achieved through the jacket using steam or electrical systems. Ingredients are mixed under controlled conditions, with options for nitrogen blanketing, CIP/SIP via spray balls, and sterile filtration. The enclosed design with electropolished surfaces ensures sterility throughout the process.

What are the key features of the Sterile Manufacturing Vessel?

ASME code design with SS 316/316L contact parts and 0.28 Ra electropolished internal finish.
No stagnant points, zero dead-leg design, and flush bottom valve.
Jacketed, insulated, and cladded with SS 304 sheet for temperature control.
CIP/SIP compatible with spray balls and load cell/ level indicators.
Top-mounted pitch-type stirrer (up to 150 RPM via VFD) and steam/electrical heating.
Capacities from 5 liters to 20,000 liters.

What are the available capacities and technical specifications?

Sterile Manufacturing Vessels are available in capacities ranging from 5 liters to 20,000 liters. Key specifications include:

Power: 0.5 HP to 75 HP
Voltage: 440V, 3 Phase, 50 Hz
Stirrer: Pitch type, SS 304/316/316L, top-mounted, 150 RPM (VFD adjustable)
Gearbox: Helical type
Design: Jacketed, insulated, electropolished internals.

Which industries use the Sterile Manufacturing Vessel?

It is primarily used in the Pharmaceutical, Biopharmaceutical, and Biotech industries for sterile injectable and parenteral production. It is also suitable for Cosmetic, Chemical, Ayurvedic, Herbal, and Nutraceutical sectors requiring high-sterility mixing and processing of sensitive formulations.

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Sterile Manufacturing Vessel

Description

Salient Features of Sterile Manufacturing Vessel

Working Principle of Sterile Manufacturing Vessel

Technical Specification of Sterile Manufacturing Vessel

Types of Preparation Vessel

Applications of Preparation Vessel

Advantages of Sterile Manufacturing Vessel

Superior Sterility & Contamination Control

Excellent Temperature Control

Regulatory Compliance & Validation

Easy Cleaning & Maintenance

Product Integrity & Safety

Key Features of Sterile Manufacturing Vessel

FAQ for Sterile Manufacturing Vessel

Countries We Export to

Partner with Industry Experts

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