Solutions

Manufacturing Vessel / Skid

Fully integrated sterile manufacturing vessels and skids for injectable, SVP and aseptic production, built to cGMP and hygienic design standards.

Overview

One Integrated Unit for Sterile Preparation

Esteril designs and manufactures sterile manufacturing vessels and skids for pharmaceutical and biopharmaceutical production. The systems prepare sterile products such as injections, inhalation solutions and other aseptic formulations with high process accuracy and repeatable results.

Each vessel is built with purpose-fitted accessories to the client’s process, with a standard or magnetic stirrer, a dish-shaped top and bottom, flanged ends and a silicone gasket for secure sealing. Process piping and all components are manufactured and tested in-house, so the skid operates as a single high-performance unit with automation programmed to 21 CFR Part 11.

Capacity

Up to 25,000 L

Compliance

cGMP · ASME BPE · 21 CFR Part 11

Contact parts

SS 316L, electropolished to 0.3 Ra

Automation

PLC / SCADA with HMI

Where it fits

Applications

Engineered for sterile preparation across injectable and aseptic formulations.

Applications

Sterile injectable formulations
Small volume parenterals
Inhalation solutions
Biopharmaceutical formulations
Oncology and high-potency products
Aseptic liquid processing applications

Built for

Standard or magnetic stirrer options
Bottom, top and high-shear mixing
Heating and cooling integration
Full or semi-automated operation
CIP / SIP integration

Sized for medium to high capacities with 100% cleanability and drainability.

How it’s engineered

Advantages and Key Features

Why it's specified

Tailor-made solutions for specific products and processes
Compact and hygienic skid design
Heating and cooling integration options
Reliable full or semi-automated operation
CIP / SIP integration capability
Improved process consistency and operational efficiency

What's built in

Sanitary design as per US FDA and cGMP guidelines
ASME BPE compliant fabrication standards
21 CFR Part 11 compliant PLC-controlled HMI / SCADA
SS 316L contact parts, electropolished to 0.3 Ra
SS 304 non-contact parts
Recipe-based process parameter settings
Bottom-mounted magnetic mixers for low / medium / high shear
Flush bottom outlet valve with sampling and sterilisation options
Load cells and level sensors for accurate monitoring
100% drainability and cleanability

Specifying questions

Frequently Asked Questions

It prepares sterile products such as injectables, small volume parenterals, inhalation solutions and aseptic formulations. The vessel, mixing, piping and controls are integrated onto one skid and operate as a single automated unit.

A standard stirrer uses a top or bottom driven shaft. A magnetic mixer is bottom-mounted with no shaft penetration through the product zone, which improves sterility and cleanability. Esteril offers both, selected to the product and shear requirement.

Systems are built to a range of capacities up to 25,000 L, for both pilot-scale and commercial-scale production.

Vessels are built to US FDA and cGMP guidelines, fabricated to ASME BPE standards, with automation compliant to 21 CFR Part 11 and full validation documentation.

Yes. CIP and SIP can be integrated into the skid so cleaning and sterilisation run as part of the automated cycle, supporting 100% drainability and cleanability.