Sterile Injectable Process Equipment for SVP and LVP Lines
Esteril designs, builds, and tests the process vessels, skids, and CIP/SIP systems that run sterile injectable lines. Every system is engineered around your product, utilities, and validation targets, from the first engineering dialogue through FAT, installation, and qualification.
Esteril supplies the process section of the line: formulation, holding, CIP/SIP and automation.
Up to 25,000 L
Trusted by leading pharmaceutical and biopharmaceutical manufacturers
A sterile injectable line is only as reliable as the equipment inside it
Every injectable process carries its own utilities, batch sizes, and validation targets. Esteril engineers each system around those specifics, from R&D and pilot scale through to commercial manufacturing. Manufacturing vessels, sterile holding vessels, CIP/SIP systems, and the automation that runs them are designed, fabricated, automated and factory tested in-house against cGMP and 21 CFR Part 11 , with qualification support at site .
Contact parts are electropolished, and every system is designed for complete drainage and effective CIP/SIP cleaning.
What goes into an injectable process line
Custom-engineered, multi-equipment skid systems for advanced pharmaceutical and biotech applications. Fully integrated and factory tested for faster installation.
Our Manufacturing Vessels and Skids offer fully integrated, customizable solutions for aseptic processes, ensuring designed for complete drainage and effective CIP/SIP
cleaning.
Our Sterile Holding Vessels ensure safe liquid storage with designed for complete drainage and effective CIP/SIP cleaning, reliable automation, and rigorous testing, supporting capacities up to 25,000 L.
Our CIP/SIP systems offer automated cleaning and sterilization for multi-tank setups, with custom, modular designs designed to support cGMP and USFDA requirements.
PLC-SCADA automation systems for sterile and biopharma facilities, built to USFDA 21 CFR Part 11 and GAMP guidelines with electronic batch record integration.
Not sure which fits?
Tell us your process requirement
Share your line constraints and validation targets. We’ll scope the right system with you.
Applications
Systems for SVP, LVP, and General Injectables
Esteril builds process equipment for small volume parenterals, large volume parenterals, and general injectable applications, with capacities up to 25,000 L. For potent and oncology injectables, see our Complex Process Skid.
Documented for audit, end to end
cGMP and 21 CFR Part 11
Systems built to cGMP, with automation compliant to 21 CFR Part 11 for electronic records and signatures.
USFDA, EMA, MHRA
Engineered to stand up to USFDA, EMA, and MHRA scrutiny with comprehensive validation packages.
DQ, IQ, OQ, PQ documentation
Structured qualification documentation for a defensible, faster validation path.
Cleaning coverage
Spray coverage verified by riboflavin testing.
Electropolished contact parts
Contact parts electropolished for contamination control.
Factory and site testing
Every system factory tested before dispatch at our in-house FAT facility, then site tested after installation.
Work flow & process
How we work with you
Esteril stays accountable across the full project lifecycle, from first dialogue to after-sales support.
Tailored Solution
We exchange ideas to identify your crucial factors and priorities, then plan and design the system around your process.
Engineering & Build
Founders with more than 25 years of combined experience in pharmaceutical engineering, and complete aseptic design, delivered under a modern quality management process.
Qualification & Validation
We support installation and validation for a quick qualification process with DQ, IQ, OQ and PQ documentation.
After-Sales Support
Training and ongoing service across the product lifecycle so your system keeps performing reliably.
Why choose Esteril
Precision engineered. Trusted worldwide.
Engineering depth, recognised quality standards, and lifecycle support behind every system
Custom Engineered Solutions
Systems designed around your process requirements, constraints, and validation targets.
Aseptic & Hygienic Design
Designed for complete drainage and effective CIP/SIP cleaning with contact parts electropolished for contamination control.
Automation Expertise
21 CFR Part 11 compliant PLC-SCADA automation on Siemens, Schneider, Allen Bradley, and Mitsubishi platforms.
Factory Acceptance Testing
Every system factory tested before dispatch at our dedicated FAT facility.
Qualification Support
DQ, IQ, OQ, and PQ documentation and support for a structured qualification process.
After-Sales Support
On-site engineer support and AMC coverage for your critical operations.
Specifying questions
Frequently asked questions
The process section of an injectable line, where the formulation is prepared and held before filling, typically uses manufacturing vessels, sterile holding vessels, a CIP/SIP system for cleaning and sterilization, integrated piping, and PLC-SCADA automation. Esteril builds and integrates all of these as one system, tested at FAT before dispatch.
Esteril builds process vessels and skids with capacities up to 25,000 L, and sterile holding vessels from 3 L upward, for both pilot and commercial scale.
Yes. Automation is built to 21 CFR Part 11 and GAMP guidelines with electronic batch records, and systems are built to cGMP.
Yes. Systems come with structured DQ, IQ, OQ, and PQ documentation, cleaning validation by riboflavin test, and both factory and site acceptance testing.
Yes. Potent, oncology, and high-potency injectables are engineered for containment through our Complex Process Skid systems.
Esteril is based in Mumbai with a fabrication facility in Vasai, and provides on-site engineer support and AMC coverage for projects across markets.