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Vessel System

Vessel System (Lyophilized Injectables)

Lyophilized injectables, also referred to as freeze-dried injections, are developed to protect sensitive drug molecules by providing stability, potency, and extended shelflife. This process makes it possible for the product to remain effective for an extended period of time and be easily reconstituted prior to administration. 

At Theon Lifesciences, we use advanced technology, a rigorous quality and testing program, and global compliance to provide world class lyophilized injectable formulations. Our aseptic manufacturing and precision-driven processes provide assurances that every vial follows international standards of safety, purity, and performance.

Key Highlights of the Vessel System

Used for manufacturing, filtration, and holding of sterile drug products.

CIP-SIP Equipped

Features Clean-in-Place and Sterilize-in-Place systems with a recipe-based program for CIP, PHT, and SIP cycles.

Fully Automated Operation

Controlled via HMI (Human Machine Interface) for precision and consistency.

SCADA Connectivity

Enables continuous monitoring, data logging, and traceability.

No Manual/Open Connections

Ensures aseptic transfer between compounding, holding, and buffer vessels.

Product Filter Provision

Can accommodate up to 4 product filters between compounding and holding vessels for maximum purity.

Load Cell Integration

Allows online weight measurement for accurate batch control.

Versatile Mixing Technology

Equipped with magnetic, high-shear, and low-shear mixers to handle diverse formulations.

Advanced Sensor

Includes online sensors for conductivity, dissolved oxygen (DO), and pH analysis to maintain precise product quality

How We Process Lyophilized Injectables?

At Theon Lifesciences, the entire manufacturing process of our sterile, lyophilized injectables is executed by following the specifications of precision engineering, strict aseptic controls, and real-time monitoring systems. The integrated process, from compounding to final packaging, yields exceptional consistency, quality, purity, and performance from vial to vial. The process we follow for making lyophilized injectables are: 

Solution Preparation (Using Advanced Vessel System)

The process originates in our fully automated vessel system with the drug substance and excipients being dissolved and compounded at controlled temperature and pressure.

  • Closed Loop System: The solution preparation occurs in a closed and sterile environment to eliminate any risk of microbial or particulate contamination.
  • Mixing & Homogenization: Different formulation characteristics will dictate the form of mixing/homogenizing; magnetic stirrers, high shear mixers, and low shear agitators are used to ensure consistency of blending and solubilization.
  • CIP/SIP Operations: Each vessel has a Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) cycle performed and validated through HMI supported recipes to guarantee aseptic capabilities prior to every batch.
  • In-line monitoring: Each solution condition for pH, conductivity and/or dissolved oxygen (DO) is monitored by advanced sensors to ensure batch to batch solution uniformity.
  • Filtration: The compounded bulk is pushed through either one or up to four different stages of 0.22 µm sterilizing-grade filters to ensure absolute clarity and sterility.

Sterile Filling

Bulk sterile solution is conveyed through closed aseptic transfer lines, directly into the filling area, ensuring there is zero exposure to the environment.

  • Grade A Filling Zone: The filling operation is conducted in a Grade A class of clean airflow under the class B background cleanroom.
  • Automated Filling Machines: Feeding the vials at high-speed filling and accurately fills per the achieved dosage per vial to a minimum of waste and becomes reproducible.
  • In-line Durable Monitoring: The complete journey of the liquid begins with feeding of the vials, filling and the partial stoppering is monitored via SCADA integrated system for real time traceability.

Partial Stoppering

Once the vial is filled, each vial is then partially stoppered with pre-treated sterilized cleaner rubber stoppers.

  • This allows moisture vapor to escape during drying, and ensures the stoppers remain sterile.
  • The stoppering occurs under Grade A laminar airflow, to assure that the vials are maintained sterile until the point of lyophilization.
  • Environmental monitoring is conducted to assure viable and non-viable monitoring is maintained within acceptable defined limits.

Lyophilization (Freeze Drying Process)

The partially stoppered vials are automatically transferred into the lyophilizer chambers. There are three main areas in the lyophilization process:

  • Freezing: The solution is frozen rapidly to create a solid matrix to stabilize the structure of the product.
  • Primary Drying (Sublimation): Under deep vacuum, ice crystals sublime directly from solid to vapor, removing the majority of water while maintaining the molecular structure of the drug.
  • Secondary Drying (Desorption): Residual moisture is lowered to almost zero (<1%) for long term stability.


The lyophilization cycle parameters of shelf temperature, chamber pressure, and time are controlled using automated recipe-based systems which allow uniformity and reproducibility across all batches.

Stoppering & Sealing

After lyophilization, the vials are automatically completely stoppered inside the lyophilizer chamber ensuring sterility.

  • The sealed vials are then moved to aluminum crimping machines where caps are applied​​​ under aseptic conditions.
  • A 100% in-process integrity check ensures every vial is perfectly sealed with no breaches to sterility or vacuum integrity.

Inspection & Packaging

Every vial goes through a layered inspection process prior to reaching the packaging line.

  • Automated Visual Inspection: High-speed cameras are utilized to detect particulate matter, fill volume deviations, and cosmetic defects.
  • Manual Quality Verification: Trained QA personnel randomly check and verify consistency throughout the batch during the inspection process.
  • Labeling & Serialization: Every vial receives a traceable batch information label, and serialization is also completed per regulatory requirements.
  • Final Packaging: Vials are packed in sterilized cartons and secondary packaging materials that are suitable for long-term transport and storage purposes.

We ensure that each step adheres to and complies with WHO, cGMP, and international regulatory guidelines; therefore, all products leaving our facility meet the highest standards of sterility, quality, and reliability globally.

Why Choose Theon Lifesciences for Lyophilized Injectables?

At Theon Lifesciences, we don’t just manufacture, we collaborate. Our partnerships are built on trust, transparency, and technical precision, making us one of the most dependable names in sterile and lyophilized injectable manufacturing.

Reliable Expertise

Having several decades of experience in manufacturing sterile and aseptic systems, Theon Lifesciences has established itself as a common partner of choice for leading global pharmaceutical companies. The focused lyophilized injectable division combines in-depth subject-matter expertise with careful execution to deliver excellence in every batch.

These facilities incorporate automated vessel systems, advanced lyophilizers, and production lines with SCADA integration, offering consistent and sterile development and ensuring continuity from batch to batch. All the processes are monitored digitally, eliminating manual risk and increasing overall product confidence.

 Our research and development team is continuously implementing new formulation techniques, cycle optimization methods, and stability enhancement strategies to deliver lyophilized products that meet the highest standards for safety, efficacy, and shelf-life performance. We emphasize both product innovation and manufacturing process innovation to provide our clients with the competitive edge they need.

All of our operations are fully compliant with WHO, cGMP, USFDA, and EMA requirements. We manufacture products according to validated SOPs at every stage from raw material sourcing to the final product release, allowing us to ensure that every injectable is audit-ready for the global markets.

Scale Up and Scale Down: We offer fully integrated contract and third-party manufacturing services from small scale development batches to greater scale and commercially manufactured products. Our modular capacity allows for rapid and seamless scale-up, providing needed flexibility to fulfill client requirements on time and at scale. 

We document all stages of production via electronic systems that are 21 CFR Part 11-compliant, providing complete traceability and data integrity – attributes for building long-term trust and transparency with our partners.

All products undergo multi-level inspection inclusive of in-process controls, environmental monitoring, and stability studies to be assured that products meet defined specifications for release before a vial is sent to the client.

Theon Lifesciences – Excellence in Lyophilized Injectable Manufacturing.

From compounding to freeze-drying, every stage is engineered for precision, safety, and superior product performance. At Theon Lifesciences, we integrate automation, data integrity, and aseptic precision at every stage to guarantee consistency, compliance, and assurance in every vial produced. Our commitment to excellence is the bedrock of our approach to producing lyophilized injectables that comply with international quality expectations and assure our partners reliable expectations.

Partner with Theon Lifesciences – Your Trusted Ally in Sterile Injectable Solutions.

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