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PFS Line

Pre-Filled Synergies

Theon Lifesciences significantly emphasizes innovation and accuracy in the manufacturing of Pre-Filled Syringes (PFS). Our fully automated PFS line employs the latest robotics, high-capacity oRABS protection, and engineering grade SCADA integration to assure sterility, accuracy, and safety throughout every manufacturing step. With minimal human interaction and full end-to-end automation, we deliver safe and reliable injectable solutions that consistently meet absolute global compliance requirements.

We are PFS formulation manufacturers, delivering high-quality, sterile, and precisely dosed pre-filled syringes that meet global regulatory standards. Our syringes are safer and more hygienic for patients and revolutionized the way medications were administered before. PFS offers numerous advantages over traditional vial and syringe systems.

Flexible Dosing Range

Fills 0.5 mL to 10 mL PFS with precision dosing pumps

High-Speed Production

Up to 100 PFS/min (1 mL size) for efficient large-scale manufacturing

Vacuum Stopper Placement

Ensures accuracy and sterility in every syringe

Inline Quality Control

IPC tare/gross weighing with 6 VPC/NVPC sensors

Smart Operations

Recipe-based programming via HMI for consistent results

Sterile Environment

Equipped with oRABS for aseptic operations

Advanced Robotics

Dual robotic system for opening, wrapping, and filling, reducing human contact to nearly zero

Data-Driven Monitoring

SCADA connectivity for real-time data recording and quality tracking

How We Manufacture Pre-Filled Synergies?

Pre-filled synergies are for a single dose of medication which has a fixed needle. It reduces the scope of error because it ensures accurate dosing by lowering the risk of contamination and needlestick injuries. It also eliminates the risk of misidentification & mix-ups, which are particularly dangerous when highly potent drugs are in play. Thus, it is easy to play and dispose of. Let’s understand the detailed breakdown

Pre-Formulation & Device Preparation

The procedure initiates comprehensive pre-formulation research to evaluate the drug’s physical and chemical features (pH stability, thermal stability, solubility, and compatibility). Then, the final injectable formulation can be developed by selecting the ideal drug candidate and excipients from the research.

Concurrently, device preparation and assembly occurs- selecting the appropriate materials for the container, defining the dosing specifications, and assembling the barrel, plunger, stopper and needle of the syringes to suit the in-development product.

Process Compatibility Studies

The formulation will then be provided to test compatibility with the syringe components. During this time, the formulation (solution, suspension or emulsion) must be provided and tested under aseptic conditions, ensuring that the formulation does not react with the syringe materials. The information obtained from these studies will be applied to process optimization practices for safe and stable manufacture.

Compounding / Bulk Solution Preparation

The selected raw materials will be compounded, and mixed under controlled conditions, allowing for consistent and reproducible preparation of the drug solution. Modern mixing technologies are used to maintain stability while also ensuring degradation of sensitive APIs does not occur.

Sterile Filtration

Bulk solution is filtered through sterile 0.22-micron membrane filters (or compressed gas/air systems, as warranted by formulation) to remove particulate material and microbial contamination. Afterwards, a filter integrity test will be conducted to demonstrate sterility.

Aseptic Filling Process

Filtered solutions will be placed in sterile filling devices and dispensed into syringes, all under aseptic conditions.

  • Conventional Filling: Syringes will be filled and closed under sterile, laminar airflow conditions.
  • Advanced Filling: The bubble-free vacuum filling followed by vacuum stoppering minimizes air entrapment and maximizes sterility assurance.

Sterilization of Components

Pre-filled syringes must be sterilized prior to final assembly:

  • Gamma or E-beam ionizing radiation – the preferred method for syringe plungers and stoppers, in the package.
  • Autoclaving – used selectively; glass and most plastics are not suitable for autoclaving, and difficult to manage with some temperature-related shifts in pH.

Closing & Stoppering

Once the syringes have been filled or lyophilized, pre-sterilized stoppers and caps are applied to seal them to facilitate sterility and maintain the integrity of the product against external contamination.

Inspection & Quality Assurance

  • Inspections occur on every syringe, both inline and at final inspection:
  • Automated visual inspection for clarity, particulate, and cosmetic defects.
  • Dimensional inspection for sealing and fill volume.
  • QC testing (sterility, endotoxins, pH, potency) pre-batch release.

Labeling

Approved syringes are labeled, allowing full traceability and compliance. The labels contain product name and description, dosage, batch number, and expiration date. In addition, advanced label solutions can aid in tamper evidence and patient compliance.

Secondary Packaging

Finally, syringes are placed into appropriate cartons, blisters, or trays, and if necessary, patient information leaflets are included as well. The secondary packaging ensures safe handling, storage, and distribution while maintaining legal and regulatory requirements on a larger scale.

Why Choose Theon Lifesciences for PFS Lines?

At Theon Lifesciences, we utilize Vessel System (Lyophilized Injectables)cutting-edge technology, global compliance, and expertise in pharmaceuticals to provide reliable and innovative Pre-Filled Syringe (PFS) packaging solutions. Here’s why top-tier global healthcare providers elect to partner with us:

Cutting-edge Infrastructure

Our state-of-the-art and completely automated PFS manufacturing lines feature oRABS, robotic handling, and SCADA integration into our manufacturing practices, ensuring accuracy, sterility, and traceability at every step.

We manufacture to EUGMP, USFDA, TGA Australia, Anvisa, and cGMP standards, enabling us to serve our partners at the highest international standards of quality and safety for every product manufactured.

Our advanced technology can accommodate dosing from 0.5mL to 10mL, producing sterile and guaranteed accuracy with vacuum-assisted stoppering and filling with no bubbles.

Through our specialized lyophilization capabilities, we support biologics and temperature-sensitive drugs to increase their shelf-life while preserving their integrity.

Each pre-filled syringe undergoes inline weight checks, automated visual inspection, and complete QC testing for reliability and patient safety.

Our R&D team is dedicated to continuous innovation to develop next-gen formulations and delivery systems, customized for our partners, that meets development needs and timelines.

Theon Lifesciences is ready and equipped to scale to commercial manufacturing while preserving quality at every level.

Theon Lifesciences: Trusted Partner in Safe, Scalable, and Compliant PFS Manufacturing.

At Theon Lifesciences, we provide accuracy, sterility, and trust at scale in producing pre-filled syringes. Our PFS lines are built to accommodate everything from biologics to lyophilized injectables with unparalleled quality and safety, supported by cutting-edge technology, worldwide regulatory compliance, and a highly qualified R&D team.

Partner with Theon Lifesciences for world-class PFS manufacturing.

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