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A complete aseptic fill–finish solution

Precision | Flexibility | Regulatory Confidence

3P innovation has partnered with IWT Pharma to deliver a small-batch, Annex 1–compliant aseptic fill–finish solution for a UK customer. By combining our Discover Range platforms with IWT’s asepticare isolator technology, we have created a fully integrated, modular system designed for clinical supply, development programmes, and small-scale GMP manufacturing.

This collaboration brings together proven isolator expertise and precision fill–finish technologies to provide a compact, high-performance solution capable of handling sterile liquids, powders, and complex formulations, all within a closed, contamination-controlled environment aligned with the latest EU GMP Annex 1 requirements.

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ASEPTICARE - Multipurpose Isolator

iwtpharma-logo-small-pngFlexible Aseptic Solution: ASEPTICARE offers a versatile, closed aseptic environment, ideal for aseptic and aseptic-toxic operations. It ensures contamination control and improves operational efficiency across various sterile processes.

Component Preparation: Safely transfers components such as EM plates, change parts, and consumables into filling lines while maintaining a sterile environment.

Aseptic Formulation: Enables the sterile formulation of both sterile and sterile-toxic products, including vaccines and other suspension products.

Small Scale Filling: Suitable for automatic or semi-automatic filling and finishing of small batches, including vials, PFS, IV bags, and medical devices.

Flexible and Modular: The modular design allows for easy customization without the need for construction work or HVAC connections, simplifying installation and setup.

Fast, Efficient Decontamination: Integrated H2O2 catalyzers facilitate rapid decontamination cycles, reducing downtime and improving productivity.

Custom Solutions: Provides validated, tailored solutions for seamless integration of equipment and devices, all controlled through a smart, unified system.

While this project showcases our successful partnership with IWT, we continue to work closely with a range of isolator providers and biological safety cabinet (BSC) manufacturers. Our platform technologies are designed for flexible integration, ensuring customers can select the containment strategy that best fits their process, facility and regulatory needs.

Inside asepticare

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Liquid Fill-Finish Technology

The Liquid Fill-Finish Platform delivers servocontrolled, bottom-up liquid filling with 100% fill-weight verification, automated stoppering, and full 21 CFR Part 11 compliance. Ultracompact, it fits seamlessly inside the ASEPTICARE isolator. 

  • Fills vials, cartridges, syringes, and custom containers
  • Closed-loop pump control for batch-to -batch consistency
  • GMP compliant, first air design
  • Optional nitrogen purge; vacuum stoppering options
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Rotary Crimping 

This aseptic, fully configurable crimper provides consistent, validated sealing of vials and cartridges. Its small footprint makes it ideal for use inside the ASEPTICARE isolator. 

  • 100% in process stopper compression force verification
  • Low particle generation
  • Adjustable parameters (force, rate, crimp wheel height, rotation speed)
  • CFR 21 Part 11–compliant HMI
  • Hydrogen peroxide compatible 
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Fill2Weight Gravimetric Powder Filler

Fill2Weight delivers high precision, non-compacting powder dosing for even the most challenging formulations. Real-time, weight-controlled dispensing and gentle vibration ensure accurate fills while preserving particle integrity. 

  • Handles ultra low dose and high potency APIs
  • 100% in process weight verification for every dose
  • Compatible with vials, cartridges, syringes, capsules and custom containers
Cryovial Filling Platform

 

cryoFIL® - cGMP cryovial filling platform

cryoFIL® enhances cell viability and maximises yield through automated cryovial filling and handling. The cryoFIL® system automates your cryovial filling process and uses Controlled Rate Freezer (CRF) compatible racks, providing seamless integration.
  • Scalable solution for your cell therapy needs.