Isolation Technology

Product Description

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 their Discover Range platforms with IWT’s ASEPTICARE isolator technology, they have created a fully integrated, modular system designed for clinical supply, development programs, and small-scale GMP manufacturing.

This collaboration combine with precision fill-finish technologies to deliver a compact, high-performance solution for sterile liquids, powders, and complex formulations, all within a closed, contamination-controlled environment aligned with the latest GMP Annex 1.

Inside ASEPTICARE

cryoFIL® – cGMP cryovial filling platform

cryoFIL® enhances cell viability and maximizes 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.

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

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

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

Main Features and Benefits

• EU-GMP Class A (ISO 5) Compliance
• Automatic Decontamination
• Modular, Plug & Play Design
• Compact and Sustainable with Enhanced Safety
• Ensures the highest level of product and operator protection for aseptic operations
• Integrates cGMP standards and Quality by Design (QbD) principles to elevate operational performance
• EU-GMP Class D environments, reducing operational and energy costs
• SCADA system integrates with MES through UPC UA, complying with 21 CFR Part 11 and GAMP5 standards for seamless process control