IMA for Pharmaceutical

High-Speed Pre-filled Syringe Processing Line

Grade A processing for maximum sterility assurance, high-speed filling up to 36,000 syringes/hr. and the ability to move towards gloveless thanks to latest-generation robotic technologies.

Aseptic Processing

Bag and Tub/Tray Opening

Aseptic Processing

Nebula

Aseptic Processing

Robotic D-Nest

Aseptic Processing

Injecta 36

Aseptic Processing

Detecta

Aseptic Processing

Isolator System

High-Speed Pre-filled Syringe Processing Lines

  1. Maximized sterility

    6-log decontamination and no-contact robotic handling ensure GMP compliance.

  2. High-speed

    Processes up to 36,000 syringes/hour with minimal delays

  3. Multi-product flexibility

    Handles various containers and components

  4. Reduced costs

    Less downtime, re-qualification, and manual intervention

  5. Space-saving

    Compact, scalable design fits cleanrooms efficiently

INJECTA WINNER OF BEST IN SHOW
AT INTERPHEX NY 2023 EXHIBITOR AWARDS

Speed and accurate
processing

A combination of technologies that are revolutionising aseptic processing

Beyond a single choice of machines, IMA takes aseptic processing to a new level with an integrated line made of cutting-edge solutions that interact for maximum performance and security.

Technologies interact,
enhancing each other

An ideal solution for vaccines or monoclonal drugs, both for speed and precision.

Fully integrated robotic bag/tub/tray-opening is a possible first step to the process before entering the Grade A environment. This can be replaced by the latest decontamination tunnel, NEBULA, which processes batches at high speeds across 3 chambers achieving 6-log decontamination using VPHP. IMA barrier and isolation technologies form an integral part of the aseptic processing line and have been developed to seamlessly accommodate the dynamic processing equipment. In the case of Ready-To-Use syringes, INJECTA 36 will process up to 36,000 nested components in one hour, all operations completed robotically in a sequence implementing No-Touch-Transfer and statistical weight control or 100% IPC. Ensuring accurate dosing at all times, INJECTA 36 also performs automatic, robotic weight cell calibration. Equipped with a plunger presence check using the DETECTA inspection system, the machine enables manual non-conformity rejection downstream during de-nesting, handled by D-NEST. Syringe assembly is than dealt with using MODULA for pre-filled syringes, performing plunger rod insertion, labelling and backstop assembly.

High-speed advanced robotic processing: NEBULA, INJECTA 36 and DETECTA

Nebula, Decontamination Tunnel & Injecta 36, High-speed Syringe Processing

Main features

Designed primarily for large-scale production of pre-filled syringes (PFS) starting from pre-sterilised, Ready-To-Use (RTU) containers, this line combines speed and advanced automation thanks to the use of anthropomorphic robots and innovative solutions for filling and capping. The filler has an in-nest filling mode to handle vials and cartridges in addition to PFS, and is optimised for high-volume pharmaceuticals such as single-dose vaccines for global campaigns or mass-market products for the treatment of diabetes and obesity – such as the latest GLP-1 antagonist medications. Full automation is provided for No-Touch-Transfer (NTT) and opening or continuous decontamination (in Nebula decontamination tunnel) of RTU components. In NTT automated solutions, Ready-To-Use (RTU) containers are fed to the line using automatic unbagging and transfer systems that avoid human contact. In the case of continuous decontamination, RTUs are fed to the line without protective bags, but are exposed to a high concentration of VPHP which reduces their surface charge (6-log reduction) ensuring a grade A rating minimising risks and at the same time avoiding the complexity of robotic manipulation.

Benefits

  1. 1.

    The line offers a complete solution for high-speed production of injectable pharmaceuticals, ensuring maximum patient safety and cutting operating costs. Thanks to flexible use of anthropomorphic robots, the manual procedures required during production can be kept to a minimum and format-specific part requirements can be reduced.

  2. 2.

    Additionally, a compact plant layout is ensured, possibly supplied with an under-isolator solution without HVAC, securing an operational advantage even in small-sized production facilities and designed to also allow integration into existing buildings (brownfields).

  3. 3.

    The use of fully automated, high-speed No-Touch-Transfer (NTT) technologies (up to 5 RTUs/minute) minimises the risk of contamination, increasing product safety, without any impact on plant productivity which can reach up to 36,000 PFS/h.

  4. 4.

    The system flexibility allows different RTU (Ready-To-Use) options to be managed and guarantees high filling precision standards, through an IPC system for weight control that can be operated whenever necessary across all production phases, for statistical or 100% PFS inspection. Injecta 36 can be combined with high-speed inspection systems for stopper presence and position checking inside the syringe or cartridge.

Focus on

Upfront costs and ROI

Implementation and compatibility

Training and skill requirements

Maintenance and downtime

Regulatory compliance and validation

Flexibility for future needs

Safety and environment

Vendor support and service

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Upfront costs and ROI

The integration of INJECTA 36 and NEBULA represents a high-value investment, but it is designed to provide a strong ROI through enhanced throughput, minimal contamination risk, and regulatory compliance. By streamlining high-speed aseptic fill-finish processes with continuous decontamination, this system reduces operational inefficiencies and downtime, which can translate into faster time-to-market—critical in a competitive environment. The combined solution also supports multi-product production, improving overall flexibility and adaptability to future needs.

Implementation and compatibility

INJECTA 36 and NEBULA are engineered to integrate seamlessly into existing IMA Life production lines with modular designs that help optimise cleanroom floor space. INJECTA’s compact isolator shell and NEBULA’s streamlined decontamination tunnel are specifically intended to fit into a variety of facility layouts, meaning that costly reconfigurations can often be minimised. Additionally, both systems are adaptable to various container formats (e.g. syringes, vials, and cartridges), making them versatile for both new and existing production lines.

Training and skill requirements

While these solutions utilise automation technologies and, in the case of INJECTA 36, advanced robotics that may require specialised training, these systems also significantly reduce the need for operator intervention. IMA Life provides comprehensive training programs and ongoing support to ensure staff are well-prepared to operate the systems, with a focus on maintaining consistent aseptic conditions and reducing human error. The automation of critical steps, such as weight-cell calibration and de-bagging, helps minimise the operational burden on staff.

Maintenance and downtime

Both systems are designed for minimal downtime through features like NEBULA’s continuous decontamination flow and INJECTA 36’s robotic handling, which reduce the need for frequent maintenance. NEBULA’s three-chamber system, using dynamic chamber segregation, ensures continuous operation, while INJECTA 36’s real-time In-Process Control (IPC) capabilities enable swift transitions without halting production. Together, these features aim to maximise uptime and reduce the likelihood of production interruptions.

Regulatory compliance and validation

INJECTA 36 and NEBULA are built to meet stringent GMP compliance standards, with advanced sterility and quality controls. NEBULA’s VPHP-based decontamination achieves a 6-log reduction in bioburden and minimal hydrogen peroxide residues on RTU components, ensuring that regulatory requirements for sterility are met. The high degree of automation in INJECTA 36 further minimises human intervention, aiding in regulatory validation and reducing re-qualification needs, particularly beneficial for GMP environments.

Flexibility for future needs

INJECTA 36 and NEBULA offer scalable, flexible solutions designed to adapt to changes in production demands, container formats, and product types. INJECTA’s IPC capabilities allow on-demand switching between different control types, enhancing multi-product adaptability, while NEBULA’s continuous decontamination flow supports high-volume processing without delays. Their modular designs allow pharmaceutical companies to scale production efficiently as demand grows.

Safety and environment

NEBULA utilises vapour-phase hydrogen peroxide (VPHP) at high concentrations to achieve rapid decontamination while ensuring containment through computational fluid dynamics and diffusion rings, reducing exposure risk and environmental impact. NEBULA also incorporates desorption strategies that limit residual hydrogen peroxide on RTU components to safe, minimal levels, aligning with environmental safety standards. These precautions ensure effective decontamination without compromising safety.

Vendor support and service

IMA Life provides extensive support services, including maintenance, training, and troubleshooting assistance to ensure the smooth operation of INJECTA 36 and NEBULA. This includes access to spare parts, technical support, and local service resources for quick resolution of any issues that may arise.

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