Flexible assembly platform for clinical batches and small-scale syringe assembly

The SAP-M (Syringe Assembly Platform Manual) is a compact and modular assembly platform for the semi-automated assembly of pre-filled syringes (PFS). The platform has been developed for R&D programmes, clinical trials and small-scale commercial production, where flexibility, reproducibility and process control are key. Thanks to its modular design, the SAP-M can handle a wide range of syringe sizes and supports various assembly methods, including torque-controlled assembly, rotational assembly and push-in assembly. Critical process parameters such as force and torque are continuously monitored and recorded, ensuring a reliable, reproducible and validated assembly process.

Validated assembly with full process control
Maximum flexibility for different injector designs
Ideal for R&D, clinical batches and upscaling

Proven assembly technology

The SAP-M utilises the same proven assembly technology as the SAP-S and SAP-A. Plunger rod assembly can be carried out using controlled rotation or torque-controlled assembly, depending on the product specifications and process requirements.

As the same assembly principles are applied across the entire SAP platform, process knowledge, validated assembly parameters and accumulated experience can easily be carried over when scaling up to higher production volumes. This simplifies technology transfer, minimises validation efforts and reduces the risks associated with scaling up production. As a result, the SAP-M is not only an efficient solution for R&D, clinical trials and small-scale production, but also a solid foundation for future growth.

The process

1. Loading components

The operator places the barrel, plunger rod and finger flange or backstop into the machine. Once the cycle has started, the indexing table automatically positions the products to the next process step.

2. Assembly of the plunger rod

Depending on the product design, the plunger rod is fitted using a push-in, rotational or torque-controlled movement. During this step, torque and force are continuously monitored to ensure optimum process control.

3. Fitting the finger flange or backstop

The finger flange or backstop is precisely fitted to the syringe. After assembly, the finished product is ejected and can be removed immediately by the operator.

Key features

Torque-controlled assembly of plunger rods
Continuous monitoring of force and torque values
Automatic fitting of finger flanges or backstops
Suitable for glass and plastic injection moulding
Flexible tooling for multiple PFS formats
Recipe-controlled product changeovers
Manual loading and unloading of components
Compact, cleanroom-compatible design
Expandable with vision inspection and data logging options

Optional modules and quality control

Depending on the application, the SAP-M can be expanded with additional modules and quality controls:

Finger flange or backstop assembly
Rotational alignment of finger flange and plunger rod
Vision inspection
Axial and radial force measurement
Reporting and audit trails in accordance with 21 CFR Part 11
Safety device assembly
Electrically height-adjustable frame
Two-hand control
Data logging and process monitoring

Curious to find out whether SAP-M fits your production process?

Our specialists will be happy to help you determine the right configuration for your application and production environment. Please contact us for further information or a demonstration.

Why choose GTE Engineering?

GTE specialises in designing and producing tailor-made machines for the medical and pharmaceutical industry. Based on your specific needs, we’ll work together on the solutions to the issues you’ve run into.

Curious about what we could do for you?

Learn more about GTE here

Project Management

SLA & Maintenance

Documentation

Risk management

Consultancy / URS

Quality control

Sustainability

Spare parts / Tooling