ELab Filler: Software (Medical/LifeScience) and Variable configuration Challenges
The Project Within: modular software environment
Let’s take a closer look at the modular software environment within the E-Lab Filler system.
Each module has been developed based on real feedback and operational needs collected over the years from our clients across various regulated sectors, ensuring readiness for even the most specific and emerging requirements.
The software architecture follows GAMP 5 guidelines, making it proactive toward any potential CFR 21 compliance requests.
It is accessible directly from the machine by operators with different roles and access levels, as well as from authorized network-connected devices.
We designed an interface that is simple, intuitive, and user-friendly, so that it can be used by anyone — not just technical staff or specialized operators.
The system supports a wide range of applications: from hospital-based filling operations to beauty industry packaging, and of course, to ISO 5 laminar flow environments for the preparation of medical devices, and, in the near future, pharmaceutical products.
E-Lab Filler is an integrated hardware and software platform designed for the control, traceability, and digital documentation of filling and packaging processes in regulated diagnostic and medical environments.
The system ensures Data Integrity, complete traceability, and smart automation integrated with mechatronic and vision components.
Our know-how builds on extensive experience in the automation of filling processes through SmartFiller machines, developed for filling luer-lock syringes for the European and U.S. markets.
The final device was typically subject to terminal sterilization (steam or gamma) and contained 0.9% saline solution, classified as a Class IIb or III medical device, depending on its intended market.
In such cases, the need for full process control and traceable production history was a mandatory requirement.
Our clients required: recipe validation and continuous process validation in line with each approved recipe.
The work order created by the production manager defined the recipe, the quantity, and automatically included all variable data associated with the batch and printed on the label.
The software tracked the complete lifecycle of each syringe — from filling to release or rejection — with all records stored both locally and in a dedicated repository.
Access control and role management, following defined hierarchies and permissions, are essential to maintaining system integrity in accordance with international standards.
ELab Filler: Filling of very variable Diagnostic Medical Devices
The Project Within: Configuration challenge
The most typical case studies involving E-Lab Filler systems concern the filling of diagnostic medical devices.
Here too, regulatory and customer-driven requirements have become increasingly strict, focusing on automated control and complete traceability of every production event.
Automation demands have evolved significantly: for instance, the ability to acquire a QR code directly from the system to log in, or to automatically upload authorized work order data when the process is not directly managed by a corporate MES or ERP.
At the same time, machine configuration interfaces have become more customizable, as clients now require the management of many different product types on the same machine.
Flexibility and Scalability Requirements.
Manual loading of very small round vials (5–8 mm), with fully automatic uncapping, filling, and recapping.
Manual loading of cylindrical vials containing internal paddles or similar components attached to the cap (e.g., DNA RNA Shield fecal collection tubes), again with fully automatic uncapping, filling, and capping.
Manual loading of complex-shaped bottles for specific analytical purposes, also managed with fully automated operations.
Productivity Challenges
As productivity increased, clients requested automatic component loading while maintaining compact, plug-and-play systems with auto-configuration capabilities.
We therefore developed stand-alone benchtop stations, which can be configured for either fully automated or semi-manual operation as needed.
As you can imagine, the software complexity behind such flexibility is considerable — yet the result is a smart, intuitive, and robust system architecture.
There are applications where even the most efficient Step Feeder reaches its natural limits.
When instant changeover, wide component compatibility, or multi-part assembly are required, for example when both vials and their caps must be transported and loaded, or when syringes and plungers need to be handled and assembled directly on the machine, the Step Feeder alone may not be the optimal solution.
In these cases, productivity and efficiency can be affected if components have significantly different geometries, materials, or feeding behaviors.
That’s why we decided to take a step further, integrating flexible feeding technologies designed to adapt dynamically to each product configuration.
Working closely with our customers, we evaluate the best feeding strategy for each project.
ELab Filler: Modular Architecture and Advanced Features
The Core of E-Lab Filler Intelligence
At the heart of the E-Lab Filler ecosystem lies a software platform engineered to bring compliance, automation, and scalability together in a single, seamless environment.
Designed for regulated medical production, it combines data integrity, process efficiency, and intuitive usability, ensuring that every batch, every fill, and every record is managed with precision and confidence.
Technology Pillars
Compliance First
Built on international standards such as GAMP 5 and CFR 21 Part 11, the platform ensures full role-based access control, audit trails, and synchronized timestamps.
Every action is traceable and authorized, maintaining the highest levels of data integrity and regulatory compliance.
Smart Automation
The system’s intelligence adapts to your process. Automatic machine configuration, guided changeover, and an AI-driven vision system for cap, fill, and closure verification guarantee reliable results and drastically reduce human error.
Cloud Ready
Through secure cloud connectivity, operators and managers can monitor equipment remotely, manage machine fleets (FARM), and synchronize data with ERP or MES systems.
Multi-site management and predictive analysis keep your production connected and always under control.
Scalable by Design
Whether managing a single batch or an entire production line, E-Lab Filler grows with your needs.
Each module can be activated independently, creating a scalable ecosystem that evolves with your workflow.
Modular Architecture: Tailored to Your Process
Base Module:
Production setup and single-batch management
Recipe editor for machine, pump, and material parameters
Automatic loading of configurations (vials, caps, carousels, and other changeover components)
Optional Modules / Premium Functions
Access Control & Audit Trail: hierarchical roles, e-signatures, and full event logging
Work Orders / eBR: electronic batch record with SOP attachments and work order management
AI Vision & Quality Check: intelligent camera verification of cap presence, fill level, and packaging integrity
Weight & Calibration Integration: dedicated scale interface for offline calibration and batch verification
Labeling & Serialization: dynamic label management compatible with any printer; UDI, variable data, and unique serials
Serial types: manual (with uniqueness check), random, progressive, or imported from external files
Multi-Project Support: isolated databases for independent project configurations
Remote & Cloud Management: cloud-based control, analytics, software updates, and group (FARM) management
Integration Hub: open communication via APIs, OPC UA, and ERP/MES/LIMS interfaces
Reporting Suite: fully customizable reports, exportable in multiple formats