Rommelag BFS Ampoule Inspection Systems

Rommelag ENGINEERING offers a suite of solutions for reliable and automated inspection of purpose formed Blow Fill Seal (BFS) plastic bottles, vials and ampoules produced on its Bottelpack systems.

These various inspection systems can be seamlessly integrated into the production process to check the quality of BFS containers as they are formed, aseptically filled and sealed.

Ampoule Inspection System (VIM)

The Rommelag Vial Inspection Machine (VIM) is a fully qualified and validated Process Control system that operates fully automatically. This allows the system to offer comprehensive tools to measure the critical quality attributes (CQA) of the primary package. Regardless whether freshly produced ampoule blocks are introduced manually or automatically, Process Control makes primary checks on fill and ampoule weight. It further measures the wall thicknesses on any predefined positions, accompanied by accurate determination of ampoule opening and separation forces with consistent absolute precision, with each check associated directly with mold and cavity number.

All checks take place unattended, even for automatic correction of the fill quantities in the bottelpack machine.

The VIM accepts blocks from different production lines and creates sophisticated electronic batch reports free from human variabilities. This means Quality Control of the production process that is seamlessly integrated with instantaneous, attributable data values, with electronically signed variations and exceptions securely documented.

High-Voltage Leak Detector (HVLD)

The Rommelag High-Voltage Leak Detector is a non-destructive, fully automatic container closure integrity (CCI) testing machine on critical areas of bfs containers. As an inline machine the HVLD can be supplied turnkey with a bottelpack system, but works also stand-alone.

The HVLD offers the easiest and fastest way to furnish legally required proof of demonstration for pharmaceutical product integrity. Depending on the shape and design of the containers and on product conductivity, up to 35,000 containers or 5,000 ampoule blocks can be inspected per hour. Containers with leaks are immediately ejected, with records maintained by the system, minimizing production risks and enhancing quality control (QC).

Automatic Particle Inspection Machine (PIM)

Integration of an Automatic Particle Inspection Machine into the bottelpack system’s follow-up processes can ensure that every product that reaches the patient is free of visible particles and cosmetically intact.

The qualified and validated PIM inspects individual containers or blocks of ampoules in all conceivable shapes and sizes, using multiple camera systems dedicated to specific areas of a container. These capabilities combine to ensure quality of the production process. The modular design of the PIM features non-destructive testing, an innovative vibration system for particle detection without need to rotate containers. It can reliably detect floating or suspended particles in liquids and particles trapped in or on the container walls. Defective lots are rejected automatically, sorted by defect category if required.

Cosmetic Inspection Machine (CIM)

The state-of-the art Rommelag Cosmetic Inspection Machine (CIM) provides customers with the highest level of automated visual inspection currently available, both for material imperfections and integrity of form. The CIM system can reliably and consistently detect any formation defects, surface impurities, such as spots, discoloration, imbedded particles, and printing flaws.

Incorporating Rommelag PIM for automated particle inspection for injectable drug product or the CIM for container quality inspections in the production process will consistently outperform any kind of human inspection for quality and cost. When combined with HVLD technology for high speed automated inspection of BFS ampoules and vials for leak detection, this automated Rommelag ‘inspection team’ can provide the key element in modern process automation.