...after ACHEMA

31/07/2015
Parma, Italy

...after ACHEMA

G.F. has been active in industrial automation since 1979, designing and manufacturing machinery for the quality and process control in the pharmaceutical and beverage sectors.
All project and manufacturing steps, from the study of the user’s technical specifications (URS) to the equipment final testing are managed directly by the G.F. Technical Department, to guarantee total quality and delivery compliance.
 
The core competences of G.F. apply to inspection machines, filling lines & related equipment, and complete ISBM systems.
 
Always attentive to technological innovation, G.F. invests its resources in the research and development of new products and processes, choosing the most reliable and advantageous market proven solutions.
 
The last ACHEMA exhibition, held this year in Frankfurt from June 15th until June 19th, was a shop window for one of the latest G.F. developments:
the VFM Manipulator 200 filling and capping machine specially designed and built by G.F. around the demands of one of our customer.
 
The following equipment would compose the complete cartridges line, configured to handle 1.8 ml cartridges, not available in nests:
 
-          Rotary Washing Machine
-          Hot air Depyrogenation Tunnel
-          Robotic Filling and Closing Machine
-          Automatic Particulate Inspection Machine
 
Cartridges are supplied to the filling and closing unit from two different sources:
 
·         from an autoclave in case of plastic (PP) cartridges
·         from the depyrogenation tunnel for glass cartridges
 
Downstream the depyrogenation tunnel cartridges are in vertical position with the mouthpiece facing downwards.
The first operation carried out by the machine is crimping, so to close one end of the two sides open container.
After crimping, cartridges and turned upside down by means of anthropomorphic robot that picks and places them into a pocketed conveyor belt. Then, they are moved to the filling and closing station. Stoppers can be inserted with or without vacuum provision.
After closing, a second anthropomorphous robot picks and places the cartridges into a discharge tray, this time with the mouthpiece complete with the aluminium seals facing upwards.
The same machine is also provided with a control station to verify that the closing operation has been carried out correctly.
Once finished cartridges are collected in trays, they are moved downstream the line to the optical inspection unit.
 
While talking about inspection…
“The presence of particulate matter in intravenous injections represents a potentially life-threatening hazard”.
International Pharmacopeia’s guidelines state that, prior to dispensing, all containers of parenteral preparations have to be inspected to the extent possible for the presence of visible foreign and particulate matter in their contents. Also, containers have to be tight to prevent alteration to their physical properties.
G.F. Spa manufacture a complete range of optical inspection machines designed and built based on a long standing experience in mechanical handling and control systems, while ensuring a constant commitment to keep up with the fast development of visual and optical devices to finally guarantee high performances and consistent detection results.
Developed to process ampoules, vials and cartridges filled with sterile products, the A&V Series of fully automated inspection machines represents the ideal solution to comply with GMP requirements and to ensure that injectable products are “essentially free of contamination”.
A&V Series machines combine multiple control stations and different lighting sources and techniques, with optimal mechanical handling and transport systems. Servomotor drives are largely used to finally tune the container spinning speeds and the relevant motion patterns. A neat design and structure allow easy cleaning of all working surfaces and direct access for maintenance operations. Changeover is rapid and simple thanks to pinned and quick-release parts.
Powerful image processing hardware and tailored up detection algorithms and programs are integrated in a sound inspection system to enhance detection capabilities and to limit false rejection rates.
In the standard execution of the A&V Series machines, each container is inspected at least three times for particles. If deemed necessary, a fourth station can also be installed.

The inspection process basically consists of the following operations:

  1. upon being loaded in the main carousel, the container is rotated at high speed and then abruptly stopped;
  2. the solution keeps rotating by its inertia, so do particles;
  3. TV cameras move synchronized with the container transport system while a sequence of images is taken;
  4. the different images are processed by the subtraction method to reproduce the particle motion path:
  5. a number of inspection parameters are set and considered to finally accept or reject that specific container.
Only moving particles are detected, while idle marks on the container surface (like printed information or logo and scratches) are ignored.
More lighting techniques are used to enhance and detect particles of various origin and nature.
Usually, the light scattering method against a dark background (Tyndall effect) is adopted for glass and similar high reflective materials.
The light transmission method (shadow detection) is instead used for fibres or low reflective bodies like rubber from the vial stoppers or carbon particles in ampoules.  
Light polarization can be also implemented to limit false rejection because of the presence of air bubbles trapped within the product.
Images and light signals can be focussed in specific areas of the container so to narrow down the inspection depending on the specific motion behaviour of particles of different materials and sizes.
Other than particle inspection, A&V Series machines provide the so-called “cosmetic” or functional controls, meaning by that the whole categories of checks for faults and defects relevant to the container itself and its closure. These are carried out to ensure the safety of the product.
In this case we need to further differentiate between “static” and “dynamic” checks. During a static check the inspection is carried out while the container is in a fix position; conversely, during a dynamic check the container rotates at low speed.
Single or multiple image processing as well as different lighting techniques are used as consequence in function of the properties of the fault to be detected.
 
In addition G.F. integrates the MONOBLOC system. This is a complete and compact modular solution to achieve 100% optical inspection and leak detection of pharmaceutical products.
Monobloc machine can also integrate rinsing modules to wash and dry the containers externally.
G.F. can integrate leak testing modules to ensure the integrity of both glass and plastic containers. Leakage prevention is a major concern when it comes to patient safety.
The testing procedure consists of the following steps:
-          Container positioning under a pressure head
-          Creation of a hermetically sealed environment
-          Vacuum application
-          Pressure variation monitoring
As alternative, high voltage leak-testing system can also be provided.

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...after ACHEMA

31/07/2015
Parma, Italy