groninger Vial filling machine

Processing vials in bulk

Aseptic processing of vials: groninger lines for all output ranges.

Vial filling machines: Washing, sterilizing, filling and closing

groninger vial filler machines are equally suitable for small and large batch filling, for product development and for clinical studies. Whether you operate commercial production or supply vaccination campaigns, our lines make it possible to cover all output ranges from 50 to 600 units per minute (3,000 to 36,000 per hour) with maximum flexibility.

Our innovative automatic vial filling equipment is developed to be used in sterile areas or clean rooms, in compliance with the cGMP requirements. The areas of application inside the pharmaceutical industry are diverse: vaccines and biologics can be filled as well as cell and gene therapies, regardless of whether they are single or multi-dose products.

The cutting-edge technology of our groninger vial fillers enable the processing of a large number of different products: with the Quickconnect system, for example, format changeover can be carried out on the entire line without having to use any tools. If needed, it can also be done with an electronically guided installation aid.

Depending on requirements, process steps such as sterilization, freeze-drying and external cleaning can be integrated. This means that aseptic, toxic processing on groninger lines up to a level of OEB5 or BSL2 is also possible.

Processing of vials in bulk
Processing of vials with one filling head

Process steps of our vial filling machines

Washing

For aseptic processing, the vials are fed into the machine via a buffer to be washed and then sterilized.

In recent years, groninger has optimized the washing process through extensive tests and CFD studies and established it as a machine standard. Consequently, vials are efficiently cleaned on the inside and outside on our lines. After the up to 3-log reducing cleaning, the vials are dried and transported to the subsequent process, generally being sterilization.

Washing vials in bulk
Washing machine for washing and drying vials

Sterilizing

Our sterile process is designed to carry out gentle yet effective sterilization to a large extent; at the same time, the corresponding line areas are very easily accessible because they can be accessed from both sides, allowing it to be cleaned without any problems.

The new type of sterile tunnel developed by groninger works with gentle heating of the objects in the entry area to the sterilization area. The object itself is subject to only a small temperature difference, which means that overkill in the sterile process can be avoided. High-end sterile filters guarantee the highest quality in this process.

Sterilization of vials
Sterile tunnel for sterilizing vials

Filling

The filling process shows how versatile groninger vial filling machines can be used – vaccines, viral vectors, orphan drugs, cell and gene therapies, sensitive proteins and biosimilars, biopharmaceuticals, generics, veterinary products, but also cosmetic medicine products are among the liquid products which can be safely processed.

We have vial fillers for a variety of different products from thin to viscous – water-like or WFI-based products, solutions. Quickly settling suspensions are just as much a part of this as products that require reliable cold filling.

The supply of pre-sterilized packaging containers may take place via an upstream sterile tunnel or via a ready-to-use supply. For quality assurance, the containers can be inspected in advance by cameras and subsequently sorted out should there by any defects.

Other integrity tests such as PUPSIT (Pre-Use-Post-Sterilization Integrity Test) can also be performed to meet the latest Annex 1 requirements. Clean-in-place or sterilization-in-place (CIP/SIP) is also possible on groninger lines.

When it comes to aseptic liquid filling, groninger relies on proven filling technologies, e.g.,

  • rotary piston pump (RKP),
  • peristaltic pump (PP) and
  • time pressure filling systems (TPF).

Of course, product-relevant tasks such as product mixing, recirculation or product filtration can be carried out on the filling path. To avoid cross-contamination, the fill path can be set up as a single-use fill path.

A 100% In-Process-Control (IPC) is now standard for groninger filling machines and is increasingly replacing the Statistical In-Process-Control (IPC). This also includes weighing the objects before and after filling to be able to check the filled content precisely. At the same time, groninger Smartfill technology minimizes product loss during the filling process, both of which save you work, material and consequently money.

Filling vials on a linear machine
Processing of vials on a linear solution with one filling head

Closing

We also ensure highest quality when it comes to closing objects, particularly, making sure that no unnecessary particles get into the product, as well as great flexibility and process reliability. groninger lines process a large number of different stoppers, including the relatively young push-on caps for vials.

To enable maximum flexibility, we limit the number of closure size-dependent sorting and feeding formats. Omitting vacuum-controlled lines makes cleaning, in particular, much easier. However, our stoppering systems are also easy to maintain and look after due to their sophisticated ergonomics and the good accessibility of all individual parts.

For the processing of sensitive products, the "headspace" can be gassed in a container to reduce the residual oxygen level to less than 1%. 

To further minimize product rejects, our vial filling machines can be designed with a re-stoppering function, allowing to the loss of a stopper to be compensated by repositioning it.

Closing of vials
Stoppering vials

Freeze drying

Freeze drying can extend the shelf life of many liquid medicines. The active ingredients remain intact and retain their effectiveness.

We have already integrated freeze drying in numerous lines. How exactly this process works, how it is mechanically and electrically integrated, is something we explain in detail for each project based on the specific requirements.

With a combined liquid and lyo line, a connection to the freeze dryer can be a great solution in a very space-saving manner. At the same time, it reduces the complexity of the isolator, which facilitates the changeover from the freeze-drying process to a liquid filling and closing process and reduces set-up times.

Connection of a freeze dryer
Integration of a freeze dryer into a groninger filling line

Sealing

For liquid pharmaceuticals, vials can be sealed within one line or immediately afterwards on a separate, compact machine. Our capping process easily meets the requirements of EU GMP Annex 1 – this is a groninger standard.

groninger relies on the patented, very proven and low-particle single-disc sealing principle. That means, all vials are closed with an adjustable and non-slip closing disc. This is done in various performance classes from 10 to 600 objects per minute with extreme process reliability. An optional extraction makes it possible to further reduce even the already low number of particles.

Compared to other solutions with several sealing discs, the line can be changed over much more quickly, and faults can be detected immediately; overall, it reduces the process risk significantly. Vials with poorly-fitting stoppers can be rejected prior to the sealing process.

Sealing of vials
Process for placing the aluminium caps and sealing the vials

External cleaning

When processing toxic products, operator protection is a top priority in addition to pure product protection. That's why we attach great importance to the fact that vials filled with these drugs – in liquid form or as a powder after a freeze-drying process – are reliably cleaned on the outside.

With our extensive portfolio in the field of exterior cleaning, we are able to offer the right system for your product as well.

External cleaning of the vials for product and operator protection
External cleaning of the vials for product and operator protection

Coding

It must be able to track or sterilize individually produced products. For this reason, printing is important to code the individual object; it is the only way to track the product life cycle.

On the groninger lines, coding is not an independent process, but rather a solution integrated into the lines. Individual objects can usually be printed using an inkjet or engraved using a laser. Inkjet printing can also use UV ink, which only certain light sources make it visible.

The information required for coding is delivered securely and reliably to the printer and the inspection system.

Tray loading

At the end of the entire process chain, the objects are collected in a tray for storage. groninger offers easy-to-use solutions for storing the objects piece by piece, either in a tray system or very gently by pick & place.

To make the system easier to use, we introduced a tiltable drawer system; this allows for extremely user-friendly closing of the plastic or metal trays.

Gentle storage of the vials
Gentle storage of the vials