It all began with the pump
Special machines for filling parenteral medication

The process used to fill medicine
into vials or syringes has to be
fast and reliable, but modular
design is also important so that
the process can be tailored to
meet the needs of the user.

The invention of the rotary piston pump in 1980 (patented in 1982) by company founder Horst Groninger laid the foundation for Groninger in Crailsheim, Germany, and the company still relies heavily on this technology today. During a single 360° rotation around the stationary piston, the pump housing is lowered and raised to create the suction and ejection action. The fit between the high-precision piston and pump housing is accurate to within 10 µm, so there is no need for seals. The medium itself performs this function.
Disposable syringes
Systems for handling pre-sterilized syringes are one of Groninger’s main product lines. These systems have obvious advantages. Pharmaceutical producers can shift the sterilization risk to packaging producers and save the cost of systems used for washing, siliconizing, assembling and sterilizing syringes in the production process. Application of parenteral medication by doctors or medical staff is also easier and safer, because in contrast to the use of ampoules:
disposable syringes pose no risk of injury to users;
there is no need to cut open containers;
no glass particles can contaminate the parenteral medication;
emergency medical teams save time and lives because the medicine can be used immediately and
the risk of mixing up medicines is significantly reduced.
Pharmaceutical producers also achieve higher yields. Vials or ampoules require overfilling of up to 23%. The excess needed for disposable syringes is only 2%, so a significantly higher number of doses can be produced from the same volume of material. This can significantly increase profits when very expensive medicines are involved such as biotechnology products. Groninger can offer special solutions for parenteral medication which has to be filled in special conditions. The company has developed a vacuum filling system (which is now patented) for filling and closing high-viscous pharmaceutical products into disposable syringes. The syringes are used primarily during eye operations. In these operations, it is critical that there are absolutely no air bubbles in the medicines that are used.
Groninger also offers a complete range of machines for handling disposable syringes. The company can provide everything from assembly and filling machines to closing and labeling equipment. The company’s customer base includes packaging manufacturers as well as pharmaceutical producers. Groninger supplies systems for placing, cleaning, sterilizing, siliconizing and assembling components. The disposable syringes are placed in trays and put into sterile packaging. The pharmaceutical producers then fill, close and label the syringes using machines supplied by Groninger.

From feeding to labeling
The systems for filling and closing
pre-sterilized syringes (DFVN 2000/
5000/10000) give users considerable flexibility. Glass or plastic or a combination of the two can be used depending on the reactivity of the active ingredients. Filling and stopper insertion can be performed in a vacuum or in an oxygen-free environment.
Output of up to 24,000 syringes per hour, sizes between 0.1–100 ml and the use of the Groninger barrier system for absolute separation of the aseptic zone from its surroundings are only some of the highlights that this series has to offer.
Companies that perform filling on a job contract basis particularly appreciate the flexibility that these systems offer. These companies have to constantly switch between the various syringe systems of a number of pharmaceutical companies. In addition to the individual machines, Groninger offers complete line solutions for disposable syringes, covering the entire spectrum from feeding to labeling.
Groninger also supplies a wide, flexible range of systems for the following applications:
cleaning,
sterilizing,
filling,
filling and closing,
labeling,
assembly of syringecomponents,
handling devices used to automate the entire process,
isolator technology and
complete “turn-key-solutions”.
Groninger can also offer a lot more to its customers than systems alone. The company provides qualification and validation documentation, and a large portion of the qualification work can be performed directly by Groninger. This includes generation of a “Validation Master Plan” as well as planning and execution of FAT, SAT, calibration, design review, IQ and OQ.
Cleaning and sterilization
Low noise, GMP-compliant cleaning machines for vials, bottles, cartridges and syringes cover the filling volume range
between 0.1 and 1000 ml, and they are very gentle on the products.
Because the systems are very flexible, they can be easily integrated into compact systems, and they can be fitted with feed and transfer equipment. The modular design enables users to quickly make size parts changes. If needed, the cleaning machines can be equipped with a siliconization unit or ultrasonic cleaning station and a recycling station.
Sterilization tunnels guarantee that the process runs safely and is reproducible. These machines use hot air or radiation to perform GMP-compliant sterilization or depyrogenation (ISO Class 5/ISO 146441) of vials, cartridges, syringes and infusion containers.
They meet the requirements of class
100 cleanrooms and the air purity classification that applies to the production of sterile pharmaceuticals (class A cleanroom). Because rapid sterilization is used, process validation and complete in-process control are feasible.
Filling and closing
The range of filling machines extends from small semi-automatic filling machines to fully-automatic high-performance systems. They can be used to handle high-viscous, crystalized, low-viscous or aggressive media. The machines offer high flexibility for metering applications, and they are able to efficiently handle nearly any type of glass or plastic objects in the 0.15–1000 ml range.
In-line sterilization can be performed during sterile filling without the need to remove pumps and needles. The filling and closing machines are designed for a wide range of filling applications involving cold, hot, aqueous, oily or high-viscous media. They are very flexible and can be used for filling, inserting stoppers, placing caps, screwing-on, crimping and loading glass and plastic bottles into magazines.
The closing machines are designed for universal use with round, flat or formed glass. They are very efficient and long wearing, and they can be used for stoppers, droppers, pipettes, spray pumps, dispenser, screw-on caps as well as crimp and PP seals.
Use in isolator applications is also possible, and this offers the pharmaceutical industry new ways to improve production reliability and reduce cost. Groninger was quick to recognize the potential of this technology and introduced a vial filling machine which complies with isolator requirements in 1994. The company developed a microbiological barrier system which provides absolute separation
between the aseptic zone and the surrounding area during the processing of pre-sterilized disposable syringes.