The customer: Vetter Pharma-Fertigung GmbH & Co. KG, Deutschland

Validated cleaning processes
Validated cleaning processes: Washing processes ensure high quality when manufacturing aseptically prefilled application systems (Source: Vetter Pharma - Fertigung GmbH & Co. KG, Ravensburg)
  • The company supports its international customers throughout the process from initial product development to clinical and commercial filling of syringes, cartridges and vials, and beyond to diverse packaging solutions. The clients are internationally active pharmaceutical and biotech companies.
  • The pharmaceutical services provider employs around 4,500 workers internationally at its sites in Germany, the USA, Singapore, Japan and South Korea. Ravensburg in Germany has been the company headquarters ever since its founding in 1950.
  • The company has numerous patents, including the Vetter Lyo Ject® dual-chamber syringe and the V-LK® dual-chamber cartridge.

www.vetter-pharma.com

The Requirements:

In the course of building a new system at its Ravensburg site, Vetter needed sterile pumps for use in PW/WFI storage and distribution systems (PW= Pure Water; WFI = Water for Injection).

The Vetter engineers established a comprehensive requirements profile for the new pumps:

  • Hygienic design
  • CIP/SIP capability
  • Fully self-draining, with no residue
  • Maximum system availability and process reliability
  • Low noise emissions
  • High efficiency
  • Documented qualifications for the system components
  • Good support and service from the supplier

The Solution:

In order to minimize the risk of downtime and guarantee maximum availability, Vetter preferred to rely on brand-name manufacturers for the installed pumps. Sterile pumps from GEA Hilge’s CONTRA range are central components of the aseptic filling process for WFI distribution systems (water for injection).

The pumps can be supplied in a number of variants, which makes them ideally suited for integration in a system layout. The selection includes both single-stage or multistage designs for horizontal or vertical installation with a standard motor. Casings made of various materials are available for all designs and can be provided with application-specific surface finishes. All seals on the casing and impellers have a gap-free design with a defined metallic stop. Effective cleaning of wetted components is guaranteed by the gap-free construction of all components within the pumps, in combination with a dead-space free design and open construction for the impellers and diffusor casings guide vanes.

GEA Hilge CONTRA pumps are manufactured from pore and blowhole-free materials (deep-drawn rolled steel and forged steel) in quality 1.4404/1.4435 (316L). Deep-drawn materials are used for the diffusor casing and the impellers, pressure stages and suction covers are all made from forged materials of equivalent quality.

The forged impellers are milled into shape, which not only ensures a high efficiency but furthermore guarantees an excellent NPSH value — and also guarantees that the pump runs evenly and quietly, something many operators value as a mark of quality.

The vertical design used for the pumps installed in the Vetter plant has been tested and certified for compliance with the EHEDG. The GEA Hilge CONTRA pumps are fully self-draining through the suction port, which guarantees safety for sterile process management.

Customers Statement:

Thomas Otto, Managing Director at Vetter
Thomas Otto, Managing Director at Vetter

Our field, ‘Commercial Manufacturing’, covers the complete production process, from the ingredient solution concept to aseptic filling and beyond to assembly. High-tech suppliers such as GEA are essential to us — their hygienic pumps ensure high product quality and system availability” - Thomas Otto, Managing Director at Vetter

Назад