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Grifols Sterile Filling (GSF) system

Minimizing a serious risk

Technical file

Innovation leader: Víctor Grífols i Lucas

Year: 1989

Period: The American influence (1960-1994)

Type of innovation: Technical procedure

Scope: Bioengineering

Patent: Yes

Geographical reach: International

Economic impact:  2-Medium

Level of innovation:  1-Disruptive

Interdisciplinary connections: -

Related innovations: -

Maintaining the sterility of plasma-derived products–or indeed any substance which is introduced into the bloodstream–is absolutely vital to maintaining the health of the patient. But it is a challenge. The environment is full of particles that we cannot see, and they all have the potential to contaminate any intravenous product, including plasma medicines.

 

Countering the invisible threat

A key stage in production and distribution where plasma medicines are vulnerable to particle contamination is when they are being transferred to vials and other containers.

The Grifols Sterile Filling System (GSF) helps to counter the invisible threat and control the risk of particles entering the container. This unique procedure makes filling bottles with a sterile product more reliable, resulting in safer plasma medicines

 

Three vital elements

The system comprises three key elements: the vial that will receive the medicine, a rubber stopper which limits particles entering the vial immediately before the filing procedure, and the plastic cap for safety sterilization.

All three elements are sterilized simultaneously. Then the cap is removed and the vial is filled in an environment that prevents particles from entering. Once filling is completed, vials are sealed and encapsulated to maintain sterility.

 

A uniquely sterile system

Two factors help ensure ours is one of the most reliable systems in terms of guaranteeing sterility. First, Grifols uses a horizontal laminar air flow, which blows any particles away from the vials which are being filled. The second is that the process keeps the time during which the vial is open to the air to the absolute minimum necessary to fill it with medicine.

GSF

Grifols Sterile Filling

A unique procedure for filling vials of plasma medicines with sterile product

 

Bibliography

  • Grífols i Lucas, V. (2009). Amb un suro i un cordill. Vivències d'un empresari de postguerra. Barcelona: Grífols Group, S.A.
  • Grifols, S.A. (2011). ¿Y si lo hacemos así? Patentes de Víctor Grífols i Lucas. Barcelona: España.
  • Avellà, R., & Miquel, B. (Eds.). (2015). Cuando un sueño se cumple. Crónica ilustrada de 75 años de Grifols . Barcelona: Grupo Grifols S.A.