Type of innovation: System
Innovation leader: Grifols i Lucas, Víctor
Maintaining the sterility of plasma-derived products–or indeed any substance that 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 this invisible threat and control the risk of particles entering the container. This procedure means that the filling process is more reliable and helps improve the safety of plasma medicines.
“The environment is full of particles that we cannot see, and they all have the potential to contaminate any intravenous product, including plasma medicines.”
Three vital elements
The system comprises three key elements: the vial that will receive the medicine, a rubber stopper that 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.
Two factors help to maximize 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.
Grifols Sterile Filling
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- Grifols, S.A. (2011). ¿Y si lo hacemos así? Patentes de Víctor Grífols i Lucas. Barcelona: Grifols, S.A.
- Avellà, R., & Miquel, B. (Eds.). (2015). Cuando un sueño se cumple. Crónica ilustrada de 75 años de Grifols. Barcelona: Grupo Grifols, S.A.