THE CABINET

Intravenous solutions

Vital solutions: How secondary products took center stage

Technical file

Type of innovation: Fluid therapy

Scope: Hospital Pharmacy

Innovation leader: Grifols i Lucas, Josep Antoni Grifols i Lucas, Víctor

Year: 1952

Period: 1909-1971

Geographical scope: Spain

Economic impact: High

Level of innovation: Adaptive

Patent: No

Interdisciplinary connections: Dye manufacturers

At first, Laboratorios Grifols developed intravenous solutions only to be able to conserve the blood that was stored in the blood bank, which was the main basis of its activities at the time.

The blood bank needed a steady supply of acid-citrate-dextrose solution to ensure the donated blood did not coagulate. Furthermore, that solution had to be guaranteed free of pyrogens: agents that can produce fever when injected into patients.

“Initially solutions such as glucosaline simply met Grifols internal needs, but it became apparent that there was a burgeoning market for them as products in their own right, and manufacture was ramped up.”

A double challenge

The challenge then was not only to manufacture acid-citrate-dextrose, but also to develop the ability to prepare non-pyrogenic solutions in order to avoid potentially dangerous secondary effects on patients.

Ensuring solutions are non-pyrogenic effectively means making them totally sterile, and this is usually done by heat treating them under pressure. Now routine, such a method for sterilizing has not always been so straightforward. 

The industrial production of the intravenous solutions used by Grifols was fairly primitive and used an autoclave bought from a dye factory to achieve the high temperatures and pressures required. But it was effective and reliable, and successfully produced glucosaline in May 1952.

A new business opportunity

Initially solutions such as glucosaline simply met Grifols internal needs, but it became apparent that there was a burgeoning market for them as products in their own right, and manufacture was ramped up.

In the early 1970s, production was moved to the company's Parets del Vallès factory, and in 1987 several studies were carried out to change the storage of the solutions from traditional glass bottles to plastic bags.

And a new material

The move to plastic came about because the company foresaw that PVC bags would play an increasingly important role, an insight which was roundly vindicated. A range of challenges had to be overcome in order to ensure the safety and practicality of plastic bags first, however, there were still difficulties in perfecting the filling process. This was overcome with a machine which had been custom designed by Dr. Víctor Grifols i Lucas.

Bibliography

  • Laboratorios Grifols, S.A. (1946). Procedimiento de obtención de aminoácidos de aplicación parenteral. Patente española de introducción, no. 172.813. Madrid: Oficina Española de Patentes.
  • Laboratorios Grifols, S.A. [ca. 1955]. El recambio hidromineral en el organismo y el tratamiento de sus alteraciones con las soluciones de hidratación parenteral. [Sales brochure]. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Laboratorios Grifols, S.A. [ca. 1960]. Manejo de nuestros frascos con dispositivo de inyección gota-a-gota. [Sales brochure]. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Laboratorios Grifols, S.A. (1969). Estudio de mercado sobre las soluciones parenterales en España. Unpublished manuscript. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Laboratorios Grifols, S.A. (1969). Soluciones parenterales. [Sales brochure]. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Grupo Grifols, tres compañías en la vanguardia de la hematología: Laboratorios Grifols, S.A.; Dade-Grifols, S.A. y Gri-Cel, S.A. (1974, June 11). Telexprés, 22-23.
  • Diario de Barcelona. (1975, March 30). Especial Parets del Vallès. Suplemento dominical del Diario de Barcelona, 1-3.
  • Laboratorios Grifols, S.A. (1980). Propuesta de normativa y documentación de control de la producción de soluciones parenterales. Unpublished manuscript. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Laboratorios Grifols, S.A. (1981). Boletín informativo del Grupo Grifols. Unpublished manuscript. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Laboratorios Grifols, S.A. (1982). Precios comparativos de soluciones parenterales de distintas fábricas. Unpublished manuscript. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Dilloway, K.P., & Akers, J.P. (1987). Report on survey of current practice employed for sterility test sampling of aseptically filled products. Journal of Parenteral Science & Technology, 41(6), 207-209.
  • Guilfoyle, D.E., &, Yager, J.F. (1984). Procedures used for sterility testing of parenteral drugs by an FDA Field Laboratory. Journal of Parenteral Science and Technology, 38(4), 138-147.
  • Grifols-Lucas, V. (1988). Informe interno sobre las compañías que integran el holding Grupo Grifols. Unpublished manuscript. Barcelona: Hemobanco de Laboratorios Grifols, S.A.
  • Rodríguez, J. (1995, January 23). Una empresa catalana abre el primer laboratorio farmacéutico de la Región: "Grifols" se dedicará a la elaboración de soluciones intravenosas. La Verdad, 16.
  • Grifols-Lucas, V. (2009). Amb un suro i un cordill. Vivències d'un empresari de postguerra. Barcelona: Grupo 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.