Homogenization of Vaccines

Pharma application — Intraveneous

Since the late nineteenth century, public health officials have recommended and enforced vaccines for a small number of highly infectious and communicable diseases. Vaccines work with the immune system's ability to recognize and destroy foreign proteins (antigens) that it determines are "nonself." Today, however, there are more than 200 new vaccines in the research pipeline, including one for HIV.

Vaccine manufacturers, health-care providers, and public health officials are correct to point out that since the introduction of the measles vaccine, the rate of disease has declined.

The major part of the vaccines are prepared for injection or iintraveneous administration.

Composition

Mainly of the vaccines produced are W/O vaccine with inactivated bacteria. A successful vaccine preparation is characterized by a mean particle size ranging from 250-500nm. With all particles below one micron.

The homogenization technology is very efficient in order to obtained the micronization required by the vaccines pharmaceutical industry. The high pressure homogenizer allows to micronize the oil droplets obtaining a very small particle size distribution (0,5 μm mean size) and stabilizing the emulsion over time.

The homogenization process

It is a wholly mechanical process, obtained by forcing a flow of product through a homogenizing valve.

Due to well-known physical laws, inside the valve they take place some contemporaneous effects of compression, acceleration, and so on, which are the cause of the homogenizing process, that acts by shattering and dispersing the solid and semisolid suspended particles.

The solution is pumped to the high pressure homogenizer. The product is homogenized at different temperature according to the components and at 1000 bar using one single stage and Rupture homogenizing valve for one or more passages. The outlet temperature has been controlled in order to keep stable the inlet temperature at about 60- 65°C.

The homogenization effect

The high pressure homogenization treatment allows to reduce the average size of particles. All the particles size is below 1 μm.

Method analysis

Particle size analyzer type Coulter LS130: it uses a laser diffraction and patented PIDS technology to rapidly determine particle size distribution of materials in an extremely wide dynamic range (0,1-1000um) with high resolution and excellent reproducibility.

The homogenization results

The samples were prepared by mixing gently and adding to the vessel. The optical model was one created especially for submicron emulsion.

Effect of the homogenization on the particle size reduction

Homogenizing machine to be used

The homogenizer used for the treatment is a machine designed for 1000bar for

• High abrasion
• Low viscosity
• 3A execution and Electropolishing of wetted parts, final surface roughness Ra>0,5μm.
• Certification Manual for Pharma validation cGMP.