The manufacture of plastic containers for medicines is carried out through a very controlled production. An exhaustive control of the materials takes place from the origin.

This is due to the special sensitivity of the products they will contain. The same happens with packaging for other industries, such as food or cosmetics.

In order to take care of the process from the first moment, it must follow some guidelines established in certain norms. These define the quality standards for materials and manufacturing processes, among other issues.

What is Pharmacopoeia?

First of all, let’s clarify the meaning of the term. Pharmacopoeia is a grouping of scientific-legal texts on substances that have medicinal properties. The pharmaceutical industry, suppliers of materials and manufacturers of packaging are obliged to comply with what Pharmacopoeia indicates.

In addition to the recipes of the drugs or the ways to prepare them, the ingredients are included and also information on the materials used in the manufacturing processes of the containers.

In this sense, the Pharmacopoeias contain specifications on the identities and purities of the active principles included in the formulas. In addition, the mandatory tests and instructions for doing them are also described.

The European Pharmacopoeia and plastic packaging for medicines

Some countries don’t have it, however, in our country, we have a Spanish Pharmacopoeia which includes the European Pharmacopoeia, and some specific national elements.

The European Pharmacopoeia belongs to the Council of Europe and has been drawn up since 1964 by the European Directorate for the Quality of Medicines.

As we have already explained, the European Pharmacopoeia details specific regulations on medicines and their ingredients as well as their containers and the materials used to make them, must comply with it. If not, they will not be able to be marketed, as they are considered unable to guarantee user safety.

Materials used in the manufacture of plastic containers for medicines

Polyolefins are mainly used in this process. They are high density polyethyene (HDPE) or low density polyethylene (LDPE), polypropylene (PP) or the well-known PVC which stands for polyvinyl chloride. Other materials used are PET (polyethylene terephthalate) and copolymers, such as vinyl acetate.

How is suitability checked?

The European Pharmacopoeia specifies the analysis and tests that these materials must pass. There are studies that are done to detect the presence of some substances from heavy metals (aluminium, zinc or nickel), to other types of additives, some of which are very common in plastic materials that we use very frequently.

The examination of these materials is carried out by means of spectrometry, ICP-MS. Through it, most of the elements of the periodic table can be identified. Right now, there are 118, 94 of which are present in nature itself.

Sometimes, one of these elements is detected during the procedure. If the quantity detected is higher than allowed, the result is that the material cannot be used.

Furthermore, it is interesting to know that to use a material other than those compiled in the European Pharmacopoeia, you have to ask for permission. Only a competent authority can grant permission for its use, and it is always the obligation of the material supplier to demonstrate that it complies with the regulations.

Examination of the functionality of materials

Not only the composition of the material has to be studied but you also have to ensure its correct functionality. And, for this, you have to take into account some specific aspects.

It is necessary to check how the container and the content interact with each other, as well as if they are chemically compatible.

The response of a particular material to the environment in which it is found must also be taken into account because plastic is an organic compound. Therefore, it is a not completely inert substance.

Because of this, there is the possibility of a chemical reaction so you have to watch closely what happens when the medicine comes into contact with the material the container is made of.

 

At Triana, we know first-hand that the considerations in this article are just a small sample of all those that may exist in the manufacture of plastic containers for medicines.

We are aware that safety is a condition that must govern the manufacture of plastic containers for medicines. Therefore, we carry out a responsible production, according to the instructions of the European and Spanish Pharmacopoeias.

We take maximum care of the quality of our work, both in the materials, as in the processes and in the spaces we use.

For more information, please contact us.

 

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