After ten or twelve of research and design of the medicine and after having defined the final product that has to reach the community, in its different presentations, with its respective approval and registration, the production process begins.
Scientific rigor, details, however minimal, and quality, play a fundamental role.
The raw material with which the medicines are manufactured and each of the manufacturing processes are subjected to rigorous quality assurance tests.
All the people involved in the production of a medicine have not only special training and ongoing training, but also have to take care of even the smallest detail. For example, they should use a special wardrobe – such as that required when entering a surgery room – in order to avoid the slightest contamination.
Of vital importance are the raw materials used during the process. Everything must go through the most demanding physical and microbiological tests and physical evaluations before being used.
1 – Bottles, lids, rubber lines or bands, ampoules, packaging. All raw materials arrive in trucks to the laboratories and are carefully taken to the warehouses.
2 – In the warehouses, each of the boxes and their contents are weighed, measured and reviewed.
3- The raw materials are subjected to physical chemical and microbiological tests.
4- Those who pass the tests are then weighed, labeled and stored.
5- Of the raw materials that have been weighed and labeled, the quantities required for the manufacture of that moment (what is called a batch) are selected and weighed.
6- These materials are placed in a cage, locked and transported to the respective area, according to the conditions required by the product to be manufactured.
7. Depending on the degree of delicacy of the medications there are special areas for their manufacture. Thus, there are some that do not support the light, others that require vacuum packaging, injectables require superspecial conditions such as fully filtered and optimal air. In general you have to think about pressure, volume, humidity, temperature, air quality, sterilization and many other things and that’s why you have equipment, machines and mechanical engineering elements SOLIDOS 8 In the case of solid forms -like tablets, dragees and capsules- the raw materials are mixed, granulated, moisturized, dried and lubricated, before taking them to the compressor, coating machines or the encapsulation process.
The mixture can be made dry or wet. Inert substances are added that allow the pharmaceutical form to be achieved.
Granulation consists in bringing the particles of the mixture to a certain size.
Drying takes place in drying hoppers or in special ovens.
In the tabletting machines the compression process is advanced, controlling at uniform intervals, among others, the uniformity of weight and hardness.
LIQUIDS 9- If they are liquids, such as syrups, drops, suspensions, the components are dissolved or suspended in a vehicle that is often water treated especially to guarantee total purity. You have the solutions in storage tanks, prepared with all the care and ready to pack them. The tank is connected by pipeline with the packing machine so the product arrives directly to the bottle.
10. During the development of each of the stages of carrying out controls in process, to ensure the required quality of the product. At the end of its preparation, strict control is again carried out in order to verify its final quality.
11. What does not pass the test is crushed or incinerated. 12. Before and during the product’s packaging, samples are taken that are analyzed in the quality control laboratories to verify that their concentration and characteristics of weight, hardness, humidity , density, viscosity and disintegration, etc., correspond exactly to the formulation approved and registered by the Pharmaceutical Research Laboratories.
The type and quality of the packaging used are essential to preserve the medicine. For example, multivitamins need a container that protects them from moisture, heat and light. The effervescent ones are packed in materials that isolate them from moisture.
13. A new quality control is carried out to verify even the smallest detail 14. Then the production is packed. Each box, envelope or container carries the number of the lot that has just been manufactured, the expiration date and the maximum retail price.
15. Finally comes the process of packing and distribution in sealed boxes. Tests are also done to see if it was well packed, if it opens easily, if it does not have holes that allow contamination.
16. But not everything ends here. It is essential to control the storage conditions of the packaged product and ensure that it is handled