Control of raw materials in swine extenders
One of the most important points is to follow the GMP (Good Manufacturing Practice) protocols applied in the pharmaceutical industry.
For this reason, the control of the raw materials is the initial and critical point because they will be an active part of the extenders.
The selection of suppliers and grading of raw materials (pharmaceutical or food grade) is decisive for good balance of the medium.
On reception, it is necessary to check the data and analytical sheet as well as making a visual inspection of components (colour, appearance, odour, etc).
After that, a quarantine period is required until all the external analyses (samples under control) are performed.
Another important aspect is to keep a ‘sample bank’ which should contain samples from all the batches and become a resource for solving any problem detected in the final product.
Raw materials should be in compliance with the technical specifications in every batch. To be sure that raw materials meet the requirements, samples must be subjected to an external analysis with several critical points.
Correct selection of raw materials is crucial in controlling possible alterations in the final extender.
The different raw materials should present a high degree of water solubility, a specific density, a pH that meets the spermatic conservation ranges of the extender, high purity and a specific rotation.
Raw materials that meet the technical specifications should be tested, especially in reference to the levels of heavy metals. Excess of some of them could change the biological and physicochemical qualities of the extender or even be harmful for spermatozoa.
For example, an excess of calcium may lead to an increase in this molecule in the final product and could produce premature sperm capacitation, just the opposite effect we intend to achieve with the conservation of spermatozoa in the extenders.
An excess of iron can also alter the physicochemical properties of extender, reducing the useful life of the product.
With supplier analysis certificates, a correct heavy metal analysis and a sample of each batch in the bank, we can manufacture the extender in a clean room with positive pressure where temperature, humidity and particles in suspension are controlled.
At this point, the metrological control of all the production process is essential.