Why is Shaker Agitator important in the laboratory for drug manufacturing?

November 15, 2022by Kalstein
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Medicines can be found in a wide variety of pharmaceutical preparations, which makes the same active ingredient found in different products, such as tablets, drops or capsules. Each of these pharmaceuticals has its own characteristics which influence the dose, time of administration and duration of treatment. Since there are many preparations falling within this category (and they are not medicines), it can be said that medicines are characterized by:

  • Substances intended for use in or on the surface of the human or animal body and intended to be products with properties to cure, relieve or prevent human or animal diseases or ailments.
  • Substances which may be used inside or on the surface of the human or animal body to restore, correct or modify physiological functions by pharmacological, immunological or metabolic action.

In both situations, the medicinal product is a preparation in the sense that it consists of several components but is perceived as a single substance. This uniformity in the composition of the drug is achieved through mixing processes, with the use of appropriate instruments, such as shaker shakers, which facilitate the homogenization of the product.

These instruments are very important in drug manufacturing laboratories, since, if a drug is not homogeneous, there are no guarantees of the doses administered to people to cure their ailments or modulate some of the physiological functions, in attention to the doctor’s prescription.

What is the manufacture of medicines?

The manufacture of medicinal products is defined as the extraction, preparation, processing, decanting, including filling, packaging, labeling and release of a medicinal product. In this chain of processes, the mixing of the ingredients is critical, because it guarantees that the drug has the prescribed dose and will have the expected therapeutic effect in the treatment of the patient’s health condition. Examples of manufacturing are:

  • Mixed injections.
  • Mixed infusions.

Thus, for example, the manufacture of mixtures of analgesic and/or anti-inflammatory drugs for pain therapy is a manufacture of drugs according to some legislations. Other examples of drug manufacture include mixing a glucose-amino acid infusion solution for parenteral nutrition, preparing a solution for oral glucose tolerance testing, preparing autologous blood injections, and preparing test allergens for epicutaneous testing.

The importance of quality control in the pharmaceutical industry

Patients should use the medicines with confidence and without this posing a risk to their own health. This trust forces everyone involved to produce high-quality and valuable medicines at all times. Guidelines have been established at the international level on how and under what conditions pharmaceutical products and active substances should be developed, manufactured, stored and transported to ensure consistent quality and efficacy.

The quality of medicines and active substances should not be the result of chance, but of careful planning, correct application and systematic follow-up. Due to the wide variety of products and uses, there are no detailed GMP standards for all applications.

Rather, there are a number of basic features, which vary depending on a number of factors. Firstly, what kind of product is produced, for example, medicinal, food or cosmetic? In addition, the region or country of production or export is also an important factor. Production methods are also important, such as:

  • Chemical.
  • Biotechnological.
  • Sterile or non-sterile.
  • Oral, parenteral or topical administration.

Regardless of the factors mentioned above or industry, the concept of GMP is always aimed at ensuring patient safety. For a product to meet these requirements, qualified personnel and production facilities, equipment, premises and buildings are required to implement and comply with the relevant requirements. In other words, it must be demonstrated that all these influencing factors are fit for purpose.

Kalstein shaker agitator for drug manufacturing

For the laboratory sector, the manufacturer of Kalstein instruments, makes available to analysts and pharmacists its shaker agitators: their use helps in the process of homogenization of medicines, and at the same time serves as support in the chemical analysis of quality control of these products in the laboratory. These agitators operate quietly, with long-life motors, and have built-in a voltage surge protection system that automatically shuts off the equipment. For purchase, pricing and other technical details please visit HERE

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