In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).
Sterility is a state or condition in which an object, area, surface, liquid, medical instrument or other item is completely free of living microorganisms such as bacteria, viruses, fungi and protozoa. The concept of sterility is significant in various fields such as medicine, pharmacy, food processing, microbiology and biology.
Sterility ensures the safety of patients, manufacturing processes and research. The importance of sterility (German translation: Sterilität) stems from the fact that the uncontrolled presence of microorganisms can lead to infections, contamination and quality defects.
In medicine, sterility plays a decisive role in surgeries, infusion therapies, invasive diagnostic procedures and other medical procedures. Surgical instruments, syringes, catheters and other medical devices must be sterile in order to avoid infections and complications.
In pharmacy, sterility is important in the manufacture of sterile dosage forms such as eye ointments or eye drops and injectable drugs (translation into German: injizierbare Arzneimittel). Such products must be absolutely sterile in order to prevent infections and risks to patients, for example during intravenous or ophthalmic use.
In the food industry, sterilization is used in food preservation to kill microorganisms and prevent their growth so that food has a long shelf life.
Various methods and technologies are employed to ensure sterility, including autoclaving (heating under pressure; German translation: autoklavieren), irradiation with UV or gamma rays, filtration, the use of antiseptics and more. It is important to maintain sterile conditions and ensure that they are not compromised during handling, storage and use to ensure the safety and efficacy of products and procedures.
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