sterilization

Concept of sterilization in the pharmaceutical area

Sterilization is the process of killing and eliminating transmissible agents effectively. These unwanted agents include bacteria, endospores, fungi, viruses, and prions. If not taken care of, these can cause severe problems ranging from allergic reactions to fatal infections.

  • The process is carried out on several potential infections spreading things including equipment, food, and medication, biological culture medium, or any surface.
  • The pharmaceutical industry comprises a vast multitude of components. Medicines, nutraceuticals, medical devices, surgical equipment are essential to maintain healthcare services.
  • Thus, it becomes crucial to monitor the efficacy with proper standards, thus ensuring safety and preventing chances of other ailments.
  • All the products are thus sterilized by different means, and the sterility testing makes an essential factor of in-process quality control.
  • The in-process controls (IPC) are standard checks essential to perform before the completion of manufacturing.
  • IPC help to adapt and optimize the processes for best quality output post-manufacturing, free from contaminations.

Read: Aseptic techniques in hospital settings

Method of sterilization and Uses 

Different methods are used to sterilize various compounds as follows. – 

  Moist heat sterilization

 Sterilizing surgical dressings, sheets, diagnostic and surgical equipment, closures and containers, ophthalmic preparations, aqueous injections

  Dry heat sterilization

 for dry powder drugs, oil, fats and waxes, soft and hard paraffin, suspension in aqueous solutions, oily injections, implants, ointments, and ointment bases

  Gaseous sterilization

  For thermolabile substances including hormones, proteins, heat-sensitive drugs, and medicaments

  Sterilization by U.V./gamma radiation

  •  Most lethal, U.V. radiation used for sterilization of garments and utensils
  • Gamma radiations – sterilization of antibiotics, sutures, plastics, hormones, and catheters

  Filtration sterilization

 For heat-sensitive injections, ophthalmic solutions, biological products, air and gases supplied in aseptic areas, industrial fermenters, freeze dryers, and centrifuges.

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