Sterilization of Parenteral Products by Radiation : Pharmaceutical Guidelines

Sterilization of Parenteral Products by Radiation

Sterilization of parenteral products is being done by radiation these day. It is effective but it has its own advantages and disadvantages those must be considered before its implementation in pharmaceutical industries.
There are many different routes through which pharmaceutical products i.e drugs, medicinal chemical, fluids etc. are administered into the body. The different ways through which drugs and other pharmaceutical products are administered into the body can be classified broadly into two simple categories. These two simple categories are enteral also known as gastrointestinal and parental.

Enteral or otherwise gastrointestinal is the administration of pharmaceutical products through the gastrointestinal tract or you can call it the digestive system either by swallowing through the mouth or administration through the rectum. Parenteral, on the other hand, is the administration of pharmaceutical products like drugs into the human body through the skin (intradermal), through injections (intravenous), eyes, ears, nasal cavity or through any other body part other than through the gastrointestinal tract.

Sterilization by Radiation
Parenteral products are administrated by devices or instruments used to administer pharmaceutical drugs or chemicals into the human body the parenteral way. Parenteral products are also drugs, fluids and chemicals administered the parenteral way. These products include syringes and needles for injecting the drugs through the skin and indwelling catheter. The other parenteral products are the solution for injection, powders to be injected and others e.g liposomes. These products are usually sterilized in pharmaceuticals before being put into use. The use of radiation in the sterilization of parenteral products has been established and used widely by pharmaceutical companies.

Sterilization of parenteral products by radiation has its share of advantages and disadvantages. It is a technique that uses radiation waves to sterilize the parenteral products. Sterilization of parenteral products by radiation can be achieved by using different forms of radiation. These different forms of radiation are x-rays, gamma rays and electron beams. Over the decades, sterilization of parenteral products by radiation and gas increased in the pharmaceutical companies. This has been promoted by the regulatory push to adopt the radiation method of sterilization.

Radiation sterilization of parenteral products can be done through gamma radiation of high energy. This is done by utilization of the gamma rays from the radioactive isotope of cobalt, usually, cobalt-60. X-rays are another option the drugs manufactures use for sterilization of parenteral products by radiation. X-rays are produced when electron at high speed and energy hit a material. This then causes the production of the electromagnetic waves. An electron beam also emits radiation for sterilization of the parenteral products although electron beams have a lower penetrative power. Of the three ways of radiation, the most commonly used way of radiation sterilization is the use of gamma rays. The radiation sterilizes the parenterals by killing the contaminating microorganisms.

Sterilization by Radiation Process

Radiation sterilization of parenteral products has its disadvantages as well. In the process of sterilization of the parenterals, there may be a damage to them. The immobilization of the contaminating organism also comes with this risk of damage to the parenterals. This is so because the radiation either from gamma rays, electromagnetic x-rays and electron beams do not know the difference between the particles making the microorganism or the particles making the parenteral product. The interaction between the radiation and the parenterals may cause a chemical reaction that may damage or even change the chemical structure of the parenteral products.

Professional handling of sterilization by radiation is necessary in order to avoid accidents which may be observed in case if there are anomalies in the process. All compounds that are subjected to radiation treatment, should be in stable forms. They should have minimal or zero degradation effects after the process, whether they form part of drug component or medical device. Safety is fostered by global rules on handling and use of radioactive materials since spillage of the same is potentially carcinogenic.

The sterilization of parenteral products by radiation is more expensive than the other methods of sterilization of parenterals. But still, it is becoming an increasingly employed method of sterilization by the pharmaceutical companies.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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1 comment: Post Yours! Read Comment Policy ▼

  1. many thanks for best information.
    I found those issues which I need.
    Regards
    Ghias Rahimi
    Beena Pharma Kabul Afg.

    ReplyDelete


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