Providers & Products

We have manufacturers, suppliers and service providers from the area Machines, devices, systems for the sterilization and decontamination of medical products

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Sterilizers - choice and quality
LabTec Labortechnik GmbH
Sterilization container
Anton Hipp GmbH

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Product sterilization of the area Cleaning & sterilization - Machines & production technology

Product sterilization Products and services from the categories Machines, devices, systems for the sterilization and decontamination of medical products in medical technology or other healthcare-related industries .

Biological indicators are a key component of a product's process validation. The presence of these bioindicators gives an indication of the process' effectiveness in reducing bioburden. These indicators are placed in the product container prior to sterilization and must be destroyed during the entire procedure. Several chemical parameters are evaluated before and after sterilization, with a few chosen analytical methods for commercial manufacturing. Detailed characterization of each of these variables can aid in the development of more effective products.

The first standard to govern a sterile process is the International Organization for Standardization (ISO). In this country, ASTM International, formerly the American Society for Testing and Materials (ASTM), has set standards for medical device sterilization. The irradiation-based process can destroy the contents of a package, such as a blood transfusion tube. The second standard is ISO 13485, which requires that a product be used for more than five consecutive days in a row.

As the need for medical devices continues to grow, regulatory agencies around the world have developed standards for the sterilization of health care products. Although common standards for product sterilization are a desirable goal, they are not always achieved. Consequently, the process of irradiation is still used to sterilise devices. The new ISO and EN standards are widely accepted in the industry. Earlier, disposable products were targeted at small-scale applications.

In addition to the ISO standard, FDA regulations mandate that all medical devices be sterilized before they can be sold. By following the FDA guidelines, sterilized products can be approved faster and with fewer risks than non-sterilized products. If your company is planning to introduce a new product to the market, ensure that it is fully compliant with the FDA. If you want to get your device approved and avoid a product recall, then it is important that your medical device manufacturer uses ISO 13485.

Sterilization methods can be of two kinds: X-rays and electron beams. An X-ray irradiator uses electrons that are converted to X-rays. Compared to an e-beam, X-rays penetrate a few centimeters and can only sterilize a single container. The e-beam is more efficient, but does not have the directional properties of a gamma-ray.

The methods of product sterilization are regulated by the FDA. To gain FDA approval, the manufacturer must comply with a strict set of guidelines for sterilizing the product. The standards must be compliant with ISO 13485 and other standards and regulations. In the US, the sterilization process is controlled by the United States Pharmacopeial Convention, which controls the production of non-sterile drugs. The latter method is more accurate than the former.

Depending on the product's sensitivity, the ionizing radiation must be used in high-temperature sterilization. Its properties make it an effective sterilant. However, it is also toxic to humans. The process of removing the sterilant residue varies with the type of chemical used. Therefore, it is important to ensure the safety of the workers involved. In this way, a high-quality process should meet the highest standards.

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