Radiation sterilization: "There is a marked increase in demand for medical consumables"

Before single-use medical devices hit the market, they must be sterilized. The present pandemic has exacerbated the situation as the number of medical consumables in laboratories has reached new heights. COMPAMED-tradefair.com wanted to know how high volume batches can be sterilized and whether there are anticipated delays due to the Coronavirus.

 

Ms. Heilmann, BGS offers the sterilization of large quantities of products, including medical devices, within a few short hours. How does your process work?

D. Eng. Annett Heilmann: BGS Beta Gamma Service (or BGS), is a specialist provider of radiation sterilization – as it is one of the key modern industrial sterilization methods. Radiation sterilization is based on the impact of energy-rich beta and gamma rays. The main difference between the two types of radiation is the ability to penetrate materials and the dose rate. The products are irradiated with a precision dose to destroy the pathogenic germs inherent to the manufacturing process. During the sterilization process, the material absorbs radiation energy. Radiation splits the DNA of germs – rendering them unable to reproduce and multiply. This necessitates an accurately defined product validation process prior to irradiation to assure reliability and consistent quality.

Radiation sterilization is essentially the last production step. After manufacture, the product is primarily packaged and reaches BGS as the commissioned sterilization service provider in its transport packaging. Irradiation is residue free and takes place without any significant temperature increase. If the validation is considered successfully completed, the product can subsequently be released and put on the market immediately after the irradiation process. The release parameter in this setting is the amount of absorbed radiation energy.

What are the main medical product groups your company handles?

Heilmann: BGS principally sterilizes disposable and single-use products before they are first used. In the medical realm, this primarily pertains to non-active medical devices and in vitro diagnostic medical devices including implants, catheters, cannulas, dialyzers, and blood collection tubes. BGS also irradiates various types of modern hydrogel-based wound management systems and related items. When it comes to in vitro diagnostic equipment, we mostly sterilize blood collection systems, urine specimens, fecal collection tubes, Petri dishes, microtiter plates, and pipette tips. These products frequently are made up of multiple plastic components.

Are there products you aren’t allowed to treat with radiation?

Heilmann: Laws and standards stringently regulate sterility requirements and establish were the radiation sterilization process is applicable. The process is generally also subject to natural limits. The type of material and its properties and characteristics determine whether it is a candidate for radiation sterilization. Some materials show low radiation resistance and get damaged, become brittle, or degrade entirely. That’s why we differentiate plastics sterilization compatibility between "well-suited/good" (for example PC, COP), "reasonably suited/fair" (polyvinyl chloride, color changes possible), and "not suited/poor" (POM, brittleness failure) materials. Radiation sterilization is also not suitable for products that contain any electronic components. As part of the validation process, any newly developed product must first be assessed in terms of compatibility as a material.

The coronavirus pandemic continues to rock the global economy. How does this affect your company?

Heilmann: Our clients include several major in vitro diagnostic product manufacturers, whose single-use products are desperately needed in the fight against the pandemic. A list of large pharmaceutical companies that are rushing to find a coronavirus drug or vaccine sterilizes the majority of their medical consumables at BGS. We notice a marked increase in demand for medical consumables and equipment. We have prepared for this increased demand at an early stage and responded by increasing our production capacity. We service the market and give emergency priority to its needs.