Sterile medical devices and sterile barrier made of (bio-)plastics

A sterile barrier packaging made of plastic ensures that medical products such as cannulas or surgical instruments remain germ-free for a long time. This is the only way they can be used safely.

BIOVOX expert Maria Heckel summarised what sterility is, why we need it and whether bioplastics are suitable as a sterile barrier.

The Basis: Sterility in Health Care

Why is sterile barrier packaging important?

Hospital infections are a global problem: on average 8.7% of hospitalized patients and as many as 25-30% of intensive care patients suffer from infectious complications during or after hospitalization. In order to keep this number as low as possible, sterility is essential for critical medical devices. But what does “sterile” actually mean?

Sterility is a condition in which a material or object is free of living microorganisms, viruses, bacteria, fungi and yeasts, including their resting stages (e.g. spores).

Legislation has introduced safety precautions through harmonised standards and directives. What sterilization procedures and standards are available, whether sterile barrier systems made of bioplastics meet the requirements and how sustainable the whole process is – ready to take a deepdive?

Deepdive: Ensuring sterility of medical devices

sterility of medical devices

What is considered sterile in theory does not succeed with 100% certainty in practice, because sterility can always be stated with only one probability. In order to be able to describe a product as “sterile”, a probability of finding a germ on a product of 1 x 10^-6 has been determined

This means that no more than one viable microorganism can be detected in one million products.

Further legal requirements are quality management according to ISO 13 485 or risk management according to ISO 14 971.

How do manufacturers sterilize their medical devices?

In the case of smaller medical devices, sterilization takes place in packaging: the product is in a so-called sterile barrier system - usually a hard blister or soft blister made of plastic, Tyvek and/or medical paper - and is sterilized together with it (according to DIN EN 556-1).

For larger medical devices, two other options exist:

Sterilisation of the whole product and subsequent packaging of it in a sterilised package.
Sterilisation of individual components and further processing and packaging under sterile conditions (“clean room”) in accordance with DIN EN 556-2.

What information do you need on the packaging of a sterile product?

Take a look at the infographic to find out what information belongs on the packaging of a sterile product.

How are reusable medical devices sterilized in hospitals?

Healthcare facilities have re-sterilization performed on-site or by a certified service provider for reusable medical devices. This process is called "reprocessing".

Processing is costly and labour-intensive: the product must be disassembled, cleaned, disinfected and dried after use (the “contamination”). This is followed by the re-contamination-proof packaging and finally the actual sterilization, as well as, if necessary, testing and restoration of technical and functional safety.

And what about bioplastics?

Sterilizing medical devices made of bioplastics – Is that possible? It is!

When developing a critical medical device, the selection of the appropriate sterilization process and the selection of materials must go hand in hand. The sterilisation process shall not cause any change in the physical, mechanical or biocompatibility properties resulting in unwanted body reactions or impairment of the functionality of the product. This applies both to medical devices made of bioplastics and to sterile barrier packaging made of bioplastics.

Bioplastics can be formulated to be resistant to thermal treatment, to gamma radiation or X-ray radiation (X-ray), and to chemicals such as ethylene oxide (EO) during sterilization.

In a nutshell: Can bioplastics guarantee sterility?

Medical Grade Plastics for medical devices are subject to strict requirements, including with regard to hygiene.

Bioplastics for medical devices or sterile barrier packaging can be formulated in such a way that they are safe even after EO, gamma or X-ray sterilization.

BIOVOX bioplastics offer in addition to reducing CO2 emissions for packaging systems and plastic components, also the highest level of safety in sterile applications.