Production of Medical Papers During Covid-19 Pandemic
The Covid-19 pandemic is affecting us all in ways that we could have never foreseen. What BillerudKorsnäs can do and are doing in these difficult times is, besides to ensure the safest possible working environment for our employees, is to ensure stable production of SteriKraft® and MediKraft® medical paper to our medical packaging customers all over the world.
In both our Skärblacka and Beetham mills we have production prioritized for medical paper. In addition, BillerudKorsnäs has comprehensive contingency plans in place in order to mitigate any potential interruptions due to raw material, other resources and workers. Our cross-functional geographical teams together with sales do their utmost to keep up the highest service level in all regions and in all aspects.
Designed to keep devices sterile
In the midst of the Covid-19 pandemic, a much more widespread understanding of the importance of sterile medical supplies and devices has emerged. Healthcare workers require a myriad of sterile medical devices such as syringes, gloves, dressings etc. Medical packaging is essential in ensuring that devices are sterile and clean at point of use.
The ability to keep medical devices sterile, that is, free from microorganisms from the time of sterilisation until the point of use, is the single most important function of medical packaging. Medical packaging papers are used alongside many other materials including packaging films, semi-rigid plastic trays, non-wovens, etc. to form the sterile barrier systems needed to keep medical devices sterile.
The effective barrier properties of medical papers are achieved through their multilayer fibre structure, an effective tortuous path of pores and well-balanced composition of paper properties. The tortuous path produces a uniform and consistent bacteriological and fluid barrier to maintain sterility and prevent microorganisms from reaching the sterile contents.
Ensuring microbial barrier
The most common test for microbial barrier used in Europe is DIN 58953-6. During the test a highly concentrated bacterial solution is dropped onto the tested material and then on the opposite side it is contacted with nutrition agar to check if any bacteria has come through the paper.
Stringent requirements on medical packaging and its design entail very high demands on the materials used. The material must be appropriate for the intended use, compatible with the chosen sterilization method, and designed to maintain sterility. To ensure that the material used in the packaging is fit for purpose, it must comply with international standards; the two most important ones being ISO 11607 (part 1) and EN 868 (parts 2-10).
ISO 11607 - specifies the requirements and test methods for materials and packaging which must be fulfilled.
EN 868 parts 2 to 10 - specifies demands on mechanical, physical and chemical parameters related to a certain type of packaging and packaging material.
Before we place any paper grades on the market to be used in medical packaging, a series of different tests are performed to ensure compliance with relevant standards.
The paper is produced according to the product standard EN 868, which specifies high demands on mechanical, physical and chemical parameters. The corresponding paper parameters, such as tear and burst strength, porosity and pore size to name a few, are continuously controlled in the paper mill, to make sure our paper always complies with the standard.
Before the paper is ready to be delivered to our customers (converters and industrial medical device manufacturers), additional testing is performed to ensure that the paper fulfils all requirements according to ISO 11607.
BillerudKorsnäs has a wealth of expertise and experience in paper packaging for medical devices. We’re known for our flexibility and are well-positioned to customize a solution for your particular needs, so please don’t hesitate to contact us. We look forward to hearing from you.