As featured in: Bio Market Insights Standardisation And Certification Developments In The Bioeconomy
Biology and the use of biotechnology is embedded in the (bio) pharmaceutical industry and many of the most recent and effective medicines are made by living cells. Research, development and utilisation of biomaterials, for example, biodegradable (for example, absorbable sutures) materials for medical and pharmaceutical purposes are intensifying. Pharma is a highly regulated industry, where standardisation and certification have important roles in supporting the introduction of new materials to usage.
Labels and certifications – Qualification and validation of systems
Plastics are broadly used in the production of biotherapeutics. In the recent two decades, the industry moved towards higher utilisation of (oil origin) plastic-based single use (SU) equipment and systems, to replace the traditional stainless-steel usage. It’s estimated that by 2025, biomanufacturers will be producing 112,000 tons of plastic waste per year, globally.(1) Some of the novel materials and systems are in direct contact with living cells. All additives — by-products or purposely added chemicals like antioxidants, UV stabilisers — are potential leachables that can have a negative effect on processes and products. Leachables and extractables need to be carefully tested and regulated.(2) Existing regulation can guide testing the materials for biocompatibility. Passing the biocompatibility tests is not sufficient for a complete risk assessment. Industry requires that the propensity for a material to leach unwanted and unknown chemicals, through testing extractables, is evaluated.
“Extractables” are chemical compounds that may migrate from product contact material under non-standard physical conditions (time, temperature). “Leachables” are compounds that may migrate into the actual drug product under normal processing conditions and may be found in the final drug product.
Recently, there has been increased collaboration between industry groups (manufacturers and end-user groups) such as the Bio-Process Systems Alliance (BPSA), BioPhorum Operations Group (BPOG), ASTM International, the International Society of Pharmaceutical Engineering (ISPE), and the American Society of Mechanical Engineers Bioprocessing Equipment (ASMEBPE) towards common standards of qualification and validation.(3)
The method for qualification and validation of single-use components had been a point of disagreement between the end-user and supplier groups. Collaboration between those industry bodies has allowed the industry to effectively police itself by providing best practice approaches, which may then be incorporated into regulatory guidance.(3) For bioplastics, there are numerous standards and test methods available, providing a framework for explaining properties such as ‘biodegradable’, and well-defined standards for biosafety (food contact) in connection with plastic materials. Industrial composting (putting biodegradability to circular use) is well defined in the European Norm EN 13432.(4) Impact of materials on waste disposal Welcoming the “European Green Deal” in the EU, François de Bie, EUBP Chairman, said: “In order to reach circularity and fossil-decarbonisation formulated in the concept, it is highly important to create a strong link between (the) bioeconomy and circular economy.”(5) Oil-based plastics will continue to co-exist with bioplastics. Recycling and waste solutions will need to deal with both types of materials.
Biodegradable plastic contributes to directing waste away from landfills to composting facilities. Karen Langhauser,(6) in “Less Space for Waste” wrote: “As SU technology becomes mainstream, biopharma companies need a better way to handle waste.” The 2018 Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production produced by the consulting company BioPlan reported almost 90% of respondents continue to use one or more SU device at some stage in bioproduction (R&D through commercial). Waste-to-energy (WtE) incineration has been an acceptable practice, offering an efficient way to collect and dispose of the waste, converting the energy released to electricity and or steam used in municipal resources.(7) However, not every region has WtE facilities near the production site, and not every WtE facility will accept single-use materials if they have been classified as bio-hazardous. These have to be sterilised first. Recycling this type of plastic waste has generated commercial interest. Recycling biohazardous waste requires specialised knowledge and ability to generate volumes that justify costs.
Triumvirate, a MA-USA specialised waste disposal corporation and MilliporeSigma, a manufacturer and supplier of SU systems for biomanufacturing, have partnered since 2015 to recycle and up-sale some of the 30,000 tons of biopharma single-use products landfilled or burned around the world each year. Triumvirate recycles used pharmaceutical plastics into general use plastic pellets, that can be further used for a variety of low-grade plastic applications. Perhaps the biggest hesitation has to do with traceability. The traditional recycling infrastructure does not allow for traceability. “biopharma customers want to make sure that their waste is properly disposed”. The recycling collaboration allows for 100% traceability.(1) Collaboration between stakeholders has an important role in establishing new products in pharmaceutical biomanufacturing, a very regulated space. In different constellations, it has advanced the harmonisation of testing and validating methods, and it has enabled recycling of what would otherwise be landfill, un-compostable waste.
- YouTube, “Millipore Sigma Tech Talks: Biopharm Recycling Program.” April 2018
- Erik Isberg (Entegris) https://www.pharmtech.com/considering-single-use-materials