Join us for part 2 of our webinar series on pharmaceutical manufacturing construction materials on Wednesday 3 February 2021 from 14:00 – 15:30
In this seminar, we will discuss how to address particulate matter findings in pharma production facilities.
• Welcome by Martin Friis-Mikkelsen, CEO
• Is particulate matter a safety concern? – by Carsten Baun Senholt, Chief Technical Officer
• Fast-track physicochemical analysis – by Kirsten Inga Kling, Senior Scientist Analysis and Characterisation
• Q&A from the chat window
Download our white paper on nanomaterials today!
The new EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR) do include specific classification rules for devices that consist of or incorporate nanomaterials. For medical device manufacturers, it is important that they can identify the use of nanomaterials in their devices to ensure that they meet the requirements of these new regulations.
At SAXOCON we have the expertise and tools for identifying and characterising nanomaterials and providing you with the required documentation for your final finished device.
Fill out the form below to read about their consequences for regulations and your manufacturing process.
Are your production equipment and systems qualified for product contact?
On Wednesday 13 January 2021 from 15:00 – 16:30, we will be hosting a webinar on the role and design of extraction studies to ensure safety and quality in pharmaceutical manufacture.
- Welcome and introduction to presenters
- How to meet regulatory expectations for risk assessment of E&L in single-use systems – with Carsten Baun Senholt, Chief Technical Officer, SAXOCON A/S
- BioPhorum Operational Group E&L for single-use systems – The final chapter – with Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk
- Q & A from the chat window
As of today, 5 January 2021, all suppliers of physical products in the EU market are required to track and report the content of substances of very high concern (SVHC). This information shall be made available to consumers and waste operators by filling in the Substance of Concern in Products (SCIP) with the European Chemical Agency (ECHA). https://echa.europa.eu/scip
SAXOCON can help you comply with your obligations for tracking your supply chain, evaluating potential SVHC, and submitting your information to ECHA, check out how we can help here.
The FDA is updating their current thinking regarding the type of biocompatibility information needed for certain devices made from common polymers and fabrics that are in contact with intact skin. Read more about the new FDA Guidance here.
SAXOCON can help you pick the right materials that will allow you to waive testing of certain medical device materials.
SAXOCON is ready for the EU MDR, are you?
On 26 May 2021 the new EU MDR (Medical Device Regulation) will be fully implemented. This will have far reaching consequences for all medical device manufacturers that want to sell their products in the European Marketplace.
So you will need to ensure that your products are in compliance with these new regulations.
Are you ready? We are.
Check out how we can help get your products into compliance.
SAXOCON now has the capacity to test and identify nanomaterials based on the EC-definition. If you have materials in your portfolio and you want to know if they are, or contain, “nano” and to ensure that they meet all relevant requirements, then check out our new analytical services here.
EFSA announced changes to the evaluation of food enzymes compiled in a joint dossier in March 2020. If you are part of a joint dossier on food enzymes you may need advice for your toxicological study strategy. SAXOCON’s highly skilled toxicologists can help you in planning, testing, and documenting the safety of your food enzymes.
Joint dossiers have led to several challenges and data gaps in submitted documentation, which is the background for EFSA requiring that enzyme applicants now send a company specific full data package. Additionally, these requirements will also require a full toxicological package conducted in accordance with current regulatory guidelines.
For years it has been possible for food enzyme producers to group their individual food enzymes under one umbrella application, provided that these enzymes have the same catalytic activities, are manufactured substantially by the same process, and originate from the same organism. However, due to confidentiality issues, this procedure has led to a lack of specific information on e.g. the production strain and the chemical composition of each food enzyme.
SAXOCON can help you quickly prepare for these regulative changes, find out more about how we can help here.
Today we held our first webinar via YouTube Live. Carsten B. Senholt, our Principal Toxicologist and CTO, discussed the breaking news about the newly released ISO/CD 10993-17. So, if you want to get up to speed on the newest requirements regarding toxicoligy risk assessment of medical device constituents the check out the webinar here.
SAXOCON A/S was proud to have hosted the first Extractables and Leachables (E&L) network meeting and we are looking forward participating in this exciting and important network going forward.
The E&L network is conceived to support competence building and knowledge sharing among Danish pharmaceutical companies.
2019 has been quite a year for us here at SAXOCON. In July we became SAXOCON A/S and today we can proudly announce that we are a GAZELLE 2019.
This has only been possible thanks to our loyal customers and our skilled and dedicated SAXOCON employees. We take great pride in delivering high-quality and timely services that make a difference, ensuring that products produced and sold around the world are biologically safe.