Clogged syringe needles in prefilled syringes (PFS)
Prefilled syringes (PFS) are increasingly used for medical treatment, e.g. with monoclonal antibodies. In very rare cases, the needles of prefilled syringes can become clogged. This can have detrimental consequences for patients if their medication does not enter the body or the dosage is too low. Precisely analysing and identifying the causes is crucial to solve these problems.
High-resolution 3D visualisation of the blockage using Synchrotron CT
Synchrotron CT is a high-resolution 3D Imaging method for analysing interfaces between air and liquid inside a needle. The method allows over 100 syringes to be analysed per day.
3D Synchrotron CT
2D visualisation of the blockage using Neutron Radiography
Neutron Radiography is a 2D Imaging method for analysing the presence of drugs inside a needle. The method makes it possible to examine over 100 syringes per day.
2D Neutron Radiography
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Success stories
For more than 100 years, the SCHOTT name has represented advanced solutions and services for the global pharmaceutical and biotech industries. With this longstanding expertise, SCHOTT Pharma provides an extensive and scientifically proven product portfolio for the safe storage and administration of injectable drugs to patients all over the world.
Using the advanced methods offered by ANAXAM enables us to gain new perspectives in the field of imaging techniques. With the help of Neutron radiography and Synchrotron CT, we want to expand our knowledge of making the next generation of drug containment and delivery solutions safer and easier to use.”
Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of whom it was once the American arm. The company does business as Merck Sharp & Dohme or MSD outside the United States and Canada. It is one of the largest pharmaceutical companies in the world, generally ranking in the global top five by revenue.
The combination of neutron imaging and synchrotron X-ray tomography provided valuable insights into the dynamics of liquid movement in staked-in-needle pre-filled syringes. The detailed morphological analysis enhanced the understanding of microstructural arrangements within the needle. This research contributes to addressing the issue of needle clogging and can guide the development of strategies to improve pre-filled syringe performance significantly.”
Novartis AG is a globally active and listed biotechnology and pharmaceutical group headquartered in Basel, Switzerland. The Group's core business is the research, development, production and distribution of prescription medicines. Development in the fields of cardiology, neurology, immunology and oncology focuses on current research results in chemistry and chemical biology as well as on innovative therapies using biotherapeutics and radioligands, RNA-based therapies, gene therapy and cell therapy.
We can only really understand many phenomena through visualisation. Visualising the behaviour of injected drugs in tissue is an important way of understanding the influence a blocked needle can have on the injection, which we have now been able to achieve in this research project. Imaging techniques, especially synchrotron X-ray tomography, made this possible in an impressive way that has never been shown before. 3D images provide even more information and show a really clear model of the injection mechanism. The great expertise of the entire interdisciplinary team made this possible.”
Answers to the most frequently asked questions
Our analytical methods can be applied to all types of pre-filled syringes and autoinjectors.
Clogging is detected by high-resolution Synchrotron CT and Neutron Radiography.
Neutron Radiography enables two-dimensional visualisation of the fluid within the needle under varying environmental conditions, which helps to identify the causes of clogging.
Synchrotron CT offers high-resolution three-dimensional imaging that provides detailed insights into the interfaces between air and liquid within the needle and can thus reveal the causes of clogging.
Yes, of course. We are here to advise you without obligation and to find out whether we can support you. Please do not hesitate to contact us.
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