Here’s a breakdown of the provided text, focusing on the scientific investigation and its findings:
The Problem:
Pharmaceutical company MSD was experiencing blockages in pre-filled syringes.
The ANAXAM team was tasked with investigating the cause of these blockages.
The Investigation Tools and Techniques:
- Swiss Light Source (SLS) at the Paul Scherrer Institute (PSI):
TOMCAT beamline: Used for computed tomography (CT).
How it effectively works: Similar to medical CT scans but uses synchrotron radiation.
Synchrotron radiation: Special X-rays that are partially coherent, allowing them to interfere.
Benefit: Enables visualization of even the tiniest materials within ultra-thin hypodermic needles (internal diameter < 200 micrometers).
Application: Used to look inside the needles and locate the blockage.
Result: Produced a clear image of dried solution inside a clogged needle.
- SR-XRF (Synchrotron-based X-ray Fluorescence):
Obligation: Dario Ferreira Sanchez from PSI.
How it works: Uses X-rays of a specific wavelength to remove an inner electron from an atom. When an electron from a higher shell fills the vacancy, X-rays are emitted.
Benefit: Produces a visual record of the characteristic “fingerprint” of specific chemical elements with high spatial resolution.
Application: To determine if zinc was present in the clogged needles.
Result: Revealed the presence of zinc in the solution blocking the needle.
The Findings:
Zinc Leaching: Zinc leaches from the needle shield into the drug solution when the syringe is stored at 40 degrees Celsius.
Mechanism of Clogging: Zinc can promote protein gelation and increase the viscosity of the drug formulation, leading to syringe clogging.
Correct storage: When stored correctly at 5 degrees Celsius, no zinc was detected.
The Impact:
The ANAXAM team’s findings provide MSD with a better understanding of the causes of pre-filled syringe blockages.
This knowledge will help MSD improve the prevention of these blockages, making their already safe and reliable syringes even safer.
About PSI (Paul Scherrer Institute):
A large research institute in Switzerland that develops, builds, and operates complex research facilities.
Focuses on future technologies, energy and climate, health innovation, and fundamentals of nature.
* Employs 2300 people and is part of the ETH domain.
