From a mother:
A while ago I wrote this about particles in injections after vaccine stoppers are punctured:
PARTICLES IN INJECTIONS – WHAT ABOUT THE PATIENT?
It is generally recognized that particles in injections may result in serious complications for patients. The potential serious adverse events resulting from the use of a sterile injectable product with particles by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis).
There are therefore official requirements for manufacturers to provide documentation to health authorities concerning particulate matter in injectable products (2)
For interest, I sometimes counted and identified particles in injections both before and after puncturing the stoppers. There were, as expected, more rubber particles after puncturing and the numbers were higher for thicker needles and several punctures.
It is surprising and disconcerning to learn from the answer received :
If there was a requirement for this, it would undoubtedly result in more awareness from the manufacturers regarding the quality choice of rubber stoppers, an aspect which surely should be considered in connection with patients’ health and safety.
(3) REPLY FROM FDA:
Thank you for your follow-up inquiry. FDA expects purity of all products in single-dose or multi-dose vials.
We hope this information is helpful.
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