14 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m
Prefilled Syringes
P
refilled syringes offer advantages to the manufacturer,
caregiver, and patient. With fewer handling steps and ease
of use compared with empty syringes, prefilled devices
can help reduce medication errors. They do, however, pose
challenges in manufacturing and require extensive testing.
Testing of empty syringes must be performed at the site where
filling will be completed as part of incoming quality control efforts.
And, filled syringes (combination of the syringe and drug product)
must also be subjected to release testing.
Knowledge and understanding of the various tests involved is es-
sential for ensuring patient safety. "The development of robust drug
products based on prefilled syringes as primary containers requires
an integrated holistic approach," asserts Thomas Schoenknecht, head
of R&D within the drug product services unit at Lonza Pharma &
Biotech. "Aspects including formulation, process, packaging, device
integration, analytics/quality control, and intimate knowledge of the
user needs all must be taken into account," he explains.
Complex testing requirements
Similar to other sterile products, prefilled syringes must be sterile
and free from pyrogens. In addition, according to Gregory Sacha,
senior research scientist at Baxter BioPharma Solutions, they must
be chemically, physically, and biologically stable with no change
in performance over the intended storage and use time. In general,
the regulatory requirements for testing prefilled syringes need to
comply with the US and European pharmacopeias, notes Nicolas
Eon, global product manager for syriQ prefillable syringes at Schott
Pharmaceutical Systems.
Test Methods and Quality
Control for Prefilled Syringes
Cynthia A. Challener
Empty and filled syringes
must pass a range of
quality control tests.
Cynthia A. Challener, PhD,
is a contributing editor to
Pharmaceutical Technology.
JOCHEN
NETZKER/STOCK.ADOBE.COM
