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Harold Murray, Project Engineer, and Robert Froio, Intern, West Pharmaceutical Services, Inc. Flange strength and dimensional variability are critical attributes when designing or selecting an auto-injector device to use in conjunction with a 1mL long syringe. Studies were performed to compare these attributes using Daikyo Crystal Zenith® (CZ) 1mL long syringes and glass 1mL long syringes.
The CZ 1mL long insert molded syringes demonstrated a significantly higher flange break force than glass 1mL long staked needle syringes samples from three separate glass vendors. The CZ 1mL long syringes required a force at least 72% and 125% higher respectively when tested using two different fixtures (drop-in and slide-in) than any of the glass syringes. The dimensional analysis demonstrated that the CZ 1mL long syringes consistently produced less variation and a lower standard deviation compared to glass 1mL long syringes for outside diameter (OD), inside diameter (ID), and wall thickness at each of three measurement points along the length of the barrel. The CZ 1mL long syringes had a standard deviation for OD measurements at least 38%, ID measurements at least 79%, and wall thickness at least 53% lower than glass 1mL long syringes.
Conclusions:
• CZ 1mL long insert molded syringes demonstrate a significant increase in flange strength compared to glass 1mL long staked needle syringes, which can help reduce breakage recalls in the fill/finish process and in auto-injector devices.
• CZ 1mL long syringes maintain consistent barrel ID throughout the length of the barrel. The low dimensional variability of CZ syringes can help ensure consistent fit and functional performance within auto-injector devices.
• CZ 1mL long syringes have a barrel ID with zero draft.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to adhesives used in their manufacture and to tungsten oxides generated during needle placement.
Market trends toward home use and patient self-administration of drugs used to treat chronic conditions (e.g., multiple sclerosis, rheumatoid arthritis and autoimmune) have made prefillable syringe systems an ideal choice for single-dose drugs. Prefilled syringe systems for vaccines, pharmaceuticals and biopharmaceuticals offer convenient, fixed dosing and are adaptable to automated injection devices.
As advancements in pharmaceutical technology increase in the use of automated injection systems for health care treatment, traditional glass vials, syringes and cartridges must withstand higher automated delivery forces and pressures. The fragile nature and dimensional variability in wall thickness of glass components may lead to breakage, which presents challenges to automatic administration systems.
In an effort to treat more complex diseases, the injectables market has seen high-value molecules dominate clinical pipelines. As modern molecules continue to gain market share, it is becoming the norm for drug manufacturers to plan containment system compatibility earlier in their drug development process due to the sensitivities of their complex molecules. With packaging systems becoming an integral part of the drug development and research process, a challenge drug manufacturers face is the plentitude of choice.
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