Specialty syringe production can present a range of design and manufacturing challenges since the product’s mechanism is more complex than standard syringes, and may require stronger focus on material compatibility issues and complex mold tooling. In this case, Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was designing a safety syringe for a customer who had no internal design team.
There are two different models: a 5-milliliter and a 10-milliliter safety syringe. Each model consists of ten different components for the individual syringe. This spatiality vacuum safety syringe is technologically more advanced than the normal 3-component syringes available in the market with a barrel, plunger and a plunger seal.
The customer provided 3D computer-aided design (CAD) files and Forefront’s engineering team utilized its standardized process to assess customer requirements create Design Development Plan (DDP) and refine the customer specification. The 3D CAD models provided by the customer were analyzed and the CAD geometry was fine-tuned to work appropriately within molding constraints. Design reviews which included functional analysis and risk evaluation were completed.
There were several potential issues identified in the design phase that needed to be addressed:
- There were 10 parts in the syringe that needed to assemble together precisely and correctly in order to perform the specified mechanical functions
- Material selection needed to meet both medical grade standards and be compatible with desired functionality requirements
- The cosmetic aspect of the parts needed to meet the customer’s appearance and transparency requirements
- The target volume quantity is 72 million units annually which added complexity to the mold scale-up strategy.