West Pharmaceutical Services

Integrated Containment and Delivery Systems

Prefillable Syringes Functionality Study

West Pharmaceutical Services

Legacy plungers, such as the West Pharmaceutical Services FluroTec® laminated plunger Article 2340 4023/50 Gray were originally developed for manual injections.

As the market evolved from manual self-injection to auto-injector device applications, a new generation FluroTec film-coated plunger was needed.

Using quality by design (QbD) philosophy and principles, West has developed a FluroTec laminated 1mL Long NovaPure® plunger based on patient and practitioner needs. Specifications and process controls were developed through:

Defined quality target product profile (QTPP) as it relates to quality, safety, and efficacy
Critical quality attributes (CQA) that can be controlled and studied
Real-time process controls to ensure quality
Risk-based change control strategy

The 1ml Long NovaPure plunger was designed with optimised break loose and gliding forces, minimised dimensional part-to-part variation and to meet highest quality standards.

Download this free whitepaper to find out more about FluroTec® laminated plunger and to see the results of a comparison functionality test between this new plunger and the steam sterilised 1ml NovaPure Plunger.

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