Jaw Crimping VS Rotary Crimping: Enhancing aseptic assurance.

In the aseptic fill-finish world, crimping is more than just a mechanical operation - it's a critical control point for safeguarding sterility and ensuring the integrity of life-saving drug products. At 3P innovation, we recently partnered with 4D Molecular Therapeutics to evaluate the comparative performance of jaw crimping vs rotary crimping across a range of vial formats, including the increasingly popular Daikyo Crystal Zenith (CZ) polymer vials. What we found has meaningful implications for manufacturers striving for GMP compliance, product integrity, and particulate control in cell and gene therapy, biologics, and sterile injectables.

Aseptic crimping: Balancing force with cleanroom integrity.

Crimping is responsible for achieving a robust seal between the stopper and vial, directly impacting Container Closure Integrity (CCI). A poor crimp can compromise the sterile barrier, leading to rejected batches, regulatory risk, and costly delays.

Traditional jaw crimping, while widely used, introduces a known risk: particulate generation. The relative motion between the jaws and the aluminium cap can generate microscopic debris, which poses a contamination risk if stoppering is performed in close proximity - while the vial is still open.

Rotary Crimping: A smarter approach.

Our Rotary Crimper tackles this challenge by employing a synchronous rotary mechanism that eliminates relative motion between the cap and crimping wheel. Both components spin at matched velocities, dramatically reducing friction and therefore particulates.

But rotary crimping brings more than just cleanliness. It introduces process control. Some of the key benefits include:

• Force feedback control: Ensures precise and consistent compression.

• In-process traceability: Logs crimp force, enabling CCI audit readiness.

• Improved residual seal force (RSF): Correlated with better sealing performance and reduced leak rates.

Test overview: Methodology at a glance.

The study evaluated crimp quality on:

• 2mL & 5mL CZ polymer vials

• 6R glass vials (Corning Valor)

with 13mm and 20mm flip-off caps from West and generic suppliers.

Key measurement criteria:

• Crimp concentricity and lip engagement (using imaging and pixel-based analysis)

• Scratch count as a proxy for particulate generation

The results: A clear case for rotary crimping.

1. Crimp Quality: Rotary crimping consistently delivered better lip engagement and reduced off-centre crimps, especially on the 2mL CZ and 6R glass formats. The 5mL CZ vial geometry presented unique challenges but is known to benefit from bespoke crimp wheel geometries - something addressed in previous client work using an adapted wheel.

2. Particulate Control: Rotary crimping reduced scratch sites by 76% compared to jaw crimping. Less scratching = less oxide removal = fewer airborne particles in critical fill–finish zones.

3. Traceable Assurance: By logging crimping force in real-time, the rotary system supports batch traceability and validation, increasing confidence in seal integrity for regulators and QA teams alike.

Conclusive thoughts.

Sterile drug production demands precision, and that extends to the final crimp. With rotary crimping, manufacturers gain a measurable edge in quality, compliance, and operational excellence. As advanced therapies push the boundaries of innovation, your crimping technology shouldn't be an afterthought. At 3P innovation, we believe in building smarter systems that go beyond automation - delivering engineering you can trust.

🔗 Learn more about our Rotary Crimper