In 2005, pharmaceutical manufacturer WALA Heilmittel GmbH invested in a PK-A ampoule leak-testing system to ensure reliable integrity control for 1 mL and 10 mL formats. The machine remained in operation for two decades, supporting quality assurance.
In 2025, during the expansion of a new production facility, WALA returned to Bonfiglioli Engineering for a new PK-A system, configured for 1 mL, 2 mL, and 10 mL ampoules.
Twenty years of reliable performance did more than justify the original investment. It defined the benchmark for the next phase of expansion.
“The decision to choose Bonfiglioli Engineering again was based on the positive experience of previous years: high machine quality, excellent service, and a trusting collaboration.” - WALA Heilmittel GmbH
In 2005, WALA required a precise and reliable leak-testing solution for 1 mL and 10 mL ampoules to ensure the highest quality standards in pharmaceutical production.
The initial design phase revealed several technical challenges:
Early operation required additional stabilization work
Specific mechanical components were modified to improve consistency
Integration into the production line involved synchronizing the ampoule feed with surrounding equipment
Testing parameters were established and validated individually for each ampoule size
The ultimate PK-A system solution was developed through ongoing exchanges between the WALA team and Bonfiglioli Engineering, with adjustments made as the machine was tested in real production conditions.
The machine provided a robust leak testing solution tailored to the specific production environment and quality requirements.
“Collaboration with Bonfiglioli Engineering was cooperative and solution-oriented from the very beginning. Particularly noteworthy are their quick response times and willingness to address individual requirements.” - WALA Heilmittel GmbH
Following optimization, the performance of the PK-A series system advanced significantly. Testing speed increased, allowing higher throughput without compromising detection capability. Process reliability also improved. This stable operation environment reduced interruptions and increased consistent production flow.
Validated parameters also remained consistent over time, contributing to sustained compliance with internal quality standards. The system became an integrated part of the manufacturing process rather than a stand-alone inspection step.
In 2025, WALA moved production to a new facility as part of a broader expansion. Rather than relocating and modifying the original machine for the new line, the company chose to invest in a new PK-A system. This allowed the company to expand leak-testing capacity while continuing to use a technology platform already proven in its operations.
The original 2005 machine was removed from the line and sold to a contract manufacturing organization, where it remains in operation, offering dependable leak detection performance.
“The decision to choose Bonfiglioli Engineering again was based on our positive experience over the years: high machine quality, excellent service, and a trusting collaboration.” - WALA Heilmittel GmbH
Over the past twenty years, support from the Bonfiglioli Engineering team has remained an active part of the relationship. Technical inquiries were handled directly, and service interventions were carried out with attention to production continuity.
Communication between Bonfiglioli Engineering and WALA was consistent and practical. When adjustments were recommended, they were discussed and implemented in coordination with the production team.
Bonfiglioli Engineering’s high quality service and support contributed to stable long-term system performance and sustained confidence in its capabilities.
“The service has always been professional, fast, and competent. We appreciate the continuous support and proactive communication.” - WALA Heilmittel GmbH
The PK-A series system installed in 2005 remains fully functional in 2025, continuing to perform its role in ampoule integrity testing.
When the time came to expand into a new facility, the decision to invest again in Bonfiglioli Engineering technology followed naturally. The return was not driven by proximity or short-term considerations; it was grounded in long-term performance and firsthand experience.
The PK-A performs non-destructive leak testing for pharmaceutical ampoules directly on the production line. Using vacuum and pressure-decay technology, it detects microleaks and seal imperfections without compromising the integrity of the container or its contents.
The system is configured to work within established production lines and plant data systems. Core capabilities include:
Real-time autotest capability
Quick format changeovers
High installation flexibility
Format flexibility is a core strength: at WALA, the PK-A accommodates typical ampoule sizes and supports expanded testing across 1 mL, 2 mL, and 10 mL formats. Its design supports continuous operation with minimal cleaning disruption, automatic drying on vacuum decay models, and ease of access for operators and maintenance staff.
Additional benefits include full batch-control testing with consistent repeatability and the ability to exchange testing data with external systems, such as MES, enabling structured performance monitoring and documentation across production runs.
Sustained performance in WALA’s daily production environments demonstrates the practical value of well-engineered leak testing equipment.
When a system remains reliable under real operating conditions decade after decade, it becomes a core component of the quality process rather than a variable within it.
Paired with strong customer and service support, operators and maintenance team feel confident in the product performance and uptime.
Equipment that remains reliable over decades reduces replacement frequency and preserves investment value.
When production expanded, WALA’s decision to return to the same Bonfiglioli Engineering technology was shaped by years of direct experience on the production floor. The machine had proven itself in daily operation, and the collaboration and customer support behind it had proven just as steady. What began as a single installation ultimately influenced how the next stage of production was planned and executed.
“Bonfiglioli Engineering is a reliable partner for us, combining quality and innovation.” - WALA Heilmittel GmbH
If your company is anticipating a capacity expansion, upgrading aging inspection systems, or optimizing ampoule integrity testing across multiple formats, Bonfiglioli Engineering can help you build a solution designed for long-term performance.
Contact Bonfiglioli Engineering to discuss how the PK-A series can support your production goals now and for decades to come.