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// From Legacy Vendor Lock-in to Flexible, Operator-Friendly Serialization!
How Purna Pharmaceuticals N.V. Implemented Vimachem SSM Level 3 and Level 4 to Support Multi-Client Liquid and Cream Packaging
// From Legacy Vendor Lock-in to Flexible, Operator-Friendly Serialization!
How Purna Pharmaceuticals N.V. Implemented Vimachem SSM Level 3 and Level 4 to Support Multi-Client Liquid and Cream Packaging
Company Profile
Organization: Purna Pharmaceuticals N.V. (Contract Manufacturer) • Company Size: 200+ employees • Location: Belgium • Industry: Pharmaceutical Manufacturing (CDMO) • Facility: FDA-inspected and EU FMD-compliant manufacturing site
Executive Summary
Challenge
Replace a costly, hard-to-support legacy serialization system that struggled to meet multi-client CDMO compliance requirements.
Solution
Implementation of the Vimachem Pharma MES Platform with the Level 3 & 4 Serialization Site Manager (SSM) and the Manual Aggregation Module (MAM), creating a single serialization hub connecting Wipotec serialization and aggregation lines and multiple client Level 4 systems.
Results
Purna gained an intuitive, scalable serialization environment that reduces IT burden, improves operator efficiency, accelerates customer onboarding, and strengthens compliance across global markets.
"In retrospect, I’m very happy with our move to Vimachem. Our users are very happy as well – they find it easy to use and a big improvement over our previous system."
Purna Pharmaceuticals N.V. is a contract manufacturer specializing in semi-solid, powders, liquids, and creams. Founded in the mid-1980s, the company has grown to more than 200 employees and now operates as a partner to multiple pharmaceutical companies, focusing on contract manufacturing projects. Operating from a single site in Antwerp, Belgium, the IT department is intentionally lean, with a two-person team managing infrastructure, software, security, and backups.
The site operates Wipotec machines within its manufacturing environment. Gunter Van Damme has been with Purna for more than 20 years, initially in validation before becoming the IT Supervisor, and has been closely involved in the validation of SAP and key manufacturing systems.
Production & Serialization Overview
- Site footprint:
→1 site, 2 buildings (main production plus a warehouse and packaging area).
- Manufacturing:
→ 11 production cubicles with dedicated tanks supporting liquid and cream manufacturing:
• 5 liquid processing units.
• 6 semi-solid (cream) processing units.
- Packaging:
• 15 packaging lines in total.
• 5 packaging lines equipped for serialization.
• 1 manual serialization station.
• 1 aggregation device available on site.
- Business model:
• Contract manufacturing for multiple pharma partners.
• Previously produced generics; now focused on customer projects and new products.
- Regulatory:
• FDA-audited site, serving multiple international markets.
Serialization and aggregation are orchestrated through Vimachem’s Level 3 platform (SSM), connected to line equipment and to external Level 5 platforms provided by Purna’s customers.
The Challenge
Modernizing Serialization Operations Amid Increasing Compliance and Customer Demands.
As Purna grew its contract manufacturing operations, the company needed a serialization platform that could keep pace with increasing customer requirements, regulatory expectations, and the complexity of running multiple packaging lines for diverse pharmaceutical partners.
1. Limitations with the Previous Level 3 and 4 Serialization Vendor
Purna’s former serialization software solution was no longer meeting the operational or business requirements of a modern CDMO.
Key challenges included:
- Slow, inconsistent support: response times often took multiple days, creating operational uncertainty.
- Contractual and commercial misalignment: changes in agreements and pricing introduced risk and unpredictability.
- User experience gaps: the system was not intuitive for operators, resulting in inefficiencies on the shop floor.
These issues collectively made the existing solution unsustainable as Purna scaled.
2. Increasing CDMO Complexity
As a multi-client manufacturer, Purna must manage:
- Serialization and aggregation across varying customer specifications.
- Rapid SKU and line changeovers across packaging lines.
- Seamless connectivity to multiple external Level 5 systems.
- Demonstrable compliance for audits and client quality reviews.
This created a clear need for a more flexible, reliable, and operator-friendly serialization software environment.
3. A Lean IT Team with Broad Responsibilities
With only two IT professionals managing infrastructure, SAP, security, and application support, Purna required a serialization solution that was:
- Easy to use for operators and supervisors.
- Fast to implement for new customers and projects.
- Straightforward to maintain, reducing ongoing support burden.
4. The Need for an Aligned, Long-Term Partner
Serialization is mission-critical and highly visible internally and to customers.
Purna sought a technology partner who could:
- Offer predictable, responsive support.
- Collaborate closely during implementation and customer onboarding.
- Provide the foundation for a scalable, future-proof serialization strategy.
Why Purna Chose Vimachem
Purna evaluated several options when replacing their legacy serialization provider and ultimately selected Vimachem, based on a combination of capability, ease of use, and strong industry validation. The site now operates the Vimachem MES Platform with the Level 3 & 4 Serialization Site Manager (SSM) and the Manual Aggregation Module (MAM).
"We looked at the market. SAP was too big and complicated; TraceLink redirected us to Vimachem. Our Wipotec partner also knew Vimachem. That combination convinced us to move away from our old vendor and sign with Vimachem."
Gunter Van Damme
IT Supervisor at Purna Pharmaceuticals N.V.
The decisive factors were:
- All-In-One Level 3 and Level 4 solution: At Purna, Vimachem SSM functions as both Level 3 and Level 4, handling shop-floor data exchange as well as serial number repositories, master data, and reporting to external Level 5 systems.
- User-friendly system: Operators found SSM intuitive and “very smooth” in daily use, a clear improvement over the previous solution.
- Trusted ecosystem partner: Recommendations from TraceLink and Wipotec technology reinforced confidence that the Vimachem Level 3 Serialization Site Manager would integrate cleanly and support future expansion.
- Quick implementation: Production-ready go-live completed in 10 weeks, with no disruption to production.
- Low maintenance: The system is easily supported by Purna’s lean two-person IT team, with configuration changes and new projects handled internally.
- Integration-ready: Proven compatibility with existing line equipment and multiple Level 4 and Level 5 systems.
- Flexible approach: Supports both automated and manual serialization and aggregation workflows, enabling scalability as customer needs evolve.
Vimachem SSM now serves as Purna’s Level 3 serialization hub, connecting multiple packaging lines, the manual station, and aggregation equipment to customer-provided Level 4 systems. The platform’s simplicity, rapid deployability, and low operational overhead have made it a strong fit for Purna’s CDMO environment.
"The users of the system are very happy. They say it is a very big improvement compared to our previous solution, and it is easy to use and simple."
Gunter Van Damme
IT Supervisor at Purna Pharmaceuticals N.V.
The Solution
Implementation Journey
Purna’s implementation experience unfolded in two key phases: an initial migration, followed by a major project that solidified the decision to partner with Vimachem.
Phase 1 – Initial Migration - Building the Serialization Foundation
-
The initial migration introduced Vimachem SSM as Purna’s central Level 3 platform, connecting multiple packaging lines, the manual station, and aggregation equipment to the diverse Level 4 systems used by their clients.
This phase encompassed solution design, configuration, operator training, and qualification. Once live, the benefits were immediate: operators embraced the simplicity of the interface, and the lean IT team could support the platform with minimal overhead. The rollout provided a stable, modern foundation capable of supporting Purna’s growing CDMO operations.
Phase 2 – Rapid Deployment for a Major US Customer
-
The next implementation, delivered for a major US client, validated the maturity and scalability of the model. The project advanced efficiently from planning through qualification, with Vimachem actively participating in customer discussions to ensure clarity and alignment.
The line went live seamlessly, and Purna’s management viewed the collaboration as a strong confirmation of their decision to adopt Vimachem.
"The project went excellently. Having Vimachem on the call with the customer was really appreciated by our management."
A Repeatable Model for Future Growth
-
With these two phases complete, Purna now operates a consistent, repeatable implementation framework. New customers, SKUs, and lines can be onboarded quickly, integrations with multiple Level 4 partners run smoothly, and qualification timelines remain predictable.
The organization is positioned to scale confidently as customer demand expands.
Results
Vimachem SSM has delivered clear operational, compliance, and business benefits for Purna, strengthening both day-to-day performance and long-term scalability.
Operational & Business Outcomes
- Improved operational efficiency: Operators and line personnel report significantly smoother execution compared to the legacy system. Daily workflows are more efficient, changeovers are quicker, and reliance on IT has decreased, contributing to more stable and predictable line performance.
- Optimized support for a multi-client CDMO model: Purna can now manage multiple customer programs, each with distinct Level 4/5 integrations, data flows, and regulatory requirements, within a unified Level 3 and Level 4 environment. This flexibility enhances Purna’s ability to scale, take on new customers, and meet diverse market expectations.
- Enhanced support responsiveness: Support responsiveness has improved markedly compared to the previous vendor, enabling faster issue resolution and helping maintain production continuity across high-throughput periods.
Compliance & Audit Readiness
Operating as an FDA-audited facility and serving highly regulated markets, Purna requires robust governance over serialization and aggregation processes.
With the Vimachem Level 3 SSM, the team can:
- Maintain granular batch-level visibility and full traceability across lines.
- Demonstrate strong data integrity and procedural control.
- Confidently support regulatory inspections and customer quality audits.
The platform provides the transparency and consistency required in stringent compliance environments.
Daily Use & Operator Experience
- High adoption and ease of use: Teams describe SSM as intuitive and straightforward, enabling faster onboarding and reducing operator workload. The improved usability compared to the legacy system translates directly into smoother daily operations.
- Greater system stability: The serialization environment is more stable and predictable, which is essential for a CDMO managing continuous production and varied customer requirements.
- Sustained capability building: Training sessions and recordings provided by Vimachem serve as ongoing reference materials and have been integrated into internal SOPs, strengthening Purna’s operational expertise.
Key Benefits of Vimachem SSM for Purna
- Operator-centric ease of use: The platform’s intuitive interface and streamlined workflows enable efficient execution for operators and supervisors, representing a clear improvement over the legacy system.
- Fast implementation and rapid time to value: New customer projects can be implemented, tested, and qualified quickly once prerequisites are aligned, without the need for large IT initiatives or extensive custom development.
- Low-maintenance operation: The system can be supported effectively by Purna’s lean two-person IT team, with configuration changes and new requirements managed internally rather than the need for ongoing engineering support.
- Purpose-built for a multi-client CDMO model: SSM supports multiple packaging lines and the manual station, integrates seamlessly with diverse customer Level 4/5 systems, and scales easily as new customers, markets, and products are added.
Conclusion
Purna Pharmaceuticals has strengthened its serialization capability by implementing the Vimachem Level 3 and Level 4 Serialization Site Manager. The transition from a restrictive, difficult-to-support legacy vendor to a modern, intuitive solution has delivered meaningful improvements across daily operations, customer onboarding, and system maintainability.
The combination of an operator-friendly interface, efficient implementations for new customer projects, and the ability to manage multi-client serialization across numerous packaging lines has validated the great decision to adopt Vimachem SSM.
With Vimachem, Purna is now well positioned to:
- Support the diverse serialization and aggregation requirements of its global customer base.
- Maintain strong compliance across regulated markets, including FDA-audited environments.
- Confidently expand operations on a platform designed to be easy to use, fast to implement, and straightforward to maintain.
Vimachem SSM provides the scalable, reliable serialization foundation required for Purna’s continued growth as a leading CDMO.
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