Semi-Automated Print Station
The Semi-automated Print Station: Fastest Solution to implement Serialization and Aggregation for low volume production.
Pharmaceutical Aggregation Solutions for Global Compliance
The global pharmaceutical industry is an ever-evolving and fast-paced environment that must always adapt to the needs of the patients while following the requirements of various national health organizations and governments.
But the question is: Why does our industry need to regulate such a well-oiled machine? The answer is simple. Counterfeit and fraudulent products are a lucrative business that is consistently on the rise, especially in the case of medicines, powered by the booming economy of online shopping, the flattening of the world and the opening of international borders.
Take Control of Aggregation Challenges
Lead the Way in Traceability
What Is Pharmaceutical Aggregation?
Pharmaceutical aggregation is the process of linking each serialized product to its packaging hierarchy, bottle to box, box to case, case to pallet, creating a digital parent-child relationship. This enables seamless tracking across the entire supply chain, from production to patient delivery.
By building on serialization, aggregation helps manufacturers ensure global compliance, streamline logistics, and enable precise, efficient recalls.
Why Pharmaceutical Aggregation Matters for Compliance
The pharmaceutical industry operates under increasing scrutiny from global regulatory bodies like the US FDA (DSCSA) and EU FMD. Aggregation is no longer optional, it’s becoming essential.
With the rise of counterfeit medicines, online distribution, and globalized supply chains, governments require manufacturers to implement serialization and aggregation for full traceability.
Aggregation ensures:
- Patient safety through full supply chain visibility
- Compliance with current and future regulations
- Rapid, accurate recall processes
- Protection of brand integrity and market access
Benefits of Serialization and Aggregation in Pharma
Pharmaceutical companies implementing serialization and aggregation gain operational, financial, and compliance advantages:
- Regulatory readiness across markets
- Supply chain optimization with real-time tracking
- Simplified returns and recall processes
- Reduction in manual errors and duplicate serials
- Data-driven insights to improve efficiency
- Decommissioning of pallets and cases made easy
- Increase in supply chain security and efficiency
Typical Challenge
Typical Challenge
From Pain Points to Best Practices
- Disruption to current workflows
- Financial impact of post-serialization integration
- Operator training and learning curves
- Temporary reduction in line productivity
- Pressure to meet fast-approaching compliance deadlines
Benefits
Benefits
How We Solve Pharma Aggregation Challenges
- Minimal downtime solutions with easy changeovers
- Tailored training and onboarding support
- Deep integration experience with existing IT, MES, and ERP systems
- Turnkey solutions that reduce complexity and risk
- End-to-end project management to ensure fast, compliant deployment
Turnkey Track & Trace Solution
WHY CHOOSE OPTEL?
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Turnkey, Fully Integrated Systems
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Integration Expertise from L1-L5
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Transparent Pricing and Scalable Options
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Flexible, No-Lock-In Architecture
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24/7 Local Support Team
FAQs on Aggregation in Pharma
Aggregation is increasingly required or strongly recommended by regulators like the US FDA (under DSCSA) and EU authorities under FMD.
Yes. OPTEL’s modular approach ensures minimal disruption and seamless integration with current systems.
OPTEL provides 24/7 global support, local presence, and a dedicated Customer Success Manager to guide your journey.
Related Products
CartonTracker
Automated serialization solution with great stability for printing and inspection, and that has an integrated ejection system
LineMaster
Software embedded in the line that records all serialization and aggregation events at the packaging level
PackStation (FMP)
Manual aggregation solution that can also serialize any level of packaging
PackStation (SAP)
Semi-automatic solution designed to read serial numbers and add them to shipping cartons
CLTracker (TE)
Solution developed for implementation in sealing units or tamper-evident features that serializes and inspects data
BottleTracker
Solution that inspects and adds bottle labels without interrupting the production flow
BundleTracker
Solution that makes the aggregation of grouped products. It checks product count and status while rejecting defective packages
PalletMaster
Aggregation solution that identifies and checks boxes and pallets with cameras and/or barcode readers for the central palletizing area
Association Station
Solution that checks serialized products and facilitates aggregation into secondary packages
Kompano
Solution that manages the serialization of products in the warehouse: prints labels, reworks, sending and receiving
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Serialization is the first step in the traceability journey. OPTEL delivers scalable pharma solutions for global compliance and end-to-end visibility.
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Production Line Automation Solutions: from the case packer to the end-of-line Cobot Palletizer, discover OPTEL’s high performing and turnkey automated line solutions.
VerifyBrand
Discover OPTEL’s VerifyBrand™ Real-Time Serialization and Traceability software for Compliance, Product Authentication, Brand Protection and Inventory Optimization.
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