The Packaging Cooperative (TPC)
The Packaging Cooperative (TPC) is a leading provider of packaging engineering, testing, and consulting services across North America. Since 2015, we’ve built a reputation for excellence by assembling a team of top-tier engineers with deep expertise in packaging, quality, regulatory, and validation solutions. With more than 150 years of combined experience—much of it in the pharmaceutical, biotech, cold chain, and medical device industries—our team brings the insight and capability needed to solve complex challenges and deliver results.
At TPC, we take a holistic, risk-based approach to packaging development. We begin by listening to our clients’ objectives, assessing the supply chain environment, evaluating equipment and end-user needs, and designing fit-for-purpose packaging strategies. Our services span from concept development and prototyping to authoring validation protocols and supporting regulatory compliance, all tailored to meet the specific needs of our clients in the life sciences and beyond.
What sets TPC apart is our cooperative model—when you work with us, you gain access to a network of specialized experts rather than a single consultant. This model allows us to offer flexible, fractional support that aligns with your timelines, budget, and evolving project goals. We pride ourselves on delivering projects efficiently and collaboratively, always focused on driving value and supporting long-term success.
At The Packaging Cooperative, we apply a rigorous, risk-based engineering methodology aligned with the V-model and ISO 13485 design control requirements to ensure packaging systems for medical devices and pharmaceuticals are developed, verified, and validated to the highest regulatory standards. Our process seamlessly integrates the principles of ISO 11607-1/-2, 21 CFR 820.30, and cGMP expectations to deliver compliant, high-performing solutions the first time.
Our development lifecycle initiates with clear definition of user needs, design inputs, and intended use criteria. Through detailed feasibility studies—including simulation, prototyping, and pre-validation assessments—we assess material compatibility, sterilization modalities, and distribution hazards early in the process. This allows us to mitigate risk, validate critical design assumptions, and optimize packaging system architecture before formal qualification.
We execute Installation Qualification (IQ) to confirm proper setup and documentation of forming, sealing, or testing equipment. Operational Qualification (OQ) follows, verifying process control parameters under defined operating ranges. Finally, Performance Qualification (PQ) validates system performance under actual or simulated use, including aging, shipping, and sterilization validations. These activities are fully aligned with ISO 11607 requirements for package system performance and sterile barrier integrity.
By embedding IQ/OQ/PQ into the V-model framework and tying each phase back to defined design outputs and traceability matrices, TPC ensures robust documentation, audit readiness, and reduced risk of nonconformance during commercialization. Our team’s deep technical expertise in cold chain, combination products, and high-risk medical devices enables efficient execution of packaging validations—accelerating market readiness while maintaining compliance and patient safety.
At The Packaging Cooperative, we combine cutting-edge technology, innovative software tools, and deep industry expertise to deliver packaging solutions that work—across every application and industry. Our team is actively developing new technologies and partnering with leading suppliers, manufacturers, testing labs, and suppliers to enhance every stage of the packaging development process. We design for long-term success.
By integrating feasibility testing early in the design phase, we validate performance, identify potential issues, and make engineering adjustments before costly mistakes occur. This proactive approach ensures your packaging is designed right the first time—minimizing the risk of validation failures, keeping your launch on schedule, and controlling costs. With TPC, you gain a strategic partner who helps accelerate development while protecting your timeline and bottom line.
Custom solutions: Designing for supply chain optimization and user requirements, incorporating human factors into the entire packaging process.
Analytics: Simulation analysis of your design before prototype failure—using science to test your supply chain performance.
Feasibility testing: Testing to failure before validation.
We aim to help you succeed by simplifying the packaging development process for commercialization.
