Empowering Your Packaging Success
In today’s challenging market landscape, navigating through the complexities of regulatory demands, supply chain continuity challenges and resource constraints can be daunting. The aftermath of the COVID-19 pandemic has intensified these challenges, urging companies to achieve more with fewer resources. With the continued scarcity of experienced packaging engineers, there’s a noticeable gap in the marketplace posing significant hurdles for healthcare companies.
However, the Lifescience industry need not worry because we understand the struggle that companies face in maintaining their new product development and sustaining engineering program timelines amidst these constraints.
We are here to bridge this gap and elevate your packaging project needs to new heights.
Tailored Packaging Process Development Solutions
In response to industry demands, DDL now offers consulting services focused on packaging process development. Our seasoned and proficient engineering team stands ready to equip you with the insights and expertise needed to conquer challenges such as:
- ISO 11607 – 1, 2 & 3 training and awareness:
- Part 1 & 2 are FDA recognized consensus standards that govern the validation of terminally sterilized medical device packaging systems. Packaging must also comply with both parts 1&2 of ISO 11607 in order to satisfy EU MDR regulations to obtain a CE Mark. Fulfilling the requirements within ISO 11607 standards ensures that a medical device packaging system allows for sterilization, provides physical protection and maintains sterility up to the point of use.
- Part 3 fills a critical gap in medical device packaging by explicitly standardizing process development for forming, sealing, and assembling sterile barrier systems (SBS) when utilizing heat sealing technologies.
- ISO 11607 compliant packaging procedures and templates: 11607 standards are subscribed and not prescribed, and therefore merely reading the standards and applying them verbatim is not practically possible. Understanding the correct interpretation, with an overlay of regulatory expectations and industry best practices, is critical to correct implementation. Interpreting ISO 11607 can be challenging.
- New packaging equipment selection, procurement and complete process validations: The list of input to selecting & designing correctly compatible packaging sealing equipment is long! Namely, 11607 requirements, packaging material properties, manufacturing considerations, projected sale volume, compatibility with manufacturing line. Selecting correct packaging sealing equipment type and design is of paramount importance when it comes to patient safety & business continuity.
- Equipment Design for highly stable processes:
- Factory Acceptance Testing & Installation Qualifications (IQ)
- Sealing Process Development/Design of Experiments (DOE) – Process development is essential to any process, especially the ones that have direct impact on patient safety. Developing a process by trial and error (or range finding) is not scientific and cannot help predict process performance. Performing a scientific statistical DOE is one of the most effective ways to minimize patient safety in long term as well as maintaining business continuity
- Operational Qualification (OQ) & Performance Qualification (PQ)
- Legacy product gap assessments & closure: Legacy medical devices can face compliance risks as regulatory standards evolve under EUMDR and FDA guidelines. DDL helps manufacturers stay ahead with strategic gap analysis and closure services that identify regulatory shortfalls and provide clear paths to compliance. DDL’s consulting team offers comprehensive assessments covering ISO 11607, ASTM standards, design validation, and worst-case scenarios—ensuring safety, supply chain continuity, and market readiness for your products.
Supply chain continuity issues, material change strategy, planning & execution: Ensuring uninterrupted supply chain performance amid disruption demands a comprehensive material change strategy, precise planning, and seamless execution. This process centers on proactively identifying vulnerabilities, crafting contingency solutions, and sustaining the consistent movement of materials and products across every link in the supply chain. - Packaging operations remediation strategy, planning & execution: Dealing with old packaging sealing and testing equipment can be a massive headache due to impact on safety, quality, and productivity. Remediating operations or any part of it is rather complex due complexities of regulatory impact and business continuity. Taking a methodical phase-based approach can assist with performing end to end operations remediation, cost improvements, and product competitive advantage.
- Packaging Design & Process Troubleshooting/Investigations: When it comes to packaging for medical or sensitive products, there’s no room for compromise. Ensuring the safety, sterility, and performance of packaging systems is critical — not only for patient outcomes but also for compliance with global regulatory standards like ISO 11607-1 and ISO 11607-2. DDL’s consulting team partners with companies across the life sciences industries to provide comprehensive packaging design, shipping simulation, and process validation services that reduce risk and accelerate market access.
Flexible Consulting Options
Our consulting program adapts to your needs, offering both hourly and full-time equivalent (FTE) options. Whether you’re validating new sealing equipment or resolving issues with existing manufacturing equipment, DDL’s experts are committed to providing unwavering support.
Trusted Excellence
With a rich history of delivering impeccable package testing solutions to the medical device and pharmaceutical industries, DDL has earned the trust of clients worldwide. From package validations to regulatory submissions, from troubleshooting to process development programs, we are by your side every step of the way.
Let DDL be your strategic partner in navigating the intricate landscape of packaging challenges. Together, let’s unlock the door to innovation and success!
Contact us today to embark on a transformative journey towards packaging excellence.
Package Development Process
From first design concept through post-market surveillance, DDL provides the protocols, reports, and qualification support that keep a packaging program compliant and on schedule.
Design & Development
The iterative loop where package concepts are built, tested, and narrowed. Getting the design right here is what prevents expensive rework downstream.
Design Verification
Proving the design output meets the design input. Two qualification tracks run in parallel off this stage — shelf-life stability and distribution/shipping.
Process Validation (Sealing Process Validation)
Establishing that the sealing process reliably produces conforming packages. Runs as operational and performance qualification, with design of experiments underpinning the operating window.
Test Method Validation
Every method used to release product must itself be validated. DDL authors and executes the protocol and report for each sterile barrier test method.
Launch & Commercialization
The gate between development and market. No standalone deliverable sits here — this is where the validated package goes into commercial production.
DDL’s support at this stage is the accumulated documentation package from stages 1–4, plus the cross-cutting Standards & Report Gap Assessment that confirms the file is submission-ready before launch. If a gap surfaces during pre-launch review, remediation support picks up immediately in stage 6.
Post-Market Surveillance
Keeping a commercialized package compliant as standards evolve, suppliers change, and field data comes back.
Regulatory Framework & Review Process
Medical device packaging is audited to ensure sterile barrier integrity and shelf-life stability. The review mechanics, however, differ significantly between the US and the EU.
GSPR vs. Design Controls
While both jurisdictions mandate that packaging protect the device, the regulatory mechanisms used to enforce this are structured differently.
Usability and Aseptic Presentation
Ensuring that a clinician can open a package without contaminating the sterile device is a shared goal, but the compliance paths diverge.
Labeling and Language Requirements
The operational execution of labeling highlights the contrast between the unified US market and the multilingual EU landscape.
Not sure which stage your program needs support in? Talk it through with an engineer.
Request a ConsultationWhere are you in the package development process?
Four questions. We’ll place you on the timeline above and show the specific DDL deliverables that apply at your stage.
Find your stage in about 30 seconds
Whether you’re selecting a concept, chasing a sealing process problem, or re-assessing a legacy package against updated standards, the support you need is different. Answer four questions and we’ll tell you exactly where you are and what typically comes next.
Where is your packaging program today?
Pick the furthest point you’ve reached.
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Do you have qualification data on a similar package or process?
This determines whether you may be able to qualify by similarity rather than running a full study, which is often the difference between weeks and months.
What best describes the situation?
This tells us whether you need forward development support or compliance remediation.
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Every program is different. A 20-minute call with a DDL engineer will confirm whether this is the right path and what it would take.
