Packaging Consulting Services

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 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 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.
• 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
• Supply chain continuity issues, material change strategy, planning & execution
• 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

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.