Our MicroPrograms are turnkey packaging systems that bundle specific services, performed by our experts, to get your product across the finish line.
PCL MicroProgram
Packaging Design Concept
After performing a technical analysis of your device, we’ll develop competing packaging solutions for your project. Together, we’ll evaluate the options, with cost analyses, high level project plan and scheduling details for each option. This MicroProgram is often used in conjunction with the Feasibility/Proof of Concept MicroProgram.
Program Details
Who It's For
Any team in the design and development process of a new medical device that will require sterile packaging.
Timeframe
Typically, 4 to 6 weeks.
What's Included
- Discovery session with your team
- Product package assessment (PPA)
- Two to four medical packaging design concepts
- Quotes for materials/tooling and equipment to produce each
- Functional prototypes where possible
- Project plan and production schedule for each
PCL MicroProgram
Feasibility / Proof of Design Concept
Vetting the packaging design concept (yours or ours) is a critical component of successful validation. We perform a series of tests to achieve two things: 1) establish viability of the existing design, and 2) identify potential failure modes for the system. This is a great tool to gain confidence before you spend big dollars on tooling and inventory. Even a small number of dummy samples can give you the results you need.
Program Details
Who It's For
Any medical device company in the process of creating a new packaging design.
Timeframe
Typically, less than 1 week.
What's Included
- Transit simulation testing
- Visual inspection and sterile barrier integrity testing
- Engineering test report, with findings and observations for all tests
- Findings meeting with your team to review results and actionable recommendations
PCL MicroProgram
Turnkey Sealer Validation
Proper sealer validation is a requirement of ISO 11607-2. A thorough qualification provides a strong foundation for your transit and aging validations going forward. Because it’s turnkey, you do nothing. We do all the leg work, from writing the protocols to performance testing and final installation at your facility.
Program Details
Who It's For
Medical device manufacturers purchasing new sterile packaging equipment or in the process of validating a new packaging system.
Timeframe
Typically, 3 to 5 weeks.
What's Included
- Authorship of protocols
- Memorandum of seal characterization and range finding memo
- Detailed work instructions for equipment and packaging
- On-site client training
- IQ/OQ/PQ validation reports
- On-site equivalency validation
PCL MicroProgram
Transit Root Cause Analysis
Transit failures happen. When they do, it’s important to take a systematic approach to finding a solution that will get the project back on track. With this program, our engineers will investigate to determine the exact cause of the failure. From there, we can identify potential options to course correct with the least possible disruption to launch.
Program Details
Who It's For
Medical device companies facing a packaging failure in the distribution environment.
Timeframe
Typically, 3 to 5 weeks.
What's Included
- Client conference to review the history of the packaging failure at issue
- Fishbone diagram
- Re-creation of failure through transit testing, if possible
- Engineering analysis of potential factors and conclusions
- Final report detailing root cause, additional findings and recommendations for path forward
PCL MicroProgram
ISO 11607 Audit
In the ever-changing regulatory environment, it is common for original validations to become outdated. Too often, this leaves companies unknowingly out of compliance. Regular reviews of your standing with current ISO 11607 requirements can protect the significant investment you made to get to market. This program is a way to identify and quantify areas of risk to prevent problems before they occur.
Program Details
Who It's For
Companies with mature product lines facing potential regulatory gaps or remediation efforts.
Timeframe
Typically, 3 to 4 weeks.
What's Included
- A thorough review of documentation records and previous validation protocols
- On-site audit of the sterile packaging process
- Comprehensive audit report of findings and actionable recommendations
Custom Packaging Engineering
Wherever you are on the packaging continuum, we can meet your project’s one-of-a-kind needs: manage, design, engineer, validate, source materials, direct production, remediate, troubleshoot… and deliver ISO 11607-compliant packaging for your medical device.
Program Details
Who It's For
Any medical device manufacturer
Timeframe
Varies, based on your project
What's Included
Comprehensive sterile packaging support at any level