Our engineering services are turnkey packaging solutions that bundle specific services, performed by our experts, to get your product across the finish line.
PCL MicroProgram
Usability Evaluation
ISO 11607 suggests performing a documented usability evaluation on your device packaging before your medical device is introduced into a healthcare environment. When healthcare professionals are able to open packages aseptically, there are fewer sterile breaches that could impact patient health as well as reduced risk for damage or loss of equipment.
We provide two solutions for usability evaluation: Panel Usability Evaluation or Clinical Usability Evaluation. Both of our solutions assess the three criteria for usability evaluation listed in ISO 11607:
• the ability to identify where to begin opening,
• the ability to recognize and perform the technique required to open the sterile barrier system without contaminating or damaging the contents, and
• the ability to subsequently present the contents aseptically.
All Usability Evaluations will take place in our simulated surgical suite.
Program Details
Who It's For
Any medical device manufacturer in the development process of a new product that requires sterile packaging.
Timeframe
Varies depending on the customization of the study.
What's Included
Panel Usability Evaluation
• Formalized Discussion Notes
• Photos and Panel Recommendations
• Objective evidence that the three items required by ISO 11607- 1:2019 have been evaluated
• Technical Summary Memo with Completed Evaluation Forms
Clinical Usability Evaluation
• Opportunity for study customization
• Technical immersion session to document device and packaging system to develop technical questions and acceptance criteria for the study
• Clinical assessor profile(s) with the user’s credentials, experience, demographics, and area(s) of expertise
• Complete details of the use environment, gowning, and surgical suite simulation
• Clinical use photographs of aseptic presentation techniques for the client’s products
• Video that captures the entire process of the clinical study
• Objective evidence that the three items required by ISO 11607- 1:2019 have been evaluated
• Protocol Report with moderator questionnaire, user responses, formal discussion notes, summary content and recommendations
PCL MicroProgram
Packaging Design Concept
After performing a technical analysis of your device, we’ll develop competing packaging solutions for your project. As part of our healthcare packaging design process, we’ll work with you to 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 testing 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, our healthcare packaging engineering solutions can meet your project’s one-of-a-kind needs: manage, design, engineer, validate, source packaging materials, direct production, remediate, troubleshoot… and deliver ISO 11607-compliant custom engineered 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