Exceptional care and attention to detail goes into designing and manufacturing a medical device, and the process of packaging our product is just as critical.
The sterile barrier packaging operations at PEP have their own infrastructure, including specialized systems, dedicated personnel and resources. These assure that package designs, tooling, packaging processes, including heat sealing, validations, and traceability are exceeding the needs of the medical industry. Here are some of the details that members of our sterile barrier packaging team perform or maintain every day.
Package Design: Pouch or blister pack. Assuring product protection, sterilization effectiveness, along with material and seal integrity. Design resources include internal staff and third party partners.
Packaging design validation includes the testing and analysis of packaging material integrity, seal integrity, shelf life (by both accelerated and real-time aging), and transit testing. Each of these validations involves unique procedures, test equipment, and staff experience.
Packaging Process Development: Including the design and manufacture of tooling used to create blisters and sealed packages.
Sterilization Processes: ETO sterilization or gamma radiation.
Sterilization Process Validation: Each product package family has its own documented sterilization program that includes initial and ongoing validation of sterilization effectiveness.
Auditing: Our device manufacturing and sterilized barrier packaging operations are subject to audits by current and new customers, ISO, JPAL, and certified auditors on our own staff (we have six). As a result we are in a continual state of readiness for information requests and our assembly and packaging, validation, and traceability processes are continually upgraded based on audit recommendations.
Industry Failure Report Analysis: Our team continuously monitors industry mandated failure reports and evaluates how problems experienced by others can be avoided in our own device manufacturing and sterilized barrier packaging operations.
International Standards Compliance: Medical device products manufactured and packaged at PEP facilities are distributed for domestic and international customers, and we make sure our customers’ packaging meets all of regulatory standards applicable to those locations.
Bottom line: PEP customers are sometimes surprised to learn that the standards we have set for sterilized barrier packaging are often higher than their own. However, we consider the packaging to be every bit as important as the medical device it protects.