Review questions on Packaging Product Design/development and design validation-Quiz #5
What are the four directives of ISO 11607 Part 2 regarding Process Validation?
-Installation Qualification (IQ) -Process Development -Operational Qualifications (OQ) -Process Qualification (PQ)
What are the six basics of Operational Qualification?
-Process of obtaining and documenting evidence that installed equipment operated within predetermined limits when used in accordance with it operational procedures -produce samples at worst case conditions of manufacture -sample size -visual testing -seal integrity -seal strength
What are the guidelines for packaging process validation?
-Written Protocols Required -Process Validation has to be completed in this order: IQ-OQ-PQ -Process Development should be considered, but is not required -process validation MUST be completed before Design Validation
What are the five features that practitioners/customers expect from medical device packaging?
-clean, fiber-free opening - double sterile packaging -printed process indicator (sterilization) -easy-open notches on chevron peel pouches -lids with adhesive transfer
What are the seven things to consider when selecting materials for medical device packaging?
-cleanliness -printing -durability -heat sealability - process compatibility -barrier requirements -safety considerations
What are the four phases of sterile medical product development?
-design inputs -material selection -packaging design -design prototype
What are the seven basics of Installation Qualifications?
-equipment acceptance -equipment installation -safety challenge -operational challenges -critical process parameters -training -when IQ complete ensure: equipment is still in calibration and equipment is in working order
What are the six out of nine design inputs that are needed to design packaging for a product?
-logistics and handling -manufacturing -marketing -customer -capital -regulatory
What are the six basics of Process Qualifications?
-produce 3 lots of samples at nominal process parameters replicating actual process variables: operators, machine setup, startup/shutdown, and time -visual testing -seal integrity -seal strength -process capability -in-process testing
What are the four elements of Package Design Validation?
-shelf life -written protocol required -simulated distribution -package integrity testing
What are ISO 11607 definitions of primary and secondary packages?
Primary: Sterile Barrier System -minimum package that prevents ingress of microorganisms and allows aseptic presentation of product at point of use Secondary: Protective Packaging -configuration of materials design to prevent damage to the sterile barrier system and its contents until point to use Primary and Secondary: Packaging System -combination of sterile barrier system and protective packaging
What is packaging and the nouns and verbs of it?
packaging- a coordinated system of preparing goods for safe transport, storage,retailing, and use noun: the design of packaging to protect, communicate, and identify a product verb: the design of packaging processes and equipment to safely and efficiently get the product into the package and ensure its safety and sterility (if required) through the distribution system
