Joe Wojcik
How does ApiJect ensure that the temperature changes which occur during BFS manufacturing do not negatively impact the drug product? Can Blow-Fill-Seal handle ultra-low temperatures? Can Blow-Fill-Seal be used for vaccines?
Joe Wojcik
Temperature is everyone’s first question. How does temperature play a major role? Does the heat affect the drug product? How is the temperature controlled?
Component Supply Chain
Josh Myers, MBA
Are polymers readily available? Does ApiJect stockpile resin/polymer? What manufacturing capacity does ApiJect have available today?
Prefilled Injectors
Dave Boerschel
How do you prevent “suck-back” where blood is drawn into containers? Is a prefilled syringe the same as an auto-injector?
Injector Components
Josh Myers, MBA
What are the components of the prefilled injector? Does the needle hub also have components? What Type of plastic is used on the container, hub, and components?
Component Manufacturing
Josh Myers, MBA
Who manufactures ApiJect’s components? What is manufactured at TRC? What about Fareva?
Pharmaceutical Packaging 2
Jon Burgess
Are any of those packaging functions trade-offs, or are they all complimentary? Have there been major advances in packaging in the last, say ten years?
Pharmaceutical Packaging
Jon Burgess
What logistical challenges arise concerning the supply chain management for different packaging materials? What are the road tests that a glass or plastic vial must pass for pharmaceutical use?
Handling Drug Product
Joe Wojcik
What formulations can ApiJect handle? What about nitrogen overlay? Describe ApiJect’s end-to-end development capabilities to ensure the right device is created.
Five Functions of Packaging
Jon Burgess
What are the five functions of pharmaceutical packaging?
Prefilled Injector Supply Chain
Dave Boerschel
How does BFS perform in sterility and particulate matter requirements?, Why can BSF containers be harder to physically inspect?, How many BFS containers would be inspected? and Is human visual inspection ever supplemented with machine photography and analysis?
Blow-Fill-Seal Container Inspection
Philip Leslie
How does BFS perform in sterility and particulate matter requirements?, Why can BSF containers be harder to physically inspect?, How many BFS containers would be inspected? and Is human visual inspection ever supplemented with machine photography and analysis?
Pharmaceutical Packaging Standards (Pt. 1)
Jon Burgess
What have been the industry standards in packaging? and Who sets these industry standards?
Blow-Fill-Seal Terminal Sterilization
Philip Leslie
What is the difference between conventional terminal sterilization and bulk sterilization?; With terminal, what other methods are used besides heat?; Has there ever been a time where terminal was used with BFS, or when it’s desirable?; What kind of equipment/space is needed? and With BFS, is sterilization always done on site?
Drug Stability Testing & Formulation
Joe Wojcik
How is drug stability maintained during BFS fill-finish?; Is the drug mixing done onsite, or at the pharmaceutical supplier?; How is stability testing handled?; What are ApiJect’s formulation capabilities? and In addition to viscous products, what are the other formulation challenges?
Aseptic Technique & Performance Requirements
Lisa Fotheringham
What are the requirements needed in aseptic processing?; What is aseptic technique in manufacturing?; and Are there any special performance requirements to create aseptic conditions?
Why Aseptic Processing is Important?
Lisa Fotheringham
Is aseptic processing truly sterile? and Why is aseptic processing important?
Launch of Did You Know: Blow-Fill-Seal
Molly Weaver, PhD
Short, technical Q&A videos where ApiJect experts provide responses to questions about BFS technology. Such as, “How does BFS handle light and oxygen sensitive drug products?” and “Does BFS manufacturing create less pollution and waste byproduct volume than glass?”
