Chapter 33 Temperature Management
Industry expert, Philip Leslie shares his knowledge on Blow-Fill-Seal Container Inspection, including 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?
In Part 1 of a 4 Part Series on packaging, Jon Burgess talks about pharmaceutical packaging and standards. Questions include: What have been the industry standards in packaging? and Who sets these industry standards?
Industry veteran, Philip Leslie, discusses Blow-Fill-Seal Terminal Sterilization. Questions include What is the difference between conventional terminal sterilization and bulk sterilization?; And then with terminal, what other methods are used besides heat?; Has there ever been a time where terminal was used with BFS, or when its desirable?; What kind of equipment and space is needed? and With BFS, is sterilization always done on site?
This episode of Did You Know features Joe Wojcik sharing insight on: 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?
Episode 2 features Lisa Fotheringham responding to: 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?
In the first segment, Lisa Fotheringham shares insight on: Is aseptic processing truly sterile? and Why is aseptic processing important?
Did you Know? – 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?”
Live with Chaudhrey: Kevin Ostrander at CPhI Worldwide Frankfurt 2022. Kevin discusses how ApiJect is advancing Blow-Fill-Seal and Injection technologies.
“From Measles to Malaria- Case for Building Delivery into Development for Vaccines & Drugs”
Live with Chaudhrey: Paul Rutter, MD At the World Vaccine Congress Europe. Paul shares insight on building delivery into the development of vaccines and injectables.
Blow-Fill-Seal has a Compact Supply Chain
Blow-Fill-Seal for Sterile Liquids, Biologics and Potent Compounds
Blow-Fill-Seal is Advancing Fill-Finish & Injection Technology
Chats with Chaudhrey: “Prototype Mold Making for BFS Processes”, Jon Burgess
Rizwan chats with Jon to learn more about ApiJect’s recently opened Technology Development Center in Florida and prototype mold making for Blow-Fill-Seal processes.
The Benefits of Plastic Injection Molding
Using the latest in Injection Molding Tooling innovations, components can prototyped to a production quality level.
Technology Development Center: Filling Tests on Rommelag Bottlepack 434 Pt. 3
Technology Development Center: Filling Tests on Rommelag Bottlepak 434 Pt. 2
Technology Development Center: Filling Tests on Rommelag Bottlepak 434 Pt. 1
Overview of Blow-Fill-Seal Manufacturing and Secondary Packaging Line
Inside the Machine Shop: Prototype Mold Cutting
Liquid is cooling fluid while cutting. All is computer controlled and automated. As it finishes, it returns to its home position.
Inside the Machine Shop: Prototype Mold Grinding
The pink wheel is spinning really fast and has feel of a stone. It runs across the top of the aluminum bronze of the mold and is taking off a very, very thin slice, about 2/10,000 of an inch or .0005 mm.
Fill-Finish Podcast 6 – “Current State and Trends Impacting Fill-Finish from Formulation through Commercialization”
ApiJect Platform Uses Efficient BFS Manufacturing Processes
Blow-Fill-Seal Creates and Fills a Container in a Continuous Process
Prefilled ApiJect Injector*—0.5mL Delivery
Elements of the Prefilled ApiJect Injector*
Prefilled ApiJect Injector*-0.5mL Delivery
How Blow-Fill-Seal Delivers Operational Efficiencies and Aseptic Fill-Finish
with Joe Wojcik, BFS Engineer
Pharma expert, Joe Wojcik, discusses the technical factors and requirements that make BFS an “advanced aseptic process” for fill-finish, and why BFS has relatively low capital requirements
Fill-Finish Podcast 5 – “Temperature Sensitive Biologics and Blow-Fill-Seal”
Fill-Finish Podcast 4 – “Evolving Trends in Aseptic Processing”
Episode 4: “Evolving Trends in Aseptic Processing”*
Project Profile: Technology Development Center
The ApiJect Center is focused on helping pharmaceutical companies prepare their drug product for high-speed, high-volume production in a new type of scalable prefilled syringe that is made largely using the Blow-Fill-Seal aseptic process. The ApiJect Center directly supports the future installation of large-scale commercial manufacturing for rapid deployment of critical medications.
Fill-Finish Podcast 3 – “Global Supply Chain Management and Capacity Planning”
Join the ApiJect team! We’re always looking for passionate teammates.
We envision a world where every country can safely, locally, and cost-effectively package and deliver all of the essential injectable medicines and vaccines its citizens need to live long, healthy lives.
Global Manufacturing Supply Chain Resiliency
We have created a compact and flexible supply chain that can be almost entirely domestic in major markets. This is because we rely on two robust manufacturing technologies to make our platform: Blow-Fill-Seal (BFS) aseptic filling and plastic injection molding.
Chapter 35: How to Get Started with Blow-Fill-Seal
Chapter 34: – BFS Delivery System Approach
Chapter 32: The Use of Foil Wrap in Blow-Fill-Seal
Chapter 31: Particulate Inspection in Blow-Fill-Seal
Chapter 30: Leak Detection with Blow-Fill-Seal
Chapter 29: Blow-Fill-Seal Punching, Engraving, and Separating
Fill-Finish Podcast 2: “The Past, Present, and Future of Advanced Aseptic Facility Design”
Chapter 28: Blow-Fill-Seal Machine and Support Systems
Chapter 27: Areas of a Blow-Fill-Seal Line
Chapter 26: low-Fill-Seal Molds
Chapter 25: Blow-Fill-Seal Manufacturing Efficiencies
Chapter 24: Blow-Fill-Seal CapEx and Fixed Costs
Chapter 23: Blow-Fill-Seal Equipment
Chapter 22: Space and Utilities Needed for Blow-Fill-Seal
Chapter 21: Blow-Fill-Seal Filling Suite Installation
Chapter 20: Sensitivity
Chapter 19: Compatibility and Feasibility Testing with Blow-Fill-Seal
Chapter 18: Cost Advantages of Blow-Fill-Seal
Chapter 17: Flexible Scaling of Blow-Fill-Seal
Chapter 16: Compact Supply Chain
Chapter 15: Breakage Resistant
Chapter 14: Transportation and Blow-Fill-Seal
Chapter 13: High Productivity with the Blow-Fill-Seal Process
Chapter 11: Blow-Fill-Seal’s Compact Manufacturing Footprint
Chapter 10: 10 – Introduction to Blow-Fill-Seal / Blow-Fill-Seal is a Cost-Efficient Manufacturing Process
Chapter 9: Sterility Assurance
ApiJect Prefilled Injector
The Prefilled ApiJect Injector* is a delivery system designed to bring together the benefits of prefilled syringes with the manufacturing efficiency of multi-dose presentations. Watch the Video by clicking below.
We are ApiJect
We are a team of passionate and dedicated people. Our mission is to make injectable medicines and vaccines safe and accessible to everyone. Click the button below to watch the video.
BFS Temperature Management
Our BFS manufacturing experts employ a variety of techniques to consistently manage the drug product’s temperature throughout the fill-finish process.
Our experts marry the efficiency and flexibility of BFS with attachable plastic components to create drug delivery systems. This approach has the potential to enable scalable and efficient manufacturing of single-dose prefilled syringe which can typically only be found in multi-dose presentations.
Partnering for Success
We help pharma companies fill-finish sterile liquids by working together to create Blow-Fill-Seal based, prefilled drug delivery systems, and then assist in the fill-finish process. The result is a prefilled drug delivery system that can be flexibly manufactured at various facilities that use BFS.
ApiJect Company Profile
ApiJect is a medical technology company that seeks to improve how companies fill-finish injectable medicines. We do this by working with pharma partners to design rapidly-scalable drug delivery systems, and assist in manufacturing those devices at their facilities or a trusted CMO/CDMO.
Chapter 8: Low Particulates Using Blow-Fill-Seal
Chapter 7: Reliable Aseptic Filling
Chapter 6: Advantages of Blow-Fill-Seal
Chapter 5: Suitable Drug Products for BFS
Chapter 4: Types of BFS Machines
Chapter 3: How Blow-Fill-Seal Works
Chapter 2: Blow-Fill-Seal in Pharma
Chapter 1: What is Blow-Fill-Seal?
Fill-Finish Podcast 1: “Current Trends in Isolation Technology and Vaccine Production”
Chats with Chaudhrey: “Fareva Licensing Agreement”. Jay Walker
Rizwan chats with Jay, Executive Chairman at ApiJect, to learn more about ApiJect’s recent licensing agreement signed with Fareva to create a France-based 500M unit annual capacity for single-dose pre-filled vaccine injections.
Project Profile: Fareva
Increasing Vaccine Fill-Finish Capacity in France: 500M Unit Annual Capacity for Single-Dose Prefilled Vaccine Injectables
Fierce Pharma: “Next Supply Chain Challenge: Syringes”
An estimated 14 to 19 billion incremental injections will be required by year-end 2022 to vaccinate the world’s population against COVID-19 while supplying related boosters and adjuvants. In response, the industry is shifting billions of syringes from routine vaccinations and therapeutics to COVID, increasing existing capacity, and building new manufacturing sites for syringes. Yet COVID’s supply chain is still expected to fall short. What is the source of this looming shortage? Is “syringe nationalism” causing export embargoes? How is the industry responding? Is it a supply chain problem?
In this webinar, three experts in pharma and global health discuss potential solutions including,
What Have Been the Biggest Surprises with COVID-19?
with Ed Kelley, PhD, Chief Global Health Officer
The pandemic’s effects have been far more wide-reaching than many health officials expected, but COVID has also accelerated some positive trends.
Advances in Sterile Liquids Packaging and Form Factors
with Jon Burgess, Packaging Engineer
Discussion on packaging factors that have led to wider acceptance of Blow-Fill-Seal technology in the pharmaceutical industry.
Strengths of Diversity in Pharma
with Amy Stewart, Chief People Officer
Companies are realizing that a strong commitment to DEI and ESG attracts employees. Word of mouth is very powerful. Companies want to do business with partners that are inclusive with positive values and environmental initiatives.
INTERPHEX Live 2021: “Creating a Sustainable Public Health Supply Chain”
Industry experts share insights on how stakeholders can maintain a robust, resilient supply chain essential to global health and vaccine security, with an accelerated response time to meet the needs of current and future pandemics. The building blocks for this supply chain resiliency include tech transfer, designing for right-size capacity, improving operational efficiencies, implementing state-of-the-art technologies, and establishing regulatory and quality systems.
INTERPHEX Live 2021 Session: “Pros and Cons of Global Fill-Finish”
Responding to the COVID-19 pandemic, governments and public health agencies worldwide are developing quality vaccine programs, including local fill-finish capacity, to support global immunization. Yet even before COVID, countries were already facing increased vaccine demand due to population growth. The panel will discuss key challenges and opportunities as governments and pharmaceutical manufacturers seek to establish fill-finish facilities around the world to enable access to greater and more diversified vaccine manufacturing while improving preparedness to respond to future pandemics.
Chats with Chaudhrey: “INTERPHEX 2021 Preview”, Josh Myers
Rizwan chats with Josh last week to learn what ApiJect was doing at INTERPHEX 2021. Learn about our Technology Platform that brings together aseptic BFS with connectable components to create high-quality prefilled drug delivery systems.
Single-Dose Drug Delivery Fill-Finish Facility that is Scalable, Flexible, and able to Deliver up to 45M Units Per Month Delivered within an Accelerated Timeline of Fewer Than 7 Months
Part 3 of Pharmaceutical Technology Post-Webinar Series
ApiJect committed to creating emergency temporary fill-finish capacity for up to 45M doses a month of a candidate COVID-19 vaccine on BFS lines by the end of 2020. All of these BFS-packaged doses could then be used, if necessary, in ApiJect Prefilled Injectors for scalable, single-dose delivery.
Solving Drug Challenges with Innovation, BFS, and a Technology Platform to Create Drug
Part 2 of Pharmaceutical Technology Post-Webinar Series
Learn how ApiJect built its Technology Platform around BFS to create innovative drug delivery systems for the prefilled syringe market and other sterile liquid pharmaceutical delivery formats.
BFS and Prefilled Syringes: A Solution for Complex Formulations
Part 1 of Pharmaceutical Technology Post-Webinar Series
Many countries, including the US, lack the necessary surge capacity to reliably fill-finish and deliver billions of incremental doses of injectable drugs and vaccines during bio-emergencies.
Chats with Chaudhrey: “Syringe Reuse”, Edward Kelley, PhD
Interesting chat with Edward Kelley, Chief Health Officer, ApiJect, and formerly the Head, Strategic Programs, at the World Health Organization about syringe reuse, the causes, impact, and how to help overcome it.
The Surprising Strengths of Blow-Fill-Seal
with Philip Leslie, Acting Head of Manufacturing
Why does the FDA calls BFS an “advanced aseptic process”? How does BFS combine high-speed, economically efficient production with notable manufacturing flexibility? Respected industry veteran Philip Leslie explains “the basics of BFS.”
Project Profile: The RiteDose Corporation
In 2020, as part of the U.S. Government’s COVID-19 response, ApiJect™ entered into a long-term strategic partnership with The Ritedose Corporation (“TRC”). Together, they were able to make operational 45 million units per month of Blow-Fill-Seal fill-finish capacity for America’s COVID-19 response within 7 months out of TRC’s facility in Columbia South Carolina.
Chats with Chaudhrey: “Blow-Fill-Seal”, Philip Leslie
Rizwan chats with Philip to learn more about the advantages and which types of products can be made using BFS.
Chats with Chaudhrey: “How to Progress your Products in BFS”, Philip Leslie
Rizwans chats with Philip to learn more about the advantages and which types of products can be made using BFS.
The ApiJect Story
It turns out that Marc’s solution to the syringe safety problem has the potential to greatly improve how pharma companies fill, finish, and deliver their liquid medicines and vaccines across the board. Read more about Marc’s amazing journey by clicking the button below.
ApiJect Prefilled Injector Assembly
The ApiJect Prefilled Injector brings together an aseptically-filled Blow-Fill-Seal (BFS) container and a pen needle-style Needle Hub* to reliably deliver injectable vaccines and medicines. Click the button below to view the video.
Special Feature: PFS & Parenteral Manufacturing: How COVID-19 Changed the Market
Drug Development & Delivery, Issue: May 2021
Worldwide, the parenteral market is seeing greater emphasis on patient safety. This is driving a strong trend toward unit-dose formats, including Blow-Fill-Seal prefilled syringe, which are now the fastest-growing format for injectables.
BFS Manufacturing Line
What makes BFS truly special is its combination of reliable aseptic filling with its speed and efficiency of production for any size output. In fact, due to its enclosed process and reliability, the industry considers BFS to be an advanced aseptic process. To view the video, click the button below.
The Heat Factor: Part 1 & 2:Why it Matters in Blow-Fill-Seal
with Jeff Price, Consulting Principal BFS Engineer
At ApiJect, our engineers have taken BFS filling enhancements even further by developing proprietary temperature control management methods that can potentially enable many temperature sensitive biologics and vaccines that are not possible on standard BFS lines.