The demand for sterile manufacturing is on the rise. One of the key reasons for this is the rapid increase of parenteral drugs, which accounted for 40% of new product approvals in 2020, and 50% of drugs in the current pipeline1. Likewise, between 2014 and 2021 there has been a 102% increase in clinical projects surrounding ophthalmic diseases1. Parenteral and ophthalmic drug products circumvent many of the body’s innate immune defenses. As a result, it is essential that these drugs are sterile to prevent the risk of microbial infection. This necessitates terminal sterilization of the final product or aseptic manufacturing processes when terminal sterilization is not possible.
Particle Sciences is committed to supporting its customers with their increasing need for sterile manufacturing. Here, in the first of the Meet the Machine blog series, we examine how Particle Sciences performs aseptic manufacturing of sterile drug products with the introduction of the Bausch 515 Aseptic Filling and Closing Machine. This is an integral machine used in the sterile fill-finish process to enable commercial-scale aseptic filling of injectables and ophthalmic solutions or suspensions.
What is the Bausch 515 Aseptic Filling & Closing Machine?
The Bausch 515 is an automated, state-of-the-art filling and closing machine that is qualified for the aseptic filling of 2–30 mL vials and 5 mL and 10 mL ophthalmic bottles. Its capabilities include:
- Filling a wide range of sterile drug products including parenteral and ophthalmic solutions and suspensions
- Accurately filling precise amounts using peristaltic pumps
- Performing non-destructive, 100% in-process volume checks throughout the filling process for further accuracy
- Ensuring a controlled atmosphere through its Restricted Access Barrier System (RABS)
Aseptic Filling in Our Commerical ISO 5 Cleanroom
At Particle Sciences, the machine is located in a qualified ISO 5 space on our site with full HEPA (high-efficiency particulate air) coverage to guarantee product sterility.
In 2020, Particle Sciences upgraded its commercial manufacturing facility, making several facility improvements to better serve the growing need for aseptic manufacturing.
How will the Bausch Filling & Closing Machine benefit you?
When choosing a contract development and manufacturing organization (CDMO) partner for sterile projects, it is important to know how the company achieves a sterile environment as well as whether it has the right tools for the job. With the the Bausch 515 Filler, Particle Sciences can offer the benefits of:
1. Aseptic filing in an FDA-inspected facility
A sterile environment is essential to deliver a high-quality parenteral or ocular product, as well as to ensure regulatory compliance.
For manufacturing in the United States, the area that filling and closing takes place in should follow FDA guidelines. FDA guidance emphasizes that clean areas are of particular importance, especially the “critical area” in which the drug product is at a stage where it will not be further sterilized. The critical area should therefore be classified as ISO 5 (or Grade A)2.
In addition to the RABS offered by the Bausch 515, Particle Sciences has designed its cleanrooms with aseptic filling in mind. The Bausch 515 resides in a 320 ft2 ISO 5 (Grade A) filling space with 100% HEPA coverage.
Our commercial facility is FDA-inspected and ready to fill your next injectable or ophthalmic drug product.
2. Flexible batch sizes to meet your unique needs
With the Bausch 515, Particle Sciences offers high-quality aseptic manufacturing and sterile filling with no minimum batch sizes. Whether your project is small- or large-scale, we will ensure your fill and finish needs are met.
We can adapt to a range of client needs, providing sterile fill-finish for:
- Registration batches
- Full-scale commercial production of high-value pharmaceutical products
- Second-source manufacturing for supply chain security
The Bausch 515 can be operated at various speeds, with a max speed of 50 vials per minute. Regardless of the timeline or size of the project, we can ensure a consistent, precise, and efficient fill-finish process.
3. Ensuring filling accuracy
Accuracy is essential during fill-finish to deliver consistent quality throughout your project and for regulatory compliance. The Bausch 515 achieves this goal by using an in-line, non-disruptive weight checker, ensuring each of the vials is within the specifications required for your drug product.
Human interference is minimized through the machine’s automation. As a result, the raw materials, solutions, and primary packaging components can be brought together with minimal risk of contamination. The machine has sensors to ensure that stoppers are placed and in the correct position and will reject vials where it is placed incorrectly. As a result, the probability of human error is lowered, and more consistent, high-quality products can be produced.
Are you ready to see the benefits of the Bausch 515 Filling & Closing Machine?
With the Bausch 515, Particle Sciences offers an accurate, flexible, and consistent sterile fill-finish process for use in your sterile manufacturing project. Be sure to follow future installments of the Meet the Machine series to find out more about other machines and processes that could benefit your manufacturing projects.
Authors: Robert Lee and Nick DiFranco