This webinar focuses on the development and advantages of ILC Dover’s aseptic flexible isolator system, soloPURE™. Presented by Martyn Ryder and Declan O’Shea, the session covers key topics such as the system’s design and benefits, its application in small-batch manufacturing and aseptic processing, and the advantages of single-use technologies. These advantages include faster market delivery, improved sterility, lower costs, and ease of facility setup compared to traditional hard shell isolators. The presenters also detail the system’s gamma-irradiated enclosure, regulatory compliance, and design features that enhance sterility and flexibility. Practical applications and case studies demonstrate soloPURE™’s real-world functionality and adaptability for various aseptic processes.
Watch the video or explore the transcript below to learn more.
Transcript
[Stephanie Arthurs] 0:05
Hello and welcome, attendees. My name is Stephanie Arthurs, Events Planner with ILC Dover, and I’ll be your host for this webinar. I’m here to help facilitate this webinar and ensure all your questions are answered. This ILC Dover webinar focuses on the development of ILC Dover’s new aseptic flexible isolator system, SoloPure. Topics to be discussed include fill finish inside a single-use disposable isolator, handling sterile potent powders, isolator regulatory compliance, sterilization (VHP versus gamma radiation), benefits of disposable isolator systems, and sterile manufacturing. This webinar will be presented by Martyn Ryder, Business and Product Development Manager at Solo Containment, an ILC Dover company, and Declan O’Shea, Product Manager at ILC Dover. During today’s webinar, please feel free to use the chat function to send us questions or comments. These will be addressed directly following the webinar. Thank you, and now our webinar will begin.
[Martyn Ryder] 1:15
Thank you, Stephanie. It’s a great pleasure to present this webinar today on an exciting topic. We believe that this single-use aseptic isolator could completely transform aseptic processing, especially for small batch manufacturing.
1:49
We’re saying, “Start today and plan for tomorrow,” and I’m pleased to say this is patented technology with a lot of design know-how and IP behind it. So why consider single-use technologies for fill finish? First, it’s faster and increases speed to market. Flexible film isolator technology has a much more rapid delivery schedule than a hard shell isolator. We’ve designed the SoloPure system for rapid facility setup, with improved sterility due to gamma irradiation. Like all flexible technologies, it’s upgradable and agile, evolving with your workflow.
2:47
Single-use technology offers lower cost. The SoloPure is around 40% of the price of a hard shell stainless steel isolator. Working with ILC Dover, this has been a stage-gated product—a standard isolated solution with no design costs. It’s a pre-validated design that reduces QA burden and the time needed for batch qualification. We’ve designed SoloPure to be small batch compliant, for nano batch fill finish setups of up to 500 or 1,000 vials hand-filled. It has a compact footprint, requires no CIP or mechanical services, runs on single-phase 120V or 230V electrical supply, and is fully mobile for easy facility integration.
4:00
The SoloPure is FDA sterile manufacturing, EU GMP, and Annex 1 compliant. With the new control system, it will also be GAMP 5 compliant for quality records.
4:30
Here’s a look at the single-use system at work. The image was supplied by one of our early customers, Disposable Lab in France. You can see the operator doing hand fill finish in this single-use disposable isolator. The system often comprises three isolators in a daisy chain. Typically, our customers use a VHP isolator on the left for sterilizing outer packaging. The main workstation uses a Grade B chamber for vial tray assembly and stopper preparation, and a Grade A chamber for vial filling and stoppering. We’re using a gamma-irradiated continuous liner to heat seal out the stopper product, eliminating expensive DPT ports.
5:51
Larger batches might use a VHP isolator, transfer isolator, bio prep isolator, and vial fill isolator. We developed this system since 2017, with the first patent lodged that year. The initial prototype showed particle analysis, molded spill trays, and unidirectional airflow. The SoloPure operates with about 900 to 1,000 air changes per hour.
7:08 The SoloPure isolator architecture includes a gamma-irradiated enclosure with HEPA filters bonded into the flexible film chamber. H14 HEPA filters, an isokinetic probe for particle count, and fill needles are all integrated. We supply a complete ready-to-run kit, including a DOP or Emery test scan tube for pre-batch HEPA filter integrity testing.
8:34
Once the isolator enclosure has undergone gamma irradiation, it remains germ-free in transit until it arrives at your facility. The SoloPure is designed to handle high potency aseptic powders, with a two-stage H14 HEPA filter on the exhaust side. Each stage can be integrity tested pre-batch.
9:19
The enclosure system, as used by early customers in France, features twin HEPA filters and a robust transit frame. The system is ready to run upon delivery. Now, I’ll hand over to Declan for a few slides.
[Declan O’Shea] 10:08
Thank you, Martyn. We have two variations of this isolator system: the fully disposable system for single-use with gamma irradiation, and a VHP in-place system as an alternative. The disposable system avoids cross-contamination and cleaning issues, making it highly beneficial. The VHP system allows for a stainless steel perforated work deck, accommodating heavier, more robust equipment.
11:50
Both systems feature unidirectional vertical laminar airflow, ensuring Grade A particle count with H14 HEPA filters. The two-stage exhaust system handles potent powders, while the stainless steel work deck option uses a single-stage disposable filter to reduce consumable costs. The single-use version is treated with 25 to 50 kilograms of gamma radiation, with dose mapping performed for validation.
13:36
Both units are pressure decay compatible, essential for VHP cycles to pass integrity tests. They protect the operator and product, maintaining the integrity of the film and system. The system can operate in both positive and negative pressure, with built-in sleeve glove integrity testers for compliance.
16:54
The SoloPure can switch from single-use to multi-use. The left side, “nano batch,” is for flexible enclosure manufacturing, while the right side, “mini batch,” is for VHP sterilized multi-use. The system supports pressure decay tests, glove leak testing, and HEPA filter integrity tests. It’s designed for easy transition between single-use and multi-use within a morning.
19:03
During batch manufacturing, the system provides 24/7 particle count and positive pressure recording. The stainless steel work deck allows for the placement of equipment and machinery, ensuring compliance and efficiency.
20:27
The system’s compact and mobile design, two-stage exhaust filtration, and easy interface with lyophilizers make it versatile. Switching from single-use to multi-use is simple, ensuring your batch requirements are met.
22:23
We offer various accessories, including VHP transfer isolators for supplies and materials, RTP ports, and custom solutions. Our systems accommodate different needs, providing flexibility and compliance.
23:28
Our experience dates back several years, working with early customers like Disposable Lab. We’ve developed systems for various applications, from lyophilizers to high-speed vial filling lines. Our technology is proven and ready for broader adoption.
30:04
We’ve worked extensively with Steris to ensure our systems’ aeration times are comparable to stainless steel variations. High airflow fans help maintain efficiency.
31:07
The SoloPure is designed for easy operation and speed, making it an agile solution. Built-in glove leak integrity testers ensure compliance and safety.
32:18
Our systems are versatile, accommodating different lyophilizer designs and process needs. We can modify the film to include interfaces as required, providing a flexible solution.
37:29
Our history with these units goes back years. Early customers have consistently used our flexible film replacement enclosures. We’ve developed systems for various applications, proving our technology’s versatility.
40:09
We offer a comprehensive qualification and validation package, ensuring our systems meet all regulatory requirements. Our audit-ready pack provides full compliance documentation.
43:11
We provide site installation and commissioning services, including operator training. Our qualification packages include full FAT, SAT, IQ, and OQ, ensuring compliant systems.
46:28
Summarizing, our isolators maximize productivity with a small footprint and mobility. They reduce costs and deliver on time, providing a turnkey solution. The lower capex cost allows for additional equipment purchases. Faster delivery times ensure rapid facility setup, and the system brings aseptic processing in-house, reducing outsourcing costs.
50:08
Our systems mitigate risk and meet all regulatory compliance. With double HEPA filter exhaust, full qualification services, and in-built integrity testing, they ensure safety and compliance.
53:01
The SoloPure enables in-house control of fill finish activities, ideal for small batch research, stability trials, clinical trials, and more. It’s a transformative technology for aseptic isolation.
54:32
We’ve covered a lot today. If you have any questions, please add them to the chat or contact us afterward. We’re here to help with any inquiries.
56:24
For further information or questions, email us at [email protected]. We look forward to assisting you with your process needs.
58:04
Thank you all for attending. We hope you’ll join us for our next webinar in May. Any other questions, visit ilcdover.com.
