Once you’ve bought a solo flexible film isolator, you’ll find areas you never even thought of using an isolator before. Here are ten reasons why our customers return to us, time and time again.
1: Assured high containment standards
We lead the field in high-performance containment and regularly carry out containment tests using the SMEPAC system to prove this. Our last test on an ADC toxin linker dispensing isolator gave some pretty impressive results. Conducted over five days, with three operators per test to create a similarly exposed group (SEG), the test was in line with EN689 2018. The data speaks for itself:
2: Zero cleaning validation
With no cleaning validation between campaigns, your efficient production process will be more agile and flexible. By making all our isolators with innovative features to assure safe and contained disposal, we enable you to be more responsive to small batch production. We will provide you with detailed standard operating procedures (SOPs) to ensure your operators will be safe during disposal. Our HEPA filters and continuous liner ports are also fully disposable.
3: Right first time
Got an old piece of machinery that will be processing a more potent ingredient and you’re not sure how to contain it? We can figure it out.
Our exceptionally clever engineering team will work with you to deliver a ‘right first time’. We can propose a solution for a range of scenarios:
- Complex machine interfaces
- Difficult ergonomics
- Safe disposal of contaminated equipment
- Aseptic fill-finish
4: Spot on SOPs
A flexible film enclosure is designed to be tough, but with a heavy-handed and dangerous approach, it won’t take much to break containment. We understand that peak isolator performance relies upon carefully evolved and well thought through SOPs. Likewise, not following a well-thought-through procedure can compromise safety and the product. We have incredible attention for detail and will think through your entire process, step-by-step to give you a clearly defined operating procedure for optimum cGMP and containment performance. We have the expertise and experience to train and mentor your production team to maximise their safety.
5: Diverse range of isolator platforms
If you want to operate at a low flow negative pressure, we can do that. But what about sensitive particle counts in a high-volume turbulent airflow? No problem, with a two-stage HEPA exhaust. Even aseptic processing can be catered for with a fully disposable unidirectional airflow system. Whatever your process, whatever your product, we have an answer for you.
6: Operational safety
Solo’s flexible isolator technology is built with maximising operator safety at its heart.
- Automatic pressure decay test cycles run at negative pressure and alert if a break is detected
- Push through glove changes make for easy change over without compromising isolation
- Gas-tight zips that are radio-frequency welded for added strength
- Bespoke engineering options for highly specialised processes
- Ergonomic designs for operator comfort
7: Optimised ergonomics
With over 100 years of combined containment experience, the Solo engineering team understands quite a bit. A variable height worktable is just one example of how we understand that ergonomic design is very important and can cater to different operator statures.
8: Solvent resistance
Solo can provide isolator with 316L stainless steel work trays to provide a secure base for a range of applications such as a small reactor or filter dryer. Alternatively, a fully disposable option would be an EPDM film base tray which can be rolled up within the isolator and disposed of.
9: Leadership in disposable aseptic processing
For small-scale, hand vial filling, Solo Containment has pioneered the development of a full uni-directional airflow in a single-use flexible film enclosure. So, no need to validate each time, just fill and dispose.
Delivered as a sterile gamma-irradiated pack, the solo aseptic system can be mounted to the isolator frame in just minutes.
10: Project expertise
Solo’s expertise is bought to life with the challenge of a new project. Our expertise covers all areas of drug development, from molecule discovery at kilo lab scale to API and HP-API processing, lyophilisation, milling, micronizing and of course, aseptic full lines. All using our flexible film, laminar flow disposable isolators.
Pulling all of this expertise together is our well-respected documentation system with FAT, SAT IQ/OQ and clear manual operations.
When you need containment solutions, invest in the future. Join the containment revolution.