Robust and flexible lateral flow manufacturing options
We offer robust and flexible manufacturing options from supply of laminated cards through to producing pouched devices or fully assembled kits. BBI Solutions are certified to ISO13485 and work in accordance with 21 CFR 820. We cater to routine manufacturing production at a range of production batch sizes or supply as part of a disaster recovery program.
With over 25 years’ experience in lateral flow manufacture, BBI have long established supply relationships with all of the major lateral flow material and reagent vendors. Combined with our secure internal reagent supply, we can assure secure supply of assays we manufacture for our partners.
Whether your assay is already established within the market, or you are transferring a newly developed assay, BBI solutions is your partner to deliver your assay to market on time and to the required quality and volume while being cost effective.
We have many years of experience including:
- Transferring assays developed by our customers into routine production at BBI Solutions
- Transferring and scaling production from benchtop scale to large volume manufacture, including to assembly automation
- Transferring of assay developed in-house at BBI Solutions
- Through our partnership with Chiara <Add link to Chiara page> we can support you by navigating quality and regulatory hurdles to bring your product to market.
BBI’s manufacturing capabilities – the facts
Our state-of-the-art manufacturing facility is based in Crumlin, Wales and has:
- 120,000 sq feet for manufacturing
- Low, medium and high volume manufacturing capabilities
- Benchtop and Reel-to-Reel membrane preparation suitable for all scales of manufacture
- Manual, semi and fully automated lamination solutions
- Rotary and guillotine strip cutting
- Manual, semi and fully automated assembly solutions
- ISO13485:2016 certified QMS system
Every customer will have a dedicated Business Development Manager as their key point of contact to discuss their lateral flow manufacturing project, this is supported by our expert operational and quality teams to ensure that we continue to deliver the highest quality of service throughout your product’s lifetime.
We work with our customers to put in place long term manufacturing agreements which provides both parties with security and peace of mind. This includes regular forecasting so that BBI can ensure security of raw material through our robust supply chain.
In addition, if required, we can provide continued QA/Regulatory on-market support through our partner Chiara