New software platform improves freeze drying process control
The LyoS 2.0 control system software is fully configurable and fully validatable for regulated pharmaceutical and biotechnology applications.
SP Scientific has launched LyoS 2.0 – a line-of-sight enabled lyophilizer control system able to control platforms from development to production units, making cycle transfer and scale-up much simpler.
The LyoS 2.0 control system delivers unmatched process control for all stages of the cycle, from freezing to primary and secondary drying. User definable process alarms protect the user's valuable product and automated system tests to ensure the lyophilizer is running optimally.
In addition, the control system is designed to control proprietary SP Scientific freeze drying technologies including ControLyo ice nucleation, SMART automatic cycle development and LyoFlux TDLAS continuous process monitoring.
Optional 21 CFR Part 11 compliance capabilities ensure that LyoS 2.0 control system software is both fully configurable and fully validatable for regulated pharmaceutical and biotechnology applications. SP Scientific offers testing protocols intended to support the processes that will be performed by the purchaser and/or end user, as well as onsite control system IQ/OQ validation support and a comprehensive factory-initiated software validation.
Designed for SP Scientific's research, development, and production lyophilizers, including the LyoCapsule, LyoStar, Genesis, Ultra and LyoConstellation. LyoS 2.0 and SP Line of Sight technologies can be upgraded on to certain other freeze dryers.
Related News
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines. -
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries. -
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
.png)
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
.png)
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance