SaniSure, Inc.
SaniSure is a global leader in single-use technologies (SUT) for complex flow paths and closed system designs, providing proprietary solutions, custom assemblies, and engineered components to support demanding bioprocessing and advanced therapies workflows. The company emphasizes innovation, flexibility, and vertical integration to help clients de-risk, grow, and innovate in biopharmaceutical manufacturing.
Industries
Nr. of Employees
small (1-50)
SaniSure, Inc.
Patents
Connector and tubing assembly and method of molding connector and tubing assembly
US-10675820-B2
View Details
Connector and tubing assembly and method of molding connector and tubing assembly
US-10675820-B2
View DetailsProducts
Sterile rigid single-use bottles (10 mL–20 L)
Rigid single-use containers manufactured in ISO-classified environments from medical-grade resins, sterile to SAL 10^-6 and compliant with particulate and endotoxin USP standards; available in multiple volumes for storage, transport, and bulk freezing.
Aseptic bottle filling assemblies and filling needles
Filling assemblies and precision filling needles manufactured without oils or adhesives for compatibility with final fill-finish machines and a range of drug products; available as standard or custom configurations.
Weldable bioprocessing tubing portfolio
Range of tubing formulations (platinum-cured silicone, TPE, speciality fluoropolymers, gamma-stable PVC alternatives) designed for weldability, gamma stability, low particulate release, and compatibility with sanitary fittings and hybrid weld scenarios.
Non-metallic sanitary clamps and fittings
Range of non-metallic clamps and sanitary fittings with calibrated compression systems to maintain seal integrity, available in single-use and reusable formats and multiple sizes and pack counts.
Gamma-stable mixing components (stir bars and integrated mixing solutions)
Gamma-stable stir bars and integrated bottle mixing components for single-use mixing applications that are animal-component-free, USP Class VI compatible, and lot traceable.
Sterile rigid single-use bottles (10 mL–20 L)
Rigid single-use containers manufactured in ISO-classified environments from medical-grade resins, sterile to SAL 10^-6 and compliant with particulate and endotoxin USP standards; available in multiple volumes for storage, transport, and bulk freezing.
Aseptic bottle filling assemblies and filling needles
Filling assemblies and precision filling needles manufactured without oils or adhesives for compatibility with final fill-finish machines and a range of drug products; available as standard or custom configurations.
Weldable bioprocessing tubing portfolio
Range of tubing formulations (platinum-cured silicone, TPE, speciality fluoropolymers, gamma-stable PVC alternatives) designed for weldability, gamma stability, low particulate release, and compatibility with sanitary fittings and hybrid weld scenarios.
Non-metallic sanitary clamps and fittings
Range of non-metallic clamps and sanitary fittings with calibrated compression systems to maintain seal integrity, available in single-use and reusable formats and multiple sizes and pack counts.
Gamma-stable mixing components (stir bars and integrated mixing solutions)
Gamma-stable stir bars and integrated bottle mixing components for single-use mixing applications that are animal-component-free, USP Class VI compatible, and lot traceable.
Services
Engineering and production of tailored aseptic assemblies to client specifications, including rapid turnarounds, stocking strategies, and integration with customer bioreactor systems.
Sterilization dose validation using established methods, bioburden testing, dose mapping, and routine audits to ensure SAL targets and sterilization consistency for single-use products.
Controlled-environment production with real-time particulate monitoring, validated gowning, material transfer controls, and endotoxin/particulate testing in accordance with USP/EP standards.
Domestic production and vertical integration services to shorten supply chains, provide full regulatory documentation, and reduce import-related delays and costs.
Engineering and production of tailored aseptic assemblies to client specifications, including rapid turnarounds, stocking strategies, and integration with customer bioreactor systems.
Sterilization dose validation using established methods, bioburden testing, dose mapping, and routine audits to ensure SAL targets and sterilization consistency for single-use products.
Controlled-environment production with real-time particulate monitoring, validated gowning, material transfer controls, and endotoxin/particulate testing in accordance with USP/EP standards.
Domestic production and vertical integration services to shorten supply chains, provide full regulatory documentation, and reduce import-related delays and costs.
Expertise Areas
- Single-use technology design and assemblies
- Aseptic fill-finish and closure systems
- Tubing extrusion and weld compatibility
- Sterilization validation and bioburden control
Key Technologies
- Single-use assemblies and closed-system flow paths
- Gamma irradiation sterilization (VDmax27.5)
- Thermoplastic and silicone tubing extrusion
- Weldable tubing and hybrid welds
News & Updates
CPHI Frankfurt 2025, taking place October 28–30 at Messe Frankfurt, is one of the world’s leading pharmaceutical exhibitions. The event brings together professionals from every stage of the pharma value chain to explore new technologies, forge partnerships, and drive innovation in development, manufacturing, and packaging.
Experience the future of bioprocessing solutions at INTERPHEX 2025, where innovation meets implementation. As a proud Bronze Sponsor, SaniSure invites you to explore our latest technologies and connect with industry experts who are shaping the future of pharmaceutical manufacturing.
Join SaniSure as a featured sponsor at the 2025 BSPA Single-Use Summit. This premier event brings together global experts to advance collaboration in single-use technologies for bioprocessing and biomanufacturing.
Join SaniSure at the ISPE Boston Product Show and Educational Seminars. This premier one-day biopharmaceutical event in the Northeast is the flagship of the ISPE Boston Area Chapter. The success of the show, the chapter, and the local industry is fueled by collaboration, knowledge sharing, and the dedication of our members and volunteers.
In Brighton, UK, the BioProcess UK conference marked its 20th anniversary with a comprehensive agenda and active participation from SaniSure, showcasing technologies and engaging with delegates to foster collaborations.
Join SaniSure as a featured sponsor at DECHEMA’s 5th Biotech Conference 2025 in Freiburg, Germany, to explore advancements in bioprocess development and manufacturing using single-use technology.
CPHI Frankfurt 2025, taking place October 28–30 at Messe Frankfurt, is one of the world’s leading pharmaceutical exhibitions. The event brings together professionals from every stage of the pharma value chain to explore new technologies, forge partnerships, and drive innovation in development, manufacturing, and packaging.
Experience the future of bioprocessing solutions at INTERPHEX 2025, where innovation meets implementation. As a proud Bronze Sponsor, SaniSure invites you to explore our latest technologies and connect with industry experts who are shaping the future of pharmaceutical manufacturing.
Join SaniSure as a featured sponsor at the 2025 BSPA Single-Use Summit. This premier event brings together global experts to advance collaboration in single-use technologies for bioprocessing and biomanufacturing.
Join SaniSure at the ISPE Boston Product Show and Educational Seminars. This premier one-day biopharmaceutical event in the Northeast is the flagship of the ISPE Boston Area Chapter. The success of the show, the chapter, and the local industry is fueled by collaboration, knowledge sharing, and the dedication of our members and volunteers.
In Brighton, UK, the BioProcess UK conference marked its 20th anniversary with a comprehensive agenda and active participation from SaniSure, showcasing technologies and engaging with delegates to foster collaborations.
Join SaniSure as a featured sponsor at DECHEMA’s 5th Biotech Conference 2025 in Freiburg, Germany, to explore advancements in bioprocess development and manufacturing using single-use technology.