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)
Products
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
Custom single-use assembly design and manufacture
Engineering and production of tailored aseptic assemblies to client specifications, including rapid turnarounds, stocking strategies, and integration with customer bioreactor systems.
Sterilization validation and ongoing sterilization monitoring
Sterilization dose validation using established methods, bioburden testing, dose mapping, and routine audits to ensure SAL targets and sterilization consistency for single-use products.
Cleanroom manufacturing with particulate and contamination control
Controlled-environment production with real-time particulate monitoring, validated gowning, material transfer controls, and endotoxin/particulate testing in accordance with USP/EP standards.
Supply chain and domestic manufacturing services
Domestic production and vertical integration services to shorten supply chains, provide full regulatory documentation, and reduce import-related delays and costs.
Custom single-use assembly design and manufacture
Engineering and production of tailored aseptic assemblies to client specifications, including rapid turnarounds, stocking strategies, and integration with customer bioreactor systems.
Sterilization validation and ongoing sterilization monitoring
Sterilization dose validation using established methods, bioburden testing, dose mapping, and routine audits to ensure SAL targets and sterilization consistency for single-use products.
Cleanroom manufacturing with particulate and contamination control
Controlled-environment production with real-time particulate monitoring, validated gowning, material transfer controls, and endotoxin/particulate testing in accordance with USP/EP standards.
Supply chain and domestic manufacturing services
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