ProSense
Brand Introduction
ProSense BV (brand website: Dissolution Accessories) , headquartered in the Netherlands, is a leading European manufacturer and supplier specializing in high-quality accessories, consumables, special fixtures, and mechanical validation tools for drug dissolution testing.
The company is known for providing solutions that are "universally compatible with all brands, strictly exceed pharmacopoeia specifications, and have complete traceability certificates (serialized & certified)". It provides highly cost-effective dissolution consumable replacement solutions that meet cGMP/FDA inspection standards to major multinational pharmaceutical companies, generic drug R&D centers, CROs/CDMOs and national drug testing agencies worldwide.
Core values
Seamless compatibility across all brands (100% Drop-In OEM Compatibility) :
We design compatible consumables for dissolution test instruments from various manufacturers worldwide, providing comprehensive and precise compatibility with mainstream brands such as Pharma Test, Agilent/VanKel, Sotax, Hanson Research/Teledyne, Erweka, Distek, Logan, and Electrolab .
Laboratories can obtain high-quality, directly replaceable parts that perfectly match the original size, without being limited by the original manufacturer's expensive consumables and long delivery times.
Strictly adheres to the Pharmacopeia Dimensional Compliance standards .
All contact and geometry related components fully comply with USP <711>, USP <724>, EP <2.9.3>, JP 18 and ChP standards.
High-precision laser measurement and CNC turning processes are used to ensure that the uniformity of the rotating basket mesh openings, the radius of the arc bottom of the dissolution cup, the tilt angle of the stirring paddle, and the concentricity are all within the strict tolerance range, eliminating flow field vortices or pseudo-dissolution variations caused by the geometric deformation of consumables .
Individual laser serial number engraving and original manufacturer's inspection report (Serialized Traceability & Full Documentation) :
Key components (dissolving cup, rotating basket, stirring paddle, rotating shaft, etc.) are calibrated by independent optical imaging and geometric measurement before leaving the factory, and a unique serial number is laser-engraved on the surface .
Each set of accessories comes with a Certificate of Analysis (CoA)/Certificate of Conformity (CoC) and a Dimensional Certificate , fully meeting the data integrity traceability requirements of FDA, EMA and TFDA inspectors.
High-quality medical-grade biomaterials :
All metal components are made of AISI 316L stainless steel (medical grade, resistant to acid and alkali corrosion) , or are provided with a food-grade high-density PTFE (Teflon) coating, which is resistant to high concentrations of acid (0.1 N HCl) and various surfactants.
All polymer consumables (filter heads, tubing, sedimentation plates) have passed the USP Class VI biocompatibility test , with no plasticizer release and no API adsorption interference.
Product direction
ProSense (Dissolution Accessories) offers a complete one-stop product line, from everyday consumables and high-end specialty reagent testing fixtures to regulatory mechanical validation tools:
1. Dissolution Vessels (USP 1 & 2)
Standard Glass Vessels : Precision blown from high borosilicate 3.3 glass, available in 100 mL, 200 mL (for small-volume micro-testing), 1,000 mL (standard), 2,000 mL, and 4,000 mL capacities. Both rimless and flanged versions are available.
Certified Precision Vessels : Each dissolution vessel undergoes multi-point laser scanning for wall thickness, roundness, and bottom hemispherical curvature, and comes with a complete geometric inspection certificate. It is designed to reduce mechanical runout and water bath resonance.
Amber Vessels : Highly uniform amber-colored light-proof cups designed specifically for photosensitive APIs and vitamin preparations.
Peak Vessels : The special triangular peak geometry at the center of the vessel bottom is designed specifically for fluid dynamics research to eliminate the coning effect of tablets accumulating in dead corners at low speeds.
Drop-resistant polycarbonate vessels : less prone to breakage, improving laboratory safety.
2. Baskets, Paddles & Shaft Systems
USP 1 Basket Assemblies :
Standard 40 mesh swivel basket, with 10, 20, 60, 80, 100 mesh and ultra-fine mesh options available for customization.
The structure includes spring clip, O-ring, bayonet lock and patented anti-fall-off quick-release fixing base.
Special specifications: Mini Baskets (100/200 mL), Japanese Pharmacopoeia Baskets, PTFE-coated Baskets resistant to strong acids, Felodipine Baskets, and Suppository Baskets.
USP 2 Paddles :
AISI 316L mirror-polished one-piece stirring paddle, and a fully coated, highly abrasion-resistant PTFE paddle.
Mini Paddles, chemically resistant PEEK paddles.
Interchangeable Spin-Shaft & Quick-Disconnect System :
The patented modular spindle design features a fixed spindle length and allows for quick replacement of the bottom tray head or stirring head without the need for height readjustment, significantly reducing maintenance and changeover time.
3. Sampling probes, filter consumables, and porous filter cartridges.
Stainless steel and PEEK sampling cannulas :
Adjustable depth sampling needles, fixed curvature sampling needles, and automatic sampling manifold matching needles conforming to USP specifications for sampling positions (the center of the cup wall and the rotating shaft, and the fluid representative area equidistant from the liquid surface).
Cannula Porous Filters :
The deep filter cartridge is specially designed for the bottom of the sampling needle and is made of materials including UHMW-PE (ultra-high molecular weight polyethylene), PTFE, and PVDF.
A full range of pore sizes: 1 µm, 2 µm, 4 µm, 10 µm, 20 µm, 35 µm, 70 µm, with low dissolution and anti-adsorption properties, effectively protecting automatic sampling pumps and HPLC/UPLC valves.
Syringe Filters (Syringe Filters / Small Flying Saucers) :
Available in 13 mm, 25 mm, and 33 mm sizes, made of materials such as nylon, PTFE, RC, and PES, meeting 21 CFR effective leaching background requirements.
4. Capsule Sinkers Series
Solving the problem of capsule formulations (hard capsules, soft capsules) floating on the surface of the solvent and failing to release properly:
Japanese Pharmacopoeia Specifications for Sinkers : Compliant with the 18th revised Japanese Pharmacopoeia standard specifications.
USP Spiral Type Sinkers : AISI 316L stainless steel, hand-wound precision (3 to 10 turns), or covered with PTFE insulation.
Basket-style and Clam-shell Sinkers : Bidirectional opening and closing cage-like structure, facilitating quick filling and removal of large or soft capsules.
Magnetic Sinkers : Suitable for identification and positioning in automated sampling robotic arms.
5. Specialty Dissolution Apparatus
USP 5 Paddle over Disk / Transdermal Sandwich : Applicable for testing the application and fixation of transdermal patches.
USP 6 Rotating Cylinder : A stainless steel precision mesh cylinder or solid cylinder used for the release of adhesive tape or special coatings.
Intrinsic Dissolution System / Wood Apparatus :
Designed specifically for measuring the Intrinsic Dissolution Rate (IDR) of API raw material powders, it is equipped with a die, base and rotating base.
Immersion Cell (Enhancer Cell) : Suitable for measuring the in vitro release rate (IVRT) of semi-solid ointments, creams, and gels.
6. Mechanical Qualification Tools - FDA MQ & USP Toolkit
High-precision metrology tools fully compliant with the US FDA Mechanical Verification (MQ) standard guidance:
Wobble Gauge : A pointer/digital high-precision micrometer for accurately measuring the rotational runout of the shaft and the turntable (specification requirement < 1.0 mm).
Vessel Centering Gauge : Three-point self-centering mechanical gauge or bidirectional laser centering gauge (center deviation < 2.0 mm).
Depth/Height Gauge : Precision block and ball gauges to verify the geometric clearance of the mixing components from the bottom of the cup by 25 mm ± 2 mm.
Digital Inclinometer : A high-precision digital level used to calibrate the perpendicularity and horizontality (< 0.5°) between the instrument drive head and the base platform.
Optical tachometer and NIST-Traceable Calibrated Thermometer .
Brand advantages
European Authentic Quality and the Most Competitive Supply Chain (Cost-Effective European Quality) : While adhering to the highest pharmaceutical quality standards (ISO 9001:2015 certified manufacturing system), ProSense provides global pharmaceutical companies with more affordable procurement costs compared to original equipment manufacturers (OEMs), significantly reducing annual routine maintenance and consumable budgets for QA/QC and R&D laboratories.
One-Stop Shop for Global Fleets : Large pharmaceutical laboratories typically house multiple dissolution analyzers from different years and brands. With ProSense, purchasing and testing personnel can meet all their laboratory's consumable and replacement parts needs for dissolution analyzers from all brands without having to separately inquire with multiple manufacturers.
Perfectly addresses global audit and data integrity requirements (Audit-Ready Compliance) : All dimensional inspection reports and analytical documentation are available both at the time of shipment and online. Each batch of consumables has an anti-counterfeiting and traceable serial number, completely eliminating the risk of receiving an FDA 483 observation form or warning letter due to consumable size disputes.
Custom Engineering Capability : In addition to standard pharmacopoeia consumables, ProSense has extensive precision machining and customization capabilities, enabling it to quickly prototype and tailor-make special fixtures for pharmaceutical companies’ special long-acting microspheres, implants, irregularly shaped patches or very small volume samples.
