DISTEK - Betatek Inc

Dissolution Testing

Model 2500

The Distek Model 2500 Dissolution System offers great flexibility and configurability. It can be configured as USP Apparatus 1, 2, 5 and 6 plus intrinsic dissolution. The extensive users, method and reporting storage capabilities are enabled by a brilliant touch screen. Unparalleled control of the instrument plus automatic storage of component serial numbers and automatic qualification reminders make the Model 2500 robust and reliable enough for QC applications yet flexible enough for R&D use.

Model 2500 RTD

The Distek Model 2500 RTD Dissolution System offers great flexibility and configurability. It can be configured as USP Apparatus 1, 2, 5 and 6 plus intrinsic dissolution. The extensive users, method and reporting storage capabilities are enabled by a brilliant touch screen. Patent pending wireless temperature sensors continuously monitor and display the in-vessel temperature for each vessel. Unparalleled control of the instrument plus automatic storage of component serial numbers and automatic qualification reminders make the Model 2500 RTD robust and reliable enough for QC applications yet flexible enough for R&D use.

Model 2500 Select

The Distek Model 2500 Select Bathless Dissolution System is the culmination of three generations of patented bathless technology with extremely short media heating times and dramatically smaller energy use. The system offers great flexibility and configurability. It can be configured as USP Apparatus 1, 2, 5 and 6 plus intrinsic dissolution. The extensive users, method and reporting storage capabilities are enabled by a brilliant touch screen. Patent pending wireless temperature sensors continuously monitor and display the in-vessel temperature for each vessel. Unparalleled control of the instrument plus automatic storage of component serial numbers and automatic qualification reminders make the Model 2500 Select robust and reliable enough for QC applications yet flexible enough for R&D use.

Dissolution Sampler

Eclipse 5300

The Distek Eclipse 5300 Automated Dissolution Sampler offers rapid, accurate sampling using precision syringe pumps. The elimination of valves and rotary pumps along with the optimized sample pathway with a minimal 4.5 mL internal volume increases reliability while reducing common sources of sample carryover. Adding a lower-cost ‘child’ sampler is a cost-effective way to sample from two baths. Each of the baths may run the same method or two different independent ones. The integrated optional filter changer enables the use of most common 25 mm syringe filters instead of requiring custom filter plates and also additional bench space.

Small Volume Dissolution

Small Volume Conversion Kit

Performing dissolution tests on high potency drugs with low concentrations of active pharmaceutical ingredients is difficult, if not impossible, with a standard apparatus 1 or 2 dissolution bath. Common analytical instruments are not sensitive enough to detect such low concentrations. Similar difficulties occur during dissolution testing of medical devices, microparticles, beads, and topical drugs, such as creams, gels, and ointments. Distek’s Small Volume Conversion Kit offers the perfect solution to all of these common dilemmas.

Disintegration with Direct Measurement

SensIR 3200

The Distek sensIR 3200 combines two exclusive technologies – bathless heating and Near IR sensing to offer the most innovative disintegration tester. Bathless heating not only reduces warm-up times but eliminates the inconveniences associated with conventional water bath- based instruments. To match your throughput requirements, the sensIR 3200 is available in two, four or six positions in the smallest foot print of any comparably equipped model.

Opt-Diss 410

No more sampling! The Distek Opt-Diss 410 in-situ fiber optic UV system measures directly in the vessel, eliminating the need for conventional sampling, and with-it consumables like filters, tubing and syringes, saving time, labor, and money. Moving light rather than liquids also allows generating near real-time dissolution data and nearly limitless sample points as frequently as every five seconds.

Sample Preparation and Clean-up

ezfill+ Dissolution Vessel Filler

Many of the main causes of OOS dissolution tests and qualification failures are related to media de-aeration and dispensing. The ezfill+, with method controlled automated de-aeration and dispensing, makes media preparation simple and error free. Reports that include method parameters and user information allow tracking your media preparation as part of a complete data integrity solution. All made possible on a stand-alone basis by a built-in controller using a brilliant touch screen. The unique compact design and optional mobile cart lets one easily move the unit from bath to bath, while the available remote dispensing nozzle allows directly filling vessels in place. The ezfill+ is compatible with most every dissolution bath on the market.

PrepEngine

The PrepEngine was developed through collaborations with leaders in the pharmaceutical and biotech industry to simplify and speed up the content uniformity sample preparation process. The result – a compact benchtop design that incorporates 10 individually powered, high-output stirring stations which can prepare content uniformity samples up to 90% faster than conventional methods.

PrepEngine Mini

The PrepEngine Mini was developed through collaborations with leaders in the pharmaceutical and biotech industry to simplify and speed up the content uniformity sample preparation process. The result – a compact benchtop design that incorporates 2 individually powered, high-output stirring stations which can prepare content uniformity samples up to 90% faster than conventional methods.

Software and Accessories

Cipher Software

The Cipher dissolution control software is a Windows based application designed and developed by Distek which can be installed locally or networked providing full access to any Distek dissolution instrument on the network. Cipher offers the flexibility to set the level of security appropriate for your laboratory. When enabling all available security features and audit trails and combined with the appropriate customer developed policies, Cipher will meet 21 CFR part 11 compliance. Easy to use and intuitive, the Cipher software features make preparing, running, monitoring, and reporting dissolution test results quick and easy.

Validation

The Distek Validation Tool Kit is suitable for all dissolution methodologies. All the tools are supplied with National Institute of Standards and Technology (NIST) traceable calibration certificates and are compliant with ASTM E2503 and USP standards for enhanced mechanical calibration.