Dissolution Supplementary Equipment
Yarden Biotec |
ציוד משלים לבדיקות מסיסות
*המחירים אינם כוללים מע"מ ועלולים להשתנות בהתאם למחירוני היצרן ולשערי המטבע
משחרר מינון PT-DR לבדיקת מסיסות של ננו ומיקרו פולמולציות
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Dispersion Releaser – Release Apparatus for Nano- and Microformulations.
The Dispersion Releaser PT-DR is a dialysis-based apparatus for the release testing of nanomedicines, microformulations and semi-solid dosage forms within a standard dissolution tester. It is composed of a sample holder cell serving as the donor compartment for dispersed dosage forms. A dialysis membrane is disposed around this housing. This donor chamber is agitated by a paddle stirrer that is connected to the USP Apparatus 2.
Advantages:
>> Reproducible release through the additional stirring movement in the donor compartment
>> Increased throughput of the dialysis process
>> Mixing inside the donor and the acceptor compartment for an optimal homogeneous suspension
Cat No.
PT-DR
רובוט לדיגום בדיקות מסיסות אוטומטי
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Dissolution Sampling Robot.
The DSR-M dissolution sampling robot is designed specifically for the sample transfer and sample processing from a six to twelve vessel dissolution bath. This unique versatile instrument allows samples to be collected over very short time intervals. The DSR-M can be equipped to collect, dilute or process samples for following UV-Visible or HPLC measurements. It can also be used for dissolution medium replenishment to conform to USP/EP volume loss rules.
Advantages:
>> Automates the taking of samples, the most labor intensive stage of a dissolution test
>> Automated sampling eliminates human errors as equal sampling times and standardized solvent transport offer high reproducibility
>> Flexible, modular design to allow auto media refill, dilution and transfer into sealed vials for six to twelve station dissolution baths
>> The CAT-MRM module eliminates the need for separate refilling tubing lines
>> Using the MFC-12 0.45 micron round filter can be exchanged easily and quickly between runs
>> Small footprint due to auto sampler design with integrated pump module
>> All moving parts are behind transparent enclosure to guarantee user safety
Cat No.
DSR-M
משאבת מזרק רב ערוצית מדוייקת
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Precise Multi Syringe Pump.
The PT-SP multi-syringe pump is designed specifically for parallel sample withdrawal and dosage of media from a dissolution bath into open vials inside a fraction collector. It is equipped with up to 8 replaceable 10ml high precision glass syringes. Each syringe is connected to a 3-way pinch valve for media flow control. The drive of the syringes is carried out simultaneously by a stepper motor. All syringes are rigidly connected to the common sturdy drive bar.
Advantages:
>> Automates the removal of samples in connection with an integrated fraction collector the most labor intensive stage of a dissolution test
>> Automated sampling eliminates human errors as equal sampling times and standardized solvent transport offer high reproducibility
>> Syringe pump technology offers excellent precision and reproducibility for dissolution sampling and media replacement
>> Flexible, modular design allows to freely combine multiple pumps
>> Supports auto media refill for six to twelve station dissolution baths
>> All moving parts are behind a transparent enclosure to guarantee user safety while retaining visibility
>> DQ/QC, IQ and OQ documents included free of charge
Cat No.
PT-SP
מערכת להכנת מדיה
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Media Preparation and Degassing System.
Media degassing or “de-aeration”, pre-heating to a temperature of 37°C and absolutely precise gravimetric dispensing according to the recommendations and demanded for dissolution testing from the US FDA authorities are standard for the Pharma Test PT-DDS4 media preparation and degasing system. De-aeration is generally recommended to prevent the formation of bubbles on the dosage form surface, which may cause a variation in active dissolution rates, by virtue of surface obscuration.
Advantages:
>> De-aerates to approx. 35% of rest gas content (residual oxygen less than 5 ppm inside PT-DDS4 container)
>> Pre-heats your media to save time during start-up of dissolution tests
>> Fill-up program under pressure (connect directly to factory de-min. water supply)
>> Fill-up program under vacuum (prime from any external container)
>> Can be upgraded to de-aerate and dispense SPS foaming media
>> Can be used to directly dose into any vessel arrangement inside the dissolution bath
>> Special adapter to handle foaming media available (optional)
>> The instrument is movable and fits underneath most laboratory benches
>> Includes a balance (load cell) and all accessories for gravimetrical dosing
>> Good access to the media tank, easy to control the cleaning and test procedure
>> The only instrument which offers a software supported calibration program to validate and calibrate dosing accuracy using a certified 1 kg weight
>> Dosing performance test possible using built-in strain gauge
>> Correct dosing accuracy by entering density of media (changes because of temperature or solvent used)
>> Maximum of 2 liters waste when media change has to be done
>> Noise protected, max. noise level approx. 55dB
>> IQ/OQ documents included free of charge
Cat No.
PT-DDS4
UV/VIS ספקטרופוטומטר
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Split Beam UV/VIS Spectrophotometer.
The T70 split-beam UV/VIS spectrophotometer offer excellent performance, high quality and are competitively priced. The T70 is well able to meet the stringent requirements required by analytical chemists. It features a wavelength range of 190 to 1100nm and is delivered with a built-in 8-cell changer as standard. It can therefore be used for both manual operation as well as for fully automated dissolution testing applications.
Advantages:
>> Excellent performance, high quality at a competitive price
>> Optimized for dissolution test applications
>> Data Printout to share data with other software. The results can be exported to Microsoft Word, Microsoft Excel, Text
>> Software Conforming to GLP
>> Log Record automatically records each operators usage, provides reliable database format to save the data log and administrator controlled access to log records and other useful tasks
>> Multi-User Management allows the administrator to create users and groups with different privileges. Access is controlled by user ID and password
>> Binary File Save Binary format to save measurement data. Binary format improves data security.
>> and saves disk space
>> Quality Control Monitor data according to the user’s setup. The system will take corrective
measures if the data is out of range
>> Printout Records of measurement results, personal settings for the report format and provides a print preview
Cat No.
T70
תוכנת מחשב לניהול ועיבוד נתוני בדיקות מסיסות
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21 CFR Part 11 compliance as well as compliance to the new requirements for Data Integrity
The WinDiss ARGUS Dissolution Software is a scientific dissolution data management software for instrument control, data acquisition, data management, processing and reporting – designed by users for users. WinDiss ARGUS Dissolution is compatible to almost all dissolution systems in the laboratory. Just one software needs to be trained and qualified. Whether you perform dissolution tests occasionally or several times each day WinDiss ARGUS Dissolution will make you more productive in running tests and analyzing results.
Advantages:
>> Instant recording of raw data
>> Standard database backup and recovery procedures
>> Long term persistence in XML
>> Detailed audit trail for electronic records
>> System log for tracking application events
>> Electronic signature support
>> Cryptographical record protection
>> Role specific access to program functions
>> IQ/OQ/PQ support with reminder function
>> Built in system suitability check
>> Failsafe technology for data recovery
>> Full Spectrometer OQ (as outlined in USP38)
>> Groupware Functionality (Enterprise Edition):
>> Method deployment via shared database
>> Centralized user account management
>> LDAP authentication (ActiveDirectory)
>> Prepared for LIMS connectivity
>> Review Data through your web browser
Cat No.
WinDiss ARGUS