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Tablet Dissolution Testing Instruments

Yarden Biotec |

מכשירים לבדיקת מסיסות

כבר מעל ל 40 שנים, חברת Pharma Test מתמחה בפיתוח ובייצור מערכות איכותיות לבדיקות מסיסות של טבליות, קפסולות, פתילות, אמפולות, וכלל תרופות מוצקות. Pharma Test מציעה טווח מוצרים מקיף החל ממכשירים ידניים, מערכות offline הכוללות אוספי דוגמאות אוטומטיים וכלה במערכות online המשלבות אנליזה ספקטרוסקופית בהליך הבדיקה והכוללות תוכנה בתאימות מלאה ל CFR 21 Part 11.
Pharma Test שמה לעצמה למטרה פיתוח מערכות באיכות התואמת את התווית המחייבת "Made In Germany".

*המחירים אינם כוללים מע"מ ועלולים להשתנות בהתאם למחירוני היצרן ולשערי המטבע
מכשיר לבדיקת מסיסות 14+2 תחנות

מכשיר לבדיקת מסיסות 14+2 תחנות

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The PTWS 1420 is a 14+2-position, “dual drive” compact tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the BP, DAB and Japanese Pharmacopeia section <15>. The instrument features 14 testing positions and includes two additional standard size vessels for media refilling and reference standard media. PTWS 1420 features independent stirrer speed control for the left and right half of stirrers.

Advantages:
>> 14 stirred vessel in one instrument is ideal for Biowaiver applications and offline automated systems
>> Dual drive configuration with independent speed control for left and right side of instrument enables flexible use of the PTWS 1420
>> Replacement media is stored in two additional heated vessels eliminating influences from cold media refilling
>> Easy to use auto vessel centering system
>> Eco friendly double walled vacuum molded water bath for improved temperature insulation
>> Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Wake up functionality to start heating at a pre-programmed time
>> Programmable infinity test
>> MonoShaft™ system to avoid re-adjustment of immersion depth after tool exchange
>> Staggered start feature for convenient manual sampling
>> Water diffuser for even temperature distribution
>> IQ/OQ documents included free of charge

Cat No.

PTWS 1420

מכשיר לבדיקת מסיסות 6 תחנות

מכשיר לבדיקת מסיסות 6 תחנות

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The PTWS 120D is a 6 position, single drive compact tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the DAB and Japanese Pharmacopeia section <15>.

Advantages:
>> Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Extraordinary safety features for pump and heating system, flow control, digital temperature control, thermo switch, thermo fuse
>> Ultra-fast heating system due to newly designed heat exchanger
>> Modular design to minimize bench space requirements
>> Individual vessel centering
>> Excellent access to all vessels
>> Eco-friendly double walled vacuum molded water bath

Cat No.

PTWS 120D

מכשיר לבדיקת מסיסות 6 תחנות עם שליטה נפרדת במהירות עבור כל תחנה

מכשיר לבדיקת מסיסות 6 תחנות עם שליטה נפרדת במהירות עבור כל תחנה

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The PTWS 120S is a 6-position, multiple drive, compact tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section <2.9.3/4> as well as the BP, DAB and Japanese Pharmacopeia section <15>. Its design for manual operation and ease of use.

Advantages:
>> 6 stirring positions, individually electronically regulated high precision drive system for each one of the 6 stirrers.
>> Grouping of stirrers, like 2 groups of 3, or 3 groups of 2 running at the same speed
>> Modular design to minimize bench space requirements
>> 3-point individual vessel centering system
>> Borosilicate glass vessels including extra low evaporation vessel covers
>> Individual vessel batch code at the top of the vessel flange for easy identification
>> Excellent access to all vessels
>> Eco saving double walled vacuum molded water bath
>> Motorized Drive Head lifting mechanism including head position programming facility
>> Screen saver functionality and count-down timer offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Wake up functionality to start heating at a pre-programmed time
>> Ultra-fast heating system due to newly designed heat exchanger, saves up to 1/3rd of the heating up time compared to most other models
>> MonoShaft™ system to avoid re-adjustment of immersion depth
>> Staggered stirrer start feature for convenient manual sampling
>> Water diffuser inside the vacuum moulded water bath for even temperature distribution and fast temperature equilibration
>> Spring loaded pump assembly to eliminate vibration transfer
>> Extraordinary safety features for pump and heating system, flow control, digital temperature control, thermo switch, thermo fuse
>> Auto stirrer stop when drive lift is moved
>> Excellent stirrer shaft verticality inside the vessels due to central position of lift columns, drive head assembly and rigid anodized aluminum framework
>> Easy removal of the water bath from of the frame work for cleaning and maintenance work
>> Energy saving double walled bath option, less heat transfer into the lab environment, less power consumption during instrument operation
>> DQ/QC, IQ and OQ documents included free of charge

Cat No.

PTWS 120S

מכשיר לבדיקת מסיסות 8 תחנות

מכשיר לבדיקת מסיסות 8 תחנות

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The PTWS 820D is an 8-position, single drive compact tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section <2.9.3/4> as well as the DAB and Japanese Pharmacopeia section <15>.

Advantages:
>> Modular design to minimize bench space requirements
>> 3-point individual vessel centering system
>> Excellent access to all vessels
>> Eco saving double walled vacuum molded water bath
>> Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Wake up functionality to start heating at a pre-programmed time
>> Ultra-fast heating system due to newly designed heat exchanger
>> MonoShaft™ system to avoid re-adjustment of immersion depth
>> Staggered stirrer start feature for convenient manual sampling
>> Water diffuser for even temperature distribution
>> Spring loaded pump assembly to eliminate vibration transfer
>> Extraordinary safety features for pump and heating system, flow control, digital temperature control, Thermo switch, Thermo fuse
>> Auto stirrer stop when instrument head is moved
>> Excellent stirrer shaft verticality inside the vessels due to central position of lift columns and drive head assembly
>> Easy removal of the water bath from of the frame work for cleaning and maintenance work
>> DQ/QC, IQ and OQ documents included free of charge

Cat No.

PTWS 820D

 מערכת הוספת המדיום האוטומטית להחלפת מדיום על ידי הוספת בופר  (half change)

מערכת הוספת המדיום האוטומטית להחלפת מדיום על ידי הוספת בופר (half change)

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The Pharma Test media addition station PTWS 820-MA together with the PTWS 820D tablet dissolution testing instrument can be used to perform the automated media half change for delayed release dosage forms. The operation is performing according to the requirements from USP <711>, EP <2.9.3> and CP <931> for delayed release dosage forms (in CP, enteric coated dosage forms). The test will start with 750ml of 0.1N HCl. After 2 hours, 250ml of concentrated, pre-heated buffer solution will be dosed quickly into the dissolution vessels. The pH will change to 6.8 and the dosage form should then start to dissolve.

Advantages:
>> Very fast buffer adding which corresponds to a pump flowrate of 500ml/min
>> According to USP <711> and EP 2.9.3 the test must be “proceeded immediately” after the 2h in 0,1N HCl
>> Includes an additional heating system which will preheat the buffer in the USP Tolerance of 37 +/-0.5°C
>> No temperature change in the dissolution vessel
>> Unattended operation for the media change

Cat No.

PTWS 820-MA

מכשיר לבדיקת מסיסות 6+2 תחנות - שורה אחת

מכשיר לבדיקת מסיסות 6+2 תחנות - שורה אחת

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The PTWS 620 is a 6 + 2 position, single drive tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the DAB/BP and Japanese Pharmacopeia section <15>. The USP monograph <1092/2.4.2> lists visual observation of the dissolution behavior as essential for identifying variables in the formulation or manufacturing process. The six vessels in the front row of PTWS 620 offer optimal visibility of the samples.

Advantages:
>> 6 front line vessels for easy access in manual operation and optimal visibility
>> Rigid aluminum water bath cover
>> Individual 3-point vessel centering
>> Excellent access to all vessels
>> Staggered start feature for convenient manual sampling
>> Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Wake up functionality to start heating at a pre-programmed time
>> Programmable infinity test
>> MonoShaft™ system to avoid re-adjustment of immersion depth
>> Ultra-fast heating system with excellent temperature stability due to newly designed heat exchanger
>> Water diffuser for even temperature distribution
>> Vibration absorber to avoid vibration transfer into the USP/EP vessels
>> Spring loaded pump assembly to eliminate vibration transfer to the frame work
>> Extraordinary safety features for pump and heating system, flow control, digital temperature control, water level sensor, thermo switch, thermo fuse
>> DQ/QC, IQ and OQ documents included free of charge

Cat No.

PTWS 620

מכשיר לבדיקת מסיסות 12 תחנות

מכשיר לבדיקת מסיסות 12 תחנות

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The PTWS 1220 is a 6+6 position, single drive tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the DAB/BP and Japanese Pharmacopeia section <15>. The instrument features two additional vessels (approx. 250ml) for media refilling and reference standard media. The PTWS 1220 is the ideal choice for Biowaiver studies and dissolution method development.

Advantages:
>> Test 12 samples in one instrument with identical conditions for comparative studies (Biowaiver)
>> 6 front line and 6 back line vessels for easy access in manual operation
>> Rigid aluminum water bath cover
>> Individual 3-point vessel centering
>> Excellent access to all vessels
>> Staggered start feature for convenient manual sampling
>> Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Wake up functionality to start heating at a pre-programmed time
>> Programmable infinity test
>> MonoShaft™ system to avoid re-adjustment of immersion depth
>> Ultra-fast heating system with excellent temperature stability due to newly designed heat exchanger
>> Water diffuser for even temperature distribution
>> Vibration absorber to avoid vibration transfer into the USP/EP vessels
>> Spring loaded pump assembly to eliminate vibration transfer to the frame work
>> Extraordinary safety features for pump and heating system, flow control, digital temperature control, water level sensor, thermo switch, thermo fuse
>> DQ/QC, IQ and OQ documents included free of charge

Cat No.

PTWS 1220

מכשיר לבדיקת מסיסות 12 תחנות עם שליטה נפרדת במהירות עבור כל שורה

מכשיר לבדיקת מסיסות 12 תחנות עם שליטה נפרדת במהירות עבור כל שורה

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The PTWS D620 is a “Dual Drive” 6+6 position, single drive tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the DAB/BP and Japanese Pharmacopeia section <15>. The instrument features two additional vessels (approx. 250ml) for media refilling and reference standard media. PTWS D620 features independent stirrer speed control for the front and back row of stirrers.

Advantages:
>> Individual speed control for front and back row of stirrers
>> 6 front line and 6 back line vessels for easy access in manual operation
>> Rigid aluminum water bath cover
>> Individual 3-point vessel centering
>> Excellent access to all vessels
>> Staggered start feature for convenient manual sampling
>> Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>> Wake up functionality to start heating at a pre-programmed time
>> Programmable infinity test
>> MonoShaft™ system to avoid re-adjustment of immersion depth
>> Ultra-fast heating system with excellent temperature stability due to newly designed heat exchanger
>> Water diffuser for even temperature distribution
>> Vibration absorber to avoid vibration transfer into the USP/EP vessels
>> Spring loaded pump assembly to eliminate vibration transfer to the frame work
>> Extraordinary safety features for pump and heating system, flow control, digital temperature control, water level sensor, thermo switch, thermo fuse
>> DQ/QC, IQ and OQ documents included free of charge

Cat No.

PTWS D620

מכשיר לבדיקת מסיסות 6+1 תחנות

מכשיר לבדיקת מסיסות 6+1 תחנות

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The PT-DT70 is the low head flip back dissolution testing instrument from Pharma Test. It provides a spacen saving, low cost entry into dissolution testing. Whether for a new laboratory or to meet tough budget requirements, the PT-DT70 offers a lot of instrument for a comparatively modest cost. The ideal instrument for all USP <711/724> and EP <2.9.3/4> applications for which automated and manual operation is required.

Advantages:
>> 7 test stations = 1 additional unstirred vessel for blank or reference medium
>> 4 + 3 format for USA FDA friendly application
>> Pneumatic lift device which allows the drive head and testing tools to be raised out of the test vessels
>> Internal Buzzer, programmable sampling information
>> Housing made from stainless steel, top cover PP moulded
>> Full USP <711/724> / EP <2.9.3/4> Pharmacopoeia conformity
>> Mono-shaft Stirrers and Stirring Adapters fur USP/EP App. 1, 2 and 6 (Standard Supply Scope includes USP/EP App. 2 stainless steel Paddle Stirrer Adapters
>> Fully adjustable and fully regulated paddle speed selection from 25 to 250 rpm
>> Built in heater with microprocessor temperature control, over the range 25 to 45O Less than 0.3°C temperature deviation within the entire water bath
>> Measurable Vibration Displacement: < 0.003 mm (if placed onto a suitable bench)
>> LED display for target (user specified) and actual temperature
>> Bi-directional RS 232C interface for control of:
>> thermostat
>> temperature
>> motor start / stop
>> speed functions
>> connect PT-DL1 Data Logger
>> U-shaped Plexiglas (Perspex) water bath with cover for all 7 working positions. Auto centering system for all vessels. Heating of Dissolution Media in full compliance to the USP recommendation = no stirring while heating media to avoid air introduction!
>> Delivery scope includes 7 round bottom test vessels
>> Delivery scope includes a set of number stainless steel mono-shaft stirrers and paddle
inserts
>> Includes a locating gauge for setting stirrer depth and centering stirrer in vessel
>> Adjustable lock-nuts for exact positioning of stirrer shafts inside the test vessels
>> Built in calibration programs for speed and temperature

Cat No.

PT-DT70

מכשיר לבדיקת מסיסות 6+2 תחנות עבור  בדיקות בנפחים גדולים

מכשיר לבדיקת מסיסות 6+2 תחנות עבור בדיקות בנפחים גדולים

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PTWS 4000 is the only tablet dissolution testing instrument available to support vessel sizes up to 4 liters for pool test applications of highly concentrated samples. PTWS 4000 contains six stirred glass vessels with a volume of approx. 4 liters each in a single row in the front side of the instrument. Furthermore, it offers two additional, unstirred 1 liter vessels to take a blank and/or a reference standard in a second row on the back side of the instrument. PTWS 4000 is fully compliant to the current USP <711/724> and EP <2.9.3/4> pharmacopeia.

Advantages:
>> The only tablet dissolution testing instrument supporting 4 liter vessels
>> Six vessels in front offer optimal view of the samples
>> Easy access to all vessels
>> Monoshaft™ system to avoid re-adjustment of immersion depth
>> Clear-view Plexiglass water bath for excellent visibility
>> TWS trafic light warning system monitors critical parameters
>> GMP compliant stainless steel housing
>> IQ/OQ documents included free of charge

Cat No.

PTWS 4000

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