dissolution media preparator qbd - mtbrandao.com

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Dissolution Media Preparator EMD21-PDO Ÿ Enables filtration, pre-heating, deaeration, and precise dosing of media in the vessel within the dissolution bath Ÿ 21 ltr media tank capacity allows filling of dissolution vessels for up to 3 dissolution tests (n = 6) Ÿ Batch degassing ensures inter-vessel degassing consistency Ÿ Volumetric dispensing with an accuracy + 1% as per USP, FDA and Ph. Eur. requirements Ÿ Special nozzle design allows the handling of surfactants and frothing media like Sodium Lauryl Sulphate (SLS) Ÿ Programmable deaeration time, temperature and vacuum for effective deaeration of different media Ÿ Maintains media under vacuum at desired temperature while in idle condition Ÿ Virtually zero dead volume minimizes wastage of media Ÿ Programmable dispense volumes from 200 ml to 4 L Ÿ Fast filling of dissolution vessels at a dispensing rate of 900 ml/min Ÿ Programmable rinse and cleaning cycle allows the instrument to run through a prevalidated self cleaning procedure Ÿ On-board memory stores 10 batch information of degassed media Quality by Design QbD Ÿ Unparalleled versatility due to 1 mL volume change increments o Ÿ 360 turning radius allows it to be maneuvered in tight places Ÿ Multifunction single hose for dispensing, aspirating, cleaning, rinsing, and draining ensures no lifting of heavy media tanks Versatility Ÿ Ergonomically designed nozzle with embedded dispense switch for ease of operation Ÿ User friendly validation and calibration of media volumes User friendly Ÿ Print out of validation, calibration, dispensed volume and temperature reports Reports With Integrated DO Probe Features of Optical DO probe : Ÿ Compliance with ASTM International Method D 888 – 05 Ÿ Quick response optical sensor technology Ÿ No membrane: Cost-effective optical sensor technology allows maintenance - free operation Ÿ No electrolyte, no drift Ÿ No O consumption: Precise in low O concentration 2 2 Ÿ No cross sensitivity with pH 1-14, CO , H S, SO 2 2 2 Ÿ Real time temperature compensation Ÿ Provides reliable and reproducible results Ÿ Rugged and robust stainless steel construction Dearates Surfactants like SLS Rugged-SS Construction Batch Capacity 21 L Dead Volume Virtually 0 Volume Change Increment 1 mL Temperature Accuracy + - o 0.5 C Memory 10 Reports DO Level <4 ppm ELECTROLAB Media Preparator Main Cycle Report Report with individual vessel DO values

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Page 1: Dissolution Media Preparator QbD - mtbrandao.com

Dissolution Media Preparator

EMD21-PDO

Ÿ Enables filtration, pre-heating, deaeration, and precise dosing of media in the vessel within the dissolution bath

Ÿ 21 ltr media tank capacity allows filling of dissolution vessels for up to 3 dissolution tests (n = 6)

Ÿ Batch degassing ensures inter-vessel degassing consistency

Ÿ Volumetric dispensing with an accuracy + 1% as per USP, FDA and Ph. Eur. requirements

Ÿ Special nozzle design allows the handling of surfactants and frothing media like Sodium Lauryl Sulphate (SLS)

Ÿ Programmable deaeration time, temperature and vacuum for effective deaeration of different media

Ÿ Maintains media under vacuum at desired temperature while in idle condition

Ÿ Virtually zero dead volume minimizes wastage of media

Ÿ Programmable dispense volumes from 200 ml to 4 L

Ÿ Fast filling of dissolution vessels at a dispensing rate of 900 ml/min

Ÿ Programmable rinse and cleaning cycle allows the instrument to run through a prevalidated self cleaning procedure

Ÿ On-board memory stores 10 batch information of degassed media

Quality by DesignQbD

Ÿ Unparalleled versatility due to 1 mL volume change increments

oŸ 360 turning radius allows it to be maneuvered

in tight placesŸ Multifunction single hose for dispensing,

aspirating, cleaning, rinsing, and draining ensures no lifting of heavy media tanks

Versatility

Ÿ Ergonomically designed nozzle with embedded dispense switch for ease of operation

Ÿ User friendly validation and calibration of media volumes

User friendly

Ÿ Print out of validation, calibration, dispensed volume and temperature reports

Reports

With Integrated DO Probe

Features of Optical DO probe :Ÿ Compliance with ASTM International Method D 888 – 05Ÿ Quick response optical sensor technologyŸ No membrane: Cost-effective optical sensor technology

allows maintenance - free operation Ÿ No electrolyte, no driftŸ No O consumption: Precise in low O concentration2 2

Ÿ No cross sensitivity with pH 1-14, CO , H S, SO2 2 2

Ÿ Real time temperature compensationŸ Provides reliable and reproducible results Ÿ Rugged and robust stainless steel construction

Dearates Surfactants like SLS

Rugged-SS Construction

Batch Capacity

21 L

Dead Volume

Virtually

0

Volume Change

Increment

1mL

Temperature

Accuracy

+

-o0.5 C

Memory

10 Reports

DO Level

<4ppm

ELECTROLAB

Media Preparator Main Cycle Report

Report with individual vessel DO values

Page 2: Dissolution Media Preparator QbD - mtbrandao.com

• Complete range of Dissolution Testers • Disintegration Testers • Friability Testers • Tablet Hardness Testers• Electromagnetic Sieve Shakers • Tap Density Tester • Bulk Density Tester • Powder Flow Tester • Leak Testers • Peristaltic Pumps

The information contained in this document is believed to be correct but ELECTROLAB accepts no liability for any errors and reserves the right to alter specifications without noticeJune, 2015 / 070F002

Our Products

< 6 ppm is recommended dissolved oxygen level for USP Prednisone Tablets RS (Ref : USP Dissolution Toolkit version 2.0)

USP 35 states “Dissolved gases can cause bubbles to form, which may change the results of the test.”

Importance of Degassing

52.3% of mean percent dissolved 11.8% of standard deviation

Effective deaeration reduces variability in results by:

Ref : Eaton J et al. Perturbation Study of Dissolution Apparatus Variables - A Designof Experiment Approach. Dissolution Technologies;14(2):20-26.

Inter & Intra Laboratory

VariabilityReliability

CE

ISO 9001ISO 9001 : 2008 CERTIFIED

SCES 047

ISSSW

2 to 21 L

± 1%

900 mL / min

0.2 to 4 L

± 1%

900 mL/min

o o 20 C to 50 Co0.5 C

100 Kg

Stainless Steel

100 to 500 mm/ Hg

High performance piston pump

230 VAC/ 50 Hz 10%110 VAC/ 50 Hz ± 10%

±

55 x 92 cm cm

± 1%

< 4 ppm of *DO

EMP-21 DO

S.S. : 0740100

230 Volts

S.S. : 0730100

110 Volts

Accuracy

Media volume

Flow rate (during run cycle)

Dispense volume

Temperature range

Accuracy

Flow rate (during run cycle)

Temperature accuracy

Piston pump accuracy

Degassing level

Media tank

Vacuum

Piston pump

Electrical power

Dimensions (Ø x H)

Weight

* Dependent on media type and conditions

Model

Product code

Specifications

Temperature :

Aspiration :

Dispense :

Other specifications :

ELECTROLABSales

&Service

Worldwide

ELECTROLAB (India) PVT. LTD.

Head Office : 401, Tirupati Udyog, I. B. Patel road, Off. Western Express highway, Goregaon (East), Mumbai - 400 063, India.

Tel : +91 - 22 - 4041 3131 • E-mail : [email protected]

Factory : EL 23/24, T. T. C., Electronic Zone, M. I. D. C, Mahape, Navi Mumbai - 400 710, India.

Tel : +91 - 22 - 4161 3131 • Website : www.electrolabindia.com

(CIN NO : U33110MH2002PTC136735)