The document discusses media degassing, which is the process of reducing dissolved gases in dissolution media. Dissolved gases can cause bubbles that may affect test results, so they should be removed prior to testing. The recommended method is to heat the media to 41-45°C under a vacuum of less than 100 mbar. Effective degassing reduces variability in dissolution results by over 50% for mean percent dissolved and nearly 12% for standard deviation. The EMP-21 Dissolution Media Preparator enables precise degassing, heating, filtration and dosing of media to ensure consistency between vessels. It allows automated degassing and dispensing of media for up to three dissolution tests.

1. Dissolution Media Preparator

2. What is media degassing?
• Media degassing is a process to reduce the level of dissolved gases in the
dissolution media
Why do you need to degass the media?
• Dissolved gases can cause bubbles to form, which may change the results of the
test. In such cases the dissolved gases should be removed prior to testing”.
(Ref: USP 33 <711>)
How to degass the media?
• Heat an appropriate volume of the medium to between vacuum 41°C-
45°C....Vacuum should be less than 100 mbar.” (Ref: USP 33 <711>)
• Other validated deaeration techniques for removal of dissolved gases may be
used.” (Ref: USP 33 <711>)
Media degassing

3. USP 35 states “Dissolved gases can cause bubbles to form, which may change
the results of the test.”
Importance of degassing
Inter and Intra Laboratory

4. < 6 ppm is recommended dissolved oxygen level for USP Prednisone Tablets
RS (Ref : USP Dissolution Toolkit version 2.0)
Effective deaeration reduces variability in results by:
• 52.3% of mean percent dissolved
• 11.8% of standard deviation
Ref : Eaton J et al. Perturbation Study of Dissolution Apparatus Variables - A Design of Experiment Approach.
Dissolution Technologies;14(2):20-26.
Importance of degassing

5. Our Solution

6. Dissolution Media Preparator
EMP-21

7. Quality by Design
Enables filtration, pre-heating, deaeration, and
precise dosing of media in the vessel within the
dissolution bath
21 ltr media tank capacity allows filling of dissolution
vessels for up to 3 dissolution tests (n = 6)
Batch degassing ensures inter-vessel degassing
consistency
Volumetric dispensing with an accuracy better than
+ 1% as per USP, FDA and Ph. Eur. Requirements
Special nozzle design allows the handling of
surfactant and frothing media like Sodium Lauryl
Sulphate (SLS)
Programmable deaeration time, temperature and
vacuum for effective deaeration of different media
EMP-21

8. Maintains media under vacuum at desired temperature
while in idle condition
Virtually zero dead volume minimizes wastage of media
Programmable dispensing volumes from 200 ml to 4 ltrs
Fast filling of dissolution vessels at a dispensing rate of
900 ml/min
Programmable rinse and cleaning cycle allows the
instrument to run through a prevalidated self cleaning
procedure
On-board memory stores 10 batch information of
degassed media
Quality by Design (contd)
EMP-21

9. Unparalleled versatility due to 1 ml volume
change increments
360 turning radius allows it to be
maneuvered in tight places
Multifunction single hose for dispensing,
aspirating, cleaning, rinsing, and draining
ensures no lifting of heavy media tanks
Versatility
EMP-21

10. Ergonomically designed nozzle with embedded
dispense switch for ease of
Operation
User friendly validation and calibration of media
volumes
User friendly
EMP-21

11. Print out of validation, calibration, dispensed
volume and temperature reports
Reports
EMP-21

12. Dissolution Media Preparator at a glance
360 turning
radius
Frothy media
handled
Programmable
vacuum
Dead volume
Volume change
increment
21 litres
No lifting of
media tanks
Clean-in-Place
Optional Accessory: DO2 meter

13. Optical Dissolved Oxygen (DO2) Meter
No calibration, no membrane, no electrolyte,
no drift
No cross sensitivity with pH 1-14, CO2 , H2S,
SO2
Real time temperature, salinity and pressure
compensation
Fast response sensor
No O consumption: Precision in low O2
concentrations
ASTM International method D 888-05
compliance

14. Thank You