New Age Instrumentation

Salient Features Of Umang Equipment

Extruder: Its various designs like screw extruder including cone, axial, radial and die roller designs are offered by UMANG.

Spher’oidizer is available with options of different plates to make various sizes of pellets from 400 – 1000 microns and above.

Automated PLC controls ensure optimum controls and batch to batch reproducibility with uncompromising product quality.

Optimum yield: Nearly 98 percent yield, negligible handling losses due to equipment design and procedure.

Turnkey projects: Umang gives the complete pellet line starting from mixing, extrusion and spher’oidization to coating or drying and sizing of pellets, ready to fill.

Variety: Mesh size available to make pellets from 400 microns – 2000 microns.

Optimum bag shaking filters: with twin bag shaking option.

UAPT: Umang advanced pelletisation technology for making pellets in a combined machine on a continally.

Wash and clean in place: for equipment cleaning.

cGMP design: in compliance with latest validation and regulatory bodies.

Process 1 : Steps Of Manufacturing

• First the material is mixed in a planetary or high shear mixer with binder (typical moisture content varies from product to product of 10-20 percent)
• The mixed material is then fed to the extruder
• These moist extrudes which discharge from the extruder are fed into the spher’oidizer
• These pellets are dried in a fluid bed dryer or tray dryer
• Further operation can be coating or direct capsule filling and blister packing

Equipment Features For Process 1

• Automated PLC controls ensuring optimum controls and batch to batch reproducibility with uncompromising product quality
• Optimum yield nearing 98 percent, negligible handling losses
• Unique mesh design for fine and coarse granulation
• Wash in place and clean in place for equipment cleaning
• cGMP design in compliance with latest validation and other regulatory bodies

Comparison Of Pellets Made By Process 1

• Shape and size:

  The pellets made by extrusion and Spher’oidization method are uniform and spherical. Pellet size ranges from 400 – 1500 microns.

• Nature of granules :

  Dense pellets typical density of  0.60 – 0.7 are produced.

• Binder :

  Typical binders used are between 2-5 percent, binders widely used are HPMC and PVP K - 30.

  Parameters For Process 1

  i.e. Extruder and Spher’oidizer.

• Percentage of moisture content.
• Extruder RPM
• Iris valve ON/OFF control.
• Spher’oidizer RPM
• Pellet Drying temperature
• Sifter mesh size
• In case the product has to be coated UPE – 02 sheet has to be referred

Process 2 : Steps Of Manufacturing

• First the NPS/pellets are feed to the drum of spher’oidizer the plate of the machine is controlled at a rotational speed of 200 RPM
• The active material / powder is then feed to the layering machine with the help of a powder feeder through a nozzle
• The binder liquid sprayed by a spray pump is controlled
• After a operation time of 25-30 minutes the drug loaded pellets are ready for further operations
• These pellets are then dried and coated by Wurster for seal and enteric coating
• Further operation can be coating, or direct capsule filling and blister packing

Equipment Features For Process 2

• Automated PLC controls ensuring optimum controls and batch to batch reproducibility with uncompromising product quality
• Optimum yield nearing 98 percent with negligible handling losses.
• Unique feeder design for having a free powder flow.
• Wash in place and clean in place for equipment cleaning.
• cGMP design in compliance with latest validation and other regulatory bodies

Comparison Of Pellets Made By Process 2

• Shape and size :

  The pellets made by Solid drug layering method is uniform and spherical. Pellet size is possible from 400 microns – 15mm.

• Nature of granules :

  Dense pellets typical density of 0.50 – 0.60 are produced.

• Powder feeder layering and Spray rate :

  Drug powder or sugar powder can be layered actively on the bed of pellets, the spray liquid should be sufficient to bind the drug powder on the bed of pellets.

Parameters For Process 2

i.e. Solid Drug layering.

• Percentage of powder to be layered
• Powder feeder RPM
• Plate rotation speed or RPM
• Percentage of binder solution sprayed
• Spray rate of powder controlled by feeder RPM.
• Spray rate of liquid controlled by spray pump RPM
• Sifter mesh size

Umang Pharmatech Pvt Ltd,
Plot No. 23, Golani Complex,
Waliv, Vasai (E).
Dist. Thane – 401 208. India.

E-mail : sales@umangpharmatech.com
www.umangpharmatech.com