2020 Viscotec Semi-automatic syringe filling system for dronabinol.
The filling system is equipped with a storage container for heating
the dronabinol to 60 – 70° C and keeping the Temperature
constant during the filling process.
The syringe is filled through the syringe tip and under a protective
gas atmosphere (e.g. argon). No air should remain in the syringe. The
filling system is suitable for the filling amounts of 265 mg, 530 mg
or 1060 mg with tight tolerance limits. The dosing accuracy of the
Pharma Dispenser 3VHD8 (0.35ml / U) amounts 1%. The repeat accuracy is
> 99%, depending on the material. Detailed material data are currently
not available. The determination of the actual dosing accuracy and
dosing time takes place during commissioning. The customer is taking
care of the process development. The storage container has a capacity
of 500 ml and withstands a pressure of 0 to +6 bar (gauge).
General information
• Filling system is designed as a tabletop device
• Pharma control including foot switch
o 1ph. 230V/60Hz, 16A – Hygienic design
o Operating modes: Quantity control or start / stop control, menu
management
o Diagnosis, parameterization and calibration function, digital
monitoring, predefined
status and error messages
o Languages German / English
o Stainless steel housing (AISI 304) including touch panel
o IP65 88-264 VAC, 1 Ph, 16A, 47-63Hz reportable lt. Art. 22 Abs 10
EG-Dual-Use VO
• Suitable for GMP Processes
• Suitable for filling 265 mg, 530 mg or 1060 mg dronabinol in glass
syringes through their
Syringe opening (Luer Cap)
• The dosing accuracy of the Hygienic Dispenser 3VHD8 (0,35ml/U)
amounts 1%. The
determination of the actual dosing accuracy and dosing time takes
place during
commissioning
• Technical Data:
o Product contacted surface < = 0,8μm
o Elastomers with FDA declaration of conformity
o Parts in contact with the product can be autoclaved (max. 15min @ +
121 ° C)
o Hygienic design: easy to dismantle and clean
o Hermetically sealed process space
• The filling of the syringes is carried out with a protective gas
bell (protective argon
atmosphere) Alternatively, e.g. a complete enclosure under a
protective atmosphere is
conceivable.
• The syringe is equipped with a Luer cap. If the connection is not
stable a bracket for fixation
can be retrofitted.
• Heatable U51258834 storage container for product feed
o Volume 0,5 litre
o Pressure range: 0 to +6 bar g
o Material 1.4404 / 316L
o Surface: sanded, Ra<0,8μm
o ND 50 mm
o Length approx. 600mm
o Covered with a double jacket divided into two heating zones
including a guide spiral
for on-site hot water via temperature control unit
o Connections:
▪ Lid with push-in fitting for pressurization using a Ø 6mm hose
▪ TC DN15 connections for inflow and outflow of the heating zones
▪ TC DN15 connection for outlet
▪ Heatable up to 60-70°C
▪ Homogeneous temperature distribution inside the storage tank
▪ Product pipe (bend from the storage container to the dispenser) DN
15 /
B90 double-walled for heating
• Parts in contact with the product are made of stainless steel
(316L) or FDA-compliant plastics
o Dispenser: 1.4404
o Storage tank 1.4404
• Handling and operation are easy to understand
o The operation takes place mainly via the graphic user interface on
the touch panel
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