Matériel médical Cantourage GmbH

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Marke: Cantourage GmbH
Semi-automatic syringe filling system for dronabinol
A device for filling dronabinol in glass syringes is constructed for a contract manufacturer of the
Cantourage GmbH. It is going to be installed and operating in the USA. 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 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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