pharmaglobiz Buyer From Mumbai Is Looking For semi-automatic Radiopharmaceutical Dispenser System
Device Will Dispense Radioactivity Using Sterile, Disposable Kits.
Will Measure Total Activity And Concentration From A Mother Vial With Appropriate Shielding.
Dispense Activity In 10 Ml Closed Vials.
A Self Shielded Peristaltic Pump Or A Similar Solution.
Will Measure The Activity Using A Dose Calibrator.
The Dose Calibrator Shall Be Installed Inside A Shielding In The Bottom Part Of The Hot Cell Or Laminar Flow Hood.
The System Shall Possess An Elevator To Measure The Activity In The Dose Calibrator.
The Dispenser Shall Have Compact Dimensions, Suitable For Positioning Inside A Manipulation Hot Cell Or Shielded Laminar Flow Hood. Small Dimensions And The Geometry Shall Not Interfere With The Hot Cell Or Laminar Air Flow Hood.
The Dispenser Dimensions Shall Leave Enough Space Inside The Hot Cell Or Shielded Laminar Flow Hood For Operators Manual Work In Case Of Maintenance.
The Dispenser Shall Be Transportable For Possible Removal From The Hot Cell.
The System Shall Include Vial Dispensing With Pre-set Activity And Volume.
The Dispenser Shall Be Classified As A Class 1m Medical Device. The Ce Code Shall Be Clearly Specified, And A Copy Of The Certificate Attached By.
The System Shall Meet The Following Technical Requirements:
The System Shall Operate At 220v, 50hz.
Shall Include An Additional External Shielding All Around The Dispenser In A Stand-alone Configuration.
An Additional Shielding Shall Be Providing In A L-block Shield Cave Configuration With A Proper Vision System.
The Additional Shielding Shall Have Enough Space To Accommodate The Dispenser System And Shall Take The Whole Width Of The Front Opening
Shall Have A 50mm Solid Lead Encased In Steel Or Interlocking Lead Bricks Encased In Steel.
Shall Have A Zero-dead Volume 4 Rollers Micro-pump Or Similar Solution.
Shall Use A Sterile Disposable Set-medical Device To Dispense Activity Into Closed Vials.
Shall Receive Radiopharmaceutical Bulk Directly From The Synthesis Module Or From An External Vial.
The Radiopharmaceutical Bulk Shall Be Placed In A Provided Shielded Area (minimum 40mm Of Lead Thickness), To Minimize The Operators Hands Exposure.
During The Retrieval Of The Dispensed Dose No Radiopharmaceutical Shall Be Present Inside The Disposable Tube Of The Set, In Order To Minimize The Operators Hands Exposure. When The Dispenser Is Not Operating The Tubes Shall Be Empty.
Shall Be Able To Dilute The Bulk Activity To The Required Concentration.
Shall Dispense Activity Into Closed Vials.
Shall Be Able To Dispense Between 0.3 And 9.8 Ml With A 10% Of Error.
The Control Software Shall Be Gamp5 And Fda 21 Cfr Part. 11 Compliant.
Shall Have A Pc And Software Able To Program, Control And Save Data Of The Dispensing Cycles.
Shall Have Data File Export And Paper Printing.
Shall Have At Least 3 Level Password (programmable).
Shall Have Customizable User Accounts.
Shall Produce Reports And Statistics.
Shall Record Events And Generate Alarms Log Files.
Shall Perform Periodical Back-up.
Shall Perform On-line Downloadable Database (excel And Encrypted Files).
Shall Have An Ethernet Line In Order To Allow Remote On-line Assistance (internet Connection) From The Manufacturers Headquarters.
The Control Software Shall Include A Calibrator Viewer Feature For A Complete Management Of The Dose Calibrator From The Dispenser Software.
Shall Be Able To Print Vial Labels, Reports, And Audit Trails. Labels Shall Be Configurable/editable.
Shall Be Able To Trace All Operations Done By The Operator During The Complete Production Cycle.
All Data Shall Be Stored And Saved Into Encrypted Files In Order To Make Impossible Their Modification Or Elimination By Malicious Users.
It Shall Be Possible To Control And Run The Dose Calibrator By Mean Of The Same Pc Used To Run The Dispenser. The Operations To Be Performed Are: Stability Check, Linearity Test And Background
There Shall Be The Possibility Of Programming The Daily Work In Advance, Not Only Manually Directly On The Dispenser Software, But Also By Uploading A Prepared Program By A Usb Key Or Remotely By
Shall Have The Possibility To Connect The Customer Sterilizing Filter To A Bubble Point Test Unit.
The Bubble Point Test Unit Shall Have The Possibility To Test Both Vented And Not Vented Filters In Automatic Mode Without Manual Intervention;
The Filter Integrity Test Data Shall Be Measured And Configured By The Bubble Point Test Unit And Connected To A Control Pc With Software In Compliance With 21cfr Part 11.
The Software Of Bubble Point Test Unit Shall Allow Performance Of The Bubble Point Test With Clear Graphics Guidance For The Operator
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