Related Manuals for FagronLab BASIC
Summary of Contents for FagronLab BASIC
- Page 1 FagronLab™ BASIC Automatic mixing/homogenization/emulsification system User Manual...
- Page 3 Lift arm with integrated quick-lock coupling • Hold the FagronLab™ logo on top of the jar to the front; insert the mixing shaft directly from the front into the lift arm • Insert the mixing unit from below •...
- Page 4 For additional support, operation handling and all other questions regarding the technology please feel free to contact your local Fagron company or dealer. Enjoy the successful production of quality assured compounding. Your FagronLab™ Compounding Support Team FagronLab™ BASIC – User Manual | 4...
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Page 5: Table Of Contents
The mixing process ....................................... 22 Mixing parameters ........................................ 24 Requirements for components of a formulation ............................. 28 After the mixing process is complete ................................29 6. General notes on the FagronLab™ mixing system ......................30 Identification number ID ....................................30 Error codes ..........................................32 Operation errors ........................................ -
Page 6: Installation Information
The socket outlet is located on the rear of the FagronLab™ BASIC. First connect the power cord to the socket outlet and then plug the power cord into the power outlet. - Page 7 FagronLab™ BASIC Description Minus button Compounding button Plus button Display Manual lift arm with quick lock coupling Pic.: FagronLab™ BASIC front Description Power button/emergency button RS232 port Socket outlet Pic.: FagronLab™ BASIC rear FagronLab™ BASIC – User Manual | 7...
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Page 8: The Unguator Technology - Competence From The Start
Mixing Blade and the jar that serves as both, a hygienic mixing jar and a hygienic dispensing jar. The principle of the preparation method using technology in the closed FagronLab™ mixing system is quick and easy to... - Page 9 The optimized mechanics and electronics ensure a quiet operation • In addition, is the FagronLab™ PRO preloaded with a database of several mixing parameters for semi-solid NRF formulations. This will optimize the manufacturing of NRF and NRF similar formulations and increase the compound quality •...
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Page 10: Fagronlab™ Assortment
Also ensure that the right shaft is used when working with the Disp. Blade. Both available shafts are marked for use with sizes 15-100 ml or 200 ml in the FagronLab™ jar. They have to be combined with the correct Disp. Blade. - Page 11 Pic.: FagronLab™ Disposable Blade Shaft FagronLab™ jar The FagronLab™ jar is both, a mixing and a dispensing jar, and is therefore designed as a disposable jar. The jar guarantees evaporation free and contamination free preparation in an air reduced mixing space.
- Page 12 The corresponding jar lids or jar bottoms can be ordered as spare parts in sets of five and used for the economical reuse of the body. FagronLab™ BASIC – User Manual | 12...
- Page 13 ďalšieho umývania. Pic.: Certificate of analysis FagronLab™ jar A detailed certificate is available for download at www.fagronlab.com/coa. A label is attached to each jar, which provides jar size, serial number (S/N), product number (PCN), date of packing, date of expiration and PPN. We recommend for a complete documentation to attach the jar label of the used jar onto the manufacturing record.
- Page 14 The diameter of the dispensing nozzle allows simple dosing of the quantity of ointment to be applied using approximate values. The regular dispensing nozzle in the screw lid of each FagronLab™ jar has a diameter of 8 mm. The varionozzles or applicators reduce the diameter to 4, 2 or 1 mm.
- Page 15 The FagronLab™ applicator long with a diameter of 2 mm allows formulations to be introduced into large orifices of the body or probes. In addition, the applicator long also comes inside each FagronLab™ 200 ml jar to help pushing up the bottom of this jar size in full.
- Page 16 • Contamination-free storage It is designed for FagronLab™ jar sizes from 300 to 2000 ml for hygienic transfer of the compound. The jar is attached to the base plate of the AirDynamic with the central hole at the bottom of the jar housing. By closing the easy-lock system on the side of the base plate, the jar is attached airtight.
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Page 17: Display Handling
Then a four digit PIN number will be provided to activate the FagronLab™ BASIC • Enter the four digit PIN on the display of the FagronLab™ BASIC Pic.: Display PIN FagronLab™ BASIC – User Manual | 17... - Page 18 Every mixing speed level runs five seconds, to test intern if the actual speed of rotation equals the level of the given speed of rotation • As soon as the FagronLab™ display shows the free spin program • Move the jar into its lowest possible position. After the process is finished, the mixing shaft automatically unlocks and the mixing unit in the lift arm can be moved to its lowest position for extracting •...
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Page 19: Compounding With The Fagronlab™ Basic
Pic.: Display OQ-Mode of the FagronLab™ device. If a repeated OQ test is not wanted, it is possible to jump to the start display by pushing the minus button for two seconds •... - Page 20 FagronLab™ BASIC • After starting up the device with the power switch, located on the back, the display shows the device type "FagronLab™ BASIC" Pic.: Display device type • Followed by the current number of preparations Pic.: Display current preparations •...
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Page 21: Aborting The Mixing Process
5. Compounding guidelines for the technology Preparing the FagronLab™ mixing unit The FagronLab™ mixing unit consists of a FagronLab™ jar, a FagronLab™ stirrer and the components of the formulation to be mixed. First, the jar cap (small red screw cap) of the jar and then the jar lid (large red, white or coloured screw cap) must be unscrewed from the jar. -
Page 22: Weighed Portion Of The Formulation
FagronLab™ BASIC is not just standard for the pharmacy. The FagronLab™ BASIC is equipped with a quiet and constantly usable permanent motor and is the ointment mixing device for individual and bulk compunding from 15 ml up to 500 ml. - Page 23 Pic.: Quick-lock coupling Hold the FagronLab™ logo, on top of the jar, to the front. Load the stirring shaft directly from the front into the lift arm. Push up the mixing unit, at the same time apply slight pressure from the top to the lift arm and with a slight turn counterclockwise (about a quarter turn) fix the mixing unit into the lift arm.
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Page 24: Mixing Parameters
Level 7 (1900 rpm) Jar size 15 - 30 ml 50 - 100 ml 200 ml 300 - 500 ml Time (min.) 1:30 2:00 3:30 4:40 Stirrer Tab: Mixing parameter suspension < 2 % FagronLab™ BASIC – User Manual | 24... - Page 25 Jar size 15 - 30 ml 50 - 100 ml 200 ml 300 - 500 ml Time (min.) 2:00 2:20 4:10 5:30 Stirrer Disp. Blade Disp. Blade Disp. Blade Tab: Mixing parameter Emulsion FagronLab™ BASIC – User Manual | 25...
- Page 26 The temperature control with a thermometer should take place in short intervals to make sure the compound is not overheating. To support the cool down process with the FagronLab™ BASIC a cooling cuff can be used around the jar and the mixing process for larger jar sizes can be repeated.
- Page 27 The suppository foundation can be warmed in a water bath directly in a transparent jar and afterwards stirred with the FagronLab™ to the soft melting point. An applicator long aids in the precise filling of the suppository mould. For a batch approximately 5 % to 10 % added allowance is recommended.
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Page 28: Requirements For Components Of A Formulation
In order to ensure better wetting of powders in aqueous compounds, micronized substances should be added after any liquid components or covered with foundation. For a solids content less than 2 %, we recommend applying the pre-grinding process together with approx. 30 % of the ointment foundation (review pre-grinding). FagronLab™ BASIC – User Manual | 28... -
Page 29: After The Mixing Process Is Complete
The jar lid is screwed back onto the jar body and equipped with a varionozzle as needed. Then the little cap or a applicator will be loosely screwed on. FagronLab™ BASIC – User Manual | 29... -
Page 30: General Notes On The Fagronlab™ Mixing System
ID and it conducts an easier documentation and an exact reproduction of the mixing process. The FagronLab™ mixing parameters are an assistance in the right handling of the technology. The manufacturing with the Fagron- Lab™ devices lies in the responsibility of the pharmaceutical personal. - Page 31 The input of the rpm is assigned to the numbers 0 - 9, in which each number correlates to a defined rpm value: Level Rotation speed (rpm) 1000 1200 1400 1650 1900 2150 2400 Tab: Number/rpm correlation FagronLab™ BASIC – User Manual | 31...
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Page 32: Error Codes
Operation errors FagronLab™ stirrer Error Troubleshooting The stirrer used is not an original FagronLab™ stirrer. The FagronLab™ BASIC has only been tested, centered The stirrer used is not compatible with the FagronLab™ and aligned with original FagronLab™ stirrers. All BASIC. - Page 33 Pic.: Quick-lock coupling Hold the FagronLab™ logo, on top of the jar, to the front. Load the stirring shaft directly from the front into the lift arm. Push the mixing unit up, at the same time apply slight pressure from the top to the lift arm and with a slight turn counterclockwise (about a quarter turn) fix the mixing unit into the lift arm.
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Page 34: Cleaning The Fagronlab™ Basic
An unauthorized opening of the FagronLab™ BASIC device is not permited. 7. Service and warranty Notes on malfunctions If the FagronLab™ device does not work, it may be due to a small problem that can be simply corrected. Before taking the unit for repair, please follow the instructions below: •... -
Page 35: Notes On Safety
The device should be allowed to acclimatize for approx. 30 minutes at initial commissioning and/or after extended storage time in cold rooms • The FagronLab™ BASIC should be placed to ensure easy access to the power switch and power cable also to avoid use by unauthorized persons •... -
Page 36: Manufacturing And Customer Service
The license manufacturer of FagronLab™ products, the Gako International GmbH, D-96110 Schesslitz, is DIN EN ISO 9001:2015 certified. For inquiries regarding FagronLab™ technology products please refer to your local Fagron company or official dealer. Customer Service With all inquiries about technical data, service, warranty, customer service or replacement parts contact the customer service of your local Fagron company or official dealer. -
Page 37: Installation Qualification Iq
Correctly installed, earthed socket with 220 V or country-specific nominal voltage and required grid frequency Before initial operation acclimate the device for 30 minutes at room temperature Excludes device handling by unauthorized persons Observe the operation manual and manufacturer's recommendations FagronLab™ BASIC – User Manual | 37... - Page 38 Place the device securely Establish the power supply, connect the device with the power outlet Turn on the FagronLab™ BASIC device with the power switch The display shows the device type "FagronLab™ BASIC" The display shows the number of current number of preparations "mixed <<---->>"...
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Page 39: Operation Qualification Oq
FagronLab™ BASIC Operation qualification (OQ) Company (Pharmacy) Device identification Assessment not OK Examination of readability of the labels on the device Serial number (SN): __________________________________________ Date of purchase: __________________________________________ FagronLab™ BASIC – User Manual | 39... - Page 40 Not OK The device is securely placed Power is supplied Turn on the FagronLab™ BASIC device with the power switch The display shows the device type "FagronLab™ BASIC" The display shows the number of current number of preparations "mixed <<---->>"...
- Page 41 FagronLab™ BASIC Notes .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... FagronLab™ BASIC – User Manual | 41...
- Page 42 FagronLab™ BASIC Notes .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... FagronLab™ BASIC – User Manual | 42...
- Page 43 FagronLab™ BASIC – User Manual | 43...
- Page 44 fagron.gr Fagron Hellas - 12 km N.R. Trikala-Larissa - P.C. 42100 Trikala Tel. +30 (0) 24310 83633-5 - Fax +30 (0) 24310 83615 - info@fagron.gr...
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