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FagronLab BASIC, User Manual

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FagronLab™ BASIC – User Manual  |  39

FagronLab™ BASIC

Operation qualification (OQ)

Device identification

Company (Pharmacy)

Assessment

OK

not OK

Examination of readability of the labels on the device

Serial number (SN): 

__________________________________________

Date of purchase:   

__________________________________________

Summary of Contents for BASIC

Page 1: ...FagronLab BASIC Automatic mixing homogenization emulsification system User Manual ...

Page 2: ......

Page 3: ...uarter turn into the lift arm Move the mixing unit in the lift arm by hand all the way up and push the compounding button Touch panel with Minus button left Compounding button middle Plus button right Start display shows jar size mixing time and mixing speed After pushing the compounding button for two seconds Start appears on the display and the jar can be mounted FagronLab BASIC Display handling...

Page 4: ...the following operation manual carefully For more information and compounding recommendation consult our homepage www fagronlab com www fagron com 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 ...

Page 5: ...agronLab mixing unit 21 Weighed portion of the formulation 21 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 32 Cleaning the FagronLab BASIC 34 7 Service and warranty 34 Notes on malfunctions 34 Notes on sa...

Page 6: ...ct your local FagronLab support team or dealer in case components are missing or arrived damaged To ensure proper return without additional costs please hold on to the original cardboard box and packing material of the FagronLab BASIC The warranty lapses if the original packing materials are not used for return deliveries If the device is exposed to cold weather conditions please allow the device ...

Page 7: ...3 2 5 4 2 No Description 1 Minus button 2 Compounding button 3 Plus button 4 Display 5 Manual lift arm with quick lock coupling Pic FagronLab BASIC front Pic FagronLab BASIC rear No Description 1 Power button emergency button 2 RS232 port 3 Socket outlet ...

Page 8: ...d of time compared to the conventional methods that were used prior to the invention 1994 For the first time it is possible to not only standardize ointments but validate them too The current FagronLab mixing devices FagronLab BASIC FagronLab EMP and FagronLab PRO are useful and advanced improvements The FagronLab mixing devices feature a high safety standard They were audited for safety by TÜV Rh...

Page 9: ...ll be useful for additional compounding needs in the pharmacy Another beneficial feature will make stirring in medicine bottles possible Integrated standard mixing programs suspension emulsion gel etc with default mixing parameters makes the production of semi solid compounds a lot easier It is possible to rescale an already created mixing program to a different jar size to ensure the constant qua...

Page 10: ... ml jar sizes it still needs a different shaft for each See also the operation instructions that come with the disposable blade shafts The flow adapted shape of the SMB generally cleans itself during the rotating penetration of the ointment Depending on ointment s ingredients compatibility of weighted formulation and also if the jar is considerably under filled e g large volumes of powder unmixed ...

Page 11: ...obligated process of final quality control the mixing blade can be removed and discarded or left inside the jar Cleaning is limited to the Disp Blade shaft We also recommend using the Disp Blade for substances that may discolor the regular blade This type of stirrer also comes with different shaft lengths Every shaft is imprinted on its thinner end with the associated range of jar sizes 15 100 ml ...

Page 12: ...troyed after repeated mixing 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 Pic FagronLab jars Pic AirDynamic spindle Jars are available in following sizes 15 20 33 ml 30 42 ml 50 70 ml 100 140 ml 200 280 ml 300 390 ml 500 600 ml 1000 1250 ml and 2000 2600 ml rated volume filling volume The standard color of the...

Page 13: ...Ph Eur USP e JP Certificado de análise detalhado disponível em fagronlab com coa Este produto pode ser utilizado de imediato sem limpeza prévia fr Ce produit utilise exclusivement des composants matériaux et couleurs qui suivent la réglementation en vigueur en Allemagne BedGgstVO en Europe règlement CE No 1935 2004 et aux États Unis 21CFR177 1520 4 2012 Le contrôle de la qualité est effectué en co...

Page 14: ... 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 To ensure an exact dosage of highly active compounds it is recommended to use the ExactDose Adapter It is possible to extract an exact amount of 0 5 ml The FagronLab applicators reduce the extracted quantity...

Page 15: ...a dispensing system for FagronLab jar sizes 300 ml or 500 ml Extract the spindle from the jar Push carefully the bottom of the jar with a disinfected SMB if not available with a disinfected spatula all the way down Air can be diminished by placing the jar with slightly open lid loosely onto a spindle and pushing the bottom upwards Before giving the jar to the customer the safety adapter needs to b...

Page 16: ...namic Pic FagronLab ExactDose By pressing the pump ball with its valve screw closed air is pumped into the lower chamber of the jar The thus generated pressure pushes the movable bottom up Thanks to the AirDynamic even thick pastes can be dispensed via the small dispensing opening in the screw cap or transferred to small jars using the coupling The material outlet velocity depends on viscosity whi...

Page 17: ... device type FagronLab BASIC Followed by the current number of preparations After a few seconds it forwards automatically to the next screen Enter the 12 digit serial number online at www fagronlab com re to register the new device 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 4 Display handling FagronLa...

Page 18: ... hand and with pushing the compounding button the mixing process starts The jar is moved by hand up and down in its available range the complete compound needs to be interpenetrated from lid to bottom Everymixingspeedlevelrunsfiveseconds totestinterniftheactualspeedofrotationequalsthelevelofthegivenspeedofrotation As soon as the FagronLab display shows the free spin program Move the jar into its l...

Page 19: ... affected by malfunctions caused by constantly usage After 1500 preparations we recommend a maintenance performed by our technical service After 1000 preparations After 1500 preparations 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 If desired the OQ functional test can be performed at any time by...

Page 20: ...he minimum mixing time will also automatically be changed Due to high rotation the levels 8 and 9 are not suitable for manufacturing in the jar sizes 300 ml and 500 ml therefore they are disabled for these quantities The lift arm is in its lowest position To insert the mixing unit into the quick lock coupling review chapter 4 quick lock coupling it is recommended to use slight pressure from the to...

Page 21: ...ossibly tare on the scale together with the jar After weighing out the formulation components into the jar the lid including the stirrer has to be screwed on Afterwards move the lid with a slight twist about half a centimeter to open it a tad By pushing the bottom up with the thumb or for large jars with help from an applicator the spindle or AirDynamic the air will escape between the jar lid and ...

Page 22: ... in the FagronLab BASIC These serve as recommended minimum mixing time and minimum mixing speed They have to be adjusted accordingly to each type of formulation Due to high rotation speed the levels 8 and 9 are not suitable for manufacturing in the jar sizes 300 ml and 500 ml they are disabled in the mixing time selection The mixing time can be set from 5 seconds to 99 30 minutes and the mixing mo...

Page 23: ...wn in its available range lid bottom The lift guidance will support the process enormously After the mixing process is finished the free spin program will be initiated The display will show Move the lift arm all the way down until the stirrer will touch the FagronLab jar lid After confirming with the compounding button the mixing motor will accelerate to level 9 The MB will be mostly clean the mix...

Page 24: ...ing on the blade The jar bottom should be pushed up as far as possible to prevent incorporating air Please inspect the preparation for agglomerates or qualitative abnormalities after the pre grinding process is completed If required the pre grinding process may be repeated Suspension 2 After finalizing the pre grinding process both the remaining foundation and all active substances will be weighed...

Page 25: ... Emulsion solution ointment With the mixing parameters Emulsion liquid components can be incorporated into hydrophilic foundations at room temperature As an example the preparation of aqueous hydrophilic ointment aqueous lanolin alcohol ointment or eucerin c aqua aa To ensure a homogenous distribution we recommend applying disp blades for jar sizes up to 200 ml and the standard mixing blades for l...

Page 26: ...lted in a hot water bath or the microwave leave the regular nozzle open and set the microwave to a low power setting 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 repeate...

Page 27: ...semi solid foundation the gelling agent can be covered between two foundation layers This will obtain a faster dispersion of the gelling agent into the foundation Suppositories With the mixing parameters Suppositories suppository compounds mixtures can be dispersed The suppository foundation can be warmed in a water bath directly in a transparent jar and afterwards stirred with the FagronLab to th...

Page 28: ... the mixing parameters specialties Level 7 1900 rpm Jar size 15 30 ml 50 100 ml 200 ml 300 500 ml Time min 1 40 2 10 4 10 5 10 Stirrer Disp Blade or SMB Disp Blade or SMB Disp Blade or SMB SMB Level 4 1200 rpm Jar size 15 30 ml 50 100 ml 200 ml 300 500 ml Time min 5 00 7 30 12 55 17 00 Stirrer Disp Blade or SMB Disp Blade or SMB Disp Blade or SMB SMB Tab Mixing parameter soft in soft Tab Mixing pa...

Page 29: ...ling time and the cooling interval can be decreased by using a refrigerator or a cooling cuff The stirrer should remain in the jar during the cooling phase Thermolabile substances Active substances or components with thermolabile characteristics should be processed with caution To protect the substances we recommend a maximum speed of 1200 rpm level4 To control the frictional heat a cooling cuff c...

Page 30: ...nd apply the FagronLab dispensing system After completion of every single process the FagronLab BASIC issues automatically an identification number ID The display shows the 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 ...

Page 31: ...h each number correlates to a defined rpm value FagronLab jar 1 2 3 4 5 6 7 8 Jar size in ml 15 20 30 50 100 200 300 500 A B C D E F G H I J K L M mm ss 0 05 0 10 0 15 0 20 0 25 0 30 0 35 0 40 0 45 0 50 0 55 1 00 1 05 a b c d e f g h i j k l m mm ss 2 20 2 30 2 40 2 50 3 00 3 10 3 20 3 30 3 40 3 50 4 00 4 20 4 40 N O P Q R S T U V W X Y Z mm ss 1 10 1 15 1 20 1 25 1 30 1 35 1 40 1 45 1 50 1 55 2 0...

Page 32: ...re compatible with the FagronLab BASIC 2 There are problems while coupling the stirrer with the FagronLab BASIC The FagronLab stirrer is bent or damaged Replace it with an intact stirrer The FagronLab stirrer is not straight in the FagronLab jar Straighten the stirrer 3 The FagronLab stirrer does not penetrate completely in the mixture since the formula is to pasty firm or in powder form To ensure...

Page 33: ...lip of the bottom with foundation After using the jar in a water bath water accumulated in the cavity on the bottom side of the jar The water cannot penetrate into the jar itself through the sealing lip remove the excess water with a paper towel 5 The jar does not attach into the lift arm The jar is not an original FagronLab jar Always use an original FagronLab jar Please observe the correct handl...

Page 34: ...Operation errors common errors Common errors Cleaning the FagronLab BASIC Always unplug the FagronLab BASIC from the wall outlet before performing a cleaning Do not use aggressive cleaning agents or abrasive cleaners For cleaning we recommend daily wiping the surface with a damp cloth with mild detergent and immediately drying it with a dry cloth For disinfecting the display can be lightly sprayed...

Page 35: ...m Immediately turn off the power switch in case of an emergency or pull the power plug Using the FagronLab devices not according to these operating instructions or with line products that the manufacturer did not deliver or recommend may impair safety FagronLab devices have not been designed for operation under hazardous conditions Heed the relevant safety regulations when handling hazardous subst...

Page 36: ...b 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 8 Ma...

Page 37: ...OK Stable flat surface observe product weight Suitable space for the device and unobstructed access to the power cord and power switch No direct air flow windows heating fans air conditions No direct sunlight No extreme humidity or temperature fluctuations Clean dry dust free Correctly installed earthed socket with 220 V or country specific nominal voltage and required grid frequency Before initia...

Page 38: ...hapter 4 into the quick lock coupling review chapter 5 The compounding button starts the IQ Mode The display shows all the levels during IQ Mode The display shows IQ Mode OK Remove the test mixing unit review chapter 5 Jump between configuration options with the compounding button Use the buttons to decrease and increase the jar size With changing the jar size mixing time and mixing parameters are...

Page 39: ...ion qualification OQ Device identification Company Pharmacy Assessment OK not OK Examination of readability of the labels on the device Serial number SN __________________________________________ Date of purchase __________________________________________ ...

Page 40: ...number of current number of preparations mixed The display shows OQ Mode Attach the test mixing unit review chapter 4 into the quick lock coupling review chapter 5 The compounding button starts the OQ Mode The display shows all the levels during OQ Mode The display shows OQ Mode OK Remove the test mixing unit review chapter 5 Observe the operation manual Performance of the test Date Signature Appr...

Page 41: ...FagronLab BASIC User Manual 41 Notes FagronLab BASIC ...

Page 42: ...FagronLab BASIC User Manual 42 Notes FagronLab BASIC ...

Page 43: ...FagronLab BASIC User Manual 43 ...

Page 44: ...BASIC UM 01 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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