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chapter 7 - page 4

Operation Quali

cation (OQ)

Company (Pharmacy)

Device Identi

cation

Assessment

not OK

Examination of readability of the labels on the device

Serial Number (SN):

___________________________

Date of Purchase:

___________________________

Содержание EMP

Страница 1: ...tton right start display shows jar size mixing time and mixing speed After pushing the gako button for two seconds the lift arm moves automatically into the mounting postition review chapter 3 Lift arm with integrated quick lock coupling Hold the gako 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 Fix the jar ...

Страница 2: ...g Please read the following operation manual carefully For more information and compounding recommendation consult our homepage www unguator com For additional support operation handling and all other questions regarding the Unguator Technology please feel free to contact us by E Mail contact unguator com Enjoy the successful production of quality assured compounding ointments Your gako competence...

Страница 3: ...Unit Weighed Portion of the Formulation The Mixing Process Mixing Parameters Requirements for Components of a Formulation After the Mixing Process is Complete General Notes on the gako unguator Mixing System Patent Protection Identification Number ID Error codes Operation Errors Cleaning the gako unguator BASIC Service and Warranty Notes on Malfunctions Manufacturer s Service and Warranty in Germa...

Страница 4: ...rs AirDynamic Spindle Certificate of analysis gako unguator jar jar label gako unguator jar gako unguator Varionozzles gako unguator Applicator short gako unguator Applicator long Operation instruction Spindle gako unguator Spindle gako unguator Coupling gako unguator AirDynamic gako unguator ExactDose Display Handling Display gako unguator EMP Display device type Display current preparations Disp...

Страница 5: ...ng guidelines for the Unguator Technology value chart rotation speed mixing parameter pre grinding mixing parameter Suspension 2 mixing parameter Suspension 2 mixing parameter Emulsion mixing parameter Emulsion mixing parameter Gel mixing parameter Soft in Soft mixing parameter Specialties General Notes on the gako unguator Mixing System number jar size correlation letter time correlation number r...

Страница 6: ...port team by E mail contact unguator com 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 gako unguator EMP The warranty lapses if the original packing materials are not used for return deliveries Initial Operation If the device is exposed to cold weather conditions please all...

Страница 7: ...Žŵ 160415_EMP1en chapter 1 page 2 Display Plus Button gako Button Minus Button automatic lift arm with quick lock coupling RS232 port pic gako unguator EMP front pic gako unguator EMP rear socket outlet power button emergency button ...

Страница 8: ...ize ointments but validate them too Mixing parameters and examples of formulation are found at www unguator com gako unguator Mixing Devices The current gako unguator Mixing Devices gako unguator BASIC gako unguator EMP and gako unguator PRO are useful and advanced improvements over the first gako unguator Device launched in 1994 The gako unguator Mixing Devices feature a high safety standard They...

Страница 9: ...eds can be set with the gako unguator EMP gako unguator PRO The gako unguator PRO the complete solution for the phar macy The gako unguator PRO will not only support GMP compoun ding of semi solid preparations up to 2000 ml It also will be useful for additional compounding needs in the pharmacy Another beneficial feature will make stirring in medicine bottles possible available End of 2016 Integra...

Страница 10: ...n Discolorations of the mixing blade are mostly irreversible and therefore harmless All SMB and Disp Blade shafts are dishwasher safe The SMB and mixing shaft of the disposable blades are coated with titanium nitride which makes them more resistant towards chemical and physical influences Assignment of the gako unguator stirrer Ensure to use the correct stirrer for the corresponding jar Selecting ...

Страница 11: ...as ethereal oils or alcohol do not evaporate from the closed Mixing Unit Cleaning the gako unguator Stirrer The stirrer is normally cleaned with a paper towel and if necessary held under hot water faucet and then dried with a paper towel The stirrers can also be cleaned in the dish washer The gako unguator devices as well as the gako unguator line of products should never be treated with sharp edg...

Страница 12: ...is 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 and 200 ml Disp Blades are specially suitable for compounding emulsion gels and soft in soft formulations For suspension ointments and pre grin ding is recommended the use of SMB gako unguator Jar The gako unguator Jar is both a mixing and a dispen...

Страница 13: ... the certified low microbiological contamination at risk We would recommend storing the jar in its plastic packaging after opening for protection against possible dust contamination A large applicator is standardly delivered with a 200 ml jar as pushing aid The jar sizes 300 to 2000 ml are particularly well suited as storage and transfer vessels for semisolids and other preparations Since the cont...

Страница 14: ...w unguator 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 Notes on Dispensing ointment Each customer should be given specific instructions with an empty jar at how to use the jars The use of the ...

Страница 15: ...tract an exact amount of 0 5 ml gako unguator Varionozzles The gako unguator Varionozzles with inner diameters of 1 2 or 4 mm can be pressed into the regular nozzle of any gako unguator Jar They reduce the opening size making it possible to safely dose even low viscosity formulations The viscosity of the finished product normally specifies the diameter of the varionozzles The softly rounded surfac...

Страница 16: ...spindle must be screwed in the jar counter clock wise from the bottom until it locks into place The spindle must be turned clockwise to extract the ointment One turn dispenses approx 20 ml of the contents of the jar Caution If the movable bottom is accidentally perforated or the spindle is permanently locked in the bottom of the jar the jar may only serve as dispensing or storage vessel and can no...

Страница 17: ... the pressure thus gene rated moves the bottom upward 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 which may be reduced through warming The air pressure that had developed in the lower chamber of the jar can be relieved by opening the va...

Страница 18: ... with the exact amount of compound and the coloured ball will be pushed up to its highest position With a 180 degree turn of the set screw the coloured ball will be in the lowest position again the compound will be extracted by pushing the jar bottom upwards and the chamber will be filled again with compound for the next dosage extraction ...

Страница 19: ...eft the gako button middle and a plus button right After starting up the device with the power switch located on the back the display shows the device type gako unguator EMP Followed by the current number of preparations After a few seconds it forwards automatically to the next screen pic Display gako unguator EMP pic Display device type pic Display current preparation ...

Страница 20: ...MP Enter the four digit PIN on the display of the gako unguator EMP The displayed numbers change with the plus and minus button By pushing on the gako button it jumps to the next position If a number is incorrect entered it is possible to navigate to the input position again By pressing the gako button for three seconds the four digit PIN is confirmed If the PIN was not entered correctly the displ...

Страница 21: ... mixing unit into the quick lock coupling review chapter 4 quick lock coupling The function test starts after a push on the gako button The lift arm moves into the start position the mixing shaft locks automatically and the mixing process begins 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 After the proces...

Страница 22: ...rform the functional test always after 1000 preparations to prove and record the proper functioning of the gako unguator device This is the only way to ensure the expected mixing results are not affected by malfunctions caused by constantly usage of the gako unguator 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 I...

Страница 23: ...service Compounding with the gako unguator EMP The touch panel is on the front of the gako EMP with a minus button left the gako button middle and a plus button right After starting up the device with the power switch located on the back the display shows the device type gako unguator EMP pic Display device type pic Display maintenance pic Display gako unguator BASIC ...

Страница 24: ...ve seconds steps by pressing the plus minus button If the plus minus button is longer pressed down the time setting changes will accelerate Depending which jar size will be used the recommended standard mixing speed level and the 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 there...

Страница 25: ...P will automatically issue an identifi cation number The identification number will help with easier documentation and exact repro duction of the mixing process We recommend to record the ID number on the manufacture protocol chapter 5 Identification Number ID Aborting the mixing process To abort the mixing process push the gako button for two seconds The device asks if the free spin program shoul...

Страница 26: ...down or possibly 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 a half 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...

Страница 27: ...e original unguator from the year 1994 featuring an automated lift arm programmable mixing time and mixing speed The gako unguator EMP is equipped with two quiet and constantly usable permanent motors and is the ointment mixing device for individual and bulk compounding from 15 ml up to 500 ml To prepare compounds homogeneously the gako unguator EMP works in a rotation range from 300 up to 2400 rp...

Страница 28: ...nt into the lift arm Push the mixing unit up and with a slight turn counterclockwise about a quarter turn fix the mixing unit into the lift arm Push the gako button the lift arm including the mixing unit moves up locks and the mixing process starts After the mixing process is finished the free spin program will be initiated The display shows pic free spin pic quick lock Coupling ...

Страница 29: ...n ointment foundation As an example the incorporation of corticoids antibiotics fungicides or hormones in an oint ment foundation In order to ensure a homogenous distribution we recommend using the stan dard mixing blade First load approximately 30 of the foundation ground covering in the jar and cover the micronized active substances with foundation The active substances has to be covered in the ...

Страница 30: ...ous distribution we recommend using the standard mixing blade For suspensions with ingredient content above 2 pre grinding process is not required In preparation add 50 of the required foundation ground covering into the jar and the micro nized solids to the middle Add the remainder of the base on top of the ingredients in order to avoid remaining powder sticking to the blades The jar bottom shoul...

Страница 31: ...quid warmed Level 8 2100 rpm 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 SMB Emulsion With the mixing parameters Emulsion liquid components can be incorporated into a melted foundation and cooling down parameters As an example the preparation containing emulsific aquosa lannette or cera To ensure a homogenous distribution we r...

Страница 32: ...emperature Gel With the mixing parameter Gel gelling agents can be incorporated into fluids or semi solid foundation As an example the preparation of ultrasonic contact gel hydroxypropyl cellulose 400 Also incorporation gelling agents like bentonite or Aerosil into a semi solid foundation To ensure a homogenous distribution we recommend applying disp blades for jar sizes up to 200 ml and the stand...

Страница 33: ...d in a water bath directly in a transparent jar and afterwards stirred with the gako unguator 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 allo wance is recommended Soft in Soft With the mixing parameters Soft in Soft semisolid substances from low viscous to pasty can be mixed together As an example combin...

Страница 34: ...substances 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 Crystalline Active Substances We recommend pulverizing active crystalline ingre...

Страница 35: ...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 level 4 To control the frictional heat a cooling cuff can be used or a cool down interval...

Страница 36: ...out of the ointment when first dispensed A large applicator is standardly delivered with a 200 ml jar as pushing aid Jars 300 ml up to 2000 ml use a spindle or the AirDynamic The little cap or the applicator may now be fasten in place A label may be attached on the jar prior forwarding to the client preferably together with a short illustration of how to use and apply the gako unguator Dispensing ...

Страница 37: ...om gako international GmbH The gako unguator Mixing System from the Gako Konietzko GmbH is the original The gako unguator Mixing System with its versatile and comprehensive line products capti vates with its simplicity Everything the pharmacist needs for the production of pharmaceutical ointments and cosmetics is covered by the mixing system The gako konietzko GmbH is not only working to ensure co...

Страница 38: ...rrelates to a defined time value 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 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 00 2 05 2 10 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 5 00 5 20 5 40 6 00 6 25 6 50 7 15 7 40 8 05...

Страница 39: ...o unguator Stirrer Error Troubleshooting 1 The stirrer used is not compatible with the gako unguator EMP The stirrer used is not an original gako unguator stirrer The gako unguator EMP has only been tested centered and aligned with original gako unguator stirrers All stirrers delivered after the year 1996 are compatible with the gako unguator EMP 2 There are problems while coupling the stirrer wit...

Страница 40: ...y to the rim of the jar bottom Ensure to cover the sealing 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 gako unguator Jar Always...

Страница 41: ...merate and the active substance dispenses homogenic 3 The finished compound is at the organoleptic final quality control inhomogeneous Instead of micronized solid substances crystalline substances are used To ensure homogeneity use the ointment mill or micronized solid substances Cleaning the gako unguator EMP Always unplug the gako unguator EMP from the wall outlet before performing a cleaning Do...

Страница 42: ... warranty will lapse should the gako unguator device be sent NOT in its original card board box and packing Please hold on to the original packaging of the gako unguator EMP materials to avoid additionally costs for a proper return gako unguator devices are included in the warranty Gako unguator Assortment are excluded The warranty claim will lapse should an unauthorized party have tempered with t...

Страница 43: ...so to avoid use by unauthorized persons Do not immerse gako unguator Devices in water Electronics part should just be dis and assembled by a certified service partner Only operate the gako unguator Stirrer inside a closed gako unguator Jars Do not touch rotating parts Keep long hair away from rotating parts During the automated lifting of the gako unguator EMP always keep long hair body parts or o...

Страница 44: ...oller in 10 steps electronic controlled Timer continuous electronically gako unguator Jar sizes 15 20 ml 500 ml Weight 22 lbs 10 kg Dimensions LxWxH in mm 255x211x512 Testing certifications CE The gako unguator EMP is certified Certificate of Conformity The certificate is available at the license holder Gako Konietzko GmbH D 96049 Bamberg The licence manufacturer of all the gako unguator products ...

Страница 45: ...H Germany Gako International GmbH works with selected distribution partners in defined territories on a global basis If generic or copied products being distributed under the registered trademark gako unguator please contact us immediately following the Gako International GmbH contact details previous mentioned Your courtesy and support helps to prevent losses in terms of intellectual property qua...

Страница 46: ... Gako International GmbH Am Steinernen Kreuz 24 96110 Scheßlitz Telefon 49 0 89 1222 387 200 Fax 49 0 89 1222 387 201 The manufacturer will accept independent from the obligations of the vendor against the buyer a warranty period of twenty four 24 months from the date of registration ...

Страница 47: ...hapter 7 page 1 Installation Qualification IQ Company Pharmacy Device Identification Assessment OK not OK Examination of readability of the labels on the device Serial Number SN ___________________________ Date of Purchase ___________________________ ...

Страница 48: ...wer 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 initial operation acclimate the device for 30 minutes at room tempera ture Excludes device handling by unauthorized persons Observ...

Страница 49: ...ing unit review chapter 3 into the quick lock coupling review chapter 4 The gako Button starts the IQ Modus The display shows all the levels during IQ Modes The display shows IQ Mode OK Remove the test mixing unit review chapter 4 Jump between configuration options with the gako button Use the buttons to decrease and increase the jar size With changing the jar size mixing time and mixing parameter...

Страница 50: ... chapter 7 page 4 Operation Qualification OQ Company Pharmacy Device Identification Assessment OK not OK Examination of readability of the labels on the device Serial Number SN ___________________________ Date of Purchase ___________________________ ...

Страница 51: ...tor EMP The display shows the number of current number of preparations mixed The display shows OQ Mode Attach the test mixing unit review chapter 3 into the quick lock coupling review chapter 4 The gako Button starts the IQ Modus The display shows all the levels during OQ Modes The display shows OQ Mode OK Remove the test mixing unit review chapter 4 Observe the operation manual Performance of the...

Страница 52: ...lyethylene gako unguator Jar Bottom Cap Polypropylene natural white white Additional gako unguator assortments gako unguator Spindle Polypropylene natural white gako unguator Applicator long with Cap Polypropylene natural white gako unguator Applicator short with Cap Polypropylene natural white gako unguator Coupling Polypropylene natural white gako unguator Varionozzle blue yellow pink Polypropyl...

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