Operating Instructions and Production Recommendations
Contents
1. Mixing System In its quality regulations for processing any semisolid preparation the German Chamber of Pharmacists is recommending to apply for dispensing and mixing a jar having a small dispensing nozzle since the year 2000 5 1 Patent Protection The UNGUATOR Mixing System consists of UNGUATOR Technology the UNGUATOR mix ing machines and various UNGUATOR assortment The UNGUATOR Mixing System and UNGUATOR Technology and the AirDynamic Pumpball System integrated therein are inventions of the pharmacist Albrecht Konietzko from Bamberg in Germany The UNGUATOR Technology and the AirDynamic Pumpball System are patented in selected countries UNGUATOR and AirDynamic are registered trademarks exclusively available from the company GAKO The UNGUATOR Mixing System with its versatile and comprehensive line products captivates with its simplicity Everything the pharmacist needs for the production of pharmaceutical ointments and cosmetics is covered by the UNGUATOR Mixing System 5 2 Troubleshooting A thermo safety element will switch off the mixing function of the UNGUATOR e s at signs of excessive stress e g due to the repeated preparation of ointments over a short period of time particulary in large UNGUATOR Jars Should this occur we recommend switching off the UNGUATOR e s using the power switch or pulling the power plug Wait 30 minutes before switching the machine back on Any irregularities are2. e s level speed level speed Tab 2 RPM table for each speed level The actual mixing process can begin after the mixing time and speed parameter have been defined This is described in the two following subsections Operating Mode AUTO and Operating Mode HAND 4 4 1 Operating Mode AUTO The UNGUATOR MB shaft of the prepared UNGUATOR Mixing System is run upward through the opening of the oscillation arm Then the male thread of the UNGUATOR Jar lid is screwed up the oscillation arm Pressing the button Start Stop will initiate the mixing process after the UNGUATOR Mixing System has been screwed tightly into the oscillation arm The oscillation arm will automatically move upward and the UNGUATOR MB will then be coupled to the bayonet receptor of the mixing motor A sensor will ensure that the UNGUATOR MB has been inserted and will immediately switch off if the UNGUATOR Mixing System has not been fixed to the oscillation arm correctly The mixing process will continue once the UNGUATOR MB is detected by the sensor The programmed mixing time will be completed at the set speed step with steady up and down movement of the UNGUATOR Mixing System The mixing time and speed parameters can also be changed during the mixing process using the same procedure as for the initial programming of the mixing process Once the mixing time is completed the free spin process will be run wich is indicated by F
3. predecessors and can therefore automatically control the mixing parameters for each UNGUATOR Jar size and different types of ointments The user may program individual mixing parameters with a maximum of 180 additional programs that can be stored The UNGUATOR 2100 can be connected to a PC via an USB interface An integrated microprocessor measures the actual revolutions of the UNGUATOR Mixing Blade carried out by Fig 4 UNGUATOR 2100 the UNGUATOR 2100 This guarantees that the selected mixing program will always be identical even for paste like preparations which usually might demand more power from the mixing motor This makes it easy to develop new ointments cosmetics etc using the UNGUATOR 2100 since only the composition changes and not the mixing program As a result ointments can now finally be reliably reproduced even in smaller quantities The adjustable stroke speed or the speed of the upward or downward motion of the automated oscillation arm is another unique feature of the UNGUATOR 2100 This allows the UNGUATOR Mixing Blade to rotate at lower speed while the UNGUATOR Jar quickly travels up and down or vice versa This new function is particularly useful using a low rotating speed of the UNGUATOR Mixing Blade since it allows the UNGUATOR Mixing Blade to mix an ointment homogeneously with a slow stroke 3 1 4 UNGUATOR Q The UNGUATOR Q is the result of continuous improvement of the UNGUATOR
4. 100 and 200 ml UNGUATOR Jar sizes it still Li needs a different shaft for each jar size Please also mind ae Unlock the operating instructions that come with the shafts Fig 8 Handling the UNGUATOR Disp Blade Fig 9 Assignment of the UNGUATOR SMB with different length of shafts Flowing recesses of the UNGUATOR SMB The flow adapted shape of the UNGUATOR SMB generally cleans itself during the rotating penetration of the ointment Unmixed ingredients may adhere to recesses of flow of the UNGUATOR SMB depending on the ointment s ingredient s compatibility sequence of weighted sample but also if the UNGUATOR Jar is considerably underfilled e g large volumes of powder These remnants should be transferred into the UNGUATOR Jar using a spatula when about half of the mixing time is complete The air should be decreased again following this process When using the UNGUATOR Disp Blade however there are no recesses and no remedial work is required Heating The heat that develops from the friction between the UNGUATOR MB and the inside wall of the UNGUATOR Jar is required Decreased viscosity increases the wettability of powders and accelerates the penetration of potential powder pockets Even the emulsifying readiness of fats and oils is benefited by heat A temperature of 54 C 129 F was the maximum taken after 6 minutes of mixing a highly pasty preparation made of vaseline and zinc oxide aa at ful
5. 2 6 UNGUATOR Coupling The UNGUATOR Coupling connects two UNGUATOR Jars by the threads of their dispensing openings and is very useful when preparing ointments in larger batches Transferring a formulation from a larger UNGUATOR Jar into a smaller UNGUATOR Jar using the UNGUATOR Coupling will ensure hygiene from the mixing process to the end user The 200 ml UNGUATOR Jar becomes a convenient transfer device j to smaller UNGUATOR Jars when their UNGUATOR Jar bottoms are G carefully pressed towards the work surface using an UNGUATOR Fig 21 unguarore Applicator long screwed on a 30 ml UNGUATOR Jar Coupling In addition to the UNGUATOR Coupling required for transferring from a 300 ml or 500 ml UNGUATOR Jar into a smaller UNGUATOR Jar both the UNGUATOR spindle and the AirDynamic Pumpball System may also be used Dispensing and transferring a formulation via the regular UNGUATOR Jar nozzle from a 1000 ml UNGUATOR Jar is practically only possible using the AirDynamic Pumpball System We recommend transferring the formulation after mixing as soon as possible since the formulation is still warm and less viscous 3 2 7 Air Dynamic Pumpball System The AirDynamic Pumball System optimizes batch preparation within the closed system Contamination free transfer Contamination free storage The AirDynamic Pumball System has been designed to apply with UNGUATOR Jars from size 300 ml to 1000 ml to ext
6. 2001S 42 47 R Eifler Bollen NRF Eschborn Prof Dr H M ller Zentrallaboratorium Deutscher Apotheker ZL Eschborn et al e 11 Leitlinie zur Qualitatssicherung nicht sterilen Rezeptur und Defekturarzneimittel Pharmazeutische Zeitung PZ Nr 29 Jhg 145 2000 Seiten 105 116 Deutsche Apothekerkammer 12 Fl ssige Chlorhexidin Cremes R hren ist kritisch Pharmazeutische Zeitung PZ Nr 10 Jhg 147 2002 Seiten 54 56 e 13 Mit zeitgem en Herstellungsverfahren r hren Pharmazeutische Zeitung PZ Nr 13 Jhg 147 2002 Seite 60 Diskussion A Konietzko GAKO und Dr H Reimann NRF 9 Manufacturer s Certificate All parts of the UNGUATOR plastic assortment are exclusively produced from materials and color components in accordance to the Regulation on Consumer Articles of the Federal Republic of Germany BedGgstVO dated 4 10 1992 new edition 23 12 1997 with latest adjustments as of 23 09 2009 the database BfR Recommendations for Materials for Food Contact and the EU Regulation 2002 95 ED RoHS Article Material Color concentration UNGUATOR Jar cap Polypropylene natural UNGUATOR Jar lid Polypropylene natural red white colored green blue UNGUATOR Jar body Polypropylene natural UNGUATOR Jar bottom Polypropylene Polyethylene UNGUATOR Jar bottom cap Polypropylene natural additional UNGUATOR products UNGUATOR Spindle Polypropylene natural UNGUATOR Aplicator long with
7. Blade for up to 200 ml The heating of fat suppository base ointment may be carried out using an infrared lamp over the open UNGUATOR Jar An UNGUATOR Applicator aids the precise filling of the suppository forms It may be reheated using a hair dryer or an infrared lamp A batch of approximately 5 to 10 is recommended 4 4 10 Powder Mixing powder to fill capsules We recommend using the UNGUATOR Disp Blade for sizes up to 200 ml Excellent mixing results will be achieved when using microfine powder with a high content of lubricious aerosil which is considered as Soft in Soft preparation Please select low rpm level 0 650 rpm preferably applying the manual Hand mode changing from Auto to Hand Please have the mixing time extended accordingly Uncuaton TECHNOLOGY To minimize the grinding noise along the sealing lip of the UNGUATOR Jar Lid when mixing powder the lip may be widened a bit using the shaft of the UNGUATOR MB The powder can be evenly distributed from the dispensing opening using the capsule filling device 4 5 Condition of the Ingredients for any Formulation Powder If possible powders should be used as microfine substances Powders should be added after any liquid constituents to ensure better wetting For substances with a low proportion of powder we recommend pregrinding by pasting the powder in minimum base inside the UNGUATOR Jar as already described before Crysta
8. Pharmazeutische Zeitung PZ Nr 30 Jhg 141 1996 S 30 33 Alberg et al Pharmaz Technologie TU Braunschweig 3 Keimzahl in wasserhaltigen Dermatika Pharmazeutische Zeitung PZ Nr 29 Jhg 142 1997 S 36 40 Alberg et al Pharmaz Technologie TU Braunschweig 4 Alternativen zum Salbenr hren im Vergleich Pharmazeutische Zeitung PZ Nr 36 Jhg 142 1997 S 24 31 Zobel et al Pharmaz Technologie Univ Frankfurt a M e 5 Das UNGUATOR R hrsystem URSY als Alternativverfahren f r die Herstellung dermatologischer Individualrezepturen Deutscher Dermatologe 46 Heft 6 1998 S 545 549 Zobel et al Pharmaz Technologie Univ Frankfurt a M 6 Bedienungsanleitung UNGUATOR R hren im geschlossenen System 1998 A Konietzko GAKO Konietzko GmbH Bamberg Uncuaton TECHNOLOGY e 7 System zur Salbenherstellung im Vergleich Pharmazeutische Zeitung PZ Nr 38 Jhg 143 1998 S 53 65 R Eifler Bollen Zentrallaboratorium Deutscher Apotheker ZL Eschborn 8 Voigt R Pharmazeutische Technologie F r Studium und Beruf Jhg 2000 9 Auflage S 314 315 Deutscher Apothekerverlag Stuttgart e 9 Qualit tssicherung bei Rezeptur und Defektursalben UNGUATOR Technologie Apotheker amp Wirtschaft Nr 7 Jhrg 2 2001 S 40 41 Albrecht Konietzko 96049 Bamberg kontakt unguator com Verlag medical economics Leipzig e 10 Qualit tssicherung in der Rezeptur Pharmazeutische Zeitung PZ Nr 14 Jhg 146
9. Polypropylene natural white cap UNGUATOR Aplicator short with Polypropylene natural white cap UNGUATOR Coupling Polypropylene natural UNGUATOR Varionozzle blue Polypropylene natural blue yellow red yellow pink UNGUATOR Disp Blade Polyamide white UNGUATOR SMB Polyoxymethylene PER 1 The licensed manufacturer SMS ELAP GmbH amp Co KG 98544 Zella Mehlis is DIN EN ISO 9001 2008 certified 2 All documents regarding the declarations of conformity for materials and color concentrates of the materials from each supplier are deposited at the licensed manufacturer 3 With certificate of analysis according to ZL Packing Instruction DK 1994 on the outer packaging issued by GAKO Konietzko GmbH Bamberg Germany production control Uncuaton TECHNOLOGY 10 Distribution Manufacturing and Customer Service GAKO Konietzko GmbH Gann Oberer Stephansberg 49g 96049 Bamberg Germany Phone 49 0 951 582 55 Fax 49 0 951 500 602 Email kontakt unguator com Web www unguator com GAKO International GmbH ga ko Dantestrasse 27 international 80637 Munich Germany Phone 49 0 89 15 88 16 88 Fax 49 0 89 15 88 14 85 Email contact unguator com Web www unguator com International Distribution Rights International distribution of the UNGUATOR line of products is generally regulated and monitored by the company GAKO International GmbH Germany GAKO International works wit
10. UNGUATOR Applicator short 11 Fig 14 UNGUATOR Varionozzles 2mm or UNGUATOR Applicator long 11 Fig 15 UNGUATOR Varionozzles 4mm 11 Fig 16 UNGUATOR Varionozzles 1 2 4 mm 12 Fig 17_UNGUATOR Applicator short 12 Fig 18 UNGUATOR Applicator long 12 Fig 19 UNGUATOR Spindle 13 Fig 20 How to operate the UNGUATOR Spindle 13 Fig 21 UNGUATOR Coupling 14 Fig 22 UNGUATOR AirDynamic Pumpballsystem 14 Fig 23 Control Panel of the UNGUATOR e s 17 Uncuaton TECHNOLOGY 1 Installation Information Select a suitable location for the UNGUATOR e s CAUTION The UNGUATOR e s weighs almost 21 Ibs 9 5 kg It is recommended to have an assistant while carrying and moving the equipment to the final destination Ensure that there is enough space to operate the UNGUATOR e s This must include sufficient space around the UNGUATOR e s to provide good ventilation Select a suitable environment Solid horizontal surface Away from direct air flow from air conditioning systems heaters open windows or fans Keep the temperature between 15 30 C 59 86 F and maximum humidity of 80 Clean dry and dust free Remove all components from the cardboard box Check to ensure that the following components are included in your shipment e UNGUATOR e s mixing device Power cable Operating instructions Please contact your responsible UNGUATOR dealer and or supplier immediately in case that
11. as high as when using the Disp Blade compared to the UNGUATOR SMB at the same mixing speed The counter rotating twist of the mixing blades causes intensive material vibration in the material to be mixed and achieves good product quality faster than using the UNGUATOR SMB We do however recommend using the same mixing time as for the UNGUATOR SMB In the process of final quality control the mixing blade can be picked up and discarded with the small end of the shaft or left inside the jar Cleaning is limited to the UNGUATOR Disp Blade shaft We recommend using the UNGUATOR Disp Blade for substances that may discolor the S regular blade This type of UNGUATOR MB also comes with different shaft lengths The range of UNGUATOR Jar sizes that can be used for the application is marked for orientation on the weak end of the shaft 15 100 ml and 200 ml respectively ou ur A gt p ENEZ TOR ne pact sr al Ge 5 tats Fig 7 UNGUATOR Disp Blade Assignment of the UNGUATOR MB Please make sure to use the correct UNGUATOR MBs for the corresponding UNGUATOR Jar Fig 6 Mixing up may cause failure messages Please also ensure that the right shaft is used with the UNGUATOR Disp Blade Both available shafts are marked for use with sizes 15 100 ml or 200 ml UNGUATOR Jar They have to be combined with the correct UNGUATOR Lock Disp Blade and while the same UNGUATOR Disp Blade is used for the
12. components are missing or arrived damaged Afterwards we will not accept any claims regarding missing or defect items they will be for your account Please hold on to the original cardboard box and packing material in case you have to send the UNGUATOR e s in for service The UNGUATOR e s Time Button RPM Button Automatic Hand Mode Button Button Start Stop Button Button Power switch Fig 1 UNGUATOR e s Display and Description Uncuaton TECHNOLOGY 2 Initial Operation You will find the power switch O I located at the rear of the UNGUATOR e s on its base This is also the emergency switch Please check that the UNGUATOR e s power switch is set to off Connect the power cord to the socket outlet You may now switch the UNGUATOR e s on using the power switch The device is now ready for operation and the display should show the default settings 2 minutes mixing time and speed level 5 3 UNGUATOR Technology The UNGUATOR Technology reduces the mechanical preparation of formulation ointments to the least common denominator The core of UNGUATOR Technology consists of the patented arrangement of the UNGUATOR Mixing Blade adapted to the requirements of prescription ointments and the UNGUATOR Jar that serves as both a hygienic mixing jar and a hygienic dispensing jar The principle of the preparation method using UNGUATOR Technology in the clo
13. generation powder mixtures should be processed only at very low speed In the following these standard formulations will be defined and the recommended procedure on weighing described This will produce a code of practice for orientation This does not exclude other possible methods for optimization For mixtures with high liquid content ensure that the ointment base on the UNGUATOR Jar Bottom is first carefully placed around the sealing lip This enhances the leak tightness of the UNGUATOR Jar when it is filled For UNGUATOR Jars of 200 ml and up an active ingredient proportion of less than 5 of the active ingredient can be filled alternating with the foundation ointment over two or more levels to speed up vertical intermixture 4 3 Preparing the Mixing Process Together with the UNGUATOR Jar Lid the UNGUATOR MB should be loosely screwed onto the UNGUATOR Jar body after the components of the formulation have been weighed out By pushing up the UNGUATOR Jar bottom with your thumb or for large UNGUATOR Jars with the help of the UNGUATOR Spindle or the AirDynamic Pumpball System the air will escape between the UNGUATOR Jar Lid and the UNGUATOR Jar body Then the UNGUATOR Mixing System should be tightly screwed down This process is called air diminuation Air diminution will prevent ointment exudation at the sealing zones of the UNGUATOR Jar through reduction of any overpressure that may have developed The mixing
14. indicated as a failure message on the display The meaning of the individual fault messages are listed in the table below Error messages will also occur if UN GUATOR MBs are used that do not match the respective size of the UNGUATOR Jar or if the end position of the previous mixing process has been left at the beginning of the mixing process rather than the start position required for a new mixing process Uncuaton TECHNOLOGY Incorrect operation or environmental influences may cause problems not listed in below list of errors If this occurs please witch off the device or pull the power plug The UNGUATOR e s may then be switched on again after period of 10 seconds Error Message Fault remedy Possible causes of error Press the Start Stop button Os Switching the device on and off cillation arm moves to the next end during a work phase or temporary position blackout Remove jar and press the Start change over between the operat Stop button Oscillation arm ing modes when a mixing unit has moves to the desired position locked in place or switching on the device when a mixing unit has locked in place Press the Start Stop button FE O Oscillation arm does not move is displayed and or very slowly Oscillation arm will automatically No mixing unit attached to oscilla return to home position tion arm in AUTO mode Press the Start Stop button Temporary motor overload possibly switch off d
15. packaging of the UNGUATOR Jars It may be removed from the plastic packaging as needed and added to the records Certificate of Analysis Date 01 03 2010 UNGUATOR JAR DISPOSABLE DO NOT RINSE BEFORE USAGE NOMINAL FILLING VOL 50 70 ml PRODUCT No 340 SHIPPING UNIT 500 units PZN 0471975 PACKIGING UNIT 10 units Examined acc to the central lab packing regulations DK 11 94 Translucency confirmed Particle Concentration confirmed Color Fastness confirmed Dichtigkeit confirmed Microbiology confirmed signed Grieser head of quality assurance G A K O Konietzko GmbH www unguator com 401341 334424 Fig 11 Certificate of Analysis for the UNGUATOR jar of 50 ml Uncuaton TECHNOLOGY Notes on Dispensing Ointment Each customer should be given specific instructions at how to apply the UNGUATOR Jars when handing to the individual client The use of the UNGUATOR Spindle should be explained for large UNGUATOR Jars Low viscosity ointments should be equipped with an UNGUATOR Applicator or an UNGUATOR Varionozzle to reduce the dispensed volume Medium viscosity ointments can easily be extracted through the regular opening of the UNGUATOR Jar Very pasty ointments e g pasta zinc may not necessarely be pressed through the regular opening even by using a spindle In this case once the UNGUATOR Jar lid has been removed the ointment can be extracted with the help of a spatula similar to handl
16. NGUATOR device does not work it may be due to a little thing that you may be able to correct yourself Before you take the unit for repair please follow instructions below If the UNGUATOR device cannot be switched on please check to ensure that there is electricity available and that the plug of the power cord has been correctly connected Uncuaton TECHNOLOGY to the device and the socket e Should faults or damage occur please also read the manufacturer s notes on the machines metal foot e Please note the machine type serial number and the occurring error message and contact your local UNGUATOR dealer and or certified UNGUATOR service partner 6 2 Manufacturer s Service and Warranty The manufacturer will accept independent from the obligations of the vendor against the buyer awarranty period oftwenty four 24 months from the date of purchase Please retain the packaging material or request its replacement from your respective representative in your individual country please contact your local UNGUATOR dealer e Deficiencies that can be related to faults in the material or manufacturing defects will be remedied free of charge within the warranty period e The respective representative in your individual country please contact your UNGUATOR dealer must be informed of necessary warranty repairs A cost estimate can be obtained for service repairs UNGUATOR MBs UNGUATOR Jars and UNGUATOR acce
17. OR Varionozzles The softly rounded surface allows ointment to be pleasantly spread directly on your skin The coloring was selected corresponding to the wavelength of light 4mm red long wavelength light 2mm yellow 1 mm blue short wavelength light 3 2 4 UNGUATOR Applicators The UNGUATOR Applicators reduce the extracted quantity of low viscosity formulations and are particularly helpful in cases where the ointment must be precisely applied UNGUATOR Applicator short The UNGUATOR Applicator short with a diameter of 1mm is obligatory for nose and ear ointments The UNGUATOR Applicator short comes with a cap to close the applicator A UNGUATOR Applicator long short UNGUATOR The UNGUATOR Applicator long with a diameter of 2 mm allows formulations to be introduced into large orifices of the body or probes Moreover the UNGUATOR Applicator long also comes 2 inside each UNGUATOR 200 ml Jar to help pushing up the bottom PA of this jar size in full The UNGUATOR Applicator long is generally available both with and without cap Fig 18 Applicator UNGUATOR long Uncuaton TECHNOLOGY 3 2 5 UNGUATOR Spindle The UNGUATOR Spindle serves as a dispensing system for UNGUATOR jar sizes 300 ml or 500 ml UNGUATOR Jars that come with UNGUATOR Spindles The spindle has to be removed by rotating it clockwise prior the mixing process The bottom can be slid up and down when th
18. Operating Instructions and Production Recommendations UncGunfor e s Dear UNGUATOR user thank you for choosing the UNGUATOR Mixing Technology a quality system for advanced prescription compounding Please read the operations manual carefully For additional information about the use and operation of the UNGUATOR Mixing Technology please feel free to contact us at contact unguator com Table of Content 1 Installation Information 1 2 Initial Operation 3 3 UNGUATOR Technology 3 3 1 UNGUATOR Mixing Machines 3 3 1 1 UNGUATOR B R 4 3 1 2 UNGUATOR e s 4 3 1 3 UNGUATOR 2100 5 3 1 4 UNGUATOR Q 5 3 2 UNGUATOR Assortment 6 3 2 1 UNGUATOR Mixing Blade MB 6 3 22 UNGUATOR Jar 9 3 2 3 UNGUATOR Varionozzles 12 3 2 4 UNGUATOR Applicators 12 3 2 5 UNGUATOR Spindle 13 3 2 6 UNGUATOR Coupling 14 3 2 7 AirDynamic Pumpball System 14 4 General Guidelines for the UNGUATOR Technology 15 4 1 Preparing the UNGUATOR Mixing System 15 4 2 Weighed Portion of the Formulation 15 4 3 Preparing the Mixing Process 16 4 4 The Mixing Process using the UNGUATOR e s 17 4 4 1 Operating Mode AUTO 18 4 4 2 Operating Mode HAND 19 4 4 3 Emulsion 20 4 4 4 Emulsion 20 4 4 5 Normal 20 4 4 6 Suspension lt 2 21 4 4 7 Suspension gt 2 21 4 4 8 Gel 22 4 4 9 Suppositories 22 4 4 10 Powder 22 4 5 Condition of the Ingredients for any Formulation 23 4 6 After the Mixing Process is Compl
19. SL on the display The oscillation arm moves downward till the mixing blade meets the UNGUATOR Jar Lid then the mixing motor is accelerated to speed level 9 The UNGUATOR MB now cleans itself via high speed rotation close to the lid At this point all ointment is removed from the UNGUATOR MB and mixing is complete The display now indicates total mixing time including reset times To remove the UNGUATOR Mixing System first unscrew the UNGUATOR Jar Lid The UNGUATOR Mixing System is then removed from the bayonet receptor by twisting the UNGUATOR MB shaft counterclockwise Uncuaton TECHNOLOGY Then the UNGUATOR Mixing System can be removed by pulling it downwards 4 4 2 Operating Mode HAND The prepared UNGUATOR Mixing System is inserted into the bayonet receptor of the UNGUATOR e s from below and pushed up as far as it will go The UNGUATOR Jar Lid and the UNGUATOR Jar body should both be held in one hand simultaneously The bayonet receptor will grip immediately when the UNGUATOR e s is switched on using the Start Stop button It will now run from the first revolution until the mixing process is complete The programmed mixing time will be completed at the set speed step The mixing time and speed parameters can also be changed during the mixing process We recommend moving the UNGUATOR Jar up and down steadily from the stop on the UNGUATOR Jar bottom to the stop on the UNGUATOR Jar Lid eve
20. djustable Tab 1 Quality improvement with increasing Automation 3 1 1 UNGUATOR B R The UNGUATOR B R is the basic machine with controlled mixing motor and manual jar guidance 3 1 2 UNGUATOR e s Fig 2 UNGUATOR B R The UNGUATOR e s machine was developed for efficient individual and batch preparations The automated stroke enables the user to leave the UNGUATOR e s during the mixing process to serve a customer for instance or to prepare the next formulation at the same time The precisely set sensor for the automatic oscillation arm will always ascertain at each upward or downward stroke the exact position of the UNGUATOR Jar bottom or lid This guarantees that the UNGUATOR Jar is always accessible to the UNGUATOR Mixing Blade despite the inevitable vertical motion during the mixing process If the stroke length of the first stroke was taken as a constant value then the active ingredient weighed out in the lower region of the UNGUATOR Jar might not be included in the mixing process by the UNGUATOR Mixing Blade getting A lost at the bottom The lifting technique of the UNGUATOR Mixing System prevents this from happening so that the result Fig 3 UNGUATOR e s of the mixing process is not just a homogeneous ointment but also one with the desired ratio of active ingredients Uncuaton TECHNOLOGY 3 1 3 UNGUATOR 2100 The UNGUATOR 2100 shows all the advantages of its
21. e UNGUATOR Spindle is screwed slightly 1 2 to max 1 turn counterclockwise without perforating the movable bottom a slight resistance can be felt before the bottom is perforated Air can be decreased by placing the UNGUATOR Jar onto the table and using both hands pushing the jar against the table Before giving the UNGUATOR Jar to the customer the UNGUATOR Spindle must be screwed in the UNGUATOR Jar counter clockwise from the bottom till it locks into place The UNGUATOR Spindle must be turned clockwise to extract the ointment To remove the ointment the UNGUATOR Spindle must be twisted to the right One turn dispenses approx 20 ml of the contents of the UNGUATOR Jar Caution If the movable bottom is accidentally perforated or the spindle is permanently locked in the bottom of the jar the UNGUATOR Jar may only serve as dispensing or storage vessel and can no longer be used for the mixing process Vor Gebrauch Jar Preparation Entnahme Extract Screw spindle to the left to properly engage Spindel links eindrehen bis zum Anschlag s 2 ssl se 5 So 8 2 oo v E en a os Ss je 2 ss c Se Ser Lo oz 2 ze eS v par or er ote oS oze E lt na gt o Be ot 2 ou 3 32 Es oS o Ze SEs gE lt oe amp wi wi 8 aia Fig 19 How to operate the UNGUATOR Spindle Fig 20 UNGUATOR Spindle 3
22. e s from the year 2003 It combines both the mixing functions of the UNGUATOR e s and the operating concept of the UNGUATOR 2100 The basic functionality of the e s System with the setting parameters of the mixing rotation speed and time are retained A significant innovation of the UNGUATOR Q is the possibility of scaling one mixing program already created automatically to another jar size This enables a constant quality of the formulations and as a consequence has a tremendous time saving result since recalculation can be very time consuming and complex ED Fig 5 UNGUATOR Q 3 2 UNGUATOR Assortment Apart from the UNGUATOR Standard Mixing Blade SMB the UNGUATOR Disposable Blade Disp Blade and the UNGUATOR Jars the UNGUATOR Assortment provides additional and useful components These include dosing aids such as the UNGUATOR Varionozzles and UNGUATOR Applicators removal or transfer aids such as the UNGUATOR Spindle the UNGUATOR Coupling andthe patented AirDynamic Pumpball System All UNGUATOR products are compatible with all UNGUATOR Mixing devices 3 2 1 UNGUATOR Mixing Blade MB The UNGUATOR Standard Mixing Blade and the UNGUATOR Disposable Blade are designated as UNGUATOR MBs The UNGUATOR MBs are steadily guided up and down inside the UNGUATOR Jar Their special design results in a tight contact between the mixing blade and the inside wall of the UNGUATOR Jar which
23. ete 24 4 7 Specific Time of Mixing and Operating Instructions 25 5 General Recommendations on the UNGUATOR Mixing System 26 5 1 Patent Protection 26 5 2 Troubleshooting 26 5 3 Potential Sources of Nonconformances 27 5 4 Quality Assurance for Ointments 28 6 Service and Warranty 28 Uncuaton TECHNOLOGY 6 1 Notes on Malfunctions 28 6 2 Manufacturer s Service and Warranty 29 6 3 Notes on Maintenance 29 6 4 Notes on Safety 30 6 5 Technical Data of the UNGUATOR e s 31 6 6 Quality and Material 31 7 References 32 8 Bibliography 32 9 Manufacture s Certificate 34 10 Distribution Manufacturing and Customer Service 35 Tables Tab 1 Quality improvement with increasing Automation 4 Tab 2 RPM table for each speed level 18 Tab 3 Minimum values for mixing time at speed level 9 in min sec 25 Tab 4 Minimum values for mixing time at speed level 5 in min sec 25 Tab 5 UNGUATOR e s error message 27 Pictures Fig 1 UNGUATOR e s Display and Description 2 Fig 2 UNGUATOR B R 4 Fig 3 UNGUATOR e s 4 Fig 4 UNGUATOR 2100 5 Fig 5 _UNGUATOR Q 5 Fig 6 UNGUATOR Standard Mixing Blade SMB 6 Fig 7 UNGUATOR Disposable Blade Disp Blade 7 Fig 8 Handling the UNGUATOR Disposable Blade 7 Fig 9 Assignment of the UNGUATOR SMB with different length of shaft 8 Fig 10 UNGUATOR Jars 9 Fig 11 Certificate of analysis for the e g 50ml UNGUATOR Jar 10 Fig 12 Regular UNGUATOR Jar Nozzle 11 Fig 13 UNGUATOR Varionozzles 1mm or
24. evice Tab 5 UNGUATOR e s error message 5 3 Potential Sources of Nonconformances e The UNGUATOR Jar bottom was not pressed fully down to the stop position prior to weighing out or filling First and foremost it is not imperative to accommodate specifically light constituents in an UNGUATOR Jar of equal weight although the filling volume is 40 more than the rated volume Please use the next largest UNGUATOR jar for the mixing e The air was not removed before the mixing preocess of semisolid preparations from the UNGUATOR Jar Then the mixing blade centrifuges the ointment against the UNGUATOR Jar wall forming an air column inside in which the UNGUATOR MB cannot clean itself and unmixed constituents may adhere to the UNGUATOR MB e The UNGUATOR Jar bottom has not been moved up The penetrating UNGUATOR MB will generate an overpressure at high rate of speed that cannot be compensated when the movable bottom yields Thus the overpressure may cause mixed material mainly liquid constituents to squeeze out of the seals on the threaded UNGUATOR Jar Lid between UNGUATOR Jar bottom and UNGUATOR Jar body and along the shaft of the UNGUATOR MB 1 e The sealing lip on the UNGUATOR Jar bottom does not retain liquids during the emulsifying process Before starting the mixing process particularly for large amounts of liquids the region round the sealing lip of the UNGUATOR Jar bottom should be carefully brushed w
25. f DIN VDE 0100 e UNGUATOR devices have been designed for operation under normal room atmospheric conditions Recommended values Ambient temperature between 15 30 C 59 86 F and relative air humidity less than 80 e The device should be allowed to acclimatize for approx 30 minutes at commissioning and or after extended storage time in cold rooms UNGUATOR power switch and cable must be easily accessible Do not immerse UNGUATOR devices in water e UNGUATOR devices should only be operated by authorized persons e Only operate the UNGUATOR MB with correctly attached UNGUATOR jars or in a plastic beaker provided for a reaction mixture e Do not touch rotating parts e Keep long hair ties and cables away from rotating parts e During the automatic lifting function of the UNGUATOR e s always keep long hair parts of the body or objects away from the lifting mechanism Immediately turn off the power switch in an emergency or pull the power plug e Always keep the air vents on the driving head back or underside of the devices free when using the device Using the UNGUATOR devices not according to these operating instructions or with line products that the manufacturer did not deliver or recommend may impair safety and will void the warranty e UNGUATOR devices have not been designed for operation under hazardous conditions Heed the relevant safety regulations when handling hazardous substances e g combustib
26. gh speed Homogenization of solid substances takes slightly longer The cooling time and hence the cooling interval can be shortened in the refrigerator or by using a water jacket The UNGUATOR MB should remain in the UNGUATOR Jar during the cooling phase For emulsions it makes sense in some cases to pregrind ingredients using the whole fatty phase and a low portion of water by a pregrinding The remaining water can then be filled in the UNGUATOR Jar in additional steps when the mixing process is interrupted The advantage of pregrinding where the basic ingredients are mixed evenly along the UNGUATOR Jar wall is a relatively fast bonding of the liquid constituents This in turn assures an increased tightness of the sealing lips even for large UNGUATOR Jars and extended mixing processes 4 6 After the Mixing Process is Complete The UNGUATOR Mixing System is released and removed from the UNGUATOR oscillation arm once the mixing process is finished Unscrew the UNGUATOR Jar Lid from the oscillation arm and or twist the UNGUATOR MB shaft counterclockwise This will only require a quarter turn which may already have happened when releasing the jar from the oscillation arm For this reason we recommend holding the UNGUATOR Mixing System tightly with one hand when removing it from the UNGUATOR In the next step the UNGUATOR Jar Lid is opened and the UNGUATOR MB removed Since this is also an opportunity execute a qualit
27. h selected distribution partners in defined territories on a global basis If you notice generic or copied products being distributed under the registered trademark UNGUATOR please contact us immediately following the GAKO contact details mentioned above Your courtesy and support helps to prevent losses in terms of intellectual property quality and customer satisfaction NOTES Uncuaton TECHNOLOGY NOTES NOTES GAKO International GmbH Dantestrasse 27 80637 M nchen GERMANY phone 49 0 89 15 88 16 88 fax 49 0 89 15 88 14 85 mail contact unguator com International gako ww UNGUATOR amp om
28. ing conventional jars with a regular lid If the UNGUATOR Jar Lid has been removed the ointment should be pushed up close to the lid after each dispensing process using the UNGUATOR Spindle or the AirDynamic System 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 UNGUATOR Jar has a diameter of 8mm The varionozzles or applicators reduce the diameter to 4 2 or 1 mm The approximate values represented in the following diagrams may also be helpful to weight out concentrated active substances or regular trituration from the UNGUATOR Jar oOo lOO nn er EEE OoOo oO oOo cec o ood o an 2 15 m 1 u 3 4 as 0 on ig 0 Fig 12 Regular UNGUATOR Jar Fig 13 UNGUATOR Varionozzles 1mm or Nozzle UNGUATOR Applicator short 4 cmm L I ed m gt 5 2 Ka 0 3 4 S 7 i Fig 14 UNGUATOR Varionozzles 2mm or Fig 15 UNGUATOR Varionozzles UNGUATOR Applicator long 4mm 3 2 3 UNGUATOR Varionozzles The UNGUATOR Varionozzles with inner diameters of 1 2 or 4 mm can be pressed into the regular nozzle 5 Sd of any UNGUATOR jar They reduce the opening gt size making it possible to safely dose even low 4 er Fig 16 UNGUATOR Varionozzles formulations The viscosity of the finished product 1 2 4mm normally specifies the diameter of the UNGUAT
29. ith foundation so as to improve its sealing quality The sealing lip of the UNGUATOR Jar Lid has been damaged by the shaft tappets of the UNGUATOR MB upon perforating the lid This will cause ointment to creep up the shaft The UNGUATOR Jar Lid is not tightened correctly and not held during the manually guided stroke This may cause the UNGUATOR Jar Lid to unscrewed during the mixing process resulting in a large mess e The user failed to remove air again or to mount a UNGUATOR Varionozzle or UNGUATOR Applicator before dispensing This will cause the user to first push the air out of the opening and the ointment will follow in a gush 1 5 4 Quality Assurance for Ointments Simple test methods convincingly demonstrate the good homogenizing capability of the UNGUATOR Mixing System Perform a homogeneity test when receiving the UNGUATOR device and document the results After a year or when needed you can repeat the test Use a recipe with a colored substance for example iron oxide micronized or Sudan Red and work this in a semi solid base You can spread out the finished recipe in a glass plate or in a microscope slide and check under the microscope the solids distribution and the grain size For a short term statement about the solids distribution in the formula basis you can test in different levels of the UNGUATOR Jars and examine these as described 6 Service and Warranty 6 1 Notes on Malfunctions If the U
30. l speed This temperature increase is generally safe for the substances used in the pharmaceutical field Ointments of low viscosity only heat slightly 2 Volatile substances such as ethereal oils or alcohol do not evaporate from the closed UNGUATOR Mixing System Uncuaton TECHNOLOGY Cleaning the UNGUATOR MB The UNGUATOR MB is normally cleaned with a paper towel and if necessary held under a hot water jet and then dried with dispensing pulp UNGUATOR MBs can also be cleaned in a conventional dishwasher All the UNGUATOR devices as well as UNGUATOR line of products must not be treated with sharp edged objects or abrasive cleaning agents 3 2 2 UNGUATOR Jar The UNGUATOR Jar is both the mixing and dispensing jar and is therefore designed as an expendable or disposable jar The UNGUATOR Jar guarantees evaporation and contamination free preparation in an air reduced mixing space The UNGUATOR Jar Lid closes the UNGUATOR Jar to ensure no loss of active ingredients Used as a dispensing jar the UNGUATOR Jar corresponds to the guidelines for quality assurance from the German Chamber of Pharmacists Apothekenkammer 11 With its small dispensing opening comparable to a tube and without an environmental contamination surface the UNGUATOR Jar guarantees the minimization of negative quality interference demanded by section 13 ApBetrO Pharmacist Operating regulations including those caused by germs on the fingers
31. le liquids such as alcohol or similar substances e UNGUATOR devices correspond to the safety standards for laboratory equipment They have to be positioned to prevent any interference or use by unauthorized persons e The UNGUATOR e s should pause for at least 5 minutes after a mixing period of 30 minutes e The device must not be disposed of in ordinary domestic waste Please deliver the device to the available collecting and recycling systems at the RX end of its life cycle Uncuaton TECHNOLocY 6 5 Technical Data of the UNGUATOR e s Electrical requirement 270 W Power consumption lifting motor 50 W Speed controller in 10 steps electronic controlled UNGUATOR Jar sizes 15 500 ml Dimensions L x W x H in mm 300x 300 x 650 1 KB 5 30 minutes interval after 5 minutes mixing operation Please mind warning messages As to KB 5 Maximum load capacity will not be reached during normal operation It is defined by 5 minutes mixing of pasta zinci in the UNGUATOR 100 ml jar at 2000 RPM and 30 minutes cooling interval A safety element may switch off the device in the case of overload condition e g at 3 ointment preparations in the 200ml UNGUATOR Jar in quick succession 6 6 Quality and Material Manufacturing facilities for the UNGUATOR line of products is certified according to DIN EN ISO 9001 2008 Regular quality control ensures both outstanding and sustainable quality of the UNGUATOR Mixing Techn
32. licator may now be fasten in place A label may be attached on the UNGUATOR Jar prior forwarding to the client preferably together with a short illustration of how to use and apply UNGUATOR dispensing system It is also a good idea to record the individual mixing parameters together with the results according to the final validation 4 7 Specific Time of Mixing and Operating Instructions The default settings that displayed 2 minutes at speed level 5 can only be used for UN GUATOR Jar sizes 15 20 with a soft in soft formulation For any new formulation the mixing parameters of time and speed should be adjusted by pressing the corresponding buttons The tables below serve as orientation for the mixing time settings of different formulations Size of the UNGUATOR jar Type of 15 30 ml 50 100 ml 200 300 ml 500 ml formulation S S Soft in 01 40 02 10 04 00 05 10 el Emulsion 02 00 00 220 20 oa e 10 0530 30 Tab 3 Minimum values for mixing time at speed level 9 in min sec Size of the UNGUATOR jar Type of 15 30 ml 50 100 ml 200 300 ml 500 ml formulation S S Soft in 02 40 03 20 06 10 07 50 Soft Tab 4 Minimum values for mixing time at speed level 5 in min sec The HAND mode should mainly be used for UNGUATOR Jar sizes 15 100 ml UNGUATOR Jar sizes 200 500 ml should be operated with both hands or preferably by making use of the AUTO mode 5 General Recommendations on the UNGUATOR
33. lline Active Ingredients We recommend pulverizing active crystalline ingredients in a mortar prior adding into the UNGUATOR Jar Should a solvent for the active crystalline ingredient be part of the formulation the ingredients may then also be dissolved in the UNGUATOR Jar For example urea with water Then the remaining formulation ingredients can be added The crystalline substance may also dissolve during the mixing process if the solvent is an ingredient of the ointment base Waxes Hydrophilic Ointment etc Either pour warm water alone lt 85 C 185 F or the heated remaining ingredients constituents over Cera Lanette N etc in the UNGUATOR Jar or pour water in the substances and heat them either in a heated water bath lt 85 C 185 F or carefully observed in a microwave oven Formulations without water containing components may be melted already directly inside the UNGUATOR Jar by placing the jar in the water bath Please note that the UNGUATOR MB must not go in a microwave oven Furthermore isolated areas of heat concentration may develop when heating in a microwave To avoid this we recommend coarsely blending the content of the jar during heating using a spatula at intervals Please also keep in mind that a microwave will only heat aqueous substances Generally it is sufficient to homogenize heated mixtures in three cooling intervals of six minutes each and apply 10 strokes each using the UNGUATOR at hi
34. ly work the substances making use of these programs the rpm and lifting speed can be individually selected and adjusted The relatively large surface of the UNGUATOR SMB benefits the formation of an agglomerate grinding process This can be quickly homogenized with the rest of the base even when using larger UNGUATOR Jar sizes After finalizing the pregrinding process both the remaining base and all substances will be weighed in 4 4 7 Suspension gt 2 Mixing semisolid substances with a portion of microfine agglomerated optionally finegrained solid substances of more than 2 Examples Zincum oxydatum acidum salicylicum We recommend using the UNGUATOR SMB For suspensions with ingredient content above 2 pregrinding is not required For preparation please add 50 of the required base in the UNGUATOR jar first and then include the micronized solid parts Add the remainder of the base on top of the ingredients in order to avoid remaining powder sticking to the blades 4 4 8 Gel Mixing of gel Example Hydroxypropyl cellulose 400 We recommend using the UNGUATOR Disp Blade for up to 200 ml Basic gel approaches are mixed with several intervals at high speed during the required swell time thus preventing agglomerations and slightly reducing soaking time Principlerelated trapped air will normally clear after the preparation would settle for a while 4 4 9 Suppositories We recommend using the UNGUATOR Disp
35. ment base should be weighed out into the UNGUATOR Jar Then the remaining constituents should be added accordingly 4 4 6 Suspension lt 2 Mixing semisolid substances with a portion of microfine agglomerated optionally finegrained solid substances of less than 2 96 Examples Cortisones antibiotics fungicides metronidazole We recommend using the UNGUATOR SMB If there is no concentrated active substance we recommend a pregrinding process e g by use of a pregrind program in the case of a suspension with a content of less than 2 active ingredients For pregrinding the solids with low base content are weighed out into the UNGUATOR Jar The movable bottom remains in the lowest position in order to make use of the full capacity of the jar including both lid and bottom areas for the dispersion process The degree of dispersion reached by pregrinding should be checked to ensure that no active substance particles or agglomerates are too large either microscopically or using a strong magnifying glass Usually the spreading on a glassplate e g object slide is sufficient to prevent inhomogeneity Eventually the pregrinding process needs to be repeated depending on the examination Due to a high speed grinding process a warming of the formulation up to 50 C 122 F may occur Since this warming may not be suitable for some of the substances e g metronidazole we recommend continiously checking the temperature In order to gent
36. ology e The UNGUATOR Aplicators Couplings and Jars are made out of Polypropylen PP and the regular UNGUATOR Varionozzles of Polyethylen PE e The UNGUATOR SMB is made out of Polyoximethylen e The UNGUATOR Disp MB is made out of Polyamid e The shaft of the UNGUATOR MB is made of NIRO Stainless steel quality standard 1 4301 and hardened titanium nitride golden color The utilized material and pigments are physiologically classified as safe 7 References The advantages of the UNGUATOR Mixing Technology and System compared to conventional manufacturing methods with mortar and pestle are frequently mentioned in the literatures below e Preparation of GMP compliant ointments in the pharmacy is possible 2 4 e Formulations for ointment is standardized 4 8 Excellent homogenity 2 4 9 e Improved microbiology 3 8 Risk of contamination is greatly reduced in the preparation process hygienic production in a closed system no transfer to a separate container 2 3 4 8 e Hygienic extraction of the formulation minimum threat of contamination by the user 2 3 4 8 e Enhanced product quality in an improved packaging ensures longer product shelf life 3 4 8 Bibliography e 1 1 Jahr UNGUATOR R hrsystem Deutsche Apothekerzeitung DAZ Nr 43 Jhg 135 1995 S 115 117 Konietzko A GAKO Konietzko GmbH Bamberg 2 Der UNGUATOR ein neuartiges Salbenr hrwerk
37. qua aa Up to 200ml we recommend using the UNGUATOR Disp Blade Cold stored foundations make the emulsification more difficult Heating up the liquid to be added may accelerate the emulsification Sometimes the heat that occurs during the mixing process inside the jar may already be sufficient and formation of emulsions 4 4 4 Emulsion Emulsifying of semisolid substances to be melted Examples Emulsific aquosa Lanette Cera Up to 200ml we recommend using the UNGUATOR Disp Blade Emulsions should always be heated then when UNGUATOR Jars of 300 ml to 500 ml are used Melting semisolid substances using max 85 C 185 F hot water can be achieved by three methods 1 Addition of hot water lt 85 C 185 F 2 Covering with cold water heat up to 200 ml in the hot water bath lt 85 C 185 F 3 Covering with cold water careful heating in the microwave mind max temperature To attain an even structure heated emulsions should be stirred until they have cooled to room temperature with a few intervalled strokes using a water jacket or by using cooling phases at medium speed during which the UNGUATOR Jars are placed in the refrigerator if necessary 4 4 5 Normal Mixing semisolid substances from low viscous to pasty Examples Off the shelf pharmaceutical ointments with base s concentrated active substances with base s liquid active ingredients in base s Uncuaton TECHNOLOGY First the oint
38. ract mixtures An adapter connected to a pumpball is affixed to the center hole on the body s bottom of the UNGUATOR Jar with an air tight connection By pumping air into the lower chamber of the UNGUATOR Jar using the pumball the pressure thus Fig 22 UNGUATOR AirDynamic generated moves the bottom upward Thanks to the Pumpball system AirDynamic Pumball System even thick pastes can be dispensed via the small dispensing opening in the screw cap or transferred to small UNGUATOR Jars using the Uncuaton TECHNOLOGY UNGUATOR Coupling The material outlet velocity depends on viscosity which may be reduced through heating The air pressure that had developed in the lower chamber of the UNGUATOR Jar can be relieved by opening the valve screw This is mandatory after the transfer process using the UNGUATOR Coupling before the smaller UNGUATOR Jar is removed Otherwise this may result in considerable contamination of the immediate environment depending on the for mulation viscosity 4 General Guidelines for the UNGUATOR Technology 4 1 Preparing the UNGUATOR Mixing System The UNGUATOR Mixing System consists of an UNGUATOR Jar an UNGUATOR MB and the components of the formulation to be mixed First the UNGUATOR jar cap small white screw cap of the UNGUATOR Jar and then the UNGUATOR Jar lid large red or white screw cap must be unscrewed from the UNGUATOR Jar Second the UNGUATOR MB is inse
39. result is also optimized since there is no trapped air We recommend mainly in the case of intermingling large quantities of powder that air diminuation be repeated after 15 seconds of the mixing process When pregrinding by pasting the solids with ointment base in the UNGUATOR Jar we recommend positioning the movable UNGUATOR Jar Bottom as far downward as possible This will guarantee that the large surface area of the inside wall of the UNGUATOR Jar also including the lid and bottom can be used for dispersion between the friction surfaces of the UNGUATOR MB and the inside surface area of the UNGUATOR Jar body Consequently no air diminuation need be carried out prior pegrinding At this point of the mixing process device specific settings will need to be implemented and the UNGUATOR Mixing System connected to the UNGUATOR Uncuaton TECHNOLOGY 4 4 The Mixing Process using the UNGUATOR e s The UNGUATOR e s is an improved version of the UNGUATOR e from 1997 It represents an improvement of the first ever UNGUATOR from 1994 with an added automated lifting device and programmable mixing time and speed The e in the name stands for the electronics necessary for the respective automated processes resulting in the simplicity of ointment preparation and the elegance of the UNGUATOR e s Due to its powerful and robust mixing motor the UNGUATOR e s guarantees safe sprucely and swift preparation of ointments res
40. rted into the UNGUATOR Jar housing sliding the UNGUATOR Jar down The UNGUATOR Jar lid is then slid onto the UNGUATOR MB standing in the UNGUATOR Jar housing and pressed down firmly using both thumbs Ensure that the sealing lip of the UNGUATOR Jar lid opening is not damaged by the bayonet noses because the ointment may otherwise rise on the UNGUATOR MB shaft during the mixing process Third the UNGUATOR MB is carefully removed from the UNGUATOR Jar and the UNGUATOR Jar lid will be moved all the way in the direction of the Blade Both parts i e the UNGUATOR MB and the UNGUATOR Jar lid are put down or possibly tarde on the balance together with the UNGUATOR Jar 4 2 Weighed Portion of the Formulation Generally oily greasy aqueous and pulverized ingredients can be weighed out into the UNGUATOR Jar all at the same time It is however advantageous to consider certain general procedures to optimize the mixing results Generally know how gained from the traditional preparation of ointments is very helpful when using the UNGUATOR Mixing System As already mentioned at the beginning of the operating instructions true to the motto learning by doing Listed below are the seven different general procedures used to produce the routine standard formulations in pharmaceutical preparation of ointments EMULSION EMULSION NORMAL SUSPENSION lt 2 SUSPENSION gt 2 as well as GEL and SUPPOSITORIES Due to the rapid heat
41. ry second while holding the UNGUATOR Mixing System tightly with at least one hand The UNGUATOR Mixing System can be switched to freespin as a special step with manual stroke movement Press the Start Stop button before the mixing process is complete to switch to freespin This will interrupt the mixing process and the display will prompt for freespin by showing FSL The UNGUATOR Mixing System needs to be removed from the UNGUATOR e s and the UNGUATOR Jar Lid slightly untwisted as if for air diminuation The UNGUATOR Jar bottom is then pushed into the full down position using the UNGUATOR MB Then the UNGUATOR Jar Lid is retightened The UNGUATOR Mixing System should now be inserted back into the bayonet receptor of the UNGUATOR e s from below and pushed up as far as it will go Now push the Start Stop button again and the UNGUATOR MB can now clean itself by means of highspeed rotation in a position close to the lid This is referred to as freespin Most of the ointment is removed from the UNGUATOR MB and the mixing process is complete The display will show the total mixing time incl the reset times after the freespin is finished The UNGUATOR Mixing System is removed from the bayonet holder by twisting the UNGUATOR MB shaft counterclockwise and then pulling it out in downward direction 4 4 3 Emulsion Emulsifying semisolid substances with water at room temperature Example Eucerin c a
42. sed UNGUATOR Mixing System is quick and easy to learn true to the motto learning by doing A little experience will make it easy to prepare ointments though they may seem rather complicated at first Using the UNGUATOR Technology enables the pharmacy to better prepare prescription ointments in a shorter period 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 3 1 UNGUATOR Mixing Machines The current UNGUATOR mixing machines the UNGUATOR B R the UNGUATOR e s the UNGUATOR 2100 and the UNGUATOR Q are useful and advanced improvements on the first UNGUATOR from 1994 They are designed for a working capacity of approx 500 work hours wich corresponds to approximately 15 000 to 20 000 preparations The UNGUATOR mixing machines feature a high safety standard and were tested by TUV Rheinland Germany for safety The devices are manufactured under license and maintained by defined service partners Product quality product uniformity and reproducibility of ointments prepared individually and in batches were improved with the increasing automation of the UNGUATOR units starting with the individual model B R through the e s Q and 2100 models Method of Pharmaceutical Uniformity of lifting arm mixing ointment Quality ointment parameters preparation UNGUATOR B R manual manually a
43. serves primarily for comminuting the substances during the mixing process Additionally forced mixing in the whole mixing unit is achieved through the shape and vibration of substances while preparing the ointment The lubricating effect of the ointment and substances generally protects the UNGUATOR Jars and the UNGUATOR MB against abrasion Discolorations of the mixing blade are mostly irreversible and therefore harmless All UNGUATOR MBs are dishwasher safe UNGUATOR Standard Mixing Blade SMB UNGUATOR SMBs are adjusted to the size of each individual UNGUATOR Jar While the UNGUATOR SMBs AAN for 100 and 200 ml and for the 300 and 500 ml jars have 7 the same mixing blade diameter their shaft length differs This must be taken into consideration particulary when using the UNGUATOR e s and the UNGUATOR 2100 since the use of the wrong lenght may cause problems Fig 6 UNGUATOR SMB with the automated stroke Always make sure the UNGUATOR MB used is the right lenght and that it is clean prior use e g with isopropanol 70 Uncuaton TECHNOLOGY UNGUATOR Disposable Blade Disp Blade The UNGUATOR Disp Blade is suitable for all UNGUATOR devices The mixing blade of UNGUATOR Disp Blade is connected to the UNGUATOR Disp Blade shaft by twisting the blade counterclockwise and can be disconnected after the mixing process with a clockwise turn The material contact in the ointment is three times
44. ssories are excluded from warranty e The warranty claim will lapse should an unauthorized party have tempered with the device Damages caused by improper use as well as force majeure or other external influences are excluded from any warranty claims e The parts replaced at maintenance and repair will become property of GAKO e Claims beyond the free rectification of faults e g indemnification cannot be made within the warranty period e Repairs within warranty will be exclusively carried out by our local service partner SMS Elap GmbH amp Co KG Germany or specifically authorized companies 6 3 Notes on Maintenance e Topreserve gears and motor for continuous untroubled operation the UNGUATOR e s should either be sent to your representative in your individual country please contact your UNGUATOR dealer or to SMS Elap GmbH amp Co KG after 20 000 preparations or after five 5 years for maintenance e After sales service and maintenance service will be billed for expenses and wearing parts at reasonable price according to the cost estimate within the warranty period as well e Upon request an UNGUATOR loaner may be provided for a one time charge that can be used while your UNGUATOR is away for maintenance and repair 6 4 Notes on Safety UNGUATOR devices must only be connected to grounding type receptacles with 230V 50Hz cps 120V 60Hz cps or rated country specific voltage installed according to the regulations o
45. to 1000 ml are particularly well suited as storage and transfer vessels for semisolids and other preparations Since the contents dispensed using the movable jar bottom are always close to the lid the UNGUATOR Jar solves the problem of the unsightly contents in traditional porcelain vessels used previously Evaporation formation of crust contamination and oxidation processes can thereby be avoided to a great extent Furthermore the contents of the UNGUATOR Jar can be moved close to the lid after spatula dispensing using the UNGUATOR Spindle or the AirDynamic Pumpball System The body of the UNGUATOR Jar sizes 300 to 1000 ml can be cleaned in a dishwasher as long as it has not left the pharmacy Asepsis has to be ensured before reuse though The movable bottom of the UNGUATOR Jar is not suitable for the dishwasher and the sealing lip of the UNGUATOR Jar Lid may be destroyed after repeated mixing The corresponding UNGUATOR Jar Lids or jar bottoms can be ordered in sets of five and used for the economical reuse of the body The UNGUATOR Jar is subject to periodic inspections in accordance to the German ZL packing regulation DK 94 A certificate of analysis is issued after batch defined examinations The documentation of primary packaging materials at the pharmacy stipulates that the manufacturer s test certificate certificate of analysis is retained after receiving visual inspection This certificate is affixed to the plastic
46. ulting in the s in its name Before using the UNGUATOR e s ensure the power switch O I located on the base at the rear ofthe UNGUATOR e s is turned to off We recommend switching the UNGUATOR e s off when not in use In addition to automated processes the UNGUATOR e s also allows for manual mixing like its predecessors Use the AUTO HAND button when the device is switched on to select manual or automatic operation The current setting is indicated on the display where either the triangle above the AUTO for auto mode or beneath HAND for manual operation lights up The oscillation arm of the UNGUATOR e s will automatically move to the corresponding position when operating mode is changed After selecting the automatic or hand mode the mixing time and speed should be defined A dot in the respective number field indicates the parameter that can be Display changed via the plus and minus buttons RPM Button 2 minutes of mixing time and 5 for the Time Button speed step are the default parameters 3 Ss Automatic Hand The mixing time can be set anywhere from one second up to 9 minutes and 55 seconds and the mixing motor is adjustable from 0 Button to 9 in 10 steps Button Start Stop See the table below for the exact speed Button of each step measured in revolutions per minute rpm Fig 23 Control Panel of the UNGUATOR
47. when dispensing the ointment Consequently the user can extract the ointment from the UNGUATOR Jar very hygienically The UNGUATOR Jar is resistant to hot water baths and microwaves with temperatures below 85 C 185 F Higher temperatures may alter the tightness of the UNGUATOR Jar and the displaceability of the bottom push up process might be negatively impacted The UNGUATOR material becomes brittle at temperatures below 0 C 32 F UNGUATOR Jars are available in the following sizes 15 28 ml 20 33 ml 30 42 ml 50 70 ml 100 140 ml 200 280 ml 300 390 ml 500 600 ml and 1000 1250 ml rated volume filling volume The standard color for the UNGUATOR Jar body is white with red lid The 300 ml 500 ml and 1000 ml UNGUATOR Jars come with white lids In addition jar sizes 20 ml to 200 ml are also available in pastel colors pink light yellow light blue and turquoise Furthermore UNGUATOR Jars from 20 to 200 ml are available with special color lids green blue and white Upon special demand and defined quantity UNGUATOR Jars from 20 to 200ml may also be ordered in customized colors All UNGUATOR Jars come sealed in plastic packaging Cleaning or Fig 10 UNGUATOR Jar disinfection prior usage could put the certified asepsis at risk We would recommend storing the UNGUATOR Jars in its plastic packaging after opening for protection against possible dust contamination The UNGUATOR Jar sizes 300
48. y check the UNGUATOR Jar Lid should also be opened after mixing when using the UNGUATOR Disp Blade Practice has proved that if the surface of the ointment looks smooth and if the minimum defined mixing time has elapsed homogeneity inside the UNGUATOR Jar in fall can be expected Push the UNGUATOR MB out of the UNGUATOR Jar Lid The ointment on the mixing blade can be fallen off into the UNGUATOR Jar using a spatula When using the UNGUATOR Disp Blade the mixing blade can be removed from the UNGUATOR Jar and disposed or left inside the UNGUATOR Jar Leaving the blade inside the jar will have no effect on dispensing the ointment through the UNGUATOR Jar Lid Removal of the mixing blade is recommended particularly when giving the ointment to elderly clients since it might otherwise cause confusion if the ointment is traditionally dispensed The UNGUATOR Jar Lid is screwed back onto the UNGUATOR Jar body and equipped with an UNGUATOR Varionozzle as needed Then a UNGUATOR Jar Lid together with an UNGUATOR Applicator is screwed on Large UNGUATOR Jars will be equipped with a spindle or the AirDynamic System Also in this case like in the the regular mixing process air diminution should be repeated A squirting out of the ointment when first dispensed Uncuaton TECHNOLOGY can be prevented by eliminating cavities that may have developed during the mixing process The UNGUATOR Jar Lid or the UNGUATOR App
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