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3.2  UNGUATOR® Assortment 

Appart 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  and the  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  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 for 100 and 200 ml and for the 300 and 500 ml 
jars have 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 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%).

The  UNGUATOR®  SMB  is  suitable  for  the  production  of  all  recipes.  For  suspension 
ointments  and  glass  cleaning  operations,  we  recommend  the  use  of  the  UNGUATOR® 
Disp. Blade.  

6

Pic. 6:  UNGUATOR®  SMB

Содержание 2100

Страница 1: ...Operating Instructions and Production Recomendations B R ...

Страница 2: ...xing 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 ...

Страница 3: ...GUATOR 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 B R 17 4 4 1 Emulsion 18 4 4 2 Emulsion 18 4 4 3 Normal 19 4 4 4 Suspension 2 19 4 4 5 Suspension 2 20 4 4 6 Gel 20 4 4 7 Suppositories 21 4 4 8 Powder 21 4 5 Requirements for the ingredients of a prescription 21 4 6 After the mixing process is complete 22...

Страница 4: ...ade SMB 6 Pic 7 UNGUATOR disposable blade 7 Pic 8 Handling the UNGUATOR disp blade 7 Pic 9 Assignment of the UNGUATOR SMB with different length of shaft 8 Pic 10 UNGUATOR Jars 9 Pic 11 Certificate of analysis for the UNGUATOR Jar 50 ml 10 Pic 12 Dispensing with regular UNGUATOR varionozzle 11 Pic 13 Dispensing with UNGUATOR 1mm varionozzles or UNGUATOR applicator short 11 Pic 14 Dispensing with UN...

Страница 5: ...ning 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 UNGUATOR B R mixing device Power cable Operating instructions Please contact your responsible UNGUATOR dealer and or supplier immediately in ...

Страница 6: ...Fig 1 UNGUATOR B R description UNGUATOR B R 2 Speed controller Drive head Power cord ...

Страница 7: ...epare 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 UNGU...

Страница 8: ...me 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 ...

Страница 9: ...ed 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 m...

Страница 10: ...ed 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 ...

Страница 11: ...ar Cleaning is limited to the UNGUATOR Disp Blade shaft We recommend using the UNGUATOR Disp Blade for substances that may discolor the 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 Assignment of the UNGUATOR ...

Страница 12: ...o 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 t...

Страница 13: ...BetrO Pharmacist Operating regulations including those caused by germs on the fingers 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 bott...

Страница 14: ...lab pack regul DK II 94 Lichtdurchlässigkeit Opaqueness OK Partikelgehalt Particle Concentration OK Farbbeständigkeit Color Fastness OK Dichtigkeit Seal Integrity OK Mikrobiologie Microbiology OK gez signed Grieser head of quality assurance GAKO www unguator com 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 b...

Страница 15: ... 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 ...

Страница 16: ...ors 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 UNGUATOR Applicator long The UNGUATOR Applicator long with a d...

Страница 17: ... 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...

Страница 18: ...aller 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...

Страница 19: ...B 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...

Страница 20: ...rmulation 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 e...

Страница 21: ...l position Then the UNGUATOR Mixing System can be removed by twisting the UNGUATOR MB counterclockwise from the bayonet receptor and pulling it down 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 every second while holding the UNGUATOR Mixing System tightly with at least one hand The number of revolutions per m...

Страница 22: ... position close to the lid This process is called freespin Most of the ointment is removed from the UNGUATOR MB and the mixing process is complete 4 4 1 Emulsion Emulsifying semisolid substances with water at room temperature Example Eucerin c aqua 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 ad...

Страница 23: ...nts should be added accordingly 4 4 4 Suspension 2 Mixing semisolid substances with a portion of microfine agglomerated optionally finegrained solid substances of less than 2 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 su...

Страница 24: ... 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 part...

Страница 25: ...ode changing from Auto to Hand Please have the mixing time extended accordingly 4 5 Requirements for the ingredients of a prescription 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...

Страница 26: ...hase 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 ...

Страница 27: ...ensed can be prevented by eliminating cavities that may have developed during the mixing process The UNGUATOR Jar Lid or the UNGUATOR Applicator 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 p...

Страница 28: ...e 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 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 ...

Страница 29: ...ot 6 2 Manufacturer s service and warranty 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 purchase Please retain the packaging material or request its replacement from your respective representative in your individual country please contact your local UNGUATOR dealer Deficiencies that can be ...

Страница 30: ...atmospheric conditions Recommended values Ambient temperature between 15 30 C 59 86 F and relative air humidity less than 80 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 UNGUATOR devices should only be operated by ...

Страница 31: ...lectronic controlled Timer UNGUATOR Jar sizes 15 200 ml Weight 15 lbs 6 8 Kg Dimensions L x W x H in mm 275x 180 x 500 Testing certifications TÜV GS 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 R...

Страница 32: ...l manufacturing methods with mortar and pestle are frequently mentioned in the literatures below Preparation of GMP compliant ointments in the pharmacy is possible 2 4 Formulations for ointment is standardized 4 8 Excellent homogenity 2 4 9 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 ...

Страница 33: ...r 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 Für Studium und Beruf Jhg 2000 9 Auflage S 314 315 Deutscher Apothekerverlag Stuttgart 9 Qualitätssicherung bei Rezeptur und Defektursalben UNGUATOR Technologie Apotheker Wirtschaft Nr 7 Jhrg 2 2001 S 40 41 ...

Страница 34: ...Regulation EU No 10 2011 The materials and raw materials used comply with Regulation EU No 10 2011 The following monomers and additives which are subject to a specific migration limit SML are included according to suppliers in the used materials Compliance with these specific migration limit is certified by the polymer manufacturers The traceability of Regulation EC No 1953 2004 of the product is ...

Страница 35: ...ibution of the UNGUATOR line of products is generally regulated and monitored by the company GAKO International GmbH Germany GAKO International works with 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...

Страница 36: ...mbH Dantestrasse 27 80637 München GERMANY phone 49 0 89 15 88 16 88 fax 49 0 89 15 88 14 85 mail contact unguator com www com Landsberger Straße 314 80687 München GERMANY phone 49 0 89 1222 387 200 fax 49 0 89 1222 387 201 ...

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