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8. Bibliography

•[1] 1 Jahr UNGUATOR®-Rührsystem Deutsche Apothekerzeitung (DAZ) Nr. 43 Jhg.
135/1995 S. 115-117 Konietzko, A., GAKO® Konietzko GmbH, Bamberg

•[2] Der UNGUATOR® ein neuartiges Salbenrührwerk 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 Salbenrühren im Vergleich Pharmazeutische Zeitung (PZ) Nr. 36
Jhg. 142/1997 S. 24 – 31 Zobel et al., Pharmaz. Technologie, Univ. Frankfurt a.M.

•[5] Das UNGUATOR®-Rührsystem (URSY) als Alternativverfahren für 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®

Rühren

im

geschlossenen

System

(1998)

A.Konietzko, GAKO® Konietzko GmbH, Bamberg

• [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 (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 Albrecht Konietzko, 96049
Bamberg, [email protected] Verlag: medical economics – Leipzig

•[10] Qualitätssicherung in der Rezeptur Pharmazeutische Zeitung (PZ) Nr. 14 Jhg. 146/2001 S. 42-47
R. Eifler-Bollen, NRF, Eschborn Prof. Dr. H. Möller, Zentrallaboratorium Deutscher Apotheker (ZL),
Eschborn, et al.

•[11] Leitlinie zur Qualitätssicherung ... nicht sterilen Rezeptur- und Defekturarzneimittel Phar-
mazeutische Zeitung (PZ) Nr. 29 Jhg. 145/2000 Seiten 105–116 Deutsche Apothekerkammer

•[12] Flüssige Chlorhexidin-Cremes: Rühren ist kritisch Pharmazeutische Zeitung (PZ)Nr. 10 Jhg.
147/2002 Seiten 54 - 56

•[13] Mit zeitgemäßen Herstellungsverfahren rühren Pharmazeutische Zeitung (PZ) Nr.13 Jhg.
147/2002 Seite 60 Diskussion: A. Konietzko (GAKO®) und Dr. H. Reimann (NRF)

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Summary of Contents for 2100

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

Page 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 ...

Page 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...

Page 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...

Page 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 ...

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

Page 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...

Page 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 ...

Page 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...

Page 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 ...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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...

Page 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 ...

Page 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 ...

Page 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 ...

Page 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...

Page 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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