Gako Unguator e/s Operating Instructions Manual
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Gako Unguator e/s Operating Instructions Manual

Mixing system
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Summary of Contents for Gako Unguator e/s

  • Page 3: Table Of Contents

    Content ® UNGUATOR Mixing System ................7 ® UNGUATOR Technology ................7 ® UNGUATOR Mixing Machines ..............10 ® 1.2.1 UNGUATOR B/R ..................11 ® 1.2.2 UNGUATOR e/s ................... 11 1.2.3 UNGUATOR ® 2100 ..................11 1.3.1 UNGUATOR ® Mixing Blade (MB) ..............11 ®...
  • Page 4 4.2.3 Heating ......................35 ® 4.2.4 Cleaning the UNGUATOR MB ..............35 4.2.5 Possible error sources to be avoided ............35 Notes on dispensing ointment ............... 36 Quality assurance of the ointments .............. 38 Service and warranty ..................39 Notes on malfunctions ................... 39 Manufacturer’s service and warranty in Germany ........
  • Page 5 Index of tables and figures Tab. 1-1: Quality improvement with increasing automation ........8 ® Fig. 1-1 UNGUATOR B/R ..................9 ® Fig. 1-2: UNGUATOR e/s ..................9 ® Fig. 1-3: UNGUATOR 2100 ................... 10 Fig. 1-4: UNGUATOR ® SMB ..................11 Fig.
  • Page 6 Please look over the operating instructions carefully , in particular the notes on ® safety, before operating the UNGUATOR e/s. After a certain period of use, it may make sense to study the operating instructions more closely for selected information. Installation notes: ®...

  • Page 7: Unguator ® Mixing System

    ® pharmaceutical ointments and cosmetics is covered by the UNGUATOR Mixing Sy- stem. To continue to ensure that this is remains so, GAKO Konietzko GmbH consistently strives to both maintain and improve the quality of the UNGUATOR ® Mixing System.

  • Page 8: Mixing Machines

    A little experience will make it easy to prepare ointments though they may seem rather complicated at first. Using UNGUATOR ® Technology enables the pharmacy to better prepare prescription ointments in a shorter period of time compared to the preparation methods that were common until 1994.

  • Page 9: Unguator B/R

    ® 1.2.1 UNGUATOR ® The UNGUATOR B/R is the basic machine with a controlled mixing motor and manual jar guidance. ® 1.2.2 UNGUATOR ® The UNGUATOR e/s lift-off machine was developed for efficient individual and batch preparation. The automated stroke enables the user to leave the ®...

  • Page 10: Unguator ® Mixing Machines

    ® The UNGUATOR 2100 can be connected to and controlled by a PC via a USB interface. This makes programming even easier, making the number of programs that can be stored practically unlimited. An integrated microprocessor measures the actual ® revolutions of the UNGUATOR Mixing Blade carried ®...
  • Page 11 ® between the mixing blade and the inside wall of the UNGUATOR Jar which serves primarily for the comminution of the substances during the mixing process. Additionally forced mixing in the whole mixing space is achieved through the shape and vibration of substances while preparing the ointment.

  • Page 12: Smb

    Fig. 1-6: Handling the ® UNGUATOR Disp. Blade ® Fig. 1-5: UNGUATOR Disp. Blade The material contact in the ointment is three times 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 ®...

  • Page 13: Unguator Jar

    contamination surface, the ® UNGUATOR guarantees the minimization of negati- ve quality interference de- manded by section 13, ApBetrO (Pharmacist Ope- rating Rules); including those caused by germs on the fingers when dispens- ing the ointment. Conse- quently, the user can re- move the prescription oint- ment from the UNGU- ®...

  • Page 14: Unguator

    the problem of the unsightly contents in traditional porcelain vessels use previously. Evaporation, the 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 ®...

  • Page 15: Varionozzles

    The softly rounded surface allows ointment to be pleasantly distributed on the skin. The coloring was selected corresponding to the wavelength of light as a mnemonic aid: • 4 mm: red (long-wavelength light) • 2 mm: yellow • 1 mm: blue (short-wavelength light) ®...

  • Page 16: Unguator Spindle

    Fig. 1-11: Note on operation 1 for the ® UNGUATOR Spindle Fig. 1-12: Note on operation 2 for the ® UNGUATOR Spindle ® Air can be diminuated by placing the UNGUATOR onto the formulation table and using both hands to move the jar against the table.

  • Page 17: Airdynamic System

    ® The 200 ml UNGUATOR Jar be- comes a convenient transfer device to smaller UNGUATOR ® Jars when their UNGUATOR ® Jar bottoms are carefully pressed towards the work ® surface using an UNGUATOR applicator screwed on a 30 ml ®...

  • Page 18: Quality Verification

    System, even thick pastes can be dispensed via the small dispensing opening in the screw cap or trans- ferred to small UNGUATOR ® Jars ® using the UNGUATOR Coupling. The material outlet velocity depends on viscosity which may be reduced through heating.

  • Page 19: General Guidelines For The Unguator

    ® General Guidelines for the UNGUATOR Mixing System 2.1 Preparing the UNGUATOR ® Mixing System ® ® ® The UNGUATOR Mixing System consists of an UNGUATOR Jar, an UNGUATOR and the formulation constituents to be mixed. First the UNGUATOR ® Jar Cap (small white screw cap) of the UNGUATOR ®...

  • Page 20: Emulsion

    and SUPPOSITORIES. Powder mixings fall under NORMAL since their mixing process is similar. In the following, these standard formulations will be defined and the recommended procedure on weighing in 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 foundation ointment on the ®...

  • Page 21: Normal

    1. Addition of hot water 2. Covering with cold water – heat up to 200 ml in the hot-water bath = 85 °C/ 185 °F. 3. Covering with cold water – careful heating in the microwave. 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 ®...

  • Page 22: Suspension > 2

    The “scratching and grinding check” on the ball of one’s thumb familiar from traditional preparation methods is often enough. Pasting should be repeated depending on the results of inspection. Pregrinding has the advantage that ingredients are distributed fairly evenly along the ®...

  • Page 23: Suppositories

    2.2.7 Suppositories Dispersion of suppository blends after heating. ® We recommend using the UNGUATOR Disp. Blade for up to 200 ml. The heating of fat suppository foundations may be carried out using an infrared lamp ® ® over the open UNGUATOR Jar.
  • Page 24 Crystalline Active Ingredients We recommend pulverizing active crystalline ingredients in the mortar prior to weighing- in 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 ®...

  • Page 25: Preparing The Mixing Process

    2.3 Preparing the Mixing Process ® ® Together with the UNGUATOR Jar Lid, the UNGUATOR MB should be loosely ® screwed onto the UNGUATOR Jar housing after the formulation constituents have ® been weighed in. By pushing up the UNGUATOR Jar bottom with a thumb or, for ®...
  • Page 26 2.5 After the Mixing Process is Complete ® ® The UNGUATOR Mixing System is released and removed from the UNGUATOR ® holder when the mixing process is complete. Unscrew the UNGUATOR Jar Lid from ® the oscillation arm and/or twist the UNGUATOR MB shaft counterclockwise.

  • Page 27: The Mixing Process Using The Unguator

    ® The Mixing Process Using the UNGUATOR ® ® The UNGUATOR e/s is an improved version of the UNGUATOR e from 1994. It represents an improvement 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 ®...

  • Page 28: Operation Mode "Auto

    Step Speed Step Speed 720 rpm 1630 rpm 900 rpm 1810 rpm 1080 rpm 1990 rpm 1260 rpm 2160 rpm 1440 rpm 2340 rpm Tabelle 3-1: Value table of the speed steps This is described in the two following subsections Operating Mode “AUTO” and Operating Mode “HAND”.

  • Page 29: Operation Mode "Hand

    ® ® To remove the UNGUATOR Mixing System, first screw off the UNGUATOR Jar Lid. ® The UNGUATOR Mixing System is then removed from the bayonet receptor by twisting the UNGUATOR ® MB shaft counterclockwise. Then the UNGUATOR ® Mixing System can be removed by pulling it downwards.

  • Page 30: General Notes On Operation

    ® 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. 3.3 General Notes on Operation The UNGUATOR ® e/s is to be operated as described in chapter 2: 1.
  • Page 31 ® Size of the UNGUATOR Type of formulation 15 to 20 ml 30 to 100 ml 200 to 300 ml 500 ml Emulsion / + 03:10 04:10 06:45 08:15 Normal 02:10 03:10 05:45 07:15 Suspension < / > 2 % 04:10 05:15 08:15...

  • Page 32: E/S Error Messages

    Fault Fault remedy Possible causes of fault display FE 0 Hit the “Start/Stop” button, Switching the device on and off during oscillation arm moves to a work phase or temporary blackout the next end position FE 1 Remove jar and change-over between the operating modes, hit the “Start/Stop”...

  • Page 33: General Notes On The Unguator Mixing System

    ® General Notes on the UNGUATOR Mixing System In its quality guideline for the production of semisolid preparations, the German Chamber of Pharmacists has recommended a closed system and delivery in dispensing containers with small dispensing opening since the year 2000. 4.1 References ®...

  • Page 34: Niches Of Flow On The Unguator Standard Mixing Blade (Smb)

    ® Fig. 4-1: Assignment of the UNGUATOR SMB with different length of shaft ® and while the same UNGUATOR Disp. Blade is used for the 100 and 200 ml ® UNGUATOR Jar sizes, it needs a different shaft for each. See also the operating instructions that come with the shafts.

  • Page 35: Heating

    ® 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 diminuated again following this process.

  • Page 36: Notes On Dispensing Ointment

    ® The air was not diminuated 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 ®...

  • Page 37: Jar Lid

    Here the ointment can be dispensed with a spatula, as from the traditional jar with lid, when the UNGUATOR ® Jar Lid is removed. If the UNGUATOR ® Jar Lid has been removed, the ointment should be pushed up close to the lid after dispensing this way ®...

  • Page 38: Quality Assurance Of The Ointments

    4.4 Quality Assurance of the Ointments Simple test methods convincingly demonstrate the good homogenizing capability of ® the UNGUATOR Mixing System. The test is performed using analog formulations with colored powders such as iron oxide (red/hydrophilic, yellow/hydrophobic) or Su- dan red and riboflavin [2] or methylene blue [4]. Here the examination of ointment streaks from various levels of the mixing jar using a magnifying glass or microscope have demonstrated the success of the mixing process, as has viewing one or more ®...

  • Page 39: Service And Warranty

    Service and Warranty 5.1 Notes on Malfunctions ® If UNGUATOR device is not functioning, it may be due to something small that you can remedy yourself. Please read and apply the tips below before returning the device for repair: • If the UNGUATOR ®...
  • Page 40 • The warranty claim will lapse should an unauthorized party have interfered with the device. Damages caused by improper use as well as Force Majeure or other external influences are excluded from any warranty claims. • The parts replaced at maintenance and repair will become property of SMS Elap GmbH &...

  • Page 41: Bibliography

    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 Zei- tung (PZ) Nr. 30 Jhg. 141/1996 S. 30-33 Alberg et al., Pharmaz. Technologie TU Braunschweig [3] Keimzahl in wasserhaltigen Dermatika.

  • Page 42: Notes On Safety

    Notes on safety ® • UNGUATOR devices must only be connected to grounding-type receptacles with 230 V or rated country-specific voltage installed according to the regulations of DIN VDE 0100. ® • UNGUATOR devices have been designed for operation under normal room atmospheric conditions.

  • Page 43: Technical Data Of The Unguator

    ® Technical data of the UNGUATOR Electrical requirement 230 V / 50 cps; 120 V / 60 cps Total power consumption 270 W Power consumption (mixing motor) 220 W Power consumption (lifting motor) 50 W Operating mode KB 5 Safety class Type of protection IP 21 Speed controller...

  • Page 44: Manufacturer's Certificate

    2) Declarations of conformity for materials and color concentrates of the materials vendors are deposited at the licensed manufacturer. 3) With certificate of analysis according to ZL Packing Instruction DK II / 1994 on the packaging hose. GAKO Konietzko GmbH D-96049 Bamberg / Germany Dipl.-Wirtsch.-Ing.

  • Page 45: Distribution, Manufacturing And Customer Service

    Distribution and Terms of Delivery ® Distribution of UNGUATOR line products is exclusively made through wholesale firms that either have a marketing agreement with GAKO Konietzko GmbH or GAKO ® International GmbH. In Germany, the UNGUATOR line products are also directly marketed by GAKO Konietzko GmbH.

  • Page 46: Warranty Certificate

    Herstellerzertifikat WARRANTY CERTIFICATE for the Date of purchase: _________ Ser. no.: ________ Stamp and signature: SMS Elap GmbH & Co. KG ® Service-Center UNGUATOR Am Köhlersgehäu 50 D-98544 Zella-Mehlis Telephone: +49 (0) 3682 / 455 199 Fax: +49 (0) 3682 / 455 206 Warranty Certificate...
  • Page 47 12 Dokumentationsblatt...

  • Page 48: Document Template

    Document template...
  • Page 52 GAKO International GmbH Dantestrasse 27 D-80637 München www.unguator.com...

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