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Summary of Contents for Gako Unguator 2100
- Page 1 Operating Instructions and Production Recommendations 2100...
- Page 2 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...
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Page 3: Table Of Contents
Table of content Installation information Initial operation Display operation Language selection UNGUATOR® Technology UNGUATOR® mixing machines 5.1.1 UNGUATOR®B/R 5.1.2 UNGUATOR® e/s 5.1.3 UNGUATOR® 2100 5.1.4 UNGUATOR® Q UNGUATOR® Assortment 5.2.1 UNGUATOR® Mixing Blade (MB) 5.2.2 UNGUATOR® Jar 5.2.3 UNGUATOR® Varionozzles 5.2.4 UNGUATOR®... - Page 4 6.4.11.4 “Delete” a manual preparation 6.4.11.5 Pregrind program 6.4.11.6 Number of strokes 6.4.11.7 Mixing time 6.4.11.8 Minimum mixing times for the “Direct“and “Manual“programs 6.4.11.9 Selecting the UNGUATOR® Jar size 6.4.12 Requirements for the ingredients of a prescription Preparing the mixing process 6.6 After the mixing process is complete General notes on the UNGUATOR® Mixing System 7.1 Patent protection 7.2 Identification number 7.3 Operating errors 7.4 Potential sources of nonconformances 7.5 Quality assurance of the ointments Service and warranty 8.1...
- Page 5 Index of pictures Pic. 1: UNGUATOR® 2100 Pic. 2: Display with splash screen Pic. 3: Language set up Pic. 4: UNGUATOR® B/R Pic. 5: UNGUATOR® e/s Pic. 6: UNGUATOR® 2100 Pic. 7: UNGUATOR® Q Pic. 8: UNGUATOR® Standard Mixing Blade (SMB) Pic. 9: UNGUATOR® Disp. Blade Pic. 10: Handling the UNGUATOR® Disposable Blade (Disp. Blade) Pic. 11: Assignment of the UNGUATOR® SMB with different length of shaft Pic.
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Page 6: Installation Information
1. Installation information Select a suitable location for the UNGUATOR® 2100. CAUTION! The UNGUATOR® 2100 weighs 36.7 lbs (16.7 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®... -
Page 7: Pic. 1: Unguator® 2100
UNGUATOR 2100 display “Esc” button-to cancel or delete the program “-” button to select “+” button to select “ok” button to confirm lifting arm power plug and USB interface main power switch/ emergency off Pic. 1: UNGUATOR® 2100... -
Page 8: Initial Operation
2. Initial operation The interfaces for the power cord and USB-cable are located on the rear side of the UNGUATOR® 2100. The power “O/I” switch is also the emergency switch and is located at the bottom right side. Please check that the power switch of the UNGUATOR® 2100 is switched off. -
Page 9: Unguator® Technology
Press the “Esc” key to move from the start screen to the language menu. The “+” and “–” keys will get you to the next or previous language setting. Enter “Ok” to enter your selection and move back to the start screen again. 5. -
Page 10: Unguator®B/R
Method of Pharmaceutical Uniformity of Lifting arm Mixing parameters ointment Quality ointment preparation Mortar and pestle manual UNGUATOR® B/R manual manually adjustable UNGUATOR® e/s automatic individually programmable UNGUATOR® Q ++++ ++++ automatic fully automatic UNGUATOR® 2100 ++++ ++++ automatic fully automatic Tab. -
Page 11: Unguator® 2100
5.1.3 UNGUATOR® 2100 The UNGUATOR® 2100 shows all the advantages of its 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 can be stored. -
Page 12: Unguator® Assortment
5.2 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®... -
Page 13: Pic. 9: Unguator® Disp. Blade
UNGUATOR® Disposable blade (Disp. blade) The UNGUATOR® Disp. Blade is suitable for all UNGUATOR® devices. The mixing blade of the 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. -
Page 14: Pic. 11: Assignment Of The Unguator® Smb With Different
Pic. 11: 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®... -
Page 15: Unguator® Jar
Cleaning the UNGUATOR® MB The UNGUATOR® MB is normally cleaned with a paper towel and, if necessary, held under a hot water faucet and then dried with the paper towel. UNGUATOR® MBs can also be cleaned in a dishwasher. The UNGUATOR® devices as well as the UNGUATOR® line of products should never be treated with sharp-edged objects or abrasive cleaning agents. -
Page 16: Pic. 13: Certificate Of Analysis For The (E.g. 50Ml) Unguator® Jar
Dichtigkeit / Seal Integrity Mikrobiologie / Microbiology gez/signed: Grieser (head of quality assurance) GAKO® * www.unguator.com Pic. 13: Certificate of Analysis for the UNGUATOR® jar of 50 ml 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. -
Page 17: Pic.14: Dispensing With Regular Unguator® Varionozzle
Notes on Dispensing ointment Each customer should be given specific instructions at how to apply the UNGUATOR® Jars when speaking to the individual client. The use of the UNGUATOR® Spindle should be explained for large UNGUATOR® Jars, size 300/500 ml. Low viscosity ointments should be equipped with an UNGUATOR®... -
Page 18: Unguator® Varionozzles
5.2.3 UNGUATOR® Varionozzles The UNGUATOR® Varionozzles with inner diameters of 1, 2 or 4 mm can be pressed into the regular nozzle of any UNGUATOR® jar. They reduce the opening size, making it possible to safely dose even low formulations. The Pic 18: UNGUATOR®... -
Page 19: Unguator® Spindle
5.2.5 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 the UNGUATOR®... -
Page 20: Unguator® Coupling
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®... -
Page 21: General Guidelines For The Unguator® Technology
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®... -
Page 22: The Mixing Process With The Unguator® 2100
Listed below are the seven different general procedures used to produce the routine standard formulations in pharmaceutical preparation of ointments: EMULSION, EMULSION +, NORMAL, SUSPENSION<2%, SUSPENSION>2% as well as GEL and SUPPOSITORIES. Due to the rapid heat 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. -
Page 23: Standard Formulation Programs
speed of the mixing motor and the mixing time may still be changed during the mixing process. Up to 180 mixing programs can be stored in the machine using the “MANUAL” program. Each of these 180 programs allows the user to change numerous mixing parameters. Users can the addition of a free spin motion program for each of these 180 programs. -
Page 24: Emulsion
With the mixing process finished, the display of the UNGUATOR® 2100 will indicate the mixing parameters that have been run through. These are mixing time, number of revolutions of the UNGUATOR® number strokes identification number of the preparation. In addition, the number of the preparation Pic. -
Page 25: Normal
1. Addition of hot water (≤ 85°C/ 185°F) 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 (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®... -
Page 26: Suspension >2
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 gently work the substances, making use of these programs, the rpm and lifting speed can be individually selected and adjusted. -
Page 27: Suppositories
6.4.7 Suppositories We recommend using the UNGUATOR® Disp. 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. -
Page 28: Automated Stroke
movement of the oscillation arm is suspended when selecting speed step “0” and the oscillation arm is moved into its full down position before the mixing process starts which allows for a manually guided stroke. 6.4.9.1 Automated stroke Once the automated stroke has been selected, the user may, depending on the size of the UNGUATOR®... -
Page 29: Manual Stroke
6.4.9.2 Manual stroke Once the manual stroke has been selected, the user may, depending on UNGUATOR® Jar size, select up to 10 different speed steps for the UNGUATOR® MB using the “+” and “–” buttons and confirm this using the “ok” button. The last of the selectable mix parameters is mixing time which may be between 10 seconds and 2 hours. -
Page 30: Pic. 27: Combination Mix
First select the “COMBINATION MIX” program in the main menu using the “+” and “–” buttons. Confirm with the “ok” button. The oscillation arm will automatically move into the full down position and the display will prompt the user to mount the mixing tools. These consist of the UNGUATOR®... -
Page 31: Manual" Program
2100 display will indicate the mixing parameters that have been run through. These are mixing time, number of revolutions of the UNGUATOR® MB, number of strokes and the identification number of the preparation. In addition, the number of the preparation and the software of the UNGUATOR®... -
Page 32: Use" A Manual Preparation
the “PROGRAM SELECT:” menu will show. First select the “MANUAL” program using the “+” and “–” buttons in the main menu. Confirm with the “ok” key and the “UNGUATOR® JAR SELECTION” menu will show. Select UNGUATOR® Jar size using the “+” and “–” buttons and confirm with the “ok” button, and the “PROGRAM SELECT:”... -
Page 33: Indicate"A Manual Preparation
6.4.11.2 “Indicate” a manual preparation The “Indicate” menu option allows the user to get a quick general idea about the currently stored mix parameters of the mixing program selected. The tabulated data can be retrieved with the two screens “INDICATE: 1” and “INDICATE: 2”. When selecting the “Indicate”... -
Page 34: Tab. 2: Mixing Parameters Of The Grinding Programs From "00" To "03
Strokes Speed of the MB Speed of the lift- Prog. -No. Prog.-No. in rpm ing motor in rpm 00 (disabled) 01 (enabled) 01/02 1500 2200 01/02 2000 1500 02 (enabled) 01/02 1500 2200 01/02 1500 1500 03 (enabled) 01/02 1500 01/02 2000 1500... -
Page 35: Delete" A Manual Preparation
Step Speed of the lift- Step Speed of the Max. jar size allowed ing motor in rpm MB in rpm (Nominal volume in ml) 1000 1500 1000 1000 2200 1000 1000 2900 1250 1000 3600 1500 1000 1750 1000 2000 1000 2250 2500... -
Page 36: Pregrind Program
6.4.11.5 Pregrind program While the pre grind program is running, the lower part of the display shows „PREGRINDING ACTIVE“. mixing process is interrupted after the pre grind program has ended and the display shows the following prompt (Picture 30: After the pre grinding program). -
Page 37: Mixing Time
6.4.11.7 Mixing time The option of setting the mixing time has been designed solely for special tasks in the field of research or for users with adequate know-how. This is because the variable speed of the lifting motor and the influence on final product quality is unreadable for the unpracticed user. -
Page 38: Selecting The Unguator® Jar Size
6.4.11.9 Selecting the UNGUATOR® jar size The selection of the UNGUATOR® Jar size was designed to protect the UNGUATOR ® 2100 from overloads. For example, the maximum speed of the UNGUATOR® MB was limited to 2000 rpm when a 1000 ml UNGUATOR® Jar has been selected. 6.4.12 Requirements for the ingredients of a prescription Powder (Mixing powder to fill capsules). -
Page 39: Preparing The Mixing Process
°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. -
Page 40: After The Mixing Process Is Complete
At this point of the mixing process, device-specific settings will need to be implemented and the UNGUATOR® Mixing System connected to the UNGUATOR®. 6.6 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. -
Page 41: General Notes On The Unguator® Mixing System
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. -
Page 42: Operating Errors
The fifth and sixth digits stand for the MANUEL mixing program: 00 = no manual mixing program 01 = Manual mixing program no. 01 02 = Manual mixing program no. 02 etc. The seventh and eighth digit stands for the number of pasting programs: 00 = no pregrinding program applied 01 = 1 pregrinding program performed 02 = 2 pregrinding programs performed... - Page 43 recommend manually pulling up the UNGUATOR® MB as far as it will go after screwing in the UNGUATOR® Mixing System, if necessary. The Jar connected to the UNGUATOR® 2100 is not an UNGUATOR® Jar. This Jar has to be replaced with an UNGUATOR® Jar. A UNGUATOR®...
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Page 44: Potential Sources Of Nonconformances
For functionally testing reason the UNGUATOR® 2100 has to be switched off at first. The device can be switched on again after 20 seconds. No UNGUATOR® MB can be attached to the device during start up or reboot. It is best to change the UNGUATOR® Jar size when performing a function test, and running a mixing process with a filled UNGUATOR®... -
Page 45: Quality Assurance Of The Ointments
To preserve 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 & Co. KG after 20,000 Gako International GmbH preparations or after five (5) years for maintenance. •... -
Page 46: Manufacturer's Service And Warranty
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 GAKO®. • Claims beyond the free rectification of faults, e.g. indemnification cannot be made within the warranty period. -
Page 47: Technical Data Of The Unguator® 2100
• 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! •... -
Page 48: Quality And Material
8.6 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 Technology. • The UNGUATOR® Aplicators, Couplings and Jars, are made out of Polypropylen (PP) and the regular UNGUATOR®... -
Page 49: Bibliography
10. 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 •... -
Page 50: Manufacturer's Certificate/ Declaration Of Conformity
The traceability of Regulation (EC) No 1953 /2004 of the product is ensured by the lot number and the application of manufacture. Specification for intended use: Kind / types of food or procedures for which the material is suitable: aqueous media acidic media ® issued by GAKO Germany - production control (as of January 2013) ® issued by GAKO... -
Page 51: Distribution, Manufacturing And Customer Service
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. - Page 52 ® GAKO International GmbH Dantestrasse 27 Landsberger Strasse 314 80687 München 80637 München GERMANY GERMANY phone: +49 (0)89/15 88 16 88 phone: +49 (0)89 1222 387 200 fax: +49 (0)89/15 88 14 85 fax: +49 (0)89 1222 387 201 mail: contact@unguator.com...
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Questions and answers
I HAVE A 2100 THAT HAS STOPPED MIXING 100 GM AND 50 GMS. THE 200 GMS WORKS FLAWLESSLY! CAN YOU HELP ME? THE 50 AND 100 GM GOES FOR ABOUT 15 SECONDS INTO THE PROGRAM AND THEN STOPS. (shuts down) It is the correct jar(s), props, and everything else just as we do the 200 gms.
A possible issue causing the Gako Unguator 2100 to stop mixing 100 g and 50 g jars after 15 seconds could be that the UNGUATOR® Jar bottom was not pressed fully down to the stop position before use. This is listed as a potential source of nonconformance and may affect proper operation.
This answer is automatically generated