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Related Manuals for Gako UNGUATOR Q
Summary of Contents for Gako UNGUATOR Q
- Page 1 Operating Instructions and Production Recommendations...
- 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 Menu guide 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 General notes on the UNGUATOR® Mixing System 7.1 Patent protection 7.2 Quality assurance of the ointments 34 7.3 Potential sources of nonconformances Service and warranty 8.1 Notes on malfunctions 8.2 Manufacturer’s service and warranty 8.3 Notes on maintenance 8.4 Notes on safety Technical data of the UNGUATOR® Q Quality and material References Bibliography Manufacturer’s certificate Distribution, manufacturing and customer service Index of pictures Pic.
- Page 5 Pic. 18: UNGUATOR® Varionozzles Pic. 19: UNGUATOR® Applicator short 14 Pic. 20: UNGUATOR® Applicator long Pic. 21: How to operate the UNGUATOR® Spindle Pic. 22: UNGUATOR® Spindle Pic. 23: UNGUATOR® Coupling Pic. 24: UNGUATOR® AirDynamic ® Pumpballsystem Pic. 25: Program “Quick-ID-Start” Pic. 26: Lifting arm in start position for the “Manual” mixing program Pic. 27: Identification Number Index of tables Tab. 1: Quality improvement with increasing automation 5 Tab. 2: Number/Jar size correlation 19 Tab. 3: Letter/Time correlation 19...
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Page 6: Installation Information
1. Installation information Select a suitable location for the UNGUATOR® Q. CAUTION! The UNGUATOR® Q weighs almost 30 lbs (16,5 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® Q. This must include sufficient space around the UNGUATOR®... -
Page 7: Pic. 1: Unguator® Q
display “Esc” button to exit or abort a program “-” button to select “+” button to select lifting arm power plug main power switch/ emergency off Pic.1: UNGUATOR® Q... -
Page 8: Initial Operation
2. Initial Operation On the back of the UNGUATOR® Q you will find the interface for the power cord. The power switch “O/I“ is also the emergency switch and it is located at the base of the machine, on the right side. Initially check if the power switch of the Unguator® is switched off. Second, connect the power cable to the device, and finally connect the power cable to the outlet. -
Page 9: Unguator® Technology
Pic. 3.: Select “display”, “language”, and “key sound” Pressing the “Esc” key you will move from the “Start Menu” to the setting options. Here, you may change the background color of your display, the operating language and acti- vate or deactivate a key sound. Changes in the language or in the color background might take a few seconds loading prior being activated. -
Page 10: Unguator® Mixing Machines
5.1 UNGUATOR® mixing machines The current UNGUATOR® mixing machines - UNGUATOR® B/R, UNGUATOR® e/s, UNGUATOR® 2100 and UNGUATOR Q - are useful and advanced improvements on the first UNGUATOR® launched in 1994. They are designed for a working capacity of approx. -
Page 11: Unguator® E/S
5.1.2 UNGUATOR® e/s 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®... -
Page 12: Unguator® Q
Blade to mix an ointment homogeneously with a slow stroke. 5.1.4 UNGUATOR® Q The UNGUATOR Q is the result of continuous improvement of the UNGUATOR® e/s from the year 2003. It combines both the mixing functions of the UNGUATOR® e/s and the operating concept of the UNGUATOR®... -
Page 13: Pic. 8: Unguator® Smb
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® MB’s are dishwasher safe. UNGUATOR® Standard mixing blade (SMB) UNGUATOR®... -
Page 14: Pic. 10: Handling The Unguator® Disp. Blade
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) Pic. -
Page 15: Unguator® Jar
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 ointment’s ingredients’ compatibility of weighted formulation and also if the UNGUATOR®... -
Page 16: Pic. 12: Unguator® Jars
With its small dispensing opening, comparable to a tube and without an environmental contamination surface, the UNGUATOR® guarantees the minimization of negative quality interference demanded by section 13, ApBetrO (Pharmacist Operating Regulations); including those caused by germs on the fingers when dispensing the ointment. -
Page 17: Pic. 13: Certificate Of Analysis For The Unguator® Jar Of 50Ml
Dichtigkeit / Seal Integrity Mikrobiologie / Microbiology gez/signed: Grieser (head of quality assurance) GAKO® Konietzko GmbH * www.unguator.com PIc. 13: Certificate of Analysis for the UNGUATOR® jar of 50 ml Notes on Dispensing Ointment Each customer should be given specific instructions at how to apply the UNGUATOR®... -
Page 18: Unguator® Varionozzles
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. Quantity of ointment in ml Quantity of ointment in ml Pic. -
Page 19: Unguator® Applicators
5.2.4 UNGUATOR® Applicators The UNGUATOR® Applicators reduce the dispensed quantity of low-viscosity formula- tions and are particularly helpful in cases where the ointment must be applied precisely. UNGUATOR® Applicator short The UNGUATOR® Applicator short with a diameter of 1mm is obligatory for nose and ear ointments. -
Page 20: Unguator® Coupling
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. -
Page 21: Airdynamic® Pumpball System
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®... -
Page 22: Weighing Portion Of The Formulation
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 inserted into the UNGUATOR® Jar housing, sliding the UNGUATOR®... -
Page 23: Formulation Programs
6.3 The mixing process with the UNGUATOR® Q The UNGUATOR® Q is the result of continuous improvements of the UNGUATOR® Technology. The integrated programmable software that automates the UNGUATOR® Q Mixing System completely turns the device into a universal machine for the production of formulations! The UNGUATOR®... -
Page 24: Tab. 2: Number/Jar Size Correlation
The first number of the UNGUATOR® identification code provides information about the jar size, whereby each jar size is assigned to one of the following numbers: ® Jar 1 Unguator Jar in ml Tab. 2: Number/Jar size correlation Enter the specific UNGUATOR® jar size you like to start with by pressing the “+” and “-” key, confirming your selection with the “ok”... -
Page 25: Auto-Q
Set with “+” or “-” the desired rpm and confirm your selection with “ok”. With this option you may define up to 6 mixing stages. With “Esc” you may go back to the previous step and edit if necessary. By confirming the final ID stage, you also confirmed the completed identification number in total. -
Page 26: Individual
size 100mI and greater the maximum rpm is restricted. This is a safety feature to optimize the power exposure for all material, jars, and mixing blades particularly when using larger jars. Afterwards you may choose the initial mixing time with “+” or “-“. The time is set to a maximum of 10 minutes to begin with. -
Page 27: Standard
Please note: As a professional user you are responsible for the quality of the final formulation. Please always check the quality of the final product prior delivering to the client. After each completed mixing process the UNGUATOR® Q generates an identification number which contains all mixing parameters. - Page 28 The movable bottom shall remain at the lowest position during the pregrinding process in order to utilize the complete inner wall of the UNGUATOR® jar as grinding surface. Please inspect the preparation for agglomerates or qualitative abnormalities after the grinding process is completed. If required, the pregrinding process may be repeated. After the pregrinding process has been completet, additional components of the formulation can be added and the ointment base may fill up the jar to the desired volume.
- Page 29 overheating of the formulation. In case the basis should not contain any water, the components that are to be melted may be softened directly in the UNGUATOR® jar on a water bath. To support cooling off during the mixing process, attaching a cooling jacket/pad on the outside of the jar for smaller jar sizes or repeating the mixing process for larger jar sizes might be applicable.
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Page 30: Manual
If a formulation shows some higher content of solids, e.g. pastes, heating of the formulation during the mixing process may occur. This temperature rise may be reduced applying cooled bases or a cooling pad. If you are processing temperature-sensitive active ingredients, we recommend selecting the “Qick-ID-Start”... -
Page 31: Mixing Time
With the “Manual” program you may start the process directly without retrieving any data from previously saved mixing programs. To begin, select the UNGUATOR® jar size using the “+” or “-” key and enter with “ok”. From jar size 100mI and greater the maximum rpm is restricted. This is a safety feature to optimize the power exposure for all material, jars, and mixing blades particularly when using larger UNGUATOR®... -
Page 32: Selecting The Unguator® Jar Size
minimum mixing time for any given formulation may vary. The following time values for each rpm serves as benchmark, which should be adjusted after each modification of rpm. Size of the UNGUATOR® Jar Type of formulation 15-30ml 50-100ml 200-300ml 500ml Suspension 02:00 02:30... - Page 33 Crystalline active ingredients In order to avoid complex postprocessing (e.g. w/ ointment mill), we recommend pulverizing active crystalline agents with the help of a mortar prior adding to 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®...
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Page 34: After The Mixing Process Is Complete
jacket or cool-down periods in a refrigerator if required. 6.8 After the mixing process is complete The UNGUATOR® Mixing System shall be released and removed from the UNGUATOR® oscillation arm once the mixing process has been completed. Unscrew the UNGUATOR® jar Lid from the oscillation arm and/or twist the UNGUATOR®... -
Page 35: Identification Number
Identification Number The 13 digit identification number (ID code) to clearly identify each preparation has the fol- lowing format: Pic. 27: Identification number The first number of the UNGUATOR® identification code provides information about the jar size, whereby each jar size is assigned to one of the following numbers: UNGUA- TOR®... -
Page 36: Operating Errors
The input of the rpm is assigned to the numbers 0-9, in which each number correlates to a defined rpm value: Level 1000 1200 1400 1650 1900 2150 2400 Tab. 9: Number/Rpm correlation 6.10 Operating errors The quality assurance system of the UNGUATOR® Q makes sure that operating errors shall be sensitively registered and displayed. - Page 37 The UNGUATOR® MB should not be pressed too deep in the UNGUATOR® Jar, thus the lifting arm can reach the bayonet. For this reason we recommend that after screwing the UNGUATOR® mixing unit on, the UNGUATOR® MB shaft should by manually drawn back to the jar lid.
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Page 38: Cleaning The Unguator® Q
nominal volume. Please use the next larger UNGUATOR® jar for mixing. Error: The air was not removed from the jar prior mixing semisolid preparations. Troubleshooting: 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®... -
Page 39: General Notes On The Unguator® Mixing System
Bamberg, 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 preparation of pharmaceutical ointments and cosmetics is covered by the UNGUATOR®... -
Page 40: Potential Sources Of Nonconformances
“sudan red” worked in a semi-solid base. You can spread out the finished mixture on a glass plate or a microscope slide and check the solids distribution and the grain particle size. For a short-term statement about the solids distribution in the formula basis, you can test in different levels of the UNGUATOR®... -
Page 41: 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 42: Notes On Safety
• 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. • Upon request an UNGUATOR® loaner may be provided for a one-time charge that can be used while your UNGUATOR®... -
Page 43: Technical Data Of The Unguator® Q
9. Technical data of the UNGUATOR® Q Electrical requirement no restrictions Total power consumption 300 W Power consumption (mixing motor) 250 W Power consumption (lifting motor) 50 W Operating mode continuous operation S1 Continuous operation S1 Safety class I Type of protection IP 20 Speed controller in 10 stages electronically controlled... -
Page 44: Bibliography
11. 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. - Page 45 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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Page 46: Manufacturer's Certificate
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) The certificate has been produced electronically and is valid without a signature... -
Page 47: Distribution, Manufacturing And Customer Service
13. Distribution, manufacturing and customer service GAKO® Konietzko GmbH Oberer Stephansberg 49g 96049 Bamberg, Germany Phone: +49 (0) 951 / 582 55 Fax: +49 (0) 951 / 500 602 Email: kontakt@gako.de Website: www.unguator.com GAKO® International GmbH Dantestraße 27 Landsberger Straße 314 D-80687 München... - Page 48 GAKO International GmbH ® Dantestrasse 27 Landsberger Straße 314 80637 München 80687 München GERMANY GERMANY Phone: +49 (0)89 1222 387 200 phone: +49 (0)89/15 88 16 88 Fax: +49 (0)89 1222 387 201 fax: +49 (0)89/15 88 14 85 mail: contact@unguator.com...