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gako unguator B/R Operatng Instructons And Producton Recomendatons

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Operating Instructions and Production Recomendations
B/R

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Summary of Contents for gako unguator B/R

  • Page 1 Operating Instructions and Production Recomendations...
  • 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...

  • Page 3: Table Of Contents

    UNGUATOR® Coupling 3.2.7 Air Dynamic® Pumpball System General guidelines for the UNGUATOR® Technology Preparing the UNGUATOR® Mixing System 4.2 Weighed portion of the formulation Preparing the mixing process The mixing process using the UNGUATOR® B/R 4.4.1 Emulsion 4.4.2 Emulsion + 4.4.3 Normal 4.4.4 Suspension <2% 4.4.5...
  • Page 4 Bibliography Distribution, manufacturing and customer service Index of tables Tab. 1. Quality improvement with increasing automation Tab. 2. Minimum values for mixing time at speed level 9 in min:sec Tab. 3. Minimum values for mixing time at speed level 5 in min:sec Index of pictures Pic. 1 UNGUATOR® B/R description Pic. 2 UNGUATOR® B/R Pic. 3 UNGUATOR® e/s Pic. 4 UNGUATOR® 2100 Pic. 5 UNGUATOR® Q Pic. 6 UNGUATOR® Standard mixing blade (SMB) Pic. 7 UNGUATOR®...

  • Page 5: Installation Information

    1. Installation information Select a suitable location for the UNGUATOR® B/R CAUTION! The UNGUATOR® B/R weighs almost 15 lbs (6,8 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® B/R. This must include sufficient space around the UNGUATOR®...
  • Page 6 UNGUATOR B/R Speed controller Drive head Power cord Fig. 1: UNGUATOR® B/R description...

  • Page 7: Initial Operation

    2. Initial operation You will find the power switch “O/I” located at the rear of the UNGUATOR® B/R on its base. This is also the emergency switch. Please check that the UNGUATOR® B/R power switch is set to off. Connect the power cord to the socket outlet. You may now switch the UNGUATOR®...

  • Page 8: Unguator® B/R

    Tab.1: Quality improvement with increasing automation 3.1.1 UNGUATOR® B/R The UNGUATOR® B/R is the basic machine with controlled mixing motor and manual jar guidance. 3.1.2 UNGUATOR® e/s Pic. 2: UNGUATOR® B/R The UNGUATOR® e/s machine was developed for efficient individual and batch preparations.

  • Page 9: Unguator® 2100

    3.1.3 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 that can be stored.

  • Page 10: Unguator® Assortment

    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 UNGUATOR®...
  • Page 11 UNGUATOR® Disposable blade (Disp. blade) The UNGUATOR® Disp. Blade is suitable for all UNGUATOR® devices. The mixing blade of 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 12 Pic. 9: 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 13: Unguator® Jar

    Cleaning the UNGUATOR® MB The UNGUATOR® MB is normally cleaned with a paper towel and, if necessary, held under a hot water jet and then dried with dispensing pulp. UNGUATOR® MBs can also be cleaned in a conventional dishwasher. All the UNGUATOR® devices as well as UNGUATOR® line of products must not be treated with sharp-edged objects or abrasive cleaning agents.
  • Page 14 disinfection prior usage could put the certified asepsis at risk. We would recommend storing the UNGUATOR® Jars in its plastic packaging after opening for protection against possible dust contamination. The UNGUATOR® Jar sizes 300 to 1000 ml are particularly well suited as storage and transfer vessels for semisolids and other preparations.
  • Page 15 Notes on dispensing ointment Each customer should be given specific instructions at how to apply the UNGUATOR® Jars when handing to the individual client. The use of the UNGUATOR® Spindle should be explained for large UNGUATOR® Jars. Low viscosity ointments should be equipped with an UNGUATOR®...

  • Page 16: Unguator® Varionozzles

    3.2.3 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.

  • Page 17: Unguator® Spindle

    3.2.5 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 18: Unguator® Coupling

    3.2.6 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® Coupling will ensure hygiene from the mixing process to the end user.

  • Page 19: General Guidelines For The Unguator® Technology

    By pumping air into the lower chamber of the UNGUATOR® Jar using the pumball, the pressure thus generated moves the bottom upward. Thanks to the AirDynamic® Pumball System, even thick pastes can be dispensed via the small dispensing opening in the screw cap or transferred to small UNGUATOR®...

  • Page 20: Preparing The Mixing Process

    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 21: The Mixing Process Using The Unguator® B/R

    The prepared UNGUATOR® Mixing System is inserted into the bayonet holder of the UNGUATOR® B/R from below and pushed up as far as it will go. The UNGUATOR® Jar Lid and the UNGUATOR® Jar housing should be held simultaneously in one hand.

  • Page 22: Emulsion

    The UNGUATOR® Mixing System can now be inserted back into the bayonet receptor of the UNGUATOR® B/R from below and pushed up as far as it will go. The UNGUATOR® MB can now clean itself through high-speed rotation in a position close to the lid.

  • Page 23: Normal

    are used. Melting semisolid substances using max. 85°C/185°F hot water can be achieved by three methods: 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.

  • Page 24: 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 25: Suppositories

    4.4.7 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 26: After The Mixing Process Is Complete

    Waxes, Hydrophilic ointment, etc. Either pour warm water alone (≤ 85 °C/185 °F) or the heated remaining ingredients constituents over Cera, Lanette N, etc. in the UNGUATOR® Jar, pour water in the substances and heat them either in a heated-water bath (≤ 85 °C/185 °F) or carefully observed in a microwave oven.

  • Page 27: Patent Protection

    has elapsed, homogeneity inside the UNGUATOR® Jar in fall can be expected. Push the UNGUATOR® MB out of the UNGUATOR® Jar Lid. The ointment on the mixing blade can be fallen off into the UNGUATOR® Jar using a spatula. When using the UNGUATOR® Disp.

  • Page 28: General Notes For The Unguator® Mixing System

    The UNGUATOR® Mixing System with its versatile and comprehensive line products captivates with its simplicity. Everything the pharmacist needs for the production of pharmaceutical ointments and cosmetics is covered by the UNGUATOR® Mixing System. 5.2 Potential sources of nonconformances • The UNGUATOR®...

  • Page 29: Service And Warranty

    Use a recipe with a colored substance, for example iron oxide (micronized) or Sudan Red and work this in a semi-solid base. You can spread out the finished recipe in a glass plate or in a microscope slide and check under the microscope the solids distribution and the grain size.

  • Page 30: Manufacturer's Service And Warranty

    • Repairs within warranty will be exclusively carried out by our local service partner, Gako International GmbH SMS Elap GmbH & Co. KG, Germany, or specifically authorized companies. 6.3 Notes on maintenance • 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 Gako International GmbH contact your UNGUATOR®...
  • Page 31 The device must not be disposed of in ordinary domestic waste. Please deliver the device to the available collecting and recycling systems at the end of its life cycle. 6.5 Technical data of the UNGUATOR® B/R Electrical requirement 90-265 V / 45-65 Hz...
  • Page 32 • The UNGUATOR® SMB is made out of Polyoximethylen. • The UNGUATOR® Disp. MB is made out of Polyamid. • The shaft of the UNGUATOR® MB is made of NIRO-Stainless steel (quality standard: 1.4301) and hardened titanium-nitride (golden color). The utilized material and pigments are physiologically classified as safe.
  • Page 33 8. Bibliography •[1] Jahr UNGUATOR®-Rührsystem Deutsche Apothekerzeitung (DAZ) 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 34 9. Manufacturer’s certificate/ Declaration of Conformity for plastic materials, which come into contact with food. Article Material standard cosmetic UNGUATOR® Jar cap Polypropylene, natural white colored UNGUATOR® Jar lid Polypropylene, natural red, white, colored green, blue UNGUATOR® Jar body Polypropylene, natural white colored UNGUATOR®...
  • Page 35 10. 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@unguator.com Web: www.unguator.com GAKO® International GmbH Dantestrasse 27 Landsberger Straße 314 80637 Munich, Germany 80687 Munich, Germany Phone: +49 (0) 89 / 15 88 16 88...
  • Page 36 ® GAKO International GmbH Dantestrasse 27 Landsberger Straße 314 80637 München 80687 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 www.

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