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12. 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,
green, blue

colored

UNGUATOR®

Jar body

Polypropylene, natural

white

colored

UNGUATOR®

Jar bottom

Polypropylene,
Polyethylene

UNGUATOR®

Jar bottom cap

Polypropylene, natural

white

Further UNGUATOR® line items

UNGUATOR®

Spindle

Polypropylene, natural

white

UNGUATOR®

Aplicator long with

cap

Polypropylene, natural

white

UNGUATOR®

Aplicator short with

cap

Polypropylene, natural

white

UNGUATOR®

Coupling

Polypropylene, natural

white

UNGUATOR®

Varionozzle blue,

yellow, pink

Polypropylene, natural

blue, yellow, red

UNGUATOR®

Disp. Blade

Polyamide, white

UNGUATOR®

SMB

Polyoxymethylene

All products listed are manufactured according to the legal requirements of plastic Regulation (EU) No 10/2011 and

(EU) No 1935/2004 (in their current version).

For applications according to formal specification both the overall and specific migration are under the legal limits of 10mg/dm3,

according to 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 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)

The certificate has been produced electronically and is valid without a signature

1) The licensed manufacturer, SMS
ELAP GmbH & Co. KG, D-98544 Zel-
la-Mehlis is DIN EN ISO 9001:2000
certified

2)  Declarations  of  conformity  for
materials  and  color  concentrates
of  the  materials  vendors  are
deposited

the

licensed

manufacturer.

Polypropylen
natur

Polyamid

Caprolactam:

SML(T) = 15 mg/kg

Polyethylen

Ref.-Nr. 68320:

SML = 6 mg/kg

Ref.-Nr. 89040:

SML = 25 mg/kg
(calculated as Zn
salt)

Polyoxymethylen

white

Ref.-Nr. 46880:

SML = 6 mg/kg

white (SMB)

Formaldehyd:

SML = 15 mg/kg

1,3-Dioxolan:

SML = 5 mg/kg

Trioxan:

SML = 5 mg/kg

white (disposable
blade)

Caprolactan:

SML(T) = 15 mg/kg

other colors

Material:

Color concentrate:

Содержание UNGUATOR Q

Страница 1: ...Operating Instructions and Production Recommendations Q ...

Страница 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 ...

Страница 3: ... Spindle 14 5 2 6 UNGUATOR Coupling 15 5 2 7 AirDynamic Pumpball System 16 6 General guidelines for the UNGUATOR Technology 16 6 1 Preparing the UNGUATOR Mixing System 16 6 2 Weighing portion of the formulation 17 6 3 The mixing process 17 6 4 Formulation programs 18 6 4 1 Quick ID Start 18 6 4 2 Auto Q 20 6 4 3 Individual 21 6 4 4 Standard 22 6 4 5 Manual 25 6 5 Mixing time 26 6 6 Selecting the U...

Страница 4: ...ctures Pic 1 UNGUATOR Q 2 Pic 2 Display with splash screen 3 Pic 3 Select display language and key sound 4 Pic 4 UNGUATOR B R 5 Pic 5 UNGUATOR e s 6 Pic 6 UNGUATOR 2100 6 Pic 7 UNGUATOR Q 7 Pic 8 UNGUATOR SMB 8 Pic 9 UNGUATOR disposable blade 8 Pic 10 Handling the UNGUATOR disp blade 9 Pic 11 Assignment of the UNGUATOR SMB with different length of shaft 9 Pic 12 UNGUATOR Jars 11 Pic 13 Certificate...

Страница 5: ...osition for the Manual mixing program 26 Pic 27 Identification Number 30 Index of tables Tab 1 Quality improvement with increasing automation 5 Tab 2 Number Jar size correlation 19 Tab 3 Letter Time correlation 19 Tab 4 Number Rpm correlation 19 Tab 5 Minimum values for mixing time at 2150 rpm in min s 27 Tab 6 Minimum values for mixing time at 1650 rpm in min s 27 Tab 7 Number Jar size correlatio...

Страница 6: ...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 Q mixing device Power cable Operating instructions Please contact your responsible UNGUATOR dealer and or supplier immediately in ca...

Страница 7: ...2 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 ...

Страница 8: ...te 3 Display operation The face of the UNGUATOR Q device shows both a panel with four keys Esc ok for manual control or command input and a display screen After turning the UNGUATOR Q on pressing the main power switch a splash screen appears on the display The splash screen of your device might vary from brelow picture 34 The top bar shows the total number of preparations and current software vers...

Страница 9: ...hnology consists of the patented arrangement of the UNGUATOR Mixing Blade adapted to the requirements of prescription ointments and the UNGUATOR Jar that serves as both a hygienic mixing jar and a hygienic dispensing jar The principle of the preparation method using UNGUATOR Technology in the closed UNGUATOR Mixing System is quick and easy to learn true to the motto learning by doing A little expe...

Страница 10: ...Product quality product uniformity and reproducibility of ointments prepared individually and in batches were improved with the increasing automation of the UNGUATOR units starting with the individual model B R through e s Q and 2100 model Method of ointment preparation Pharmaceutical Quality Uniformity of ointment Lifting arm Mixing parameters Mortar and pestle n a manual UNGUATOR B R manual manu...

Страница 11: ...eous ointment but also one with the desired ratio of active ingredients 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 that may be individually saved ...

Страница 12: ...lculation can be very time consuming and complex 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 Spindle the UNGU...

Страница 13: ...glass cleaning operations we recommend the use of the UNGUATOR Disp Blade 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 The material contact in the oint...

Страница 14: ...de may cause problems and failure messages Please also ensure that the right shaft is used when working with the UNGUATOR Disp Blade Both available shafts are marked for use with sizes 15 100ml or 200ml in the UNGUATOR Jar They have to be combined with the correct UNGUATOR Disp Blade and while the same UNGUATOR Disp Blade is used for the 100 and 200ml UNGUATOR Jar sizes it still needs a different ...

Страница 15: ... was the maximum taken after 6 minutes of mixing a highly pasty preparation made of vaseline and zinc oxide aa at full speed This temperature increase is generally safe for the substances used in the pharmaceutical field Ointments of low viscosity only heat slightly 2 Volatile substances such as ethereal oils or alcohol do not evaporate from the closed UNGUATOR Mixing System Cleaning the UNGUATOR ...

Страница 16: ...een blue and white Upon special demand and defined quantity UNGUATOR Jars from 20 to 200ml may also be ordered in customized colors All UNGUATOR Jars come sealed in plastic packaging Cleaning or 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 U...

Страница 17: ...gkeit Seal Integrity OK Mikrobiologie Microbiology OK gez signed Grieser head of quality assurance GAKO Konietzko GmbH www unguator com 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 e...

Страница 18: ...es The softly rounded surface allows ointment to be pleasantly distributed on the skin The coloring was selected corresponding to the wavelength of light 4 mm red long wavelength light 2 mm yellow 1 mm blue short wavelength light Pic 18 UNGUATOR Varionozzles 13 Lenght of ointment rope in cm Lenght of ointment rope in cm Lenght of ointment rope in cm Pic 14 Dispensing with regular UNGUATOR varionoz...

Страница 19: ...nerally available both with and without cap 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 Spindle is screwed slightly 1 2 to max 1 turn counterclockwise...

Страница 20: ... 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 The 200ml UNGUATOR Jar becomes a convenient transfer device to smaller UNGUATOR Jars when their UNGUATOR ...

Страница 21: ... bottom of the UNGUATOR Jar with an air tight connection 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 Jars using the UNGUATOR Coupling The material outlet velo...

Страница 22: ...ain general procedures to optimize the mixing results Generally know how gained from the traditional preparation of ointments is very helpful when using the UNGUATOR Mixing System As already mentioned at the beginning of the operating instructions true to the motto learning by doing Listed below are the seven different general procedures used to produce the routine standardformulationsinpharmaceut...

Страница 23: ...ze of the UNGUATOR Jar a microprocessor controls the mixing parameters for a consistent and reproducible product quality After the completion of each preparation the UNGUATOR Q automatically assigns an identification number It is used for simple documentation and the accurate reproduction of the mixing process and will appear on the display after the mixing process 6 4 Formulation programs 6 4 1 Q...

Страница 24: ...nd time mm ss for each step of the six possible mixing levels The time is specified in upper and lowercase letters whereas each letter is assigned to a specific time value A B C D E F G H I J K L M mm ss 00 05 00 10 00 15 00 20 00 25 00 30 00 35 00 40 00 45 00 50 00 55 01 00 01 05 N O P Q R S T U V W X Y Z mm ss 01 10 01 15 01 20 01 25 01 30 01 35 01 40 01 45 01 50 01 55 02 00 02 05 02 10 a b c d ...

Страница 25: ... scales all previously entered mixing parameters adjusted for the actual jar size Scaling is limited to a minimum of 5 seconds and maximum 10 minutes for each mixing level Hence smaller or greater time intervals cannot be processed 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...

Страница 26: ...an be max 10 minutes long the total mixing time is 60 minutes After each completed mixing process the UNGUATOR Q generates an identification number which contains all mixing parameters You have the opportunity to save record or reject the number Saving the formulation enables you to individually name it Rejecting the identification number would not allow the data being retrieved again and the info...

Страница 27: ...idual formulation select the defined formulation with or and press down the ESC key for min 3 seconds You may now delete the defined formulation To verify a security inquiry will appear which you may accept or reject 6 4 4 Standard The Standard program allows you to choose from a list of standard mixing programs based on the galenic administration of the particular formulation to be manufactured W...

Страница 28: ...lades for larger batches In preparation the entire ointment base should be weigh out inside the jar covering the bottom Then add the required amount of liquid or solution in room temperature In some cases you may experience difficulties emulsifying refrigerated bases In that case the process of emulsification can be accelerated by adding heated liquid Emulsion The Emulsion program allows you to ac...

Страница 29: ...erwards cover the substance with the remaining base At a jar size 200ml or greater you may also implement multiple layering in order to ensure a faster mixing of the final formulation Suspension 2 After a pregrinding process has been completet the Suspension 2 program gives you the opportunity to finalize the formulation with ointment base Suspension 2 Selecting the Suspension 2 program you may in...

Страница 30: ... prepare please weigh out the liquid phase into the UNGUATOR jar Soluble solids may be added and dissolved directly in the jar The welling agent is then sprinkled on If the welling agent is incorporated into a semi solid base you may embed the welling substance between the base layers That way you would obtain a faster dispersion of the welling agent in the base After each mixing performance the U...

Страница 31: ...r starting the mixing process by entering the ok key The UNGUATOR mixing unit shall now be evenly and at a moderate rate moved up and down all the way from the bottom to the top of the jar lid and vice versa During the mixing process you may modify the mixing time if needed by pushing the or key With ok you may also move to the rpm setting The speed may also be adjusted with or After pushing ok yo...

Страница 32: ...UNGUATOR Jar Size The maximum rpm for jar sizes 100ml and greater is restricted This is a safety feature to optimize the power exposure for all material jars and mixing blades particularly when using larger UNGUATOR jars 6 7 Condition of the ingredients for any formula Powder Generally powders should be used as microfine substances In order to ensure better wetting of powders in aqueous formulatio...

Страница 33: ...served in a microwave oven In order to ovoid overpressure please mind having the white cap on the lid removed Formulations without water containing components may be melted already directly inside the UNGUATOR Jar by placing the jar in a warm water bath Please be aware that UNGUATOR MB s must not go in the microwave oven Furthermore due to irregular mixing of adipose and water phases reaching the ...

Страница 34: ... to the standard mixing blade can be scraped off the blades using a spatula When using the UNGUATOR disp bade the mixing blade can be removed from the UNGUATOR jar and discarded or left inside the jar Leaving the disposable blade inside the jar will have no adverse effects in any way Nevertheless removing the disposable mixing blade is recommended particularly when forwarding the ointment to elder...

Страница 35: ...sented The time specification is represented with large and lowercase letters in which each letter correlates to a defined time value A B C D E F G H I J K L M mm ss 0 05 0 10 0 15 0 20 0 25 0 30 0 35 0 40 0 45 0 50 0 55 1 00 1 05 N O P Q R S T U V W X Y Z mm ss 01 10 01 15 01 20 01 25 01 30 01 35 01 40 01 45 01 50 01 55 02 00 02 05 02 10 a b c d e f g h i j k l m mm ss 02 20 02 30 02 40 02 50 03 ...

Страница 36: ...unctionally testing reasons the UNGUATOR Q has to be switched off first The device can be switched on again after 20 seconds Please make sure that no UNGUATOR MB is attached to the device during start up or rebooting process We recommend changing the UNGUATOR jar size for the initial functionality testing process and e g running a mixing process with a filled UNGUATOR jar size 30 or 50ml Please co...

Страница 37: ... MB does not penetrate completely in the mixture since the formula is to pasty firm or in powder form Troubleshooting The reverse power of the lifting arm is from 3 to 5kp intentionally low to avoid material damages For this reason the UNGUATOR Q registers the resistance and the return of the stroke direction To ensure the complete mixing of the recipe you can for example warm cold recipe substanc...

Страница 38: ...sealing lip on the UNGUATOR jar bottom does not retain liquids during the emulsifying process Troubleshooting Please be aware that when setting up the UNGUATOR jar lid with the UNGUATOR mixing shaft the sealing lip is not damaged by the bayonets of the shaft Reduce the air prior the mixing process and use the appropriate mixing program Error The user failed to decrease air again or to mount a UNGU...

Страница 39: ...mixing machines and various UNGUATOR assortment The UNGUATOR Mixing System UNGUATOR Technology and the AirDynamic Pumpball System integrated therein are inventions of the German pharmacist Albrecht Konietzko 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 c...

Страница 40: ...t been moved up The penetrating UNGUATOR MB will generate an overpressure at high rate of speed that cannot be compensated when the movable bottom yields Thus the overpressure may cause 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 t...

Страница 41: ...TOR dealer Deficiencies that can be related to faults in the material or manufacturing defects will be remedied free of charge within the warranty period The respective representative in your individual country please contact your UNGUATOR dealer must be informed of necessary warranty repairs A cost estimate can be obtained for service repairs UNGUATOR MBs UNGUATOR Jars and UNGUATOR Accessories ar...

Страница 42: ...TOR MB with correctly attached UNGUATOR jars or in a plastic beaker provided for a reaction mixture Do not touch rotating parts Keep long hair ties and cables away from rotating parts During the automatic lifting function of the UNGUATOR always keep long hair parts of the body or objects away from the lifting mechanism Immediately turn off the power switch in an emergency or pull the power plug Al...

Страница 43: ...es 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 Varionozzles of Polyethylen PE The UNGUATOR SMB is made out of Polyoximethylen The UNGUATOR Disp MB is made o...

Страница 44: ...eutische 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 54...

Страница 45: ...alitätssicherung 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 D...

Страница 46: ...ation 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 ensur...

Страница 47: ...51 582 55 Fax 49 0 951 500 602 Email kontakt gako de Website www unguator com GAKO International GmbH Dantestraße 27 D 80637 Munich Phone 49 0 89 15 88 16 88 Fax 49 0 89 15 88 14 85 Email contact unguator com Website www unguator com 42 2 4 Landsberger Straße 314 D 80687 München Phone 49 0 89 1222 387 200 Fax 49 0 89 1222 387 201 ...

Страница 48: ...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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