Gako Unguator e/s User manual

Content

1 UNGUATOR

Mixing System ..........................................................................7

1.1 UNGUATOR

Technology ................................................................................7

1.2 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

1.3.2 UNGUATOR

Jar ...........................................................................................13

1.3.3 UNGUATOR

Varionozzles ........................................................................... 15

1.3.4 UNGUATOR

Applicators ..............................................................................15

1.3.5 UNGUATOR

Spindle ....................................................................................16

1.3.6 UNGUATOR

Coupling .................................................................................. 17

1.3.7 AirDynamic

System .....................................................................................18

1.4 Quality verification .........................................................................................18

2 General guidelines for the UNGUATOR

Mixing System .............................19

2.1 Preparing the UNGUATOR

Mixing System .................................................19

2.2 Weighing in the formulation constituents ......................................................19

2.2.1 Emulsion ........................................................................................................20

2.2.2 Emulsion + .....................................................................................................20

2.2.3 Normal ........................................................................................................... 21

2.2.4 Suspension < 2% ..........................................................................................21

2.2.5 Suspension > 2% ..........................................................................................22

2.2.6 Gel .................................................................................................................22

2.2.7 Suppositories.................................................................................................23

2.2.8 Powder ...........................................................................................................23

2.2.9 General notes ................................................................................................23

2.3 Preparing the mixing process .......................................................................25

2.4 The mixing process ....................................................................................... 25

2.5 After the mixing process is complete ............................................................25

3 The mixing process using the UNGUATOR

e/s...........................................27

3.1 Operation mode “AUTO“ ............................................................................... 28

3.2 Operation mode “HAND“ ...............................................................................29

3.3 General notes on operation ..........................................................................30

4 General notes on the UNGUATOR

Mixing System .....................................33

4.1 References ....................................................................................................33

4.2 Notes on the mixing process .........................................................................33

4.2.1 Assignment of the UNGUATOR

MB ............................................................ 33

4.2.2 Niches of flow on the UNGUATOR

Standard Mixing Blade (SMB) ............. 34

4Content

4.2.3 Heating ..........................................................................................................35

4.2.4 Cleaning the UNGUATOR

MB ..................................................................... 35

4.2.5 Possible error sources to be avoided ............................................................35

4.3 Notes on dispensing ointment.......................................................................36

4.4 Quality assurance of the ointments ..............................................................38

5 Service and warranty ....................................................................................39

5.1 Notes on malfunctions ...................................................................................39

5.2 Manufacturer’s service and warranty in Germany ........................................39

6 Bibliography ...................................................................................................41

7 Notes on safety ............................................................................................. 42

8 Technical data of the UNGUATOR

e/s.........................................................43

9 Manufacturer’s Certificate .............................................................................44

10 Distribution, manufacturing and customer service .......................................45

11 WARRANTY CERTIFICATE ..........................................................................46

12 Document template .......................................................................................48

Indes of tables and figures

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. 1-5: UNGUATOR

Disp. Blade ......................................................................... 12

Fig. 1-6: Handling the UNGUATOR

Disp. Blade.................................................... 12

Fig. 1-7: UNGUATOR

Jars ..................................................................................... 13

Fig. 1-8: Certificate of analysis for the 100 ml UNGUATOR

Jar ........................... 14

Fig. 1-9: UNGUATOR

Varionozzles ....................................................................... 15

Fig. 1-10: UNGUATOR

Applicator short and long ................................................. 15

Fig. 1-11: Note on operation 1 for the UNGUATOR

Spindle ................................... 16

Fig. 1-12: Note on operation 2 for the UNGUATOR

Spindle ................................... 16

Fig. 1-13: UNGUATOR

Spindle ............................................................................... 16

Fig. 1-14: Transfer using a 200 ml UNGUATOR

Jar................................................ 17

Fig. 1-15: UNGUATOR

Coupling ............................................................................. 17

Fig. 1-16: AirDynamic

System ................................................................................. 18

Fig. 3-1: Control panel ofthe UNGUATOR

e/s....................................................... 27

Tab. 3-1: Value table of the speed steps ................................................................. 28

Tab. 3-2: Minimum values for mixing time at speed step 9 in min:sec .................... 30

Tab. 3-3: Minimum values for mixing time at speed step 5 in min:sec .................... 31

Tab. 3-4: Minimum values for mixing time at speed step 1 in min:sec .................... 31

Tab. 3-5: UNGUATOR

e/s error messages ............................................................ 32

Fig. 4-1: Assignment of the UNGUATOR

SMB with different

lengths of shaft ......................................................................................... 34

Fig. 4-2: Opening of the UNGUATOR

Jar Lid........................................................ 37

Fig. 4-3: Opening of the UNGUATOR

Varionozzle 4 mm ..................................... 37

Fig. 4-4: Opening of the UNGUATOR

Varionozzle 2 mm

or of the UNGUATOR

Applicator long .................................................... 37

Fig. 4-5: Opening of the UNGUATOR

Varionozzle 1 mm

or of the UNGUATOR

Applicator short .................................................. 37

6UNGUATOR®Mixing System

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:

Select a suitable location for the UNGUATOR

e/s. CAUTION! The UNGUATOR

e/s

weighs almost 21 lbs.

Ensure that there is enough space to operate the UNGUATOR

e/s.This must include

sufficient space around the UNGUATOR

e/s to provide good ventilation.

Select a suitable environment:

•

Solid, level surface

•

Away from direct air flow from air conditioning systems, heaters, open windows

or fans

•

Removed from direct insolation, extreme humidity or temperature fluctuations

•

Clean, dry and dust-free

Remove all components from the cardboard box. Check to ensure that the following

components were included in shipment:

•

UNGUATOR

e/s

•

Operating instructions

Please contact customer service at SMS Elap GmbH & Co. KG. in the event that

components are missing or damaged. Contact information is at the end of these

operating instructions. Keep the cardboard box and the packing material in case you

have to send the UNGUATOR

e/s in for service.

You will find the power switch „O/I“ at the rear of the UNGUATOR

e/s on its base.

This is also the emergency switch. Please check now that the UNGUATOR

e/s power

switch is set to off. Connect the power cord to the socket outlet. You may now switch

the UNGUATOR

e/s on using the power switch. It is now ready for operation and

should show the default settings 2 minutes mixing time and speed step „5“ on the

display.

UNGUATOR®Mixing System

UNGUATOR®-Rührsystem

1 UNGUATOR®Mixing System

The UNGUATOR

Mixing System consists of UNGUATOR

Technology, the

UNGUATOR

mixing machines and further UNGUATOR

line products.

The UNGUATOR

Mixing System, and UNGUATOR

Technology and the AirDynamic

System integrated therein are inventions of the pharmacist Albrecht Konietzko from

Bamberg in Germany. UNGUATOR

Technology and the AirDynamic

System are

patented in selected countries. UNGUATOR

and AirDynamic

are protected

trademarks and exclusively refer to devices and line products from GAKO

Konietzko GmbH or under license of GAKO International GmbH.

The UNGUATOR

Mixing System from GAKO Konietzko GmbH is the original.

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 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.

To achieve this aim we continue to search for efficient improvements in addition to

periodic quality controls. This objective is actively supported by application of vast

know-how of the inventor of the UNGUATOR

Mixing System, pharmacist Albrecht

Konietzko.

1.1 UNGUATOR®Technology

UNGUATOR

Technology reduces the mechanical preparation of formulation ointments

to the least common denominator. The core of UNGUATOR

Technology 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. Despite the almost countless

number of possible combinations of ingredients used in a pharmacy, there is no need

here to offer or list instructions for preparation. The motto here is:

learning by doing.

8UNGUATOR®Mixing System

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. For the first time, it is possible to not only standardize ointments,

but validate them too.

1.2 UNGUATOR®Mixing Machines

The current UNGUATOR

mixing machines - the UNGUATOR

B/R, the UNGU-

ATOR

e/s and the UNGUATOR

2100 - are useful and advanced improvements on

the first UNGUATOR

from 1994. They are designed for a working capacity of approx.

500 work hours which corresponds to approximately 15,000 to 20,000 prescriptions.

The UNGUATOR

mixing machines feature a high safety standard and were tested by

TÜV-Rhineland for their safety. They are manufactured under license and maintained

by SMS Elap GmbH & Co. KG in Zella Mehlis (Germany).

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 B/R through the e/s to the 2100.

Notes on production Pharmaceutical Homogeneity Stroke Mixing parameters

quality of ointment guidance (speed, mixing time)

Mortar and pestle ++ + (–) (individual)

UNGUATOR

B/R +++ ++ individual individually adjustable

UNGUATOR

e/s +++ +++ automatisch individually programmable

UNGUATOR

2100 ++++ ++++ automatic fully automatic

Tab. 1-1: Quality improvement with increasing automation

UNGUATOR®Mixing System

1.2.1 UNGUATOR®B/R

The UNGUATOR

B/R is the basic machine with a

controlled mixing motor and manual jar guidance.

1.2.2 UNGUATOR®e/s

The UNGUATOR

e/s lift-off machine was developed

for efficient individual and batch preparation. 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

preparation.

The precisely set sensor for the automatic oscillation

arm will always ascertain at each upward or downward

stroke the exact position of the UNGUATOR

Jar

bottom or lid. This guarantees that the UNGU-

ATOR

Jar is always accessible to the UNGUATOR

Mixing Blade despite the inevitable displacement

motion during the mixing process. If the stroke length

of the first stroke was taken as a constant value, then

the active ingredient weighed in into the lower region

of the UNGUATOR

Jar might not be included in the

mixing process by the UNGUATOR

Mixing Blade,

getting “lost” at the bottom.The lifting technique of the

UNGUATOR

Mixing System prevents this from

happening, so that the result of the mixing process is

not just a homogeneous ointment, but also one with

the desired ratio of active ingredients.

1.2.3 UNGUATOR®2100

The UNGUATOR

2100 has all advantages of its predecessors and can therefore

automatically control the mixing parameters for each UNGUATOR

Jar size and diffe-

rent types of ointments. The user may program his or her own mixing programs into

the device and a maximum of 180 additional programs can be stored.

Fig. 1-2: UNGUATOR®e/s

Fig. 1-1: UNGUATOR®B/R

10 UNGUATOR®Mixing System

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

out by the UNGUATOR

2100. This guarantees that

the mixing program called up will always be identical,

also for paste preparations which demand more

power from the mixing motor. This makes it easy to

develop new ointments, cosmetics, etc. using the

UNGUATOR

2100 since only the composition

changes and not the mixing program. As a result,

ointments can now finally be reliably reproduced in

smaller quantities.

The adjustable stroke speed, or the speed of the upward or downward motion of the

automated oscillation arm, is another unique feature of the UNGUATOR

2100. This

allows the UNGUATOR

Mixing Blade to rotate at lower speed while UNGUATOR

Jar

quickly travels up and down, or vice versa. This new function is particularly useful

using a low rotating speed of the UNGUATOR

Mixing Blade since it allows the

UNGUATOR

Mixing Blade to mix an ointment homogeneously by slow stroke.

1.3 UNGUATOR®Assortment

In addition to the UNGUATOR

Standard Mixing Blade (SMB), the UNGUATOR

Disposable Blade (Disp. Blade) and the UNGUATOR

Jar, all essential for preparing

ointments using the UNGUATOR

Mixing System, the UNGUATOR

assortment

includes other additional and very useful components.These include dosing aids such

as the UNGUATOR

varionozzles and UNGUATOR

Applicators, removal or transfer

aids such as the UNGUATOR

Spindle, the UNGUATOR

Coupling and the patented

AirDynamic

System. All UNGUATOR

products are compatible with each other.

1.3.1 UNGUATOR®Mixing Blade (MB)

The UNGUATOR

Standard Mixing Blade and the UNGUATOR

Disposable Blade are

designated as the UNGUATOR

MBs. The UNGUATOR

MBs are steadily guided up

and down inside the UNGUATOR

Jar. Their special design results in tight contact

Fig. 1-3: UNGUATOR®2100

UNGUATOR®Mixing System

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.

The lubricating effect of the foundation ointment protects the UNGUATOR

Jars and

the UNGUATOR

MB against abrasion. Discolorations of the mixing blade are mostly

irreversible and therefore harmless. All UNGUATOR

MBs are dishwasher safe.

UNGUATOR

Standard Mixing Blade (SMB)

UNGUATOR

SMBs are adjusted to the size of each individual UNGUATOR

Jar.While

the UNGUATOR

SMBs for 100 and 200 ml and for the 300 and 500 ml jars have the

same mixing blade diameter, their shaft length differs. This must be taken into

consideration, particularly when using the UNGUATOR

e/s and the UNGU-

ATOR

2100, since the use of the wrong length may cause problems with the automated

stroke. Always make sure the UNGUATOR

MB used is the right length, and that it is

clean prior to use.

UNGUATOR

Disposable Blade (Disp. Blade)

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.

Fig. 1-4: UNGUATOR®SMB

Fig. 1-5: UNGUATOR®Disp. Blade

UNGUATOR®Mixing System

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

be mixed and achieves good product quality faster than using the UNGUATOR

SMB.

We do however recommend using the same mixing time as for the UNGUATOR

SMB.

In the process of final quality control the mixing blade should be picked up with the

weak end of the shaft and thrown away. Cleaning is confined to the UNGUATOR

Disp.

Blade shaft. We recommend using the UNGUATOR

Disp. Blade for substances that

may discolor the regular blade. This type of UNGUATOR

MB also comes with diffe-

rent shaft lengths. On the weak end of the shaft, the range of UNGUATOR

Jar sizes

that can be used (15-100 ml and 200 ml respectively) for the application is marked for

orientation.

1.3.2 UNGUATOR®Jar

The UNGUATOR

Jar is both the mixing and the dispensing jar and is therefore

designed as an expendable or disposable jar. The UNGUATOR

Jar guarantees

evaporation-free and contamination-free preparation in the air-reduced mixing space.

The UNGUATOR

Jar Lid closes the UNGUATOR

Jar to ensure no loss of active

ingredients.

Used as a dispensing jar, the UNGUATOR

Jar corresponds to the guidelines for quality

assurance from the German Chamber of Pharmacists (Apothekenkammer) [11]. With

its small dispensing opening, comparable to a tube and without an environmental

Fig. 1-6: Handling the

UNGUATOR®Disp. Blade

UNGUATOR®Mixing System

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-

ATOR

Jar very hygienically.

The UNGUATOR

Jar is

resistant to hot-water baths

and microwaves (temperatures less than 85 °C/185 °F). Higher temperatures (e.g.

rinsing machines) can change the tightness of the UNGUATOR

Jar and the

displaceability of the bottom (“push-up” jars).The UNGUATOR

material becomes brittle

at temperatures below 0 °C/32 °F.

UNGUATOR

Jars are available in following sizes: 15/28 ml, 20/33 ml, 30/42 ml, 50/

70 ml, 100/140 ml, 200/280 ml, 300/390 ml, 500/600 ml and 1000/1250 ml (rated

volume/filling volume).

The standard color for the UNGUATOR

Jar housing is white and the UNGUATOR

Jar

Lid is red. The 300 ml, 500 ml and 1000 ml UNGUATOR

Jars come with white lids. In

addition, the 20 ml to 100 ml UNGUATOR

Jars are available in the pastel colors pink,

light yellow, light blue and turquoise. Furthermore, UNGUATOR

Jars from 20 to 200 ml

can be ordered with UNGUATOR

Jar Lids in the special colors green, blue and white.

The UNGUATOR

Jar comes sealed in plastic wrap. Cleaning or disinfection prior to

use could put the tested sterility at risk. We would recommend storing the remaining

UNGUATOR

Jars in the plastic wrap 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.Since the contents are dispensed

using the movable jar bottom and always close to the life, The UNGUATOR

Jar solves

Fig. 1-7: UNGUATOR®Jars

14 UNGUATOR®Mixing System

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

Spindle or

the AirDynamic

System.

The housing of the UNGUATOR

Jar sizes 300 to 1000 ml can be cleaned in a

dishwasher as long as it has not left the pharmacy. Sterility has to be ensured before

reuse though. The movable bottom of the UNGUATOR

Jar is not suitable for the

dishwasher and the sealing lip of the UNGUATOR

Jar Lid may be destroyed after

repeated mixing. The corresponding UNGUATOR

Jar Lids or jar bottoms can be

ordered in sets of five and used for the economical reuse of the housings.

The UNGUATOR

Jar is subject to periodic inspection in accordance with ZL packing

regulation DK II/94. A certificate of analysis is issued after batch-defined examinations.

The documentation of primary packaging materials at the pharmacy stipulates that

the manufacturer’s test certificate (certificate of analysis) after visual receiving inspection

be retained. This certificate is affixed to the plastic wrapping in which the UNGU-

ATOR

Jars are packed. It may be removed from the plastic wrapping as needed and

added to the records.

1.3.3 UNGUATOR®Varionozzles

The UNGUATOR

Varionozzles with inner diameters of 1, 2 or 4 mm can be pressed

into the dispensing opening of the UNGUATOR

jar lid. They reduce the opening size,

making it possible to safely dose even low-viscous formulations. The viscosity of the

finished product normally specifies the diameter of the UNGUATOR

Varionozzles.

Fig. 1-8: Certificate of analysis for the 100 ml UNGUATOR®Jar

Certificate of Analysis

DISPOSABLE / DO NOT RINSE BEFORE USAGE

CH.No.*: 7202/05P00 NOMINAL-/ FILLING VOL.: 100/140 ml

PRODUCT No.: 340 SHIPPING UNIT: 500 units

PZN**: 0702570 : 10 units

Examined acc. to the central lab. packing regulations

Translucency

Date May 6, 2007

UNGUATOR - JAR

PACKING UNIT

signed: Grieser (head of quality assurance)

G-A-K-O Konietzko GmbH * 96049 Bamberg

: DK II/94

: confirmed

Particle Concentration :

Color Fastness :

confirmed

Dichtigkeit : confirmed

Microbiology : confirmed

***Internal Registration No. Pharmaceutical Ref. No.

UNGUATOR®Mixing System

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)

1.3.4 UNGUATOR®Applicators

The UNGUATOR

Applicators reduce the dispensed

quantity of low-viscous formulations and are particularly

helpful in cases where the ointment must be applied

precisely.

UNGUATOR

Applicator short

The UNGUATOR

Applicator short with an opening

diameter of 1 mm is obligatory for nose and ear ointments.

UNGUATOR

Applicator long

The UNGUATOR

Applicator long with an opening diameter

of 2 mm allows formulations to be introduced into large

orifices of the body or probes. Moreover, the UNGU-

ATOR

Applicator long is also available as a sliding aid

together with the 200 ml UNGUATOR

Jar.

1.3.5 UNGUATOR®Spindle

The UNGUATOR

Spindle serves as a dispensing system for the 200 ml or 500 ml

UNGUATOR

Jar. The spindle has to be removed by rotating it clockwise on the new

UNGUATOR

Jars that come with UNGUATOR

Spindles. The bottom can be slid up

and down when the UNGUATOR

Spindle is screwed in slightly (1/2 to max. 1 turn)

counterclockwise without perforating the movable bottom (a slight resistance can be

felt before the bottom is perforated).

Fig. 1-10: UNGUATOR®

Applicator short and long

Fig. 1-9: UNGUATOR®Varionozzles

16 UNGUATOR®Mixing System

Air can be diminuated by placing the UNGUATOR

Jar

onto the formulation table and using both hands to

move the jar against the table. The formulation can

be transferred into small UNGUATOR

Jars with the

aid of the UNGUATOR

coupling.

Before giving the UNGUATOR

Jar to the customer,

the UNGUATOR

Spindle must be screwed into the

UNGUATOR

Jar counterclockwise from the bottom

till it locks into place.The UNGUATOR

Spindle must

be turned clockwise to dispense ointment. One turn

dispenses approx. 20 ml of the contents of UNGU-

ATOR

Jar.

Caution! If the movable bottom is accidentally

perforated or the spindle locks onto the insert per-

manently then the UNGUATOR

Jar may only serve as dispensing or storage vessel

and cannot be used for the mixing process.

1.3.6 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 that the UNGU-

ATOR

Mixing System remains uncontaminated from the mixing process to the end

user.

Fig. 1-13: UNGUATOR®Spindle

Fig. 1-11: Note on operation 1 for the

UNGUATOR®Spindle

Fig. 1-12: Note on operation 2 for the

UNGUATOR®Spindle

UNGUATOR®Mixing 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

UNGUATOR

Jar.

In addition to the UNGUATOR

Coupling, required for transfer from

a from a 300 ml or 500 ml UNGU-

ATOR

Jar into a smaller UNGU-

ATOR

Jar, both the UNGUATOR

spindle and the AirDynamic

System

may also be used. Dispensing and

transferring a formulation via the dis-

pensing opening in the UNGU-

ATOR

Jar Lid from the 1000 ml

UNGUATOR

Jar is practically only

possible using the AirDynamic

Sys-

tem.

We recommend transferring the formulation as soon after mixing as possible, since

the formulation has then hardly cooled and is still warm and less viscous.

1.3.7 AirDynamic®System

The AirDynamic

System optimizes batch preparation within the closed system:

• contamination-free transfer

• contamination-free storage

The AirDynamic

System has been designed to use UNGUATOR

Jars from 300 ml to

1000 ml for dispensing mixtures. An adapter connected to a pump ball is affixed the

center hole on the housing bottom of the UNGUATOR

Jar with an air-tight connection.

By pumping air into the lower chamber of the UNGUATOR

using the pump ball, the

pressure thus generated moves the movable bottom upward.Thanks to the AirDynamic

Fig. 1-15: UNGUATOR®Coupling

Fig. 1-14:

Transfer using a 200 ml UNGUATOR®Jar

18 UNGUATOR®Mixing System

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.

The air pressure that had developed

in the lower chamber of the UNGU-

ATOR

Jar can be relieved by open-

ing the valve screw. This is manda-

tory after the transfer process using

the UNGUATOR

Coupling before

the smaller UNGUATOR

Jar is

removed. Otherwise this may result

in considerable contamination of the

immediate environment, depending

on formulation viscosity.

1.4 Quality Verification

The production site for all UNGUATOR

products is certified in accordance with DIN

EN ISO 9001. Periodic quality controls not only guarantee the outstanding but also

most notably the lasting quality of the UNGUATOR

Mixing System.

• UNGUATOR

Applicators, couplings and jars are made of polypropylene (PP)

and the UNGUATOR

Varionozzles of polyethylene (PE),

• The head of the UNGUATOR

SMB is made of polyoxymethylene (POM) and

the mixing blades of the UNGUATOR

Disp. Blade of polyamide (PA).

• The shaft of the UNGUATOR

MB is made of stainless steel (quality: 1.4301)

and hardened through titan nitration (gold-colored).

• The materials and pigments deployed are physiologically safe.

• All priceable UNGUATOR

line products (UNGUATOR

Jar, Disp. Blade,

Applicator and Varionozzle) can be found under UNGUATOR

... since the

designations start with UNGUATOR

in the EPDS and the German “Hilfstaxe”

(a database of approx.340.000 medicines and other pharmaceutical products).

Fig. 1-16: AirDynamic®System

General guidelines for the UNGUATOR®Mixing System

2 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

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

Jar Bottom down. The UNGUATOR

Jar Lid is then slid onto the

UNGUATOR

MB standing in the UNGUATOR

Jar housing and pressed down firmly

using both thumbs. Ensure that the sealing lip of the UNGUATOR

Jar Lid opening is

not damaged by the bayonet noses because the ointment may otherwise rise on the

UNGUATOR

MB shaft during the mixing process.

Third the UNGUATOR

MB is removed from the UNGUATOR

Jar housing by pulling

with a slight counterclockwise turn. The UNGUATOR

Jar Lid will be moved in Mixing

Blade direction. Both parts, i.e. the UNGUATOR

MB and UNGUATOR

Jar lid are put

down or possibly tared on the balance together with the UNGUATOR

Jar housing.

2.2 Weighing in the Formulation Constituents

Generally, oily, greasy, aqueous and pulverized constituents can be weighed in into

the UNGUATOR

Jar at the same time. It is however advantageous to heed certain

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, the motto for use

is:

Learning by doing

Listed below are the seven different general procedures used to produce the routine

standard formulations in pharmaceutical preparation of ointments: EMULSION, EMUL-

SION +, NORMAL, SUSPENSION < 2% AND SUSPENSION > 2% as well as GEL

20 General guidelines for the UNGUATOR®Mixing System

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

UNGUATOR

Jar bottom is first carefully placed around the sealing lip. This enhances

the leak tightness of the jar the UNGUATOR

Jar is filled. For UNGUATOR

Jars of

200 ml and up an active ingredient proportion of less than 5 %, the active ingredient

can be filled alternating with the foundation ointment over two or more levels to speed

up vertical intermixture.

2.2.1 Emulsion

Emulsifying semisolid substances with water at room temperature

Example: Eucerin c. aqua aa

We recommend using the UNGUATOR

Disp. Blade.

Emulsification can be more difficult using refrigerated foundations. Emulsification can

be sped up by heating the water to be added; however, often the heat that develops

inside the Jar during the mixing process may already be sufficient.Adapted emulsifiers

can, after consultation with the physician, promote stability and the formation of emulsion

or reverse phase separation. For instance, liquor carbon. detergens in vaseline

emulsifies better containing a small portion of lanolin or wool fat ointment (unguentum

alcoholum lanae).

2.2.2 Emulsion +

Emulsifying of semisolid substances to be melted.

Examples: Emulsific. aquosa, Lanette, Cera

We recommend using the UNGUATOR

Disp. Blade.

Emulsions should always be heated then when UNGUATOR

Jars of 300 ml to 500 ml

are employed with UNGUATOR

B/R or e/s.

Melting the semisolid substances using max. 85 °C/185 °F hot water can be achieved

by three methods:

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