Caleva Process Solutions Tablet coater Mini Coater Drier-2 Mini
Coater Drier-2 General Description Single tablets and small
quantities of spheroids can be coated and dried in minutes,
potentially saving significant amounts from your R&D budget.
Tablet and pellet coaters generally require a minimum batch of
between 300g and 500g to work effectively, but this robust,
simple-to-operate, bench-top unit provides a cost-effective
solution for drying and coating particles. Batches from as small as
a single tablet or a few grams. The MCD-2 can coat from one to
about 150 tablets a world first - thus cutting quantities of
expensive pharmaceutical ingredients required for trials. It offers
excellent uniformity within and between batches, allowing
technicians to trial all possible combinations and variables
without cost or product availability being a limiting factor. The
practical unit, which is fully compliant with principles of Good
Laboratory Practice, can satisfy other applications such as the
experimental coating of granules with catalytic material, food
material and fluid-filled gelatin capsules. Use: Laboratory &
Development: Pilot plant: Production: Minimum batch size:One tablet
or a few grams of pellets Maximum capacity:About 150 standard sized
tablets or about 60 g of pellets Contents General Description
........................................ 1 The Basic Machine
......................................... 2 Main Uses
......................................................... 5
Standard Design Configuration ................... 6 General
Arrangement Diagram ................... 7 Options Overview
............................................ 8 Training and
Validation Options................. 9 Accessories included
...................................11 Consumables (optional)
..............................12 Recommended Spares
................................13 Recommendations
........................................14 Tel: +44(0) 1258
47-11-22www.caleva.com1 27 Feb 2013 Tablet coater Caleva Process
Solutions Mini Coater Drier-2 The Basic Machine Production
capacity: Tablets or pellets (spheroids) are coated in batches.
Maximum and minimum batch sizes are shown below. Typically batches
take about 15 to 30 minutes to achieve a suitable coating.
Minimumbatch: Coat from a single tabl et Coat very small quantities
of tablets saving expensive or scarce material Coat from 1 to about
150 tablets (dependent on tablet size) A practical batch size
giving representative samples Excellent uniformity within and
between batches Results show that uniform and high quality coatings
can be obtained Coat from a few grams of pellets (spheroids) Coat
from a few grams of pellets Coat up to about 60 g of pellets A
practical batch size ideal partner for the Caleva MBS Spheronizer
120 or the Caleva Multi Lab (CML) Static generation problems with
some spheroid formulations of small pellets can be minimized with
the optional anti static system Dry pellet batch sizes up to
approximatel y 100g Ideal size capacity for the Caleva Spheronizer
120 Cost effective laboratory drying apparatus Save time and costs
during early stages of product development Partner equipment for
other Caleva products. Contact us for small scale extruders and
spheronizers for R&D and teaching.Scale-up: The desire for a
scalable process is understandable but not always relevant. The
Caleva Mini Coater/Drier has the unique ability to coat very small
samples sizes and is typically used at a very early stage in the
development of new products and new formulations. A typicalproblem
( from a real case) The development scientist working on
formulation development with a new experimental active ingredient.
As part of this program 8 possible formulations and 10 possible
coating materials were available. That is, 80 different
combinations! This situation is probably not uncommon and if the
number of variables to be looked at increases only slightly then
the possible number of combinations will increase dramatically. For
these trials, six tablets from each of these combinations were
required to do a preliminary dissolution test. Using the Caleva
Mini Coater/Drier six tablets of each combination could be made
quickly and easily without any wastage of material. 2Tel: +44(0)
1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions
Tablet coater Mini Coater Drier-2 The tablet coater available in
the laboratory could work effectively with a minimum batch size of
3 kg. The choice was:- To make 80 batches of 6 tablets each with
the Caleva MCD-2 (a purchase cost involved!); or to make 80 batches
of 3 kg each with the equipment he had in his laboratory (no
additional purchase cost). The logistics of coating either 480
tablets (using the Caleva MCD) or 240kg of tablets (using the
coater in his laboratory) demonstrated that the Caleva MCD-2 has
significant advantages.The active ingredient being tested might be
a new experimental material and as such was not only expensive but
also scarce. In this circumstance it was very easy to do a quick
calculation of the cost saving that could be achieved by making 80
samples of six tablets (approximately 0.1kg of tablets) compared
with making 80 samples 3 kg (approximately 240kg of tablets!). The
Conclusion This real example shows that the savings made in this
single experiment alone would more than pay for the cost of the
MCD-2.This did not take into account the savings in time and effort
of using the Caleva MCD-2 and the additional cost savings that that
would be made in future work with this or other products. The
question of scale up did not arise. This is irrelevant at this
early stage of product development. Once the material is tested and
the properties are established on small scale (proof of concept)
then the issues of scale up to production can be subsequently
addressed. Restrictions: Considerations when making a risk
assessment for the use of organic sol-vents Product Statement The
airflow into the spray chamber passes an electrical heating
element. Caleva cannot give any ATEX rating or recommendations for
the use of spray solutions containing flammable organic solvents
with the Caleva Mini Coater Drier. Caleva has not designed the
equipment to any ATEX rating. Before considering the use of coating
materials with solvents the user should undertake their own risk
assessment. The following key points can be considered when a risk
assessment is being compiled by a user, the information offered is
not exhaustive and in no way underwrites the safe operation of
organic solvents with this equipment. Considerations Ai rflow
direction: The airflow only flows into the spray chamber after it
has passed over the heating element. There is a theoretical
potential for the spray solution to flow down the inlet tube to the
heating element. The chance of this hap-pening is low as the
airflow is moving in the opposite direction. The ma-chine has a
safety feature designed to cut power to the heating element should
the fan stop moving air. Flow rate: The normal flow rate for
application within the Caleva Mini Coater Drier would be about 12
to 15 ml per hour. If a spray solution was made up of Tel: +44(0)
1258 47-11-22www.caleva.com3 27 Feb 2013 Tablet coater Caleva
Process Solutions Mini Coater Drier-2 20 % organic solvents then at
the higher flow rate about 3 ml of solvent per hour would be
released into the spray chamber. This is about 0.25 ml of solvent
every 5 minutes. This quantity of solvent is released into an air
stream, blowing away from the heating element and would be
dispersed by around 12 and 32 litres of air moving away from the
heater during this 5 minute period. Therefore the risk of
significant solvent accumulation within the equipment is small.
Cleaning: The Mini Coater Drier should be cleaned and emptied of
product at the end of every working session. If this is not done
and a spray solution containing organic solvents has been used then
it is possible that spray solutions could drip from the nozzle (if
left over the spray chamber) into the spray chamber and then
evaporate into the air inlet pipe and then in-to the internal area
of the equipment. If this were to happen solvent ac-cumulations
could build up within the air inside the equipment. The chance of
this is considered low because: The spray head has a needle value
to close the spray opening to prevent product dripping The material
in the spray head is not under any pressure The amounts of
materials are very small.The internal area of the equipment
contains numerous electronic connec-tions and a potentially
dangerous situation could arise the next time the machine is
switched on and the equipment is full of fumes. This will not
happen if the equipment is cleaned properly. Summary 1.The MCD-2 is
not designed to any ATEX rating or classification. The key areas of
risk for use of spray solutions containing organ-ic solvents are
given above but they are not exhaustive. 2.The user should fully
consider the points made above, make and adopt their own risk
assessment before making a decision on the use of spray solutions
containing flammable materials. 3.For further information or if you
require further guidance you must contact Caleva directly before
using the equipment.Documentation package: Full pharmaceutical
industry qualification documentation packages are available if
required. Materials certificates: Certified copies of original mill
certificates for all product contact parts are available as an
option if required. Availability It is our intention to keep one or
more machines in stock at all times. However, stock machines may be
sold or may not be the specifications that you require.The actual
delivery date will depend on the level of work that we have at the
time of order. In general if we do not have a suitable machine in
stock then delivery will be between 2 and 6 weeks. Please contact
us for an exact delivery date when the required specifications are
known. 4Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva
Process Solutions Tablet coater Mini Coater Drier-2 Main Uses
Tablet and pellet coaters generally require a minimum batch size of
about 300 to 500g to work effectively. With the Caleva Mini
Coater/Drier2 (MCD-2) it is possible to dry and coat as little as a
single tablet or a few grams of spheroids. The apparatus is a
robust, simple to operate and practical unit that is easy to place
within a laboratory The coaster is currently used in several
industries ranging from pharmaceuticals, catalysts and food items
as well as R&D and teaching in Universities. It is an ideal
companion to the Caleva Multi Lab The MCD-2 can satisfy other
applications such as experimental coating of; granules with
catalytic material, food material and fluid filled gelatin capsules
Tel: +44(0) 1258 47-11-22www.caleva.com5 27 Feb 2013 Tablet coater
Caleva Process Solutions Mini Coater Drier-2 Standard Design
Configuration SizeApproximately 50 x 55 x 60 cm.
WeightApproximately 32kg. MaterialCabinet is 304 stainless steel.
Contact parts316 stainless steel, PTFE & polypropylene, food
grade polymer. Coating solution flow Controlled by an Integrated
Watson-Marlow Peristaltic pump Important note The coating spray is
generated by an atomizing spray nozzle. This requires an external
supply of compressed air (see below).Utility requirements
Electrical suppl y Electrical supply single phase. Voltage
according to customer requirements. Please inform us at the time of
order if you require 220/240 or 110 volts (we are able to offer the
voltage that you specify). If voltage is not specified at time of
order, then 220/240V equipment will be supplied.Ai r Suppl y The
user will need to provide an external air supply with the following
minimum characteristics:- Compressed air up to 2.5 bar required. A
4mm external diameter supply pipe.Flow required =60l/min at 2 bar.A
small compressor or a cylinder or by preference a standard
laboratory piped supply is suitable. Please take note of the flow
volume requirement Operation and controls Custom designed micro
controller based system with monochrome LCD graphic display
Mechanical agitation control variable from 10 to 25 Hz. Airflow
control variable up to 60CFM at source Peristaltic pump variable
from 5 to 50ml per hour (dependant on delivery pipe diameter).
Different diameters are supplied. Air temperature variable from
ambient up to 60 degrees C with feedback loop control. Count up
timer with start/stop and reset controls. A wakeup condition.The
last used experiment parameters will be stored and when the machine
is switched on all parameters will start set at their last used
condition. All controls are soft for future development such as PC
control and data logging Standard documentation supplied
Installation and operation Manual. Completed quality control check
sheet. CE declaration of conformity 6Tel: +44(0) 1258
47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet
coater Mini Coater Drier-2 General Arrangement Diagram Pipework and
anti-static unit not shown Tel: +44(0) 1258 47-11-22www.caleva.com7
27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater
Drier-2 Options Overview All machines are supplied suitable for use
with tablets and pellets. If it is foreseen that pellets are to be
coated then some additional options are recommended. Please ensure
that you discuss with us about your intended use. There are no
required options. A set of recommended spares/consumable items is
available. 8Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010
Caleva Process Solutions Tablet coater Mini Coater Drier-2 Training
and Validation Options Installation/commissioning/training at the
customer site Training within the UK or in any European
country.Including one day installation and training and two days
travelling is available if required. All travel and subsistence
costs are included in the cost if this option is chosen. Please
contact us for a cost if this is required. Training outside Europe.
Including one day installation and training and four days
travelling is available if required. All travel and subsistence
costs are included in the cost if this option is chosen. Please
contact us for a cost if this is required. Training includes
installation, commissioning and training at customer site of up to
one day, but does not include IQ/OQ which is separately chargeable.
The customer will provide local transport for the Caleva technician
if required. The customer will supply all consumable products
required according to further discussion. Trained electricians will
be provided by the customer if required (generally not required).
Installation does not include any alteration to the customer site
and does not include installation of any electrical services. The
customer will be responsible for the unpacking and location of the
machines at the site. This is not included in the quotation. If
more than one item is purchased then training can be done together
for other equipment with considerable savings in cost. Contact us
for details. Factory acceptance test at Caleva UK site We make our
own quality check before the extruder is shipped (a copy is
supplied to the customer) and thus a separate FAT is not normally
necessary but the quality check at the Caleva site can be completed
with the customer if required. The customer will be responsible for
all expenses incurred in getting to and from the Caleva site.
Customer training at the Caleva site (overseas customers) Training
is recommended to the company but it is not essential. Contact us
for additional information and options. Customers from outside the
UK will be collected at any London main airport and transferred to
Bournemouth, accommodation and all meals for one trainee whilst in
Bournemouth, UK. Transport to and from the Caleva site is included.
Any extras (such as phone calls etc.) at hotel are for guests
account. One night bed & breakfast in London hotel before
return flight to home country can be included if requested. Up to
two days training (as required) can be provided at the Caleva site
on customers own equipment prior to shipment. Please contact us for
a cost if this is required. Transport to and from the customers own
country to a London main airport is not included and is for the
customers account. If more than one item is purchased then training
can be done together with considerable savings in cost. Contact us
for details. Tel: +44(0) 1258 47-11-22www.caleva.com9 27 Feb 2013
Tablet coater Caleva Process Solutions Mini Coater Drier-2
Validation and IQ/OQ documentation package Recommended if required
for regulatory purposes. At Caleva site: The IQ/OQ package
completed at the Caleva site by us. The customer can attend if he
or she wished to do so at their own cost. An additional set of
blank documents will be provided to allow the customer to re-do the
IQ/OQ in their own facility if required. At customer site: IQ/OQ
and installation completed at the customer site as part of the
training (training will be charged separately). The cost shown is
an additional cost for the IQ/OQ in addition to the costs for
installation and training. Note: there may be additional
country-specific charges depending on location. Contact us for
details. Material certificates In line with current standards
Caleva does not automatically supply copies of material
certificates for product contact parts. If requested, Caleva will
provide, free of charge, a certificate naming the product contact
parts and confirming that we or our suppliers can provide full
traceability to original certificates if this is requested. If
certified copies of material certificates are required then these
can be provided at the additional cost. 10Tel: +44(0) 1258
47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet
coater Mini Coater Drier-2 Accessories included Anti -Static system
Some formulations of spheroids are prone to generate static
electricity. This can cause the pellets to stick together or to the
sides of the application chamber.The effect of this can be
minimized by use of the included anti-static gun incorporated into
the design of the Mini Coater/Drier.The gun is mounted into a
custom built mount incorporated into the spray head and the
required high voltage electronics and controls are incorporated in
the body of the MCD-2.The use of the antistatic system is not
required for coating of tablets. Drying hood If more than a few
grams of pellets are to be dried or if the pellets to be dried are
not >1.0 mm in diameter then a drying hood unit can be used on
the top of the drying cone.This use is recommended if drying of
spheroid (or other light-weight items) is a foreseen use.If the
foreseen use is only for the coating of tablets using the provided
sleeve is not required.Spheroid coating sleeve If the unit is to be
used for the coating of spheroids the spheroid coating sleeve unit
is normally required if the pellets are below 1.0mm in diameter or
very light..If the foreseen use is only for the coating of tablets
this option is not required.This option will be supplied as
standard. Tel: +44(0) 1258 47-11-22www.caleva.com11 27 Feb 2013
Tablet coater Caleva Process Solutions Mini Coater Drier-2
Consumables (optional) Teflon sealing ring for spray nozzle Teflon
sealing rings for inside the spray nozzle. These can be damaged
accidentally or lost as they are quite small and we would recommend
that an additional 10 be purchased with the machine especially if
this is to be used (and cleaned) by students or several different
people. Replacement spray chamber discs (Pol yethylene) Replacement
disc for base of the spray chamber. These items can be again,
damaged or lost. We would recommend that an additional 50 be
purchased with the machine. Replacement silicon tube for
peristaltic pump Silicon tube (0.8mm internal diameter) for the
peristaltic pump. We recommend that an additional 15m is purchased
Silicon tube (01.6mm internal diameter) for the peristaltic pump.
We recommend that an additional 15m is purchased Replacement cone
assembl y Replacement lower cone including made to fit mesh
retainer Drive collar for the base of the cone (temperature probe
not included). This is taken off the machine to be washed and could
be lost or damaged Replacement upper cone Replacement connecting
ring for upper and lower cone 12Tel: +44(0) 1258
47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet
coater Mini Coater Drier-2 Recommended Spares Spare parts utility
pack A single pack containing all recommended options as shown
below: Some of these items are considered consumable in normal
operation.This spare parts pack is particularly recommended (but
not essential) for purchases outside the EU and where supply might
be difficult. All these items can be priced separately if required.
Contact us for details Teflon sealing rings for inside the spray
nozzle. These can be damaged accidentally or lost as they are quite
small and we would recommend that an additional 10 be purchased
with the machine especially if this is to be used (and cleaned) by
students or several different people. Replacement disc for base of
the spray chamber. These items can be again, damaged or lost. We
would recommend that an additional 50 be purchased with the
machine. Silicon tube (0.8mm internal diameter) for the peristaltic
pump. We recommend that an additional 15m is purchased Silicon tube
(01.6mm internal diameter) for the peristaltic pump. We recommend
that an additional 15m is purchased Replacement thermocouple
(temperature sensor). Can be broken by careless use. Replacement
lower cone including made to fit mesh retainer Drive collar for the
base of the cone (temperature probe not included). This is taken
off the machine to be washed and could be lost or damaged
Replacement upper cone Replacement connecting ring for upper and
lower cone Tel: +44(0) 1258 47-11-22www.caleva.com13 27 Feb 2013
Tablet coater Caleva Process Solutions Mini Coater Drier-2
Recommendations1 Options There are no required options. The basic
equipment as offered is fully functional. If you require any advice
regarding the options or wish us to make any recommendations based
on your planned use then please contact us. Anti static option If
it is foreseen that only tablets are to be coated then the use of
the included anti-static option is not required. However, if
pellets are to be coated then the anti-static unit is strongly
recommended. Spares and consumables We recommend you consider the
spare parts utility pack. This is a single pack containing all
recommended spares options, as shown above. This option is
recommended for users outside of the EU and suggested for other
users. IQ/OQ before shipment Installation can be provided at
customer site if required but is not considered necessary for this
equipment. Installation charges are listed in Training and
Validation Options on next page. This option is recommended only if
required for regulatory purposes. TrainingTraining in the use of
the equipment at the customer site or at our site in the UK prior
to shipment is available and this is recommended. 1Strongly
recommended: We consider that this option is a must for most cases
unless you have specific reasons why this option is not needed.
Highly recommended: Most users would consider this option as
something that they would want. Recommended: We consider that it is
sensible to purchase these options. Suggested: We suggest that you
consider these options according to circumstances. Please contact
us for any advice. 14Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug
2010