Bulk Manufacture - Scale Up - Society of Cosmetic Scientists

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Processing and Manufacturing
1.
Information transfer
2.
Bulk Manufacturing – Processing
3.
Product -Filling Equipment
Processing and Manufacturing
•Bulk Manufacturing – Scale Up
•Scale Up – defined as the successful duplication of the products primary characteristics over a
range of increasing batch sizes and across a variety of manufacturing equipment or vessels of
different sizes.
•In the Scale Up process there are easy products having a low to medium viscosity that can be
manufactured repeatedly with a high degree of consistency.
•But there are products that are difficult to scale up – those with high viscosity or rheological
profiles.
•The main factors that can influence the Scale Up Process :
•Heating and cooling times
•Transfer and mixing times
•High energy mixing (RPM) – homogenisation rotor/stator and type
•Raw material addition rates or transfer times oil phase to water phase
•Better still formulate with production equipment in mind and use raw materials that do not
require special treatment.
Processing and Manufacturing
•Bulk Manufacture - Scale Up - Vessels
•Pilot equipment –using the pilot size vessel – 100 KG scale equipment such as the
Becomix, Fryma and IKA which can be computer controlled. The manufacturing sequence
can be transferred to the production size vessels. This helps to reduce the variability in the
different parameters of heating, cooling, mixing and homogenisation.
•Using the Becomix, Fryma or IKA mixing units for the manufacture of gel type products
using Carbomer type thickeners the level of thickener may need to be adjusted up or down
to give the required finished viscosity.
•Pilot equipment – using 100 Kg size vessel that does not represent the same type of
mixing and cooling rates as used on a production vessel the scale up process is more
complex due to the variability in the different parameters heating, cooling, mixing and
homogenisation times. This can result in a product formulation having a different
appearance to the standard agreed between R&D and Marketing.
•This is a common mistake and has been seen in number of different processing plants
Processing and Manufacturing
•Bulk Manufacture - Scale Up
•Outcomes from Pilot Batch:
•Temperature - heating graph & - cooling graph
•Homogeniser and Mixer speed and timings
•Viscosity adjustment graph
•Rheology - profile
•Ph adjustment – depending upon formulation
•Particles size - depending upon formulation
•With the use of Human Machine Interface graphics/pc’s this data is collected and then
used to programme the Production plant.
•Typical Software Pantek – Wonderware – In-touch and In-batch
Processing and Manufacturing
•Bulk Manufacturing
•Processing is the large scale mixing of raw materials - chemicals in a controlled way to
produce a finished bulk.
•A batch of bulk can be from 500 to 25,000 kg and then on to continuous processing.
•Before planning of a Works Experimental or Pilot batch a Risk Assessment must be carried
out to identify and review all risks.
•Whatever the batch size a Works Experimental or Pilot batch should use equipment that
reflects the Production batch equipment.
•Agree parameters with R&D –viscosity, mixing and homogenisation speeds, heating and
cooling temperatures and rates.
Processing and Manufacturing
•Bulk Manufacture – Equipment Selection
•The selection of equipment depends on the formulation and the manufacturing process, batch size,
batch time, product fill, hot, cold, mixing or homogenisation and cooling rate.
•Detergent based formulations – propeller and vessel design – 70 % SLES dilution – homogeniser
size.
•Vessel design height to diameter ratio, 1 to 2
•Blade width 50% of vessel diameter
•Blade position on shaft 0.80 meter from top and bottom
•Blade design
•Emulsion formulation – new vessel design:
•Environmental issues are having a big impact on the design of new processing vessels:
•Electric power requirements
•Heating and cooling cycle time
•Steam and Water volume
•Hot and cold emulsion processing
•Wash cycle – CIP system
Processing and Manufacturing
•Bulk Manufacture – Equipment Selection
•Creams – emulsions – homogeniser rota & stator and contra rotating bladed with side
wipes - GUISTI type
•Creams – emulsions – homogeniser rota & stator with a structured agitator mixing
blade- Becomix/Fryma/IKA type
•Gels – depends upon formulation Carbomer or associative type systems.
•Decide if in-vessel or in-line homogenisers is required for your formulation.
Processing and Manufacturing
•Bulk Manufacture – Equipment Selection
•GUISTI type – typical British design - flexible – pressure/vacuum vessel with in vessel
homogeniser – rota/stator and contra rotating scraper blades. A recirculation pipe can be
fitted to take bulk from the bottom of the vessel into the top of the vessel. Or a
recirculation pipe can be fitted to in – line homogeniser like a Silverson which can have a
greater power input able to homogenise thicker creams. Ideally fitted with load cells and
computer control to ensure uniformity of manufacture.
•Becomix/Fryma/IKA type – typical European design – pressure/vacuum vessel with in
vessel homogeniser – rota/stator and pump with a structured agitator mixing blade. With
this design recirculation pipe not required. These type of mixing vessels are ideally suited
to computer control which would include load cells, to ensure uniformity of manufacture
and the recording of specified parameters.
Processing and Manufacturing
•Bulk Manufacture – Equipment Selection
•Secondary equipment:
•Wax melter
•Phase vessel with stirrer – Oil or Water - steam heated or water cool recirculation
•Powder inductor – in vessel or standard alone unit – Flash Blender type units – Ystral Conti
TDS
•LEV - Local extraction and ventilation units
•Waste collection units – IBC’s – Trade Effluent Consent rules
•Dispensary system
•Water treatment – demineralised, soft water or mains
Processing and Manufacturing
•Bulk Manufacturing - Bulk Storage
•This depends upon the type and quantity and hazards of the bulk to be stored. Typical
examples are as follows:
•Shower Gels, Foam Baths and Shampoos - Storage Tank
•Creams – Stainless Steel Drums or IBC, or Bag in Box:
•IBC stainless steel – require washout and sanitising before reuse. Wastage can be high due
to design.
•Bag in Box Flow boxes which with the use of a mangle can reduce the wastage to a
minimum. The advantage of Bag in Box is that they is no washout required of the storage
container as with IBC.
•Drums with pump follower diaphragm - require washout and sanitising before reuse.
Wastage can be high due to design.
Processing and Manufacturing
•Bulk Manufacturing - Bulk Raw Material Storage
•This will depend upon the raw material quantity, hazards and the storage conditions as
recommended by the supplier. Typical examples are as follows:
•SLES – stored in insulated warmed storage tanks with a fail safe heating system – as it
becomes to hot then you get thermal decomposition – not nice.
•All external storage tanks used for raw materials containing water should be insulated for
frost protection and to reduce temperature shock if used in an emulsion
•Ethanol – stored in a tank that is intrinsically safe and fuller protected with fire fighting
systems
•Water – storage tanks cleanable with CIP system – but depends upon water treatment
process.
•All tanks need to be in a bunded area to contain the contents should the tank or tanks split
and loss the contents. Tank farms are becoming an environmental issue depending upon site
location and surface drainage conditions.
Processing and Manufacturing
•Filling and packaging
•All filling lines operate on the same principle:
•Filling
•Capping
•Labelling with coding
•Pack to secondary packaging carton, tray & shrink wrap
•Pack to outer
•Pack to pallet.
•The filling and packing of cosmetics and toiletries is a complex operation driven by volume and
market. Plus the cost of equipment can be very high and delivery times up to 6 months. An new
automatic filling line to fill toiletries can cost £1 to 2.0 million depending how much automation is
installed. And the use of pucks is increasing due to its flexibility – able to fill different size
containers.
Processing and Manufacturing
•Filling and packaging - Filling Machines
•There is a variety of filling machines available from simple hand operated to highly complex
multi headed computer controlled automatic filling, capping, labelling and packaging.
•The viscosity, rheology and any product foaming, primary components - tube, pot, jar or toggle
will dictate the filling method. The planned unit run and OEE will need to be taken into account
as no filling line runs at 100% efficiency. So you will need decide the cost of filling?
•A fully automatic filler that runs at 120 units per minute but at an OEE of 80% giving 96 units
per minute. The filling line takes a complete shift to clean and reset ready for the next product
run.
•A machine speed of 36 units per minute at an OEE of 75% with manual pack off into cartons at
6 units per minute per operator. The filling line takes 2 hours to clean and reset ready for the next
product run.
Processing and Manufacturing
•Filling and packaging - Filling Machines
•Vacuum filling - is the most basic and widely used type of filling after hand filling. Operates
by inducing a vacuum in the container normally glass as it with stands the vacuum. Vacuum
filling is relatively cheap and effective and can operate at 20 to 30 units per minute.
•Volumetric type filling - is based on a variable volumetric cylinder and can fill medium
viscosity creams and lotions. The fill is controlled by the size of the cylinder and the position
of the piston. With this type of filler the volume fill is infinitely adjustable and cycle time 3 to
5 seconds by unit fill.
•Mini pump filler - has been developed over the last 10 to 15 years and can be fitted with a
wide range of nozzles to cope with a wide range of viscosities. Mini pumps can be as single
units or as banks of 4 or 6 and index fill together. The mini pump pulls bulk from either a
header tank or from drums.
Processing and Manufacturing
•Filling and packaging Secondary packaging
•These are cartons, leaflets, trays, shrink film, shippers
•Straight on Trays normally hold 6 or 12 units depending upon how many facings on shelf.
•Shrink film – applied my healing sealing machine and heat tunnel to shrink a round pack.
•Shelf Ready Packaging – this is the latest idea but know clear design. Industry meeting later
in year to seek agreement. But has big implication for industry because until format agree
design of automatic loading equipment is not possible.
•Pallet Layout – important for high street stores as all pallets delivered into the warehouse are
scanned in as proof of delivery. Therefore units/packs per pallet is a key issue for the stores
and it costs to load and verify data on to the computer systems.
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