MANUFACTURING

How to Eliminate Cleaning and Be

Rewarded with Substantially Improved
OEE
Summary the IBC itself, and the other part is the cleaning as there is no product
‘Tumbling’ is a widely used way of dry clamping mechanism which picks up and transfer and associated risk of
powder blending in the oral solid dosage rotates the IBC (figure 1). product exposure or contact.
(OSD) manufacturing environment.
The possible downside of using an IBC
The aim of this article is to demonstrate Blender is that there is more limitation in
how IBC blenders, when compared with batch size, as the IBC needs to remain a
other methods of dry powder blending, transportable size. However, modern IBC
can significantly increase your blending blenders are available up to 3500 litres
capacity and reduce your manufacturing in volume, effectively holding a batch of
costs. 1200 - 1400 kg.

Batch size selection criterion is challenged Stationary blenders can be used for
- can we get closer to a ‘batch to order’ larger volumes, however in practice,
philosophy? due to room height limitations, sensible
capacities do not usually go above 4000
Inline sampling is scrutinised - is it now litres gross volume.
unnecessary and overly expensive?
What Drives the Requirement for Larger
And finally attention is paid to the actual Batch Volumes?
transfer of the batch from the blender Regulatory bodies require specific
to the next process. How does an IBC sampling methods and quantities to
container ensure that the uniformity of analyse and validate that a blend is
the carefully blended batch is not ‘lost in uniform. The cost of such sampling is
transition’? significant and it makes sense to increase
the batch size in order to reduce the ‘QC
Introduction Figure 1 cost per kg’.
All dry blend operations rely on three
basic blending mechanisms: This separation of chamber and However, with quality by design (QbD)
mechanism is the most important efforts and strict control over the raw
1. Convection – the overall transfer difference between mobile shell and material properties, the need for blend
of lots from one place to another, stationary shell blenders. It has striking sampling could become a thing of the
forced by a rotating mixing element benefits in terms of overall blending past, or at least reduced. PAT methods
(ribbon blenders, conical screw capacity and operational costs: such as the use of NIR spectroscopy
blenders etc.) might replace blend sampling altogether
2. Diffusion – a re-distribution of • IBC blenders do not have to be and in some applications it does already.
particles, a relative change of place cleaned, not even at product change Having said that, some companies have
in the blend (tumble blending) because as the IBC is the cleaning their own mandatory procedures which
3. Shear – the actual forced movement vessel, the cleaning can be done off- make sampling definitely not yet extinct.
over slip planes (plough shear line in a separate washing area.
blenders etc.) • IBC blenders are loaded and Efficiency of IBC Blending
unloaded very quickly (placement The following calculation (figure 2)
Most blenders used are tumble blenders, or removal of the IBC) which means demonstrates the difference between
either ‘stationary’ shell (V-cone, that a high OEE for blending can be IBC and stationary blenders in a more
hexagonal, double cone etc.) or ‘mobile’ achieved. quantitative way. The comparison is
shell (IBC or drum blenders). The main • One blender can take multiple done on 1200 kg quantity of collected
reason for their popularity is that these IBC sizes, therefore the blending lots. The loading and unloading of the
blenders are quicker and easier to clean ‘chamber’ can match the ordered IBC blender is simply a matter of placing
thanks to the absence of internal mixing batch size and removing the IBC. For the stationary
elements. They therefore present less • Modern IBC blenders can nowadays blender, we have assumed the loading is
cross contamination risks. also process large batches (up to done using a vacuum transfer system. The
1400 kg) unloading is assumed to be by gravity,
The Benefits of IBC Blending • Sampling can be done ‘off line’, straight into a batch container.
Intermediate bulk container (or IBC) not affecting the availability of the We have assumed cleaning is required
blenders basically consist of two parts. machine. after five batches and we estimate it takes
One is the blending chamber, which is • The blender room does not require three hours for the stationary blender

68 INTERNATIONAL PHARMACEUTICAL INDUSTRY Summer 2014 Volume 6 Issue 2

MANUFACTURING

and room to be cleaned. This means an for example), a novel solution is now ‘heap’ that will create more rolling effects
average of 36 cleaning minutes per run. available. Matcon have designed a over the top surface.
lubricant addition system, which will
In this scenario, the overall blending allow the addition to be loaded into the Using an IBC Blender removes the
capacity of the IBC blender is more than IBC without the need to open it. This way, transfer risk as the product remains in
three times that of the stationary blender! the room will not need to be cleaned or the IBC throughout the whole process.
the IBC to be transported back and forth As for the discharge process, using a
What does this mean? From a capital to the dispensary. This further adds to the cone valve IBC ensures the powder flows
investment point of view, a single IBC ‘lean’ approach of OSD manufacturing. under mass flow – the cone ‘holds back’
blender situated in a relatively small room the batch in the centre and promotes
produces the same number of blends How do you Prevent Segregation during flow from the sides, thus avoiding any
rolling effects. This mass flow maintains
the blend uniformity during the whole
discharge process, particularly important
when using direct compression.

Concluding
Cone Valve IBC Blenders (figure 1) have
striking benefits over stationary blenders
– they provide:

• A much higher overall blending

throughput, replacing 2-3 stationary
blenders
• The ability to blend up to 1400 kg
Figure 3: Stationary Blender Segregation during discharge • Reduced operational cost and high
OEE
per time as three stationary blenders Transfer? • Avoiding segregation (with cone
with consequently three cleanrooms and Sampling protocols and tools do get a lot valve technology)
associated cleaning time. Although an of attention in order to avoid ‘disturbing’ • Optional Contained Lubricant
individual IBC blender is normally more of the batch and to ensure the samples addition system
expensive than a similar sized stationary form a representative image of the batch
blender, the total investment to achieve a as a whole. Yet the actual transfer of the It’s perfectly possible to reduce the
certain blending capacity is often lower. It batch from the stationary blender to the number of blenders whilst trebling your
also means less operator intervention, so next process step is where the batch is blending throughput.
reduced running costs. most likely to become ‘very disturbed’.
That changes things considerably,
How do you Accommodate Multi-stage and the batch is in danger of losing its
Blending? mandatory degree of uniformity. Wim Spook (BSc Engineering)
is a professional powder
The concept of fully contained IBC
handling specialist with
blending is challenged when multi-stage The material has to flow out by gravity extensive experience working
blending is required. It would not be a and possible rolling effects present a in hygiene business
good idea to open up the IBC inside the segregation risk that cannot be ignored. environments for many years.
blender room, because that activity would This happens typically when a batch He joined Matcon Ltd in 1997
contaminate the room. An approach is to discharge shows a funnel flow discharge as Sales Manager for Holland
and Belgium, focusing on the
bring the IBC back to the dispensing area pattern (figure 3). food and pharmaceutical
to receive the addition. industries. In 2009, he became Pharmaceutical
An additional negative effect occurs in Business Development Director of Matcon Ltd
For adding a lubricant (a stearate the drum or IBC as the granules form a UK. Email: [email protected]

70 INTERNATIONAL PHARMACEUTICAL INDUSTRY Summer 2014 Volume 6 Issue 2