Penn Pharma Case Study - v3-00 · 2017. 8. 31. · CASE STUDY PCI Pharma Gerteis Roller Compactor...
Transcript of Penn Pharma Case Study - v3-00 · 2017. 8. 31. · CASE STUDY PCI Pharma Gerteis Roller Compactor...
CASE STUDY
PCI Pharma
Gerteis Roller Compactor for Highly Potent Contained Manufacturing Facility
BACKGROUND
PCI Pharma Services Tredegar (formerly known
as Penn Pharma), provides an outsourced
contract and manufacturing formulation
development service to many of the world’s
leading pharmaceutical companies. PCI has
invested extensively in expanding their
capabilities and their service o�ering –
completing the design and build of one of the
most advanced contained manufacturing
facilities for highly potent products in the World.
Clients were impressed with the new facility –
the building, the equipment, the infrastructure
and the early adoption of continuous
manufacturing methods, however there
appeared to be an increasing interest in dry
granulation. PCI quickly recognised the market
trend and the need to increase capabilities to
include roller compaction technology into their
existing contained manufacturing facility -
satisfying growing customer demand and
maintaining their market leading position.
Having previously worked with PCI during the
development of their containment strategy,
S3 Process were re-engaged to design an
e�ective strategy to install a new Gerteis
Mini-Pactor into a potent manufacturing facility
that was purpose built for the processes it
already contained. S3 Process were involved
from the very beginning, from initial conceptual
layout designs, through to project execution
installation, acceptance testing and quali�cation.
CHALLENGE
As part of their state-of-the art facility, PCI had
two manufacturing suites; one with equipment
designed for capacities of 1-120kg for formulation
development and small batch production, and
another with equipment designed for a capacity
of 300kg for commercial batch production. In
order to maximise the value of the investment,
the new roller compactor would need to be made
available to both manufacturing suites. This
meant the materials handling system for the new
roller compactor would need to be speci�ed and
allow adaption to interface with di�erent types of
IBCs and di�erent sizes of containment valves.
In order to seamlessly integrate with both
process lines, the roller compactor would need
to be ideally situated between the two existing
manufacturing suites. There was only one room
that was suitable, but it was very small and
located in the middle of the facility with limited
access – not only was this a challenge for the
installation, but this proved a challenge in terms
of equipment layout and materials handling for
day-to-day operation.
Every aspect of this project needed to be
meticulously designed and managed – the user
requirement speci�cation, the software design,
the mechanical and electrical design, room
layout, handling requirements and every step of
the installation, from how to lift the equipment
in, to how to manoeuvre the equipment in such
a constrained space. There was only one
opportunity to get this right.
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SOLUTION
Being involved from the start enabled S3 Process
to provide the full bene�t of their experience and
add value throughout the entire project.
Approaching the problem with a clear strategy to
integrate a new piece of equipment, optimise the
value of the investment, minimise disruption to
the business and improve the manufacturing
process wherever possible. From the outset, a
dedicated S3 project manager was appointed to
ensure the project ran smoothly.
Speci�cation
The user requirement speci�cation highlighted
that it was critical for the new roller compactor to
interface between processes, with con�gurable
components and the ability to quickly change
from one product to another in a highly potent
contained suite. Technical, environmental and
health & safety concerns were highlighted and
during a comprehensive speci�cation process,
each of the concerns were systematically and
thoroughly addressed.
Layout
There was only one room between the two
manufacturing suites that could feasibly be used,
and it was very small, but very tall – requiring an
innovative design. The ideal layout was achieved,
considering how materials would �ow in and out
of the room, how materials would �ow through
the equipment, how materials would be handled
and with what handling equipment – all while
keeping the process as e�cient as possible.
To make most e�cient use of the available
space, the roller compactor was designed in a
top-down con�guration – lifting materials in an
IBC to 6m and, with a single vertical column of
powder �ow, collecting the granulated material
into the receiving IBC at ground level. The design
of the suite included a mezzanine platform with
stairs leading to an elevated operating area, a
post hoist and a dual-purpose mobile platform
for accessing the top of the equipment as well as
safely lifting disassembled machine components
to ground level for cleaning.
Due to the unusual layout, particular attention
was paid to ergonomics for day-to-day
operation, as well as considering any potential
risks and the health & safety of the operator –
utilising the post hoist for all lifting and installing
multiple exits from the platform.
s3process.co.uk
Installation
The new dry granulation process suite was right in the middle of the
manufacturing facility. Due to narrow and winding corridors, there was no
access for a forklift truck and dismantling other rooms in the facility was not
an option. The only way to install the new roller compactor and the mezzanine
platform was to lift the roof, drop the equipment through and assemble
everything in the room.
Having devised a meticulous step-by-step installation methodology, the roller
compactor was attached to a custom designed lifting rig, the roof was lifted
and the equipment, including all the components of the mezzanine platform,
systematically craned into the room. The roller compactor was then detached
from the lifting rig and attached to the mezzanine �oor, before being lifted
again by the crane, so the mezzanine platform legs could be attached. The
complete structure, now weighing in excess of 3 tonnes, was then skidded into
its �nal position on the other side of the room.
Once the equipment was installed, it was a matter of days before acceptance
testing was underway, snagging complete and processes improved.
Quali�cation was completed to schedule and the new roller compactor was
fully operational within 10 days of being installed.
Sounds simple, but PCI is located on a windy hill top in South-Wales, the equipment on skids had just a few millimetres clearance from the ceiling, and all manoeuvring was done manually whilst protecting a brand new GMP finish floor. There was a great deal to be concerned about, and apart from one failed attempt due to bad weather, the installation went without issue.
“The training and support we received on the new equipment was outstanding. The process for resolving issues during our acceptance testing was really professional. It was clear that both S3 Process and Gerteis had a lot of experience and everyone in the acceptance team felt they couldn’t have done more to help us.”
Kevin Howells
Process Manager
PCI Pharma Services
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“Due to the complexity of the challenge, we needed multiple contractors to work together. We asked S3 Process to manage the whole project, including install, acceptance testing and qualification. S3 Process worked exceptionally well with the other parties and the installation went very well.”
PCI Pharma Services
Engineering Department
s3process.co.uk
Batch Development
Parameters such as mixing speed, drying
temperature, drying time and so on cannot be
changed once the development batch has been
started; a batch will need to be completed
before being ready to sample. As new
parameters are used as part of the DoE, then
the process starts over, using up expensive API
and valuable time.
Continuous Process Development
Parameters are easily changed; a small residence
time in the granulation zone means that the
result from a parameter change is seen within
seconds, allowing a sample to be immediately
taken. Multiple experiments can be achieved
within a very short period of time, saving valuable
API. The result is signi�cantly lower development
costs and a reduction in the time it takes to take
new products to market.
Why the Gerteis®Roller Compactor?
• Gerteis® has earned a reputation within the
industry as having the most advanced roller
compaction technology available.
• The Gerteis® roller compactor has several
unique patented features which allows for a
far greater range of formulation to be dry
granulated, up to 90% of formulations that
can be wet granulated can be dry granulated
on Gerteis®.
• Rapid DoE with no scale up from R&D work to
production scale, the Mini-Pactor® can process
from 10g up to 100kg/hour.
• High-containment designs allowing OEB5 APIs
to be handled, with proven Wash-in-Place and
Clean-in-Place designs.
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“We provide a very high calibre service to our clients and expected the same from S3 Process. At the time we were demanding, especially around requirements, drawings, documentation. S3 Process were very good at responding to challenges and helping us resolve issues quickly. There never seemed to be a hurdle too big.”
PCI Pharma Services
Engineering Department
RESULTS
Since building their contained manufacturing
facility, formulation development had become a
more substantial part of PCI’s service o�ering.
With the latest addition of the Gerteis Mini-Pactor
roller compactor, PCI has improved their R&D
capabilities – now conducting more experiments
with smaller quantities of materials, not only
saving on expensive API and research time, but
improving the depth and quality of research.
Continuous �ow production means there is no
traditional ‘scale up’ from formulation
development to commercial manufacturing –
once formulations are approved, the parameters
used for batches of 1kg are the same as they are
for batches of 100kg. This has resulted in PCI
being able to manufacture products of a
commercial standard far sooner, enabling their
customers to bring products to market potentially
years earlier – maximising the revenue customers
can generate from Commercial Supply.
Having invested in the most advanced roller
compactor available on the market, PCI has
maintained their position at the forefront of
contract manufacturing and is able to
continue to o�er operational excellence in
the development and manufacture of higher
potency products and continue to satisfy the
demands of a growing market.
s3process.co.uk6
“S3 Process is very experienced and has good process manufacturing knowledge. They work with various pharmaceutical equipment suppliers to provide complete manufacturing solutions. They’re diligent, friendly and very easy to work with.”
PCI Pharma Services
Engineering Department
+ 44 (0) 845 5053530T
E
Walton-on-Trent, Derbyshire, DE12 8LL, UK
© S3 Process Limited Registered in England & Wales: 06864748
S3 Process Limited, East Cartshed Barn, Borough Hill Farm, Catton Road,
[email protected] s3process.co.uk
Talk with us today to see how the combination of our expertise and the world’s leading process technologies can help drive e�ciencies and improve your process.