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

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Walton-on-Trent, Derbyshire, DE12 8LL, UK

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S3 Process Limited, East Cartshed Barn, Borough Hill Farm, Catton Road,

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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.