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focusFOSTER WHEELER S PHARMACEUTICALS BUSINESS MAGAZINE
ISSUE 6
Focus on containment
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blished by
ter Wheeler
nfield Park
ading
kshire RG2 9FW
w.fwc.com
naging Editors
olyn Greenhalgh
ector, Corporate Communications
lobal Marketing
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queline Hogarty
rketing Consultant
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duced by FW Graphics Group
oster Wheeler
FOCUS ON CONTAINMENT
As a change from the norm, this issue of focus is given over to a single topic.
The protection of operators and the environment has always been a priority forthe pharmaceutical industry. The production of active materials in smallerquantities with much higher potency is driving an increasing number ofmanufacturers of bulk drug substances and final dosage forms to examine their
containment options. The increasingly risk-based regulatory framework and developmentsin containment technology are driving changes to the design and operation ofcontainment devices.
At Foster Wheeler we have gained considerable cutting-edge, practical experiencein devising and supplying containment solutions, to the point where we have beenselected as global containment consultants by one of our key multinational customers.
As part of our ongoing quality improvement program we recently held an informationexchange forum on containment to which we invited a number of clients, to share ourjoint experiences based on real-life case studies and a wide range of projects. Thecontents of this focus issue are based on that event, an idea that the participants activelyencouraged us to repeat in other technical areas.
Clive MullinsGlobal business director
The Containment Forum held in Milano was a very valuable experience.
Bringing together industry expertise from both engineering and operating companies inan informal setting to share non-proprietary knowledge and experiences allowed foropen discussion and debate as to good engineering practices relative to containmentsystem design.
I believe all involved gained some knowledge which will be applied to the improvementof future installations.
Paul Richards
Project & technology engineerPfizer Global Research and Development
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setting the scene
Why is containment important?When considering containment there are multiple
drivers. The mix of critical factors will change
application-by-application, and the solutions will
vary accordingly. This leads to a very complex
subject and Paul Richards of Pfizer addresses
this range of solutions on page 9. Typically,
drivers will include operational hygiene for
operator protection, plant safety, product
quality, reduced environmental impact, and
operational improvement.
The operational health impacts on the operator
can be very serious. The use of personal
protective equipment has been shown to be
poorly effective in practice and its use for routine
operations has been discouraged by regulation.
All of this drives us to ensure better protection
for the operator. Pam Davison, in describing
GSKs forward strategy, addresses this area
on page 5.
Safety is, of course, dominant, for example in
handling materials in an inert environment. Theprime interest of the pharmaceutical product
regulators is patient safety, via the quality of the
medicinal product, and containment has to
prevent contamination or cross-contamination
of this product. As well as the internal plant
environment we are interested in preventing
material escaping to the external environment.
For some compounds, operator health may not
be an issue but potentially there could be
significant external environmental impact.
Recent changesPharmaceutical companies tend to specialise in certain therapeutic
areas, and the activity of their compounds reflects that. We see the
need to handle increasingly active compounds. We also see new
guidance, for example for cytotoxics, and the need to transfer
techniques from other industries such as the nuclear industry.
The pharmaceutical industry is now prepared to learn to SWIPE,
(Steal With Integrity and PridE) from other industries. Huw Thomas
describes what others are doing in dose form manufacture,
page 10. David Ainsworth covers the need to treat the
commissioning and qualification of facilities for nanogram
containment differently on page 11.
We are also seeing production of smaller quantities of materials, partly
due to their activity, and partly due to demand. This is changing the
associated method of containment and is addressed in
Nanocontainment and Small Scale Manufacture by Marco
Mascarenhas on page 3.
We are seeing an increase in the need to contain not only powders but
also aerosols potentially generated in liquid filling. Germana Molinari
gives a review of fill-finish design on page 7, and David Ainsworth
looks at a case study at a Janssen highly potent powder handling
unit (Facility of the Year Finalist 2006) on page 8.
Other changes involve increasing use of new solutions such as flexible
plastic, and increased use of gloveboxes. Huw Thomas, page 6, and
Emilio Moia, page 4, address these two areas respectively.
The use of risk assessments in many areas of life has become an
everyday subject. In the pharmaceutical industry they are embodied in
much guidance, now reinforced by ICH Q9. Their use in containment
occurs both at macro and micro levels and John Nichols discusses
this in an article on hierarchy and risk-based approaches on page 2.
What is
containment?If an overall manufacturing facility consists of three components pharmaceutical material, personnel, and the environment surrounding
them containment is the isolation of the first of these components from
the other two. ISPE
A KEY TECHNOLOGY AREA IN THE SPOTLIGHT
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An holistic approachThe containment chapter of the draft ISPE BPC Baseline
Guide, to be issued in 2007, recommends
a similar holistic approach to that adopted for HSE, following the steps below in sequential order to
alleviate an exposure potential wherever possible:
Selection of containment elementsValues for the containment obtainable under typical operating conditions for an average material with
good operating practice (as illustrated on the enclosed reference card) can be used as guidance for
potential protection. However, all factors should be taken into account in selecting equipment for
a specific application.
There is potential for improving the performance of standard equipment by adding additional layers
of protection, such as illustrated on the card by a downflow booth with several typical upgrades.
Risk assessmentRisk assessment using a variety of tools is a widely-used technique. With the issue of ICH Q9, andthe ISPE RiskMAPP initiative, its use in pharmaceutical containment has been reinforced. Ranking the
exposure potential enables a better choice of an appropriate methodology for containment equipment
selection, taking into account particular circumstances.
Foster Wheeler has developed a method for assessing the risk from widely different operations and
has used it for a number of projects to identify highest-risk operations and to prioritise upgrade work.
focus
holisticviewTHE HIERARCHICAL APPROACH TO CONTAINMENT
Successful containment requires an holistic approach:development of the correct strategy, selection ofcontainment elements by their capability for typical
operations and a risk assessment technique for rankingthe exposure potential.
ISPE Baseline Approach:Hierarchy of Containment
Modify process to remove hazard
Sealed equipment and connections
Localized containment devices
Contain in the facility
Use of procedures
Eliminate
Reduce
Isolate
Contain
PPE/Discipline
JOHN NICHOLS
John NicholsGlobal technology director
HSE Approach
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nano-containmentEXTREME POTENCY AT A SMALL SCALE
Firstly, the increasing activity or potency of active
pharmaceutical ingredients for certain therapeutic areas
has warranted some materials being given an occupationalexposure level (OEL) of the order of 5-10 nanogram/m3
(plutonium is 0.1 nanogram/m3).
Secondly, some compounds are being manufactured in ever-
decreasing quantities, with some annual production quantities
of less than 1 kg, and we have even seen an instance of annual
production of about 0.1 kg.
These trends clearly impact on the design of pharmaceutical
facilities and equipment, and especially containment.
Established technology uses glovebox isolators with
rapid transfer ports and measures to reduce the
internal challenge to achieve the required containment.
Glovebox isolators are the chosen solution for small-scale nanogram operation and some standard units
are available from suppliers. Establishing the right
technology is driven by analysis using risk
assessment, and by custom and practice.
A recent project executed by Foster Wheeler for
a cytotoxic API involved the whole non-aseptic
cytotoxic production - including weighing/dispensing,
solution preparation, reaction, crystallization, filtering,
drying and weighing/filling - taking place inside one
five-chambered isolator.
Achieving 1-10 nanogram/m3
is highly demanding,and it should be appreciated that the glovebox
isolation technology for this level of containment is different
from that required to achieve microgram containment.
With continuing increased potency of pharmaceuticals, and
the prospect of manufacture of smaller quantities for responder
groups and so on, we see this type of facility becoming
more common.
Two significant trends are impacting themanufacture of active drug substances. These
trends are delivering some exciting innovations inglovebox isolators, plug and play concepts, processinterlinking, secondary containment and control.
MARCO MASCARENHAS
Marco Mascarenhas
Manager, bulk pharmaceuticals
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Continuous development, innovation anda stringent attention to detail in design andmanufacture, maintains our product portfolio
at the cutting edge of technology.
isolatorsTHE DRIVE FOR INNOVATION
Steril, Foster Wheelers manufacturing division, designs and manufactures
a comprehensive range of vertical and horizontal laminar flow benches,
bio-safety cabinets and isolators for powder containment.
This is done in strict compliance with the exacting standards and design
guidance for containment which include:
ISO 14644-7: Separative devices (clean air hoods, gloveboxes,
isolators, etc)
ISO 10648-1: Containment enclosures
Part 1: design principles
ISO 10648-2: Containment enclosures
Part 2: classification
AGS-G001-1998: Guideline for gloveboxes
EN 12469: Performance criteria for microbiological
safety cabinets
In addition, a continuous research and development programme maintains
Sterils equipment at the forefront of LAF and containment technology.
Results from this development programme include:
An innovative isolator exhaust system that, in the event of an accident,
has a zero transition time to safe operation. This development has been
operating in a high potency drug facility in Italy since 2005.
Containment solutions for gaseous decontamination involving products
that are effective against biological agents but which can, after use, be
rendered harmless.
EMILIO MOIA
Emilio Moia
Manager contamination control
& containment
Pharma i
Both of these developments were covered in more depth in the
previous issue of focus which can be found at:http://www.fwc.com/publications/focus.cfm
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occupationalhealthAN OPERATIONAL PERSPECTIVE
Adverse health effects related to chemical agents canseriously affect a persons quality of life and in somecases be life-threatening. Of these, allergic and dermatitic
reactions form a significant proportion of reportableoccupational diseases. Clearly the industry has a dutyof care to protect workers from exposure to such agents.
A study looking at ten pharmaceuticalmanufacturing sites owned by different
companies, showed that of the 211 subjects
tested, 145 (69%) had leaking respirators.
The study also showed no correlation
between the effectiveness of the respiratory
protective equipment and the frequency of
use, experience or training. In addition it can
be shown that if a respirator is only effective,
say, even 98% of the time, it can fail to meet
the desired application requirements.
GSK has set itself a challenge to have 80%
of its unit operations respirator-free by 2010.
Further, when matching engineered controlsolutions to problems it is necessary to
understand that it is not just a direct
relationship to the Occupational Exposure
Level (OEL).
Factors such as scale, dustiness, process
energy, and API content can alter the most
applicable control strategy for a given OEL.
GSKs integrated strategic approach
includes documented established solutions,
communities for engineers and hygienists,
tracking performance, hygienist networking
and training, a behaviours program, engineer
training, and established partnershipswith suppliers.
focus
Pam Davison
Technical directorGlaxoSmithKline
PAM DAVISON
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flexiblecontainmentA TABLET MANUFACTURING CASE STUDY
Disposable systems can provide efficient, cost-effective containment inthe right application. They are very adaptable and can accommodatea wide range of applications, but are not the best solution for all
applications. Taking a wider viewpoint, using the layered approach isa good underlying principle for containment selection and design.
A recent project involved the specification of
a containment upgrade to allow manufacture
of a particular higher potency product in anexisting small-scale tablet manufacturing facility
with granulator capacity of 400 litres. The
operator exposure limit for the compound being
handled was 10g/m3, and we needed to
implement short-term upgrades quickly before
the next campaign, with minimum disruption to
manufacturing operations.
Flexible, disposable containment was the key
to this project, and it had to be designed,
made, tested, modified, installed and the
operators trained in just thirty days!
The results of personnel monitoring (outside
air suits) showed exposure was reduced by
up to 1000-fold by the use of flexible barrier
containment. Although exposure was still
affected by operator action, it was less so
than with the use of personal protective
equipment alone.
In addition to the flexible glovebags, use was
made of Spraylat
floor covering to trap any
potential surface contamination. There was a
significant reduction in surface contamination,
leading to a 20-fold reduction in room cleaning
times. The disposable Spraylat
floor waspeeled up, thrown away, and the surface
swabs were clean.
Future use of disposable containment may
include the design of granulator and fluid bed
drying glovebags, modified and extended to
the other granulation sites in the facility.
Longer-term engineering improvements need
to be made to areas not suitable for flexible
containment, for example through-floor feeders,
automated bin charging and discharging.
Some useful containment figures:
One sugar crystal ~ 1000 gmOne grain of sand ~ 100 gm
100 particles of pollen ~ 10 gmHousehold dust ~ 1000 gm/m3
Typical airborne concentrations from open handling:
Dispensing 1,000 - 10,000 g/m3
Manual charging 10,000 - 50,000 g/m3
Granulation (scraping) 10,000 - 50,000 g/m3
Drying (open transfer) 5,000 - 100,000 g/m3
Compression 10 - 300 g/m3
Disposable / Flexible Containment Principles
OPERATORPROTECTION ONLY
AIRBORNE CONTAMINATIONCONTROL BEST
POOR
SURFACE CONTAMINATIONCONTROL BEST
IMPLIED INHERENT
FLEXIBILITYERGONOMIC FLEXIBILITY
CAREFUL
DESIGNREQUIRED
HUW THOMAS
Huw Thomas
nior pharmaceutical
engineer
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fill-finishTHE CONTAINMENT SOLUTION FOR YOUR OPERATION
In the absence of a one size fits all solution to thecontainment of fill finish operations, a logical approach
to the design of effective protection is required. Key tosuccess is the correct combination of working areaconfinement and personnel gowning.
Previous solutions often relied on personal
protective equipment (PPE) together with
contained rooms or departments to protect the
environment. Now, more and more, the approach
is to use primary containment at the very
source of product exposure, using secondarycontainment as a back up solution and PPE
as an emergency/short-term intervention
protective device.
The essential first step is identification of the
critical operations, typically:
The range of containment devices applicable to
the different operations is wide and includes:
contained connection - split valve, high
containment valve, rapid transfer port,
continuous liner
glovebox isolator
closed restricted access barrier system
(C-RABS)
Crucial is the awareness that there are no
universal solutions applicable to every situation.The selection of the proper containment solution
should include an analysis of the key features of
the operation to be contained, typically:
product potency - low, medium, high
product form - liquid or solid
product diffusion capability - aerosol
generation, powder spread
activity duration - occasional or shift-based
product exposure - open or closed activity
aseptic processing requirements - meeting
HSE and GMP requirements
product potency issue or only cross-contamination prevention
Three possible indicative decision trees are below:
Injectables Facility
Dispensing
Formulation
Filling
Lyos unloading
Oral Solid Dosage Facility
Dispensing
Product transfer
Tabletting/capsule filling
Blistering/bottle filling
Working area protection LIQUID
Potency
StandardApproach
C-RABS(only for cross-contamination)
C-RABS(for personnel safety)
Containment
Isolator
Medium
High
Very High
Low
Aerosol?
N
Y
HP : no PPE use
Working area protection SOLID
C-RABS(only for cross-contamination)
C-RABS(for personnel safety)
ContainmentIsolator
Medium
High
Very High
Low
Potency
HP : no PPE use
Verypowdery?
N
Y
Y
N
Almost notpowdery?
Product Transfer SOLID
Medium
Very High
Low
Potency
HP : no PPE use
Open process allowed orClosed process with butterfly valves
Closed processwith standard split valves
Tight closed process withhigh containment valves
Tight closed process withRTP parts and glove box
High
GERMANA MOLINARI
Germana MolinariSenior finishing &
formulation engineer
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highlyactivepowdersCASE STUDY OF AN AWARD WINNING PROJECT
Janssens major primary pharmaceutical manufacturingsite at Geel in Belgium produces thousands of tonnes peryear of active pharmaceuticals and intermediates. The site
has almost 100 reactors and manufactures a wide range ofmaterials of varying levels of potency. The most potent
products OEL of less than 5 micrograms/m3 means veryhigh containment requirements.
Recently, Foster Wheeler and local Belgian partner BnS
worked together to deliver a high containment solids handling
facility. The process involved delumping, milling, sieving,
homogenizing and pack-off and all of these operations were
designed to be undertaken within a series of bespoke
gloveboxes. Glovebox design had to take full account of the
processing needs and also enable full disassembly and
cleaning of the solids processing equipment.
Complex ergonomic mock-up models of the process
equipment were developed to ensure that the design on
paper was practical and enabled all of the required
operations to be undertaken by an operator working via
gloves. Heavy equipment was mounted either on hingesor slides, flexible connections were needed in the powder
transport piping system and full nitrogen inertion was
necessary to prevent explosions!
The design containment level of 50 nanograms/m3 was
achieved, the project was completed from concept to process
start-up in two years and the degree of innovation achieved
was recognized by the project being selected as a finalist in
the prestigious Facility of the Year Awards in 2006.
Foster Wheeler is delighted to announce that the General Technical Services Department of JanssenPharmaceutica NV has awarded its annual Quality Certificate to Foster Wheeler, in recognition of its
contribution to the development of the concept study for the recently announced Chemical Development
Pilot Plant (CDPP).
Foster Wheeler scored the highest possible rating, AA, in this award, which is given to the best performing
contractor at Janssens Geel and Beerse sites in Belgium.
Foster Wheeler is continuing to support Janssen with the BOD-B (FEED) phase of the project.
DAVID AINSWORTH
David AinsworthPrincipal consultant
Quality
Award
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bulkchemicalmanufactureA GUIDE TO CONTAINMENT OPTIONS IN API PLANTS
There are many engineering control options forcontainment. What option is most suitable for yourapplication? What is the range of performance
expected with various containment solutions?Who are the primary vendors? And what are thebudgetary costs? Question, questions .
But a useful starting point is: what are we trying toachieve? If we consider that 1 granule of sugar is
about 3 milligrams, then a containment level of
3 g/m3 is like dispersing 1/1000th of 1 granule of
sugar in 1m3 of air - pretty exacting stuff!
In API plants, the movement of materials, supplies,
tools, wastes, and recovery systems into and out of
the contained environment is the key to successful
containment. The performance of an isolator is only
as good as the transfer devices on the isolator.
There are many different transfer devices available
on the market, each with its own pros and cons.
A primary concern with split butterfly valves, forexample, is material on the faces of the valves
after undocking, and concerns with cleaning
extraction rings.
Some recommendations include:
Contain at the source
Avoid technique-dependent systems
Many containment technologies are
available and continue to evolve
Transfer system selection is a key to
successful containment
Design below the operator exposure limit
Consider ergonomics, cleaning, sampling,
waste, material compatibility
Provide redundancy/secondary containment
Engineer out the reliance on personal
protective equipment
And the golden rule is, there is no silver-
bullet containment solution!
focus
Paul Richards
Project & technology engineerPfizer
PAUL RICHARDS
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oralsolidsmanufactureSURVEY DEFINES BEST PRACTICE
BackgroundThe pharma company currently has
no OSD facility designed to handle
actives of
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factoryacceptancetestsHIGH CONTAINMENT ISOLATOR CASE STUDY
Bearing in mind that a required containment level of less than5 nanograms/m3 is the equivalent of one grain of pollen in anaverage-sized living room, factory acceptance testing at such
levels can be pretty exacting.
To demonstrate the performance of a number
of high containment gloveboxes to be installed
in an existing primary pharmaceutical
manufacturing unit, Foster Wheeler went to
extraordinary lengths. Testing of the units
covered:
ergonomics - operations, controls and
sequences
documentation - GA, P&ID and materials
checks
lighting and noise level checks
surface finishes, cleanability and drainability
airflows, operating pressure and inertion
times
accuracy of instrumentation
connections to pressure systems
leak performance - pressure and vacuum
testing
containment performance - surrogate
material testing
In particular the containment performance
testing of each glovebox was stringent.
A surrogate material, Sodium Naproxen,
detectable at levels as low as 0.5 nanograms,
was used to mimic the actual operations that
would be conducted in each glovebox. The
surrogate test material was kept in double-
sealed containers inside a small storage room
(actually a garden shed bought locally!).
This was segregated from the rest of the
factory by a temporary polythene sheeted
antechamber to guard against inadvertently
contaminating the glovebox test environment.
Surrogate test material to be used in testing
each glovebox was loaded into sealedcontainers in this storage room; the
containers were then cleaned and passed
out of the room for further cleaning outside
the factory.
Once the containers were thoroughly clean
and free of any of the test material on the
outside, the container was double-bagged
and sealed and then brought back into the
facility for use in the glovebox testing area.
The container was docked onto the glovebox
in the test area and the surrogate material
introduced via rapid transfer port into theglovebox interior. Here a full cycle of the
required operations was conducted. During
this cycle of glovebox operations, both
airborne and surface samples were collected
from the surrounding environment.
The entire operation was undertaken on
three separate occasions to demonstrate
the effectiveness of the glovebox. At Foster
Wheeler, we really do roll up our sleeves
and get on with the job!
DAVID AINSWORTH
Photos from l to r: Store, Test Enclosure,
Preparing for Testing, Inside the Test Chamber.
David AinsworthPrincipal consultant
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Secondary
General
Infrastructure
Validation
API
Biotech
R&D
Medical Devices
Category Key
focus2
fwpharmasuccessGLOBAL ROUND-UP OF RECENT WINS
We are very pleased to
work with Foster Wheeler
again and have every
confidence that our joint
teams will work together to
successfully complete this
phase of the project on
schedule. This will provide
a firm foundation upon
which to build for
subsequent phases
of the project.
We have been working
successfully with Foster
Wheeler since 2001
we are pleased with Foster
Wheelers professionalism,
responsiveness to our
needs and capability to
mobilise highly qualified
resources from its
European offices...
We have selected Foster
Wheeler for this challenging
project because of its ability
to make available skilled
resources from its various
operations centers, under
the management of Foster
Wheeler Milan.
The team has a very
proactive approach and
the team members are not
afraid to roll up their
sleeves. There are too
many names to mention
individually, but the whole
Alliance team has made
an outstanding contribution
to achieving our business
objectives.
Elsewhere, our clients continue to value the quality
of our teams and the facilities we design and build.
We continue to secure significant new pharma business
around the world, across the full range of technologies.
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&
focus 13
John Nichols, pharmaceutical technology director, has been re-electedto the ISPE Board of Directors. This two-year appointment is Johnssecond, and is a significant achievement. John has contributed a greatdeal to ISPE. He works on a number of ISPE committees: theInternational and European Education Committees, Facility of the YearCommittee, Body of Knowledge Task Team and API Community of
Practice (CoP) and CoP Council. In 2003, John was a member of the ISPEs Facilityof the Year Task Team which received the Committee of the Year award. He alsoregularly chairs and speaks at ISPE conferences promoting Innovation in the Industry.
ISPE Congress, ViennaThe Annual European Congress wasattended by a large cross-section oftechnical specialists from across Europeand even beyond. John Nichols, ourglobal technology director, co-chaireda well-attended session which exploredhow to introduce continuous processing
into pharma facilities.
ISPE Annual MeetingOnce again, the ISPE Annual Meeting this year in Orlando, Florida attracteda large audience, as well as almost300 table-top exhibitors.
John Nichols was course organizer andchair for the seminar on ContinuousProcessing in the Real World.
Our presence in the exhibit hall (and inthe committee rooms), enabled us tomake contact with a large number ofkey clients who were attending.
Society of Chemical IndustryAt the SCIs Process DevelopmentSymposium in Cambridge, MarkDickson, senior process engineer,presented on Continuous Technology...when, how and why we shouldchange, highlighting the advantagesof continuous processing over
traditional batch operations for lowtonnage products.
ISPE BrusselsThe ISPE year ended at Brusselswhere Foster Wheeler had a significantpresence.
John Nichols participated in the sessionreporting on the latest update of the BulkPharmaceutical Chemicals Baseline
Guide, speaking on containment and
the activities of the API Communityof Practice.
Huw Thomas, senior pharmaceuticalengineer, contributed to the OralSolid Dosage session with a paperon containment.
Exhibitions
Conferences
ISPE Appointment
Come and meet us at:
ISPE Tampa Conference,
Florida
12-15 February
ISPE Copenhagen Classroom
Training, Denmark
26 February - 1 March
Bob Adamson, our pharmaceuticalcompliance manager, will be discussingtheApplication of Commissioning andQualification and Bob Davies, principalbiopharma consultant, will be lecturing onBiopharmaceutical Process Development.
ISPE Paris Conference,France
16-19 April
John Nichols will be chairing a session onnanotechnology, and Paul Frey, ourprincipal facilities consultant, will bepresenting a baseline approach tomodification of a WFI system.
Interphex, New York
24-26 April
Visit us at booth #143.
ISPE Washington Conference
Arlington, Virginia
4-7 June
ISPE Singapore Conference
10-12 June
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Technical consult ancy
Feasibility studies
Concept design
Sit e select ion
Sit e master planning
Permitting
Environmental consultancy
Process simulat ion
Basic design
Detailed engineering
Proj ect management
ProcurementConst ruct ion management
Commissioning
Validation
Plant operation
Maintenance
Sit e remediation
the right people with a
can do attitude and the
commitment to deliver
PHARMACEUTICALS - BIOTECHNOLOGY - HEALTHCARE
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