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Excellence in powder handling

CONTAINMENT TECHNOLOGY ASSESSMENT
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Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

3
Who is Dec?
Company

• Family-owned company
• Established 1987 in Switzerland
• Two subsidiaries in Ireland and India
• Represented in more than 25 countries worldwide
• Experts in transfer and dispensing of powders
• Dec develops technologies patented and designed
  for Pharmaceutical and Fine Chemical Industries
• Dec specializes since 1996 in active reactor
  loading and powder containment

4
Dec Activities
Company

• Dec designs and supplies custom made solutions
  for powder handling
• Transfer
• Dosing, Dispensing
• Mixing
• Handling / Packaging
• The expertise of Dec
• Supply of equipment and turn key projects
• Automate and optimize existing production
  facilities
• Control and increase the quality of operation
• Improve the hygiene and safety of the working
  environment

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Head office located in Lausanne/Switzerland
Company

6
References
Company
More than 200 companies worldwide have already
successfully integrated over 2000 Dec systems
into their production sites

• Abbott Laboratories
• Albright Wilson
• Allied Signal
• AstraZeneca
• Banyu
• BASF
• Bayer
• Bayer Healthcare
• Boehringer Ingelheim
• Borregaard
• Bristol Myers Squibb
• Cardinal Health
• Ciba Specialty Chemicals
• Cilag
• Chimex
• Clariant
• Dow
• DSM
• DuPont De Nemours

• Firmenich
• Fournier
• Gea Farmaceutiks
• Gedeon Richter
• Givaudan
• GlaxoSmithKline
• GE Healthcare
• Great Lakes
• Hoffmann-La Roche
• Honeywell
• Huntsman
• Janssen Ortho
• Kodak
• LEK
• Lonza
• Lundbeck
• Macfarlan Smith
• Merck
• Merck Sharp Dohme

• PCAS
• Pfizer
• Procter Gamble
• Rhodia
• Rohm Haas
• Sandoz
• Sanofi-Aventis
• Sanovo
• Schering GmbH
• Schering-Plough
• Siegfried
• SNPE
• Solvay
• Sylachim Finorga
• Syngenta
• Synkem
• Syntese
• TEVA
• UCB

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Excellence in powder handling
Philosophy
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Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

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Excellence in powder handling
Presentation of Dec Technologies
10
PTS Description

• Pneumatic (vacuum/pressure) system for
  transferring powders from / to any type of
  receiver
• Dust free, easy to clean and safe system for
  handling toxic, explosive or powders with very
  low MIE
• As the PTS does not have its own potential
  ignition source is not subject to guideline
• Atex 94/9/EG
• Transfer of large varieties of powders from few
  kilos to tons
• First technology 100 CIP and SIP
• More than 1800 PTS installations are already in
  operation

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Company
PTS Design
V1 Product inlet valve V3 Vacuum valve V2
Product outlet valve V4 Pressure valve
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PTS Operation
Product Vacuum Gas
V1 Product inlet valve V3 Vacuum valve V2
Product outlet valve V4 Pressure valve
13
Company
PTS Design
14
Company
PTS Filter Design
Suction phase (Vacuum) Filtration
Filter membrane lt 1 ?m
Discharge phase (Pressure) Cleaning
15
Company
PTS Filter Design
Easy dismantling of the hygienic designed filter
body equipped with three o-rings
16
Company
PTS Internal Design
Simple tubular design without any dead zone
17
Company
PTS Finish

• All parts are made of stainless steel
  1.4435/1.4404/316 L or equivalent
• Welding of parts is made by TIG or WIG procedure
• Specification for polishing
• Internal surface Ra lt 0,8 ?m, electro polished
• External surface Ra lt 0,8 ?m, electro polished

18
Company
PTS Triclamp Design
Hygienic design with triclamps
19
Company
PTS Feeder
PTS Feeder with DCS for filling drums or big bags
20
Company
PTS Feeder

• Advantages of the PTS Feeder
• Discharge of several types of equipment with only
  one station space saving, mobile.
• High transfer rate
• Precise powder dosing with integrated dosing
  device.
• Discharges equipment even with limited headroom.
• Combination of DCS and PTS-Feeder for
  contamination free dosing and filling of bags,
  drums or FIBCs.
• High containment level (lt1µg/m3)
• Optimal protection of operator and product.
• Drums can be filled under inert conditions.
• GMP-conform design - easy to clean.

PTS Feeder for filling continuous liners
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Company
PTS Feeder
22
Company
PTS Feeder
PTS Feeder filling stations
23
PTS Feeder with DCS
24
Company
PTS Cleaning
25
Company
PTS Cleaning
Spray nozzle integrated in the body
Liquid separator (float)
26
Company
PTS Options
27
DCS System

• The DCS Drum Containment System is a
  technology which can be used for various
  applications and offers a simple solution to high
  containment issues.
• The DCS is a mobile and compact containment
  system and allows to
• Protect the operator against dust exposure
• Protect the environment against dust release
• Cancel any risk of product contamination from
  exposure to external atmosphere
• The system can be used for
• Emptying drums or big-bags
• Filling drums
• Sampling, etc...

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DCS Description

DCS Drum Containment System
Suction lance
PTS Powder Transfer System
Vessel
29
DCS Design
01 Glove box 02 Suction lance with
bellows 03 Bracket 04 Pneumatic lifting
column 05 Two hand safe operated control panels
to lift and lower the glove box 06 Drum with
double liner 07 Roller conveyor with limit
stops 08 Attachment device for the double liner
and the gasket
03
02
01
04
08
05
06
07
30
Company
DCS Operation
31
Charging API with a DCS
32
DCS Drum Filling
33
DCS Drum Filling Station
34
DCS Drum Filling Station for large drums
35
DCS Big Bag Filling
36
DCS Big Bag Emptying
37
DCS Big Bag Emptying
38
DCS System for Total Containment lt 50 ng/m3
DCS with Alpha Beta Connection
lt 50 ng/m3
39
DCS System for Total Containment lt 50 ng/m3
40
DCS System for Total Containment lt 50 ng/m3
DCS with Alpha Beta Connection
41
DCS Inverter
42

• Contamination free emptying of drums of various
  sizes equipped with double inliners.
• Fast and complete discharge by inverting the
  drum.
• Optimal discharge of lumpy and agglomerated
  materials due to lump breaker.
• High containment level (lt1µg/m3)
• Perfect protection of operator and product -
  user-friendly system.
• Drums can be discharged under inert conditions.
• GMP-conform design - easy to clean.

DCS Inverter
43
DCS Inverter Example of Application
44
Drum Filling Emptying
45
Drum Filling Emptying
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DCS Cleaning
Cleaning drum
Connector for cleaning liquids
Spray system
47
DCS Cleaning
48
DCS Cleaning Drum
49
DCS Options
Dryer Emptying Filling
50
Operation Sequence Filling the Dryer
51
Operation Sequence Emptying the Dryer
52
Emptying Conical Dryer with Milling
53
DCS for Sampling
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PFL Powderflex
Patent pending
PFL Description

• Combined system for conveying and dosing powders
  with great precision (/- 1-2)
• Very precise dosing (lt 1g) when combined with a
  weighing device
• Automatic adjustment of the transfer capacity
• Conveys product over long distances (gt 50 m)
• Sucks powders from many different types of
  container (Big-Bags, silos, drums, etc.)
• Economical system which allows to create dosing
  stations with many different products
• Compact, mobile, easy to dismantle

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PFL Powderflex
Patent pending
PFL Design
Powderflex mobile
Powderflex fix device
Powderflex internal design
56
PFL Powderflex
Patent pending
PFL Operation
57
PFL Powderflex
Patent pending
PFL Operation
58
PFL Powderflex
Patent pending
PFL Example of Application
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PFL Powderflex
Patent pending
PFL Dosing Station
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MPTS Micro Powder Transfer System
Patented
MPTS System

• Sampling from dryers, mixers, packaging units
• Sampling from equipment with poor accessibility
  or where personnel is not allowed
• Sampling from a remote area and without
  mechanical device inside the equipment

61
MPTS Micro Powder Transfer System
Patented
MPTS Operation
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MPTS Micro Powder Transfer System
Patented
MPTS Design
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PTS Batchmixer
Patent pending
Batchmixer

• A closed self-filling mixing system ensuring a
  high level of containment.
• Highly efficient mixing with reduced mixing times
  compared to traditional systems.
• Mixes diverse powders with large differences in
  ratio (1/10000).
• Operates under inert conditions with low nitrogen
  consumption.
• The system discharges completely and can be
  cleaned in place (CIP).
• Small quantities of additional components can be
  introduced into the circulating powder without
  interrupting the mixing process.
• Product characteristics are not modified during
  mixing.

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PTS Batchmixer
Patent pending
Batchmixer Operation
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PTS Batchmixer
Patent pending

• Fixed installation which can suck powders from
  different types of containers (drums, Big-Bags,
  silos, etc.).
• Powders can be transferred over considerable
  distances.
• Highly reliable system with few moving parts
  requires only a minimum of maintenance.

Batchmixer Design
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PTS Batchmixer
Patent pending
Batchmixer Application
Centrifuge dryer
Batchmixer
PTS-Feeder
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PTS Batchmixer
Patent pending
Batchmixer Cleaning
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Excellence in powder handling
Suction hopper with integrated lump breaker
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Excellence in powder handling
Suction hopper with integrated lump breaker
70
Excellence in powder handling
LBSL Lump breaker suction lance
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Excellence in powder handling
SCC Single Charge Container
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Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

73
Excellence in powder handling
Containment
OEL Occupational Exposure Limit
high toxic
lt 1µg/m3 1 - 10 µg/m3 10 100 µg/m3 100
1000 µg/m3 1000 5000 µg/m3
5
toxic
4
less toxic
3
almost non-toxic
2
1
non-toxic
OEL
OEB
Toxicity
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Excellence in powder handling
Containment vs. Safety
75
Excellence in powder handling
Dec Solutions
OEL Occupational Exposure Limit
PTS DCS lt 500 ng/m3 Alpha Beta Connection
lt 1µg/m3 1 - 10 µg/m3 10 100 µg/m3 100
1000 µg/m3 1000 5000 µg/m3
5
PTS DCS
4
PTS with Laminar Flow Booth
3
PTS with local extraction
2
1
PTS
OEL
OEB
Dec Solutions
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Excellence in powder handling
Dec Solutions

• Advantages compared to standard isolation
  systems
• The DCS technology can be used for various
  operations for instance for filling and emptying
  process equipment (centrifuge, dryer, etc.)
• The technology is adaptable to various types of
  packaging of various sizes (drum, Big-Bag, etc.).
  
• Concept adaptable to the level of containment
  required (based on the powder toxicity) and
  upgradeable to containment levels of less than 30
  nanogram/m3.
• The DCS technology is very compact and mobile.
• Concept can be easily implemented into existing
  plant.

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Excellence in powder handling
Dec Solutions

• Concept can be easily implemented into existing
  plant.
• Full CIP system
• The system can handle small and large quantities
  and therefore can be used in pilot plant and
  large scale production areas.
• Full containment can be reached by
  interconnecting the process equipment. For
  instance by emptying a centrifuge directly into a
  dryer or reactor by using the PTS.
• Cancellation of the requirement of clean rooms by
  using the DCS as a local clean room environment
  (HEPA 10 or 13 filters).

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Excellence in powder handling
ATEX and OEB
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Excellence in powder handling
Containment test methods - Air
TEST METHODS AND SYSTEMS DCS-DRUM CONTAINMENT
SYSTEM Measurement methods and instruments for
work hygiene Dust exposure Determination of
exposure and concentration of airborne APIs in
the breathing and ambient air.
IOM inhalable dust sampler (www.skcinc.com) The
IOM Personal Inhalable Sampler is a sampling head
with a specified filter for the collection of
inhalable airborne particles. (Developed by the
IOM Institute of Occupational Medicine in
Scotland). When attached to a personal sampling
pump operating at 2 l/min and clipped near the
workers breathing zone, the IOM traps particles
up to 100 ?m (Ø aero-dynamic) and closely
simulates the manner in which airborne workplace
particles are inhaled through the nose and mouth
of humans.
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Excellence in powder handling
Containment test methods - Air
Particle Size-Selective Sampling The ACGIH
recommends that particle-size selective TLVs be
expressed in three forms  
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Excellence in powder handling
Containment test methods - Air

• Grimm Dust Monitors and Aerosol spectrometers
  (series 1.101/1.108/1.109)
• (www.grimm-aerosol.com)
• Dust monitoring
• Scattered light measurement of particles
• Sample airflow 1,2 l/min
• continuous sampling
• Principle A random sampling head collects the
  dust and leads the particles directly into the
  optical chamber with the integrated laser. There
  each particle is classified by size, counted and
  the concentration is proportional to the
  collected time.
• Hygrometer (measurement of humidity and
  temperature is necessary)

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Excellence in powder handling
Containment test methods - Air

• Casella AMS 950 IS (Aerosol monitor)
• BSRIA Instrument Solutions (www.bis.fm)
• Model 224
• The AMS 950 is a handheld instrument with
  detachable probe for the survey of airborne
  particulate concentrations.

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Excellence in powder handling
Containment test methods - Surface
Measurement methods and instruments for work
hygiene Surface load Determination of exposure
and concentration of airborne APIs by
implementation of swab samples at places with an
enlarged probability of contamination.

• Swab samples (not standardised method)
• Defined areas (templates used) are wiped with
  general purpose swabs that are designed to clean
  surfaces and hard-to-reach areas.
• The general purpose swabs consist of laundered,
  knitted and well supported polyester heads, which
  are extremely clean and have long handles.
• Their cleanliness provides a neutral background
  in instrumental analysis for the samples
  collected.

84
Excellence in powder handling
Containment test methods - Surface - Measuring
positions

• Measuring points (air)
• 20 cm in front of the system
• 20 cm off of the system
• 1 m off of the system close to operator
• back of the system
• above the receiving container
• Measuring points (surface)
• drum cover surface
• container surface
• Glove box surface
• gasket under Glove box cover
• metallic ring in Glove box
• Vacuum pump
• PTS-membrane cover
• PTS-membrane grid

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Excellence in powder handling
Containment test methods - Surface - Measuring
positions
Front window
Position 1  on the drum by the instrument
device, height 1 m Position 2  over the manhole,
height 1.40 m Position 3  on the DCS, height
1.2 m Position 4  on the fan near front window,
height 1.4 m Position 5  on the desk height 1.3
m
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Excellence in powder handling
Containment test methods - Results
Results of the monitoring of the concentration of
an API during loading
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Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

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Excellence in powder handling
Explosive Atmosphere

• Minimum ignition temperature
• Minimum ignition energy (MIE)
• Dust concentration
• Lower Explosion Limit (LEL)
• Powder Concentration (inflammable) insufficient
  to produce a flame (explosion)
• Maximum Explosion Limit (MEL)
• Oxygen concentration
• insufficient to maintain
• a flame (explosion)

89
Excellence in powder handling
Minimum Ignition Energy

• MIE corresponds to optimal powder
  concentration in the air.
• MIE depends on several parameters influencing
  the degree of energy.
• MIE is a reference value measured in optimal
  conditions.
• Change of one parameter can influence greatly
  MIE value
• (up to10 times).

90
Excellence in powder handling
Ignition Sources

• Sources
• Open flames
• Grinding and mechanical sparks
• Electrical sparks
• Hot surfaces
• Electrostatic discharges

• Incenditivity of the ignition source
• Surface temperature
• Sparks energy
• Energy of electrostatic discharges

• Safety measures
• Fire protection regulations
• Work instructions
• Thermal insulation
• Explosion-proof equipment
• Earthing
• Use of conductive material

91
Excellence in powder handling
Electrostatic Discharge

• Spark Discharges

• Discharges between two conductive objects at
  different potentials.
• Discharges along the surface of a thin dielectric
  (insulating) layer
• (dielectric strength gt 4 kV)
• Isolated discharges at the bulked material
  surface (powder heap) gt 1 m3
• Propagating weak discharges between grounded
  electrode introduced in a high electric field

• Propagating Brush Discharges

• Cone Discharges

• Corona/Brush Discharges

92
Excellence in powder handling
Comparison

• Comparison of minimum ignition energies with
  incendivity of electrostatic discharges

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Excellence in powder handling
Safety Measures

• Standard safety measures
• Closed system
• Dust-free
• Use of conductive materials
• Earthing, etc.
• Maintenance
• Cleaning

• Special safety measures
• Inerting
• Dustless and static free equipment
• Change of process
• Explosion containment
• Venting

94
Excellence in powder handling
Oxygen concentration in the reactor
Charging a reactor through an open manhole
Charging a reactor with a PTS

• Charging a reactor with a PTS
• No increase in oxygen during the charging
• Keeps reactor inert and prevents vapors from
  escaping
• Low nitrogen requirement

95
Excellence in powder handling
Vapour pressure of solvents and formation risk of
hybrid mixtures

• Relationship between vapour pressure curve,
  explosive range and flashpoint of methanol.

• Vapour pressure curve for different solvents at
  concentrations below the lower explosion limit.

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Excellence in powder handling
Hybrid Mixture

• Even if the concentration of both components
  (dust cloud and solvent vapour) lies below lower
  explosion limit (LEL), the hybrid mixture might
  be in explosive range.
• MIE of hybrid mixture usually lies between MIE of
  components.
• MIE of hybrid mixture is usually much lower than
  MIE of pure powder, even if flash point of
  solvent is above ambient temperature (If the gas
  or vapour concentration is below 20 LEL, the
  effect of the gas or vapour can be neglected).
• Concentrations of below 20 LEL is commonly
  reached at a temperature of about 30 to 40 K
  below the flash point.
• 30 to 40 K rule can be used as a rule of thumb
  to judge the probability of a hybrid mixture
  formation.

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Excellence in powder handling
Oxygen
Fig. 3 Oxygen enrichment during transfer of
powder into pre-inerted vessel C1 Oxygen
concentration in the reactor before the
transfer V1 Volume of the gas phase in the
reactor before the transfer D1 Bulk density of
the powder transferred D2 Skeletal density of
the powder transferred.
98
Excellence in powder handling
Reactor Charging

• Manual loading
• Screw conveyor
• Elevator
• Big bag discharging by gravity
• Sluice
• Rotary valve
• Suction system with rotary valve
• Container docking system
• PTS - Powder Transfer System

99
Excellence in powder handling
Problems

• System difficult to inert. Formation of dust
  cloud.

• System should not be used in the presence of
  flammable solvents.

• Discharging by gravity. Blockage in the chute.

• Should not be used with products with poor flow
  characteristics. Low flexibility.

• Large space required above the reactor.

• Difficult to install in existing plants. Often
  requires installation on the floor above.

• Complex mechanical components.

• High maintenance, risk of mechanical failure.
  Difficult to clean.

100
Comparison of methods
Source Glor, M. (2005), Swiss Safety Institute,
Basel
101
Comparison of methods
Source Glor, M. (2005), Swiss Safety Institute,
Basel
102
Excellence in powder handling
Pneumatic Conveying

• PTS Transfer
• dense phase
• low velocity
• low electrostatic charging
• no powder attrition
• keeps product homogeneous

Transfer phase during horizontal pneumatic
transfer
103
Excellence in powder handling
Electrical field
Radial electrical field of insulated powder in
hose Rqd Es 2
??o? q Charge to mass ratio - Pneumatic
transfer with high velocity 10-4 to 10-6
C/Kg - Pouring 10-7 to 10-9 C/kg d Bulk
density R Radius of the heap ?o Permittivity
of the vacuum (8,85 x10 -12 AS/Vm) ? Relative
permittivity of the bulked powder for R lt 25-30
mm Es ltlt 30 kV/cm (dielectric strength of
air) No ignition possible for powder with a
MIE gt 3 mJ
104
Excellence in powder handling
Safety - Conclusion

• According to the previous equation, it can be
  assured that during the transfer with air of a
  dry powder with a MIE lt 1mJ, no explosion risk
  occurs, provided that the following conditions
  are observed
• All components of PTS System (PTS-chamber,
  valves, hoses , filter etc.) are made of
  conductive materials.
• Whole System is earthed. Electrical
  continuity between components is guaranteed.
• PTS-System is emptied with nitrogen.
• Container is made of conductive material, is
  earthed and contains no mechanical parts which
  may create friction.
• Transferred powder can not self-ignite.
• Dry powder (solvent concentration lt 0,5 ).

105
Excellence in powder handling
ATEX 95
PTS-Powder Transfer System according to standard
94/9/EG (ATEX95)

• PTS is not an equipment of group II, category 1,
  2 or 3 of the 94/9/EG (ATEX 95) standard.
• (Comment of Prof. Dr. T. Redeker, Managing
  Director of
• IBExU Institute for Safety Technology GmbH,
  Freiberg)
• Motivation
• ATEX 95 is only valid for an explosive atmosphere
  under atmospheric conditions (pressure range from
  0,8 until 1,1 bar).
• There is no explosion hazard for the PTS by
  using nitrogen for emptying purposes.
• PTS system does not show own potential ignition
  sources.

106
Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

107
Excellence in powder handling
Productivity

• Process optimization
• Process isolation
• Process linking
• Flexibility
• Process Upgradeability

108
Excellence in powder handling
Productivity - Process optimization

• Optimization of the reaction process due to
  market evolution
• (i.e. generics, decrease of prices, increasing
  costs)
• Close collaboration of research and production
  facilities
• Influencing the efficiency of the reaction by
  optimizing powder handling
• Optimal temperature and pressure during charging
• Speed of addition
• Sequence of addition (solvent powders, etc.)
• Agitation speed
• Changing from loading reactors by gravity to
  active loading
• PTS System uses external sources (vacuum,
  pressure)
• Controlled reaction guaranteed

109
Excellence in powder handling
Productivity - Process optimization Advantages

• Better control of the reaction (exothermic, pH
  adjustment, etc.)
• Optimization of the reaction
• Decrease of the reaction time
• Improvement of the product quality
• Decrease of the energy consumption
• Decrease of the nitrogen consumption
• No repeated inertion required before and after
  charging
• No pre-flushing required (i.e. pre-flushing is
  required when charging powder by gravity through
  a chute)
• No requirement of nitrogen for transferring the
  powder
• Limited nitrogen consumption during powder
  introduction

110
Excellence in powder handling
Productivity - Process optimization Advantages

• Equipment preservation
• Increase life time of reactor (Less abrasion,
  Less stress on the agitator)
• Decrease of the maintenance requirement
• Decrease of the overall batch time (more than
  50)
• Shorter inerting time
• Fast powder introduction without preparation time
• Decreased reaction time
• Shorter cleaning sequence
• Higher safety
• Higher reliability (elimination of the
  requirement of complex instrumentation and
  interlocks)

111
Excellence in powder handling
Productivity - Process Isolation

• PTS-System guarantees isolation of process
  equipment during charging
• Simplification of the safety assessment and
  validation as the system is independent from the
  process parameters (compliance with ATEX
  requirement).
• No risk of vapors escaping the vessels which
  could lead to the formation of an explosive
  atmosphere in the production area and therefore,
  clear zone classification according ATEX.
  Possibility to downgrade the explosive area.
• No possibility of powder blockage at the charging
  point from rising vapors (i.e. elimination of the
  charge chute).
• No requirement of expensive isolation valves
  (gate valve, etc.).
• No risk of corrosion of the upstream equipment.
• No requirement for a pressure release system
  (i.e. explosion containment)
• No risk of cross-contamination or loss of
  product.
• Higher flexibility of operation as the system is
  independent from the process conditions inside
  the vessel.

112
Excellence in powder handling
Productivity - Process Linking

• PTS System allows conveying powders over long
  distances and can link therefore different
  processes in a closed way
• Totally closed operation preventing cross
  contamination or product exposure (GMP
  compliant).
• Higher safety.
• Full containment. Elimination of the requirement
  of docking or containment system.
• Elimination of the requirement of clean room.
• No intermediate storage required.
• Increase of the plant productivity with higher
  throughput.
• Possibility of complete automation of the
  process.
• Lower investments.
• Interconnecting multiple equipments, process
  steps.
• Full CIP, SIP operation

113
Excellence in powder handling
Productivity - Flexibility

• DEC technologies offer the following advantages
  compared to standard technologies
• Simplified layout of the plant and the
  possibility to reorganize the production facility
  without large investments.
• Minimal space required and the possibility to
  eliminate a top floor dedicated to powder
  handling.
• Elimination of the requirement of a specific lift
  as the handling of the powder can be carried out
  from the ground floor.
• Compact and mobile technologies which can be used
  at various areas of the plant for different
  applications and packaging. Simple and economical
  upgrade of existing plant.

114
Excellence in powder handling
Productivity - Flexibility

• Similar powder handling technologies can be used
  for pilot plant and production area (scale-up and
  simulation of process)
• Elimination of the dispensing area. Possibility
  to carry out partial emptying of packaging with
  high containment with accuracy directly in the
  production area (i.e. charge a reactor from a
  drum by using a DCS-Drum Containment System on
  load cells).
• Possibility to have a centralized powder handling
  area and feed various process equipments.
• Charge small quantities (lt 1 kg) and large
  quantities (gt 1000 kg) with the same technology
  with large transfer distances (gt 50 m).
• Low maintenance requirement and consumable costs.
  

115
Excellence in powder handling
Productivity Process upgradeability

• PTS System combined with the DCS System offers
  the opportunity to work in different levels of
  containment.
• System adaptable to the level of containment
  required.
• Decrease operating time and consumable costs.
• Possibility to handle various types of packaging
  and selection of the suitable type of containment
  system according product toxicity.
• Mobile technology upgradeable with minimum
  investment (DCS technology, etc.)
• Less consumable costs and shorter operating time
  compared to glove-box technology.
• Decrease cleaning requirements and less loss of
  products.
• Reduction in operator error due to the fact that
  the system used for OEB 3 is similar for OEB 5,
  etc.

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Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

117
Excellence in powder handling
Maintenance
118
Excellence in powder handling
Consumable parts
119
Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Application
• Conclusion

120
Excellence in powder handling
Operating time
) The size of the PTS is determined according to
the quantity of powder which needs to be
transferred therefore the transfer time should
approximately remains the same in case of
transferring small quantities (Pilot plant) or
large quantities (production plant) of powder.
121
Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of application
• Conclusion

122
Excellence in powder handling
Cleaning
123
Excellence in powder handling
Content

• Company Profile
• Presentation of Dec Technologies
• Advantages and Features of presented Technologies
  
• Containment
• Safety
• Productivity
• Maintenance / Consumable parts
• Operating time
• Cleaning
• Examples of Applications
• Conclusion

124
Excellence in powder handling
Charging a small reactor
125
Excellence in powder handling
Charging a reactor with DCS and PTS
126
Excellence in powder handling
Charging reactors Advantages

• High containment levels with improved safety in
  operation are achieved
• PTS and Powderflex guarantee an inert atmosphere
  in the reactor at all times.
• Primary and secondary containment guaranteed by
  the DCS system
• (lt 1 µg/m3)
• System upgradeable to higher containment (lt 30
  ng/m3)
• Reactor charging under various process conditions
  (high pressure or temperature, etc). The speed of
  powder addition can also be controlled.
• Compact system with minimum space requirements.
• No equipment needs to be installed on the small
  reactors as the connection between the Powderflex
  and the reactor is a flexible hose (DN 15).

127
Excellence in powder handling
Charging reactors Advantages

• The containment system can be installed away from
  the vessel improving plant layout accessibility
  of the equipment.
• Standard drums with double liners of various
  sizes can be used.
• The system is mobile and one single system can be
  used to charge a number of reactors.
• Can charge very small accurate amounts (lt 5kg)
• Elimination of the pre-dispensing operation as
  accurate dosing is possible (lt100 g accuracy)
  directly out of the drums.
• Full CIP of the system

128
Excellence in powder handling
Discharge of a filter dryer

• Advantages
• Full automated discharge.
• Primary and secondary containment guaranteed by
  the DCS system (lt 1 µg/m3)
• System upgradeable to higher containment (lt 30
  ng/m3)
• The DCS Filling station with the PTS-Feeder is a
  mobile unit and therefore can be used for
  discharging various equipment.
• Improved ergonomics since the operation does not
  take place below the dryer.
• Standard drums with double liners of various
  sizes can be filled.
• Possibility to fill accurately a predefined
  quantity of powder.
• Full CIP of the system

129
Excellence in powder handling
Discharge of a filter dryer
Discharge of a filter dryer with and without
milling step
130
Excellence in powder handling
Discharge of a filter dryer - Advantages

• Full automated discharge.
• No requirement of an additional filter separator
  when using a sieve/delumper system. Complete
  discharge of the dryer (heel removal) can be
  guaranteed with minimal nitrogen consumption.
• Reduced loss of powder and cleaning requirements
  as the cyclone separator of the mill can be
  by-passed when no milling operation is required.
  The powder is transferred from the dryer into the
  drums directly by using the PTS-Feeder.
• Contained charging of the mill.

131
Excellence in powder handling
Discharge of a filter dryer - Advantages

• Adjustable powder feed to the mill by the
  Powderflex system.
• Primary and secondary containment guaranteed by
  the DCS system (lt 1 µg/m3).
• System upgradeable to higher containment (lt 30
  ng/m3)
• The DCS Filling station with the PTS-Feeder is a
  mobile unit and therefore can be used for
  discharging various equipment.
• Standard drums with double liners of various
  sizes can be filled.
• Possibility to fill accurately a predefined
  quantity of powder.
• Full CIP system

132
Excellence in powder handling
Centrifuge discharge in a filter dryer
133
Excellence in powder handling
Centrifuge discharge in a filter dryer -
Advantages

• More space available on the ground floor for the
  installation of the milling process.
• Higher GMP and safety compliance due to the clear
  separation of the operating area (dry / wet
  process). Ground floor dedicated to the dry
  milling and packaging operation and top floor to
  the centrifugation and drying process.
• No chute required (elimination of blockage or
  cleaning issues).
• Possibility to mill powder from external source
  stored in standard drums.
• Less loss of powder and cleaning requirements
  since the cyclone separator of the mill can be
  by-passed when no milling operation is required.
  The powder is transferred directly from the dryer
  into the drums by using the PTS-Feeder.

134
Excellence in powder handling
Centrifuge discharge in a filter dryer -
Advantages

• Contained charging of the mill.
• Adjustable powder feed to the mill by the
  Powderflex system.
• Primary and secondary containment guaranteed by
  the DCS system
• (lt 1 µg/m3).
• System upgradeable to higher containment (lt 30
  ng/m3)
• The DCS Filling station with the PTS-Feeder is a
  mobile unit and therefore can be used for
  discharging various equipment.
• Standard drums with double liners of various
  sizes can be filled.
• Possibility to fill predefined quantities of
  powder accurately.
• Full CIP system

135
Excellence in powder handling
Conical dryer
136
Excellence in powder handling
Conical dryer - Advantages

• Closed and automatic charging and emptying of the
  dryer.
• Full discharge of the dryer possible without
  manual intervention.
• Mobile high containment Big-Bag emptying station
  which can be used for several dryers.
• Primary and secondary containment guaranteed by
  the DCS system
• (lt 1 µg/m3).
• The DCS Filling station with the PTS-Feeder is a
  mobile unit and therefore can be used for
  discharging various equipment.
• Standard drums with double liners of various
  sizes can be filled.
• Possibility to fill accurately a predefined
  quantity of powder.
• Full CIP system

137
Excellence in powder handling
Sampling from a filter dryer
138
Excellence in powder handling
Sampling from a filter dryer - Advantages

• The system is totally closed and guarantees a
  high level of containment.
• Representative sampling.
• Better accessibility as the glove box with the
  MPTS can be installed beside the filter dryer at
  an optimal operating level.
• Secondary containment is provided by the small
  glove box.

139
Excellence in powder handling
Charging Powder into a Reactor
140
Excellence in powder handling
Charging Powder into a Reactor- Advantages

• By combining the DCS and PTS, high levels
  containment and safety can be achieved. The PTS
  guarantees an inert atmosphere in the reactor at
  all times.
• Elimination of the chute (No risk of blockage,
  decreasing cleaning requirements and nitrogen
  consumption).
• Mobile high containment Big Bag emptying station
  which can be used for several reactors.
• Primary and secondary containment guaranteed by
  the DCS System (lt 1 µg/m3).
• System upgradeable to higher containment (lt 30
  ng/m3).
• The reactor can be charged under various process
  conditions (high pressure or temperature, etc.).
• The speed of addition can be controlled.

141
Excellence in powder handling
Charging Powder into a Reactor - Advantages

• Process isolation (Big Bag is isolated from the
  reactor during charging, no risk of pressure
  surge back into the charging area).
• The system is very compact and requires a minimum
  amount of space.
• The containment system can be installed at a
  certain distance away from the vessel thus
  improving a better layout and accessibility of
  the equipment.
• The system is mobile and one system can be used
  to charge several reactors.
• Full CIP of the system

142
Excellence in powder handling
Summary - Conclusion
143
Excellence in powder handling
Contact
Dietrich Engineering Consultants sa
Z. I. Larges Pièces A Chemin du Dévent P.O. Box
9 1024 Ecublens - Switzerland Phone [phone]
20 40 Fax [phone] E-mail info_at_dec-sa.ch
Internet www.dec-sa.com
Thank you for your attention!