S ti IVa Section IV Selecting g the Right g Feeder for your Food or Pharmaceutical Process Sharon Nowak K Tron K-Tron Global Business Development Manager, Food and Pharmaceuticals

Agenda Session I - Corporate Introduction Session II - Bulk Materials Basics (K-Tron) Session III - Pneumatic Conveying Technology and Product Overview (K-Tron) Session IV – Feeding Technology and Product Overview (K-Tron) Session V – Advances in Twin Screw Compounding (Coperion) Session VI (Coperion) Session A: Food Extrusion on Twin Screw Extruders Session B: New Developments in the Compounding of Plastics Session VII (K-Tron) Session A: Selecting the Right Feeder for Food/Pharmaceuticals Session B: Selecting the Right Feeder for Plastics Session VIII Pneumatic Conveying (K-Tron) Session A: Pneumatic Conveying Systems for Food/Pharmaceuticals Session B: Pneumatic Conveying Systems for Plastics

Food Industries Served By K-Tron Pet Food Soup mixes, cake mixes, drink mixes, food powder blends Pasta Cereal Candy/Sugar/Confectionary Spices Snack Foods Fruits & Vegetables Ice Cream Ingredient Addition

K-Tron Experience in Food System Designs p y g Continuous Food Processing Continuous Extrusion • Gravimetric LIW Feeders for Ingredient Delivery • LIW Liquid Feeders for water/liquid flavor addition in lieu of flowmeters • Pneumatic Receivers for material transfer and refill on continuous feeders Blending/Mixing

Continuous Mixing • Gravimetric Feeders for ingredient feeding as well as probiotics and trace elements

Ingredient Dosing/Batching Multi component Snack Mixes Micro/Macro Ingredient Batch Weighing • LIW Feeders and GIW Batching Systems

Material Transfer Dilute Dil t Phase Ph Vacuum V and d Positive P iti Pressure P systems t Dense Phase Vacuum for short distances/rates and Preblends

Feeders for Food Extrusion Feeders are required for both powder and liquid component feeding Metered and accurate feed rates t affect ff t overallll screw fill of the mixer/extruder which affects product quality lit Feeders used in continuous mixer/extrusion are LIW with high degree of accuracy and control

Application: Dosing Applications in the Confectionaryy Industryy Highly accurate dosing of powders (minors and d majors) j ) into i t mixing i i ttanks k and d cookers k Typical materials : sugar, salt, acids or flavors Continuous dosing via LIW (Loss in Weight) screw feeders Batch dosing via GIW (Gain in Weight) volumetric screw feeders f Continuous LIW feeding into extruders Liquids and powders Addition of powdered wax coating for continuous coaters D i off active Dosing ti iingredients di t iinto t reactors t ffor hard candies for the medical industry

Food Processing Trends Continued interest in overall g cost ingredient g reduction of high addition Requires higher accuracy in feeding of higher cost ingredients to process Higher accuracies = lower costs =

higher profitability • Current examples – Ice Cream Ingredient Addition – Mixed Nut Mixes

Contained Ingredient Feeding Probiotics Addition to Processes – Continuous and Batch

Typical Dry Powder Feeder Applications in Pharmaceutical Operations Batch Applications B t h Dispensing Batch Di i • LIW and GIW

Reactor Batch Loading Batching from Centrifuges and Vacuum Dryers Milling and Micronization (Batch) T bl t P Tablet Press Lubrication

Continuous Operations Wett Granulation W G l ti Hot Melt Extrusion Micronization/Milling (semi-batch) Continuous Coating Continuous Direct Compression Continuous Blending

Why are Feeders Necessary in Food or Pharmaceutical Processing? g To set the precise throughput to a downstream process Allows for more efficient processing via continuous modes Continuous processes such as mixing or extrusion become “slaves” to the feeders Provide an accurate blend of bulk solids and liquids for a formulation Eliminate pre-mixing of solids/segregation Premixing can lead to segregation Premixing requires additional space and cleaning requirements – more labor intensive Feeders are used to set the flowrates of both liquids and bulk solids. To accurately batch out key ingredients to the process

Typical Food Processing Flow Batch Weighing and Conveying To Batch Mixer -Majors Minor Ingredients Batch Weighing to Mixer

Major Ingredients Truck / Railcar Unloading

Premix and Liquids Fed to Extruder

Batch Mixed Ingredients to Continuous Mixer and Dense Phase Convey to Extruder

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Feeder Applications for Batch Processes for Food Applications

Types of Ingredient Batching or Dosing Devices in Food Processing g Gain in Weight (GIW) Scaling or Batch Weighing Devices Material is either conveyed directly or dosed by volumetric feeders into hoppers on load cells Often used for Macro ingredient dosing Loss in Weight (LIW) Batch Weighing Devices Used for Minor and Micro ingredient weighing where ingredient % and accuracies required outside the realm of GIW or scaling applications (.5% of full load ) Utilize Screw Feeders on Load Cells Food applications often combine both types of systems dependent upon scope of ingredients

GIW Batching via Volumetric Feeders Volumetric feeders dose bulk material into a weigh hopper Increase in collection hopper weight is measured Scale’s Scale s weight info is used to control each feeder based upon setpoint or recipe

volumetric feeders

hopper on load cells

Loss-in-Weight g Batch Principle p Loss-in-weight feeders dose bulk material into a collection hopper

Continuous and Batch Blending g Feeders are used as LIW for g consistent ingredient feed to continuous blenders Feeders are also used to batch in specific ifi amounts t to t batch b t h blending operations in both LIW and GIW configurations g Scale Hoppers are also used for batching of various ingredients Pneumatic conveying is used for transfer of these ingredients direct to the blender

Cooker/Mixer Dosing K-Tron LIW feeders are used d tto feed f d minor i ingredients by batching to a cooker Both units are on rails so they can easily slide out of place for calibration requirements K-Tron volumetric feeders are also used with cooker on load cells

Contained Probiotics Addition

Feeder Applications for Batch Processes for Pharmaceutical Applications

Loss In Weight Batching to Reactors K Tron LIW feeders K-Tron are used to feed major and minor ingredients by batching to a reactor Both units are on rails so they can easily slide out of place for calibration requirements

GIW Batching from Centrifuges or Vacuum Dryers

GIW Batching into an Isolator

Automatic Dispensary Elements Material Receiving Broaching Unloading Transfer IBC Filling Batching GIW LIW Filling (Containment) IBC Handling M Manual l Automated

LIW Batching to dispense and weigh API and excipients to Batch tumbler blender

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Semi Continuous and C ti Continuous Feeder F d Process P Examples p for Food Applications

Process Example: Pet Food Processing – Weigh g Belts and Screw Feeders Combined Weigh Belt Feeders used to meter raw ingredients to mixer = cost savings due to higher accuracies! Screw feeders used to add p powdered vitamins and minerals to blend Screw feeders (LIW) also used for high accuracy feed pf premix and colorants l t tto extruder t d

Continuous Food Blending – Introduction of Minors and Majors into Mixer Inlet j Multi feeders for different ingredients Microfeeder used for high value ingredient , low rate feeding All feeders stacked up to feed direct to mixer inlet K-Tron MT12 Microfeeder

Mixer inlet

LIW Feeders for addition of g seasonings/Vitamins/Additives

Food Systems – French Fry Production and Seasoning Mixes

Typical Snack Food Production Line – Combining GIW and LIW Batching as well as Continuous LIW Feeding

Process Example: Multi Ingredient Feeding – Weigh g Belts Use of multi weigh belt units to produce high accuracy blends SWB Feeders for 30diff 30different t bl blends d – 14 feeders/3 lines Feed Smart !– SWB technology using Ktron high accuracy load cells allows for recipe i control t l and d control over high value ingredient costs

Continuous Mixing

Multi Feeder Dispensing to Continuous Blender

Typical Continuous Mixing System– Fortified Drink Mixes

Process Example: Pet Food Processing – Weigh Belts and Screw Feeders Combined Weigh Belt Feeders used to meter raw ingredients to mixer = cost savings due to higher accuracies! Screw feeders used to add p powdered vitamins and minerals to blend Screw feeders (LIW) also l used d ffor hi high h accuracy feed pf premix and colorants to extruder

High g Volume Belt Feeder Pet food Belt Feeder – 1000 SWB Feeding kibble (dog food prior to oil and additive coatings) Design 1500lb/min, 22lb/cuft

Existing Food System – Combines all Processes described

Semi Continuous and C ti Continuous Feeder F d Process P Examples p for Pharma Applications

Feeders used in Milling and Micronization p Operations K-Tron SIP Feeder with FPS SIP micronizer for penicillin

K-Tron Feeder with ith Hosoka Hosokawa a Pin Mill in a glove box

K-Tron T12 Feeder with 2” micronizer

What's New? –Continuous Processing API and excipients prescreened before continuous blender

API high content to granulator feeder

Preblended high % API direct to press API and excipients to Delumper and continuous blender

•Refill options – pneumatic receiver or combo unit

Excipients to continuous blender

Blend direct to continuous granulator /dryer or extruder/pelletizer Option for lubricant or dry coating direct spray to press or coater

Blended product dense phase conveyed to press

What is K-Tron’s Feeding Experience for Continuous Pharmaceutical Processes? Of top 10 pharmaceutical companies by revenue , KT K-Tron working ki with ith att least l t 8 in i some sortt off continuous processing K-Tron K T is i currently tl on th the b board d off th the consortium ti for continuous processing – ERC The automated Th t t d LIW feeding f di and d refill fill systems t as supplied by K-Tron have been an integral part of continuous systems in the food and plastics industry for decades

Feeding in Continuous Extrusion

Vacuum loader for  refill

Feeder device

Feeding of Continuous Extrusion

Feeders in Gloveboxes or Isolators

Continuous Direct Compression Feeders 2x K‐tron Twin screw Compact weigh Feeder type K‐CL‐SFS‐KT20 LIW Twin screw microfeeder type K‐CL‐SFS‐MT12 Roller Compactor Hosokawa Pharmapaktor L  200/30 P with Flake Crusher  FC 200 Feeders 3x, K‐tron  LIW type K‐ML‐D5‐KT20  20

Mixer Hosokawa Modulomix

Conveyor for powder

Mixer Hosokawa d l i Modulomix

Conveyor for  granules K‐TRON Premier  K TRON Premier Pneumatics Central  Powder receiver 10  type P10‐BV‐100

Tablet machine PTK PR 1000 with PTK PR‐1000 with  PISCon T2.5

Rutgers CDC Test Rig

Keyy consideration: Feeder Clusters Typical Rate Ranges API%:Can be as low as 1% and as high as 85% Typical Excipients Handled: • • • • • •

X-Povidone MCC Lactose Monohydrate Silicone Dioxide Starch Talc

Number of feeders typical –up to 5 plus lubricant

Lubricant Feeder generally low% 250 gm/hr and higher

Typical Cluster Arrangements Continuous K PH ML D5 KT20 20L ASYM K-PH-ML-D5-KT20HOPPER

K-PH-CL-MT12- 2L HOPPERWINDSHIELD

K-PH-CL-MT16- 6L HOPPER

200 X 100 COLLECTION HOPPER

Layouts with pneumatic receiver/volumetric feeder: “Combi unit”

Existing Layout for OTC analgesic via g continuous extrusion granulation

Consigma Installation – GEA Niro Collette – Continuous Pharma granulation •Continuous Granulation,, Drying in one unit •Fed by means of K-Tron T20 for preblend or by T20 and T12 for API separate addition •Two weigh receivers after drying to determine moisture content

Direct Lubrication of Tablet Press Addition of lubricant – magnesium stearate Done directly at press in lieu of p during batch blending Magnesium stearate is blown into the press with compressed d air i

Attachment of venturi line to press Each tablet press design is different so connection designed by press manufacturer The connections usually include direct connect of feeder line and a vacuum hose for excess dust

Other Feeder/Venturi Applications Dry Powder (e.g. wax) addition to the continuous coating process

Coating Unit with Integrated Feeders

Continuous Coating Feeders used in two areas Delivery of uncoated tablets to coater via vibratory feeders Delivery of wax additive gravimetrically

Sanitary Design in the Food and Pharma Industries

Sanitary Design: Key Elements of Concern Materials of construction – product contact and non contact t t surfaces f – Global Gl b l Specifications S ifi ti Compatability with cleaning materials Certification requirements

Surface Finish Defined P Passivation i ti vs El Electropolish t li h Area Classification In Pharma Typically Div 2 but Class I & II due to solvents used for cleaning Flours/Sugars – beware of dust explosions

Containment Issues – Dust vs Potency

Additional Key Design Features in Food and Pharma Systems Design Regulations g to be adhered 3A, FDA, EHEDG, ATEX, UL Explosion Protection Requirements • Sugar, Flour Installations, eg

Options in sanitary design and execution Cleaning /Washing in Place Materials of construction -compatability with cleaning materials

Flow Aid devices and options available FAT Requirement R i t

K-Tron PH Feeder Types for the Pharmaceutical Industry Powder cGMP design feeders for API and excipient feeding

Liquid Used for liquid binder addition for continuous granulation and extrusion processes

PHT20 with HEPA filter for vent

Roll in cart design for liquid loss in weight PH feeder for extrusion

Product Changeover & Cleanability

Materials of Construction (MOC) Choose Compatible MOC All contact surfaces usually Stainless steel : 304/316 or 316L? • E Evaluate l t need d ffor corrosion i resistance

Noncontact surfaces – also corrosion i resistant i t t • Stainless (304) is typical

Gaskets/Orings/Seals g • FDA approved Materials – • Silicone/Teflon/EPDM/White Buna/Neoprene

Surface Finish Comparisons p Grit Size

RMS (Micron)

80

RMS (Microinch ) 80

120

Equiv Sheet Finish (approx)

Ra (Micron)

2.03

Ra (Microinch ) 71

58

1.47

52

1.32

#3

150

47

1.20

42

1.06

#4

180

34

0.86

25-30 13-16

0.76 .32-.40

#4

180 EP

1.8

PHARMA/DAIRY

240

17

0.43

15

.38

6

320

14

0.36

12

.30

7

320EP

4-8

.08-.19

8

400

10

Surface Finish Reports p Typical reports include surface finish measurements taken by means of a profilometer Key positions where measurements t are taken t k are identified Surface finish reports p now included in all PH feeder base pricing

Design g Standards in the Industryy Clean! Clean! Clean! All surfaces f polished li h d – minimum i i 0 0.8 8 micron i R Ra Minimal welds/no weld seams 316L for product contact due to anti corrosion capabilities All gaskets/O rings – FDA approved substance compatible with the cleaning solvents used Use of CIP where applicable – retractable spray balls in hopper housings Purges g on shaft seals to p prevent material flow into seal/bearing area • Purge often nitrogen due to explosivity issues SIP requirements defined – pressure/temp

Optimization of Feeder Configurations Improper Selection of components can affect resultant RSD and flow rates t Lower Rates are highly influenced by component selection In Microfeeding EVERYTHING matters

Addition of screen at outlet of feeder helps with back pressure and resultant screw fill for some products For poor flowing products – screw fill is affected Requires Proper screw type configuration FDA Coatings available Sometimes blend of flow aids will help

Summary – How to Choose the right feeder • Evaluate

the materials you are looking to feed •Review all material characteristics to determine the correct feeding solution • Evaluate the installation requirements •Maintain the equipment long-term •Determine best design solution to optimize cleaning and sanitary requirements • Evaluate the accuracy requirements of the process •Choose correct feeder type (volumetric/gravimetric) • Evaluate your connectivity options •Determine the complexity of the control architecture

Summary: Key Design Considerations when choosing Feeders and Material Handling for Continuous Processing in the Pharmaceutical Industry Review of material characteristics and flow properties also critical to ensure constant flow without interruption of the continuous process Consult with feeder manufacturer – proper configuration of components is important to improved accuracy and performance

Short term accuracy and repeatability are critical Gravimetric devices versus volumetric High accuracy weigh cells – high resolution Quick response control systems necessary for second to second accuracy Refill f Arrays to ensure constant feeding f Microfeeding devices for low rate feeding Refill of the feeders must also be evaluated to ensure constant and consistent supply of ingredients to the process Design of overall system, refill plus feed plus integration of controls and instrumentation must be carefully considered to ensure accurate and safe ingredient delivery and process quality Evaluate containment issues, cleanability, validatability of the overall process

Q Questions?