COMPOUNDING OF HIGHLY HAZARDOUS PRODUCTS

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COMPOUNDING OF HIGHLY HAZARDOUS PRODUCTS Challenges and technical solutions with twin-screw extruders Albrecht Huber

CONTENT Introduction Leistritz Basics of Twin Screw Technology Basics for containment Solutions: OEB 5 plant Flexible containment Plant with spiral cooling conveyor Solutions for small-scale extruder Glove box Feeder Barrel cover Extruder 2

LEISTRITZ BUSINESS UNITS TURBINE TECHNOLOGY PUMP TECHNOLOGY EXTRUSION TECHNOLOGY PRODUCTION TECHNOLOGY 3

PRODUCTION FACILITIES 1: Nuernberg / Germany - HQ & main facility 2: Remscheid / Germany 3: Pleystein / Germany 4: Chonburi / Thailand 5: Belisce / Croatia 4

EXTRUDERS & EXTRUSION LINES Co-rotating twin screws For the plastics and pharmaceutical industry From 12 to 260 mm screw diameter and throughputs from 20 g/h to 35 t/h 5

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CO-ROTATING TWIN SCREW EXTRUDERS IN GMP Available sizes: 12,16,18,27,40,50 mm 7

LINE LAYOUT Feeder and refill Extruder Various downstream equipment for cooling and shaping 8

DOWNSTREAM INTERMEDIATE PRODUCTS Extruder Strand Pelletizer Hot die Face Cutter Chill Roll & Mill Vibrating Conveyer Pellets (cylindrical) Pellets (cylindrical, spherical) Flakes, Powder granules 12.04.2016 9

DOWNSTREAM DIRECT SHAPING Extruder Injection Molding Direct Cutting Co- Extrusion Profile extrusion Tablets, Implants Tablets Multilayer Stents, Catheters 12.04.2016 10

CONTAINMENT BASICS Primary and secondary containment Isolators, RTP, liner systems, split-butterfly valves WIP concepts Bag systems For extruder lines technical Solutions had to be elaborated by the suppliers 11

PROCESSING HIGH POTENTS BASIC QUESTIONS OEB level Company s Guidelines e.g. two barriers? Output in kg/h Batchsize 12 R&D or production Is the product water soluble? Downstream equipment Single product line or multiple products

CONTAINMENT (1) OEB LEVEL 5 ZSE 18 HP-PH WITH INTEGRATED CHILL ROLL Split-butterfly valve for continuous feeding Handling of process Parts through gloves RTP WIP process Maximum allowed Pressure loss in 120 seconds: 30 Pa 7 rotating shafts to be sealed Feeder, Extruder, chill roll inside isolator Technical parts outside isolator 19.04.2016 13 Powtech 2016 Nürnberg

CONTAINMENT (1) DETAILS OF ZSE 18 HP-PH 14

SCREWS IN RTP 15

REFILL BY BAGS 16

EMPTY ISOLATOR 17

CHILL ROLL ASSEMBLY 18

PROCESS PART ASSEMBLY 19

CONNECTION DRIVE SECTION 20

FEEDER 21

WIP PROCESS START 22

WIP PROCESS DETERGENT 23

WIP PROCESS COLD WATER 24

CONTAINMENT (2) SINGLE USE ISOLATOR ZSE 18 / ONLY FEEDER IN FLEXIBLE ISOLATOR Concept: Plant is used only partially for high potents Extruder is defined as a tight device Only the feeding unit is built inside a flexible Isolator Refill by bags After batch, wetting and disposal of isolator WIP devices 19.04.2016 25 Powtech 2016 Nürnberg

CONTAINMENT (2) FILTER CHANGE 26

CONTAINMENT (2) SINGLE USE ISOLATOR ZSE 18 / ONLY FEEDER IN FLEXIBLE ISOLATOR Details Refill by containment bags Optionally a bigger hopper for the feeder to keep one complete batch in the hopper WIP of extruder lantern 19.04.2016 27 Powtech 2016 Nürnberg

CONTAINMENT (3) ZSE 27 WITH SPIRAL COOLING CONVEYOR Details Various WIP installations Spiral cooling conveyor is operated in negative pressure Intra-batch WIP 28

CONTAINMENT (3) ZSE 27 WITH SPIRAL COOLING CONVEYOR INTRA-BATCH WIP PROCESS Feeder Valve Open during operation cloesed during Intra-batch WIP Spray nozzle 29

INTRA-BATCH WIP PROCESS 30

CONTAINMENT (4) ZSE 12 HP-PH FLEXIBLE CONTAINMENT Feeder, extruder, and cooling belt inside flexible isolator 31

CONTAINMENT (5) ZSE 12/18 HP-PH CONTAINED REFILLING PASSIVE ACTIVE Courtesy from Chargepoint 32

CONTAINMENT (5) ZSE 12/18 HP-PH CONTAINED REFILLING Small scale rigid containers, 0.5 20L Polypropylene, HDPE, Stainless steel Pressure rated and sightglass viewing options Improve flow and yield Vibration Wet / dry flush port 33

CONTAINMENT (5) ZSE 18 HP-PH CONTAINED REFILLING 34

COMPOUNDING OF HIGHLY HAZARDOUS PRODUCTS Challenges and technical solutions with twin-screw extruders Thank you