COMPOUNDING OF HIGHLY HAZARDOUS PRODUCTS

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

2 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

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

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

5 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

6 6

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

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

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

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

11 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

12 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

13 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 Powtech 2016 Nürnberg

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

15 SCREWS IN RTP 15

16 REFILL BY BAGS 16

17 EMPTY ISOLATOR 17

18 CHILL ROLL ASSEMBLY 18

19 PROCESS PART ASSEMBLY 19

20 CONNECTION DRIVE SECTION 20

21 FEEDER 21

22 WIP PROCESS START 22

23 WIP PROCESS DETERGENT 23

24 WIP PROCESS COLD WATER 24

25 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 Powtech 2016 Nürnberg

26 CONTAINMENT (2) FILTER CHANGE 26

27 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 Powtech 2016 Nürnberg

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

29 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

30 INTRA-BATCH WIP PROCESS 30

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

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

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

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

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