DESIGN REQUIREMENTS FOR COMPONENTS AND SYSTEMS IN PVC COMPOUNDING FOR MEDICAL APPLICATIONS. Rochus Hofmann, Zeppelin Systems GmbH, Germany
|
|
- Elwin McLaughlin
- 6 years ago
- Views:
Transcription
1 DESIGN REQUIREMENTS FOR COMPONENTS AND SYSTEMS IN PVC COMPOUNDING FOR MEDICAL APPLICATIONS Rochus Hofmann, Zeppelin Systems GmbH, Germany
2 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 2
3 1. OUR VALUES go back to the founder of our company Archiv der Luftschiffbau Zeppelin GmbH Archiv der Luftschiffbau Zeppelin GmbH Archiv der Luftschiffbau Zeppelin GmbH THE PEOPLE AT ZEPPELIN make you think overcome boundaries tip their hats leave their footprint stay on course fail successfully move your heart attract Grafen get others on board receive support 3
4 ZEPPELIN STIFTUNG Administered by the city of Friedrichshafen Luftschiffbau Zeppelin GmbH Friedrichshafen FIGURES 2015 ZF AG Friedrichshafen Turnover: 29,2 bill. Employees: 138,300 Locations: 230 ZEPPELIN GmbH Friedrichshafen/Munich FIGURES 2015 Turnover: 2.33 bill. Employees: 7,800 Locations: 190 4
5 GROUP OVERVIEW Managementholding: Zeppelin GmbH Shareholders: Zeppelin Foundation/Luftschiffbau Zeppelin GmbH Turnover 2015: 2.33 bill. Employees: 7,800 (incl. trainees) Locations: 190 locations in 30 countries CONSTRUCTION EQUIPMENT EU CONSTRUCTION EQUIPMENT CIS RENTAL POWER SYSTEMS PLANT ENGINEERING Sales and service of construction machines Sales and service of construction and agricultural machines Rental and project solutions for construction and industry Propulsion & energy systems Plant engineering 5
6 SBU ZEPPELIN PLANT ENGINEERING From the local hopper fabricant to an international engineering company Locations worldwide: 19 Turnover: 328 mil. EUR in 2015 Employees worldwide: over 1,376 Shop floor area worldwide: approx. 60,000 m 2 Engineering worldwide: more than h per year Silos fabricated per year: 350 6
7 OUR SCOPE OF SUPPLY is oriented at the customers value added chain PRODUCER FORWARDER COMPOUNDER/ PROCESSOR Conveying, storage Cooling, degassing, drying Blending, dedusting Packing, loading, distribution Storage, conveying Metering, weighing, procssing, mixing 7
8 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 8
9 2. VALIDATION OF SYSTEMS Comprehensive validation includes raw materials, equipment, process, process parameters and control Processing Combine, mix and process individual raw materials according to recipe and processing methods Documentation Traceability from which raw materials the product has build up Documentation of the process conditions under which the product has build up, including the equipment / machines used 9
10 STANDARDS UND GUIDELINES Authorities, organizations FDA GMP+ GAMP 5 ICH Q9 EU-GMP PIC/S WHO Computer Software Validierung (CVS) GAMP 5 = Good Automated Manufacturing Practice GAMP is an accepted guide for the validation of computer-based systems GAMP is a quasi-standard, but not legally binding. 10
11 VALIDATION OF SYSTEMS Steps for successful validation time Analysis of the overall system Documented test with material General and detailed design specifications Documented test without material details Definition of documents Documented integration in the system Determination of the necessary tests Documented test of every unit at factory side Design mechanical and electrical Hard- and Software 11
12 FUNCTIONAL EXPIRATION OF VALIDATION DQ: Design Qualification Demand analysis Requirements Purchase contract GMP GAMP 5 Good Manufacturing Practice Good Automated Manufacturing Practice Verifying of installation and installed equipment IQ: Installation Qualification Document check Visual inspection FMEA HACCP PDS Failure Mode and Effects Analysis Hazard Analysis of Critical Control Points Process Design Specification FDS Function Design Specification Test of all functions under production conditions OQ: Operational Qualification HDS SDS DQ IQ Hardware Design Specification Software Design Specification Design Qualification Installations Qualification OQ Operational Qualification Verification of the required performance data PQ: Performance Qualification Operation Maintenance Calibration PQ FAT Performance Qualification Factory-Acceptance-Test 12
13 DESIGN OF VALIDATION SYSTEMS Requires comprehensive documentation of all project stages Replaces punctual quality assurance with a comprehensive concept Not legally binding, is based on nonsynchronized, partially contradictory international rules So far, limited to pharmaceuticals, medicine and partial foods Requires clear coordination with the customer about relevance, application, scope and delivery limit 13
14 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 14
15 3. 3D PLANNING OF THE PLANT 15
16 3D PLANNING OF THE PLANT Links site planning with component construction Enables the integration of a larger group of people into planning 3D scanners allow the recording of the building contours Complex space situations can be analyzed excellently Reduces construction site expenses by means of collision tests Another "view" of integrated engineering Integrated engineering is very helpful for the validation steps planning and documentation 16
17 INTEGRATED ENGINEERING WITH PDMS From the database-based planning tool (Comos PT) to 3D planning until now: Integriertes Engineering: Access - Claims - Std- kont. - etc. Word - Specs - Anfragen - Doku - etc. UNIPPS - Bestellung - Budget - etc. Excel - Data Sheets - Listen - etc. TRICAD - 3D Planung - Isometrie - P& ID s - etc. Power Point - Doku. - Infos - etc. And. Format - Doku. - Infos - etc. Verzeichnisstrukt ur Serverstruktur There is no logical link between the documents, each document stands alone! database Engineering Tool Reports z. B. construction lists LOOP Database as a basis 17
18 INTEGRIERTES ENGINEERING Working with objects PFD P&ID Berechn. Piping 3D Iso FUP MSR\ET Wartung P&ID Fuctional plan PFD OQ-Documents -Objekt- database e. g. Pump - FUP - Berechn - PID - PFD - EMR - 3D - ISO - service Loop 3D - Planning Isometrie PFD Etc. Operating manual 18
19 INTEGRATED ENGINEERING Summery Through integrated, database-driven planning, increasing, diverse requirements to the validation, supply chain, planning, etc. are met. Fulfilling the high demands placed on machinery and equipment for medical products Planning and construction of complex plants Through integrated, database-driven planning, increasing requirements for validation, supply chain, planning, etc. are met. 19
20 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment mixing concept 7 Summary 20
21 4. BATCH TRACING Laws and regulations to be considered EU Regulation 178/2002 (Focus on the Food and Feed Industry) or GMP + Consumer protection, proof of origin, labeling requirements Risk minimization, recall of defective products Quality control through the supply chain Asset validation Optimization potential Determination of liability 21
22 PRODUCT FLOW ALONG THE SUPPLY CHAIN (supply chain) Rohstoffe Händler, Veredler Endverarbeiter Traceability makes it possible to reconstruct the entire supply chain as well as parts of the supply chain. 22
23 REQUIREMENTS Unique identification of raw materials Documentation of critical processing steps, formulations, process parameters and quality control Clear identification of your own products and allocation of production lots Proper treatment of batching, overlapping, cleaning and carryover Traceable and accurate detection, recording and archiving of all necessary data, compressing to information 23
24 EQUIPMENT REQUIREMENTS No cross contamination 24
25 RETRACEABILITY Summary No mixing during storage, discharge and dosing Avoid cross-contamination and carryover No mixing of identical raw materials of different batches - clear assignment to batch number Careful cleaning of the containers Avoidance of data acquisition errors, control of manual operations Control concept and data compaction to information, communication with ERP systems Batch tracking does not end at the factory limit!! 25
26 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material For medical application 6 Equipment Mixing concept 7 Summary 26
27 5. SOFT PVC - P COMPOUNDING Standard soft PVC - homogeneous absorption of plasticizer - dry Dryblend - variable raw material selection - high throughput up to 9,5 batches/hr - with up to 85 % filling Important: Very fast plasticizer absorption Medical soft PVC - absolutely complete homogeneous plasticizer absorption - free-flowing Dryblend with no gelled agglomerates, - without any influence to the compounding parameters - nearly free of any pits - constant valuable parameter Important: Shear near the bottom 27
28 PROCESSING STEPS PVC-P FORMULATION Feeding of all components into the mixer. Heating of the mixture by friction up to approx C with a tip speed of up to 40 m/sec. Validation process: Reduction of tip speed to m/sec. Start to adding plasticizer, depending on the temperature increase after final liquid adding increase of speed up to 40 m/s After reaching the final temperature of C: Reduction of tip speed to 20 m/sec. Discharging into intermediate hopper or cooler mixer. If cooling is desired, cooling down to C. Documentation and recording of each processing step With - Times - Temperatures - Velocities 28
29 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 29
30 6. MIXING TECHNOLOGY Complex mixing tasks need intelligent solutions Applications Rigid and soft PVC Masterbatch and coating powder Natural fibre compounds Battery massas Chemicals, stabilisers, additives Coating, bonding Food Metal/ceramics (MIM/CIM) Technologies Mixer from 4 to 8,000 l Heating mixer Cooling mixer (vertical/horizontal) Universal mixer Container mixer Continuous mixer Laboratory mixer 30
31 HENSCHEL FLUID MIXER Motor Bearing Belt pulley bearing Belt tension Belt pulley Belt Belt pulley 31
32 DISCHARGE Easy cleaning with Swing-away cylinder Swing-away cylinder for faster, easier cleaning of the discharge area. 32
33 PVC-P PLANT FLEXIBLE PVC PLANT FOR MEDICAL HOSES WITH COOLING MIXER FLEXIBLE PVC PLANT FOR MEDICAL HOSES WITHOUT COOLING MIXER 33
34 PVC-P PLANT without any mixer for medical application Formulation: Bulk density: Throughput: medical hoses 0,60 kg/l 1,1 t/hr Inline compounding: All steps inside the Extruder: - Mixing, heating - difusion of plastciser - Melting - pressure buildup - profiling 34
35 PROCESS TECHNOLOGY Patented conical shaped mixing elements (EP ) with self-cleaning effect for soft and gentle melting of polymer and homogenising of fillers and/or fibers 35
36 PROCESS TECHNOLOGY screws HENSCHEL Compounder conventional Compounder Low shearing and less mechanical forces Homogenous thermal distribution without temperature peaks Reduced energy demand due to low torque Less wearing due to bigger gap between screw elements 36
37 COMPOUNDING WITHOUT MIXER process and production competent system for continuous preparation of PVC-P With: Consequent energy reduction Flexibility Reduction of building complexity 37
38 COMPOUNDING WITHOUT MIXER 1. Extreme energy savings (55%) (future energy cost, background energy transition) 2. Simple and clear production 3. Low installation expense 4. No segregation because intermediate storage is omitted 5. No cross-contamination and thus less damage and less scrap 6. Saving of up to 2/3 of the building height is possible 7. Strongly simplified standard buildings 8. Low cleaning expense for formulation or colour changes 9. High flexibility in recipe changes 10. Easier operation by means of less complexity and easier overall controls 38
39 AGENDA 1 Zeppelin Company Overview 2 Validation of systems Overview and steps 3 Design Integration with PDMS and COMOS 4 Design Retraceability 5 Material for medical application 6 Equipment Mixing concept 7 Summary 39
40 7. SUMMARY Planning and documentation of the system for producing medical grades Planning and documentation of all materials used General documentation of every influencing factor in all processing steps Use automated and integrated Processes for planning and documentation Use optimized machines and equipment Planning and designing of optimized systems 40
41 VIELEN DANK FÜR IHRE AUFMERKSAMKEIT!
Top Performance for Challenging Tasks. Henschel Mixing Technology
Top Performance for Challenging Tasks. Henschel Mixing Technology 1 Innovation. Tradition. Zeppelin 2010 engineering your success. Zeppelin plant engineering 2010 business areas Polymer Plants Plants for
More informationLCM CC & TCC. A member of the Possehl Group
LCM CC & TCC A member of the Possehl Group LCM LONG CONTINUOUS MIXERS These continuous mixers compete with the quality level of products obtained by discontinuous internal mixers. They overcome both processing
More informationFILM SERIES SHREDDER-FEEDER-EXTRUDER COMBINATION E:GRAN.
FILM SERIES SHREDDER-FEEDER-EXTRUDER COMBINATION E:GRAN > ONE-STEP Technology > High Performance for a small floor space requirement > One-button automatic On/Off control > For automatic inline production
More informationgreenprofile wpc Wood plastic composite (WPC) profile extrusion
greenprofile wpc Wood plastic composite (WPC) profile extrusion Setting benchmarks battenfeld-cincinnati stands not only for state-of-the-art machine manufacturing and innovative technologies, but also
More informationAdvances in Twin Screw Compounding Technology
Advances in Twin Screw Compounding Technology Extrusion technology from micro to production scale Ing. Manfred Dobersberger 19.08.2011 Labor- and Pilotanlagen für die Kunststoffverarbeitung, Dr. Collin
More informationUNiVeRSAl SeRieS SHReddeR-FeedeR-exTRUdeR COmBiNATiON S:GRAN.
UNiVeRSAl SeRieS SHReddeR-FeedeR-exTRUdeR COmBiNATiON S:GRAN > ONe-STeP technology > Process bulky plastic scrap > One-button automatic On/Off control > dump and RUN operation www.ngr.at TeCHNOlOGY THe
More informationFILM SERIES CHOPPER-FEEDER-EXTRUDER COMBINATION E:GRAN
FILM SERIES CHOPPER-FEEDER-EXTRUDER COMBINATION E:GRAN > ONE-STEP Technology > High Performance for a small floor space requirement > One-button automatic On/Off control > For automatic inline production
More informationThe perfect PVC Additives
The perfect PVC Additives INNOVATIONS FOR PVC PROCESSING 2 About Us Our focus is on the supply of stabilisers for window profiles, foamed profiles, technical profiles and etruded sheets made from rigid
More informationPHARMACEUTICAL EXTRUSION. Continuous extrusion process for pharmaceutical masses
PHARMACEUTICAL EXTRUSION Continuous extrusion process for pharmaceutical masses 1 Overview Overview PHARMACEUTICAL TWIN SCREW EXTRUSION Application fields Compounding with co-rotating twin-screws has been
More informationAPP Seminar China
20140513 APP Seminar China Compounding Highly Filled Compounds with Twin Screw Extruder Gavin Wang Head of Sales Coperion (Nanjing) Machinery Co., Ltd. APP Seminar I Manila & Hanoi I 2015-05-26/28 I Page
More informationSIZE REDUCTION TECHNOLOGY
SIZE REDUCTION TECHNOLOGY HOSOKAWA Alpine Size Reduction Technology Process Solutions for Granulation Requirements Alpine offers a variety of techniques tailored to meet the requirements of your business.
More informationReciPure System. ReciPure The Mix Factory of the Future.
ReciPure System ReciPure The Mix Factory of the Future. Mobile Containers Instead of Stationary Hoppers, The ReciPure System from Reimelt is the answer to the quickly changing market requirements in the
More informationIngtec Technik AG Company Presentation EnMat EN Feb 2016
Ingtec Technik AG Company Presentation EnMat EN Feb 2016 Ingtec Technik AG Ingtec Technik in a nutshell Ingtec Technik AG is an innovative Swiss engineering company, operating globally in the field of
More informationStandard Monitoring System
Cleanroom-Requirements according to Annex 1, EU-GMP-Guidelines Strict requirements for compliance with the environmental conditions in the relative cleanroom classes Continuous data recording and archiving
More informationGelimat Technology. Ultrahigh-Speed Thermokinetic Mixing, Compounding & Fluxing. Processing Excellence in Motion DUSATEC DUSATEC, INC.
Gelimat Technology Ultrahigh-Speed Thermokinetic Mixing, Compounding & Fluxing Processing Excellence in Motion www.dusatec.com DUSATEC, Inc. 19 Spear Road Ramsey, NJ 07446 USA Phone: +1-201-773-8000 E-mail:
More informationGAMP 4/5 Prospective / retrospective Qualification of water treatment plants) P. Dony
GAMP 4/5 Prospective / retrospective Qualification of water treatment plants) P. Dony 31.03.2008 Table of contents Slide 2 1. GAMP 4 and GAMP 5 differences 2. CHRIST prospective Qualification strategy
More informationCLEANING IN MEDICAL INDUSTRY
CLEANING AND SURFACE PROCESSING CLEANING IN MEDICAL INDUSTRY Hannes Köble, Sales parts2clean expert forum 2016 www.durr.com OVERVIEW 1. Parts / Requirements 2. Validation and qualification Machine equipment
More information36D twin-screw extruders pipe extrusion series
STRONG ON PERFORMANCE, VERSATILE AND HIGHLY COMPETITIVE ON COST 36D twin-screw extruders pipe extrusion series IN PARTNERSHIP WITH INDUSTRY KraussMaffei is a premium partner for the plastics and rubber
More informationExamination of the Performance of a High Speed Single Screw Extruder for Several Different Extrusion Applications
Examination of the Performance of a High Speed Single Screw Extruder for Several Different Extrusion Applications Modified on Monday, 04 May 2015 10:19 PM by mpieler Categorized as: Paper of the Month
More informationCost savings and quality improvements in plastics processing
mixing nozzles Cost savings and quality improvements in plastics processing melt Blenders Foam extrusion systems melt Coolers trust the leader Mixing nozzles and static Mixers for injection Molding Mixing
More informationMission Statement. Our commitment is to execute this with integrity, honesty, and accountability to each and every customer.
MesabiControl Engineering Mix Vision We know the compounding process... For over 30 years Mesabi has worked to meet the compounding control system needs of the rubber industry. From simple to complex compounding
More informationTypical Clientele. Products
Message From Chairman Our company was created over 50 years ago specifically to supply a high quality range of process cleaning and sanitary processing equipment. To continually achieve our goals, we use
More informationpowder coating pharmaceuticals. The parallel, segmented compounder
The Concept The continuous compounding of polymers, technical ceramics and foodstuffs whilst miing in various additives at specific points along the etruder barrel is an established technique used in the
More informationDOSING AND MIXING. Single units - Dosing and mixing MINICOLOR GRAVICOLOR
DOSING AND MIXING Single units - Dosing and mixing MINICOLOR GRAVICOLOR DOSING AND MIXING INCREASING PRODUCTIVITY WITH THE LEAST CAPITAL EXPENDITURE motan s single units comprise a range of equipment for
More informationProcess development and basic GMP
Process development and basic GMP Aulton Chapter 45, handouts Specification, stability, inprocess controls and validation Product development Process development Critical Product Qualities issues Critical
More informationA Review of PVC Applications using 4 Flight Kneader Systems
A Review of PVC Applications using 4 Flight Kneader Systems PVC 2008 Colin Richardson & Remy Frank Buss AG Contents Introduction The reciprocating screw Kneader Typical Applications Manufacturing Requirements
More informationFEED ENHANCEMENT TECHNOLOGY FOR LOW BULK DENSITY MATERIAL INTO CO-ROTATING TWIN-SCREW COMPOUNDING EXTRUDERS
FEED ENHANCEMENT TECHNOLOGY FOR LOW BULK DENSITY MATERIAL INTO CO-ROTATING TWIN-SCREW COMPOUNDING EXTRUDERS Paul G. Andersen, Coperion Corporation, Ramsey, NJ Maria Hoelzel and Thorsten Stirner, Coperion
More informationAdvances in Plastics Processing: Cost Saving Techniques Sep 2015 Compounding of Filled Polymers with the Co-rotating Twin Screw Extruder ZSK and STS
Sep 2015 Compounding of Filled Polymers with the Co-rotating Twin Screw Extruder ZSK and STS Page 1 Compounding of Filled Polymers with the Co-rotating Twin Screw Extruder ZSK and STS Dr. Oliver Eitel
More informationintroduction Introduction.1 contents Irrigation Warehouse Group Pty Ltd Ph
contents Vinidex the Company 3 Quality Policy 3 Product Background 4 Worldwide Use 4 Australian Use 4 Pipe Extrusion 5 Fittings 6 End Treatments 6 Product Standards 7 Relevant Australian Standards 7 Introduction.1
More informationAnhydro Drying Systems FOR THE PHARMACEUTICAL INDUSTRY
Anhydro Drying Systems FOR THE PHARMACEUTICAL INDUSTRY SPX Flow Technology Danmark A/S is an international engineering company with a consistent goal to provide our customers with the optimal processing
More informationEXTRUSION TECHNOLOGY. Extruders and extrusion lines
EXTRUSION TECHNOLOGY Extruders and extrusion lines 1 Business unit Product EXTRUSION TECHNOLOGY With experience and passion TWIN SCREW EXTRUDERS Flexible and efficient The alpha and omega for producing
More informationOur commitment is to execute this with integrity, honesty, and accountability to each and every customer.
Mesabi Control Engineering The Leader in Compounding Control For over 30 years Mesabi has worked to meet the compounding control system needs of the rubber industry. From simple to complex compounding
More informationThe AZO product and service spectrum - right to the point.
The AZO product and service spectrum - right to the point. Systems and individual solutions for bulk material handling. Right to the point. AZO headquarter, Osterburken, Germany Reliability you can count
More informationAstraZeneca. CaseStudy. Batch solution facilitates compliance with FDA regulations at AstraZeneca s Plankstadt site THE CHALLENGE
AstraZeneca Batch solution facilitates compliance with FDA regulations at AstraZeneca s Plankstadt site THE CHALLENGE To comply with new FDA 21 CFR Part 11 regulations whilst meeting the G@MP4 standards.
More informationContents. Contents (13) 1 Qualification (21)
1 Qualification (21) 1.A Official requirements (23) 1.A.1 Legal aspects of qualification (23) 1.A.2 Documentation of the qualification (26) 1.A.3 Design Qualification (DQ) (27) 1.A.4 Installation Qualification
More informationEfficiency in a class of its own - the MAS Recycling Compounder
PRESS RELEASE from MAS Maschinen- und Anlagenbau Schulz GmbH Pucking near Linz / Austria, Photo: Author Fig.1: Processing film flakes and additives to high-quality compounds on one system and in a continuous
More informationAZO Benelux The expert partner in your neighbourhood
AZO Benelux The expert partner in your neighbourhood AZO GmbH - Innovative, worldwide AZO-Osterburken with the new technology centre in the foreground. From the invention of the first cyclone screener
More informationSeamless Integration of ASTM E2500, Annex 15, FDA Process Validation Guideline and Chinese GMP in Large CapEx Project in China Daniel Nilsson
Seamless Integration of ASTM E2500, Annex 15, FDA Process Validation Guideline and Chinese GMP in Large CapEx Project in China Daniel Nilsson Senior Management Consultant Agenda Introduction A state-of
More informationThe Best Solutions In Material Handling
D E L I V E R Y P R O G R A M The Best Solutions In Material Handling J-Tec Material Handling creates solutions for storing, handling, dosing and processing dry and liquid ingredients. Solutions can extend
More informationMIXING EQUIPMENTS AND SERVICES FOR PVC DRY-BLEND, POWDER COATINGS, MASTER BATCH AND WPC
MIXING EQUIPMENTS AND SERVICES FOR PVC DRY-BLEND, POWDER COATINGS, MASTER BATCH AND WPC WHO WE ARE YOUR PARTNER IN MIXING since 1967 PVC mixing Powder coatings Master batch and pigments Other applications
More informationDevelop a Roadmap for the Implementation of a Global CSV Program. Eileen Cortes April 26, 2017
Develop a Roadmap for the Implementation of a Global CSV Program Eileen Cortes April 26, 2017 Agenda CSV Regulation Principles CSV Lifecycle Approach CSV and Quality Management Governance Program and CSV
More informationCo-Rotating Twin-Screw Extruder Herausgegeben von Klemens Kohlgrüber
Co-Rotating Twin-Screw Extruder Herausgegeben von Klemens Kohlgrüber ISBN-10: 3-446-41372-3 ISBN-13: 978-3-446-41372-6 Leseprobe Weitere Informationen oder Bestellungen unter http://www.hanser.de/978-3-446-41372-6
More informationLatino America Consultores Innovation & Technology to make your Business Compliant
Latino America Consultores Innovation & Technology to make your Business Compliant Annex 15 & EMA Process Validation Guide Line 1 Changes in Requirements The Pharmaceutical Industry has adapted its business
More informationInnovative Weighing Solutions
K o n t r o l s & I n d u s t r i a l We i g h i n g C o n s u l ti n g D e s i g n M a n u f a c t u re E n g i n e e r Innovative Weighing Solutions W e i g h i n g S o l u t i o n s B a t c h i n g
More informationSCREW DESIGN BASICS The Processor Point Of View. Andrew W. Christie Optex Process Solutions, LLC
SCREW DESIGN BASICS The Processor Point Of View Andrew W. Christie Optex Process Solutions, LLC www.optexprocesssolutions.com Outline Define the goal Review basic extruder components Discuss process elements
More informationCleverly combined! ISEC.
High-performance flexibility ISEC adapts ideally to your scrap logistics. Efficient processing of many different plastic types and forms Discontinuous feeding of a wide variety of material forms no problem
More informationPELLETIZING TECHNOLOGY EXTRUSION AND SPHERONIZATION
PELLETIZING TECHNOLOGY EXTRUSION AND SPHERONIZATION HOSOKAWA ALPINE Pelletizing Technology Extrusion and Spheronization With the technologies of low pressure extrusion and spheronization, cylindrical,
More informationPassionate about fibres. Stabilizing asphalt: TECHNOCEL TOPCEL. Cellulose fibres. Pellets
Passionate about fibres Stabilizing asphalt: TECHNOCEL Cellulose fibres TOPCEL Pellets TECHNOCEL TOPCEL SMA - A Long Life Pavement leads the way Stone Mastic Asphalt (SMA) was developed in Germany 30 years
More informationBlown Film Lines with water cooling
EXTRUSION LINES FOR MEDICAL APPLICATIONS Laboratory machines for the processing of polymers Blown Film Lines with water cooling The new and reliable system for the production of sterile multi-layer-tubes
More informationFOOD + PHARMA. SCHRADER unites process-based solutions, system components and process control to create turn-key, highly automated production plants.
FOOD + PHARMA SCHRADER unites process-based solutions, system components and process control to create turn-key, highly automated production plants. Schrader Food + Pharma 13 Schrader intelligently crafted,
More informationLengths in front Single-screw extruders for pipe extrusion
Lengths in front Single-screw extruders for pipe extrusion Engineering Value 2 Single-screw extruders for pipe extrusion Facts and figures Facts and figures regarding the single-screw extruder pipe extrusion
More informationJoncryl ADR Functional Additives. Functional Additives. Polymeric Chain Extender for Food Contact Applications. Technical Information Joncryl
Technical Information Joncryl Technical Information Joncryl TI / EV/BX 001 e March 2014 TI / EV/BX 001 e March 2014 Page 1 of 6 Page 1 of 6 Functional Additives Functional Additives Joncryl is a registered
More informationContinuous Processing. MODCOS for Continuous Oral Solid Dosage Production Textmasterformat in Mastervorlage eingeben
Continuous Processing MODCOS for Continuous Oral Solid Dosage Production 1 Why continuous production 2 Why Continuous Production? Saving manufacturing costs High productivity because of substantial time
More informationLengths in front Single-screw extruders for pipe extrusion
Lengths in front Single-screw extruders for pipe extrusion Engineering Value 2 Single-screw extruders for pipe extrusion Facts and figures Facts and figures regarding the single-screw extruder pipe extrusion
More informationNew generation of aluminium hydroxide flame retardant filler for the wire and cable industry
New generation of aluminium hydroxide flame retardant filler for the wire and cable industry Dr. Reiner Sauerwein Nabaltec GmbH Overview Introduction New ATH quality product characteristics Powder handling
More informationJ-Tec Material Handling Mixing Solutions
M i x i n g s o l u t i o n s Mixing Solutions creates solutions for storing, handling, dosing and processing dry and liquid ingredients. Solutions can extend from optimizing components to plant upgrades...
More informationImagineering Air-Driven Solutions.
Imagineering Air-Driven Solutions. Pneumatic Conveying Systems Air-driven solutions. Corporate Profile VAC-U-MAX specializes in design and manufacture of pneumatic systems and support equipment for conveying,
More informationLAB DIVISION. STERILIZATION cglp Process Equipment for Research and Microbiological Laboratories
LAB DIVISION STERILIZATION cglp Process Equipment for Research and Microbiological Laboratories LAB division Company LAST Technology is the worldwide provider for cleaning, decontamination, disinfection
More informationUnderstanding Manufacturing Execution Systems (MES)
Understanding Manufacturing Execution Systems (MES) What is a Manufacturing Execution System (MES)? AMR Research, a Boston-based industry and market analysis firm, defines a Manufacturing Executing System
More informationLFK Twin-Shaft Continuous Mixer. Intense mixing of dry and moist minerals
LFK Twin-Shaft Continuous Mixer Intense mixing of dry and moist minerals Headquarters of BHS-Sonthofen The company BHS-Sonthofen, headquartered in Sonthofen, is an owneroperated group of companies in the
More informationá1058ñ ANALYTICAL INSTRUMENT QUALIFICATION
USP 41 General Information / á1058ñ 1 á1058ñ ANALYTICAL INSTRUMENT QUALIFICATION INTRODUCTION A large variety of analytical instruments, ranging from a simple apparatus to complex computerized systems,
More informationThe Sandvik double belt system
The Sandvik double belt system Sandvik steel belts around the world Sandvik steel belt technology forms the basis for all of our double belt systems and delivers a range of proven benefits. Hard and smooth
More informationSESSION 14. Documentation Requirements and Management for Validation. 30 March Frits Vogt
Validation Services SESSION 14 Documentation Requirements and Management for Validation 30 March 2017 Frits Vogt fritsvogt@valserv.nl Content Documentation Requirements and Management for Validation I.
More informationUnderwater pelletizing systems. Page 1
Underwater pelletizing systems. www.bkg.de Page 1 Content The complete perspective. The detail in focus. About Nordson BKG................. 3 Excellence is our standard. Optimized down to the last detail.
More informationTesto Expert Knowledge. The GxP Dictionary 1st edition. Definitions relating to GxP and Quality Assurance
Testo Expert Knowledge The GxP Dictionary 1st edition Definitions relating to GxP and Quality Assurance Note: Some of the information contained in this GxP Dictionary does not apply equally to all countries.
More informationManaging Validation. Paperless Recorders
Managing Validation Paperless Recorders Multitrend Plus Validation Background The past five years has seen an increase in the use of computerized systems and products in the pharmaceutical and bio-pharmaceutical
More informationPETFOOD OUTLOADING CONCEPTS FINISHED KIBBLE HANDLING FROM SILO TO PACKAGING
PETFOOD OUTLOADING CONCEPTS FINISHED KIBBLE HANDLING FROM SILO TO PACKAGING OPTIMIZE FINISHED PRODUCT ELIMINATE CROSS-CONTAMINATION & DAMAGE OF High capacity finished kibble dosing and blending with 100%
More informationOVERVIEW PLASTICS RECYCLING MACHINES.
PLASTICS RECYCLING MACHINES OVERVIEW > High quality pellets > Innovative technology > Easy operation > Power intelligence > Cost-effective machine use > Excellent customer service www.ngr.at NGR KEEP VALUABLE
More informationAUTOMATED PRODUCTION LINES STREAMLINING MANY STAGES INTO ONE. laska.at
AUTOMATED PRODUCTION LINES STREAMLINING MANY STAGES INTO ONE. laska.at 3 QUESTIONS ABOUT AUTOMATED LINES. 3 HONEST ANSWERS. WHAT YOU HAVE TO DO TO INCREASE OUTPUT AND ACHIEVE HIGH QUALITY: NEXT TO NOTHING.
More informationMixing & Milling Technology
Mixing & Milling Technology Equipment for the Pharmaceutical Industry Proven performance in the field of dispersion, ultra fine wet grinding, nano wet grinding, and dry mixing Willy A. Bachofen AG Maschinenfabrik
More informationThermoforming packaging machine R 145 with MULTIVAC Clean Design. Maximum process reliability and cleanroom suitability
Thermoforming packaging machine R 145 with MULTIVAC Clean Design Maximum process reliability and cleanroom suitability MULTIVAC R 145 Clean Design Thermoforming packaging machine R 145 with MULTIVAC Clean
More informationPlastCoat PC 15. The compact one. Interior and exterior plaster spraying with easy to use technology.
PlastCoat PC 15 The compact one Interior and exterior plaster spraying with easy to use technology. With their plaster spraying units Wagner have made it easier to get into the machine-assisted application
More informationHigh Speed Container Mixers
High Speed Container Mixers Promixon: New Generation Great Experience Our vocation is to manufacture high quality mixing plants that boost the performance parameters of user companies and meet the needs
More informationPRODUCTION LINES PRODUCTIVITY AND RELIABILITY TAILORED TO YOUR PRODUCT
PRODUCTION LINES PRODUCTIVITY AND RELIABILITY TAILORED TO YOUR PRODUCT EN www.laska.at APPLICATIONS OF THE LASKA PRODUCTION LINES The demand for automatic production lines is rising sharply worldwide.
More informationVACUREMA. Food Contact Approved Recycling. With highly efficient decontamination BEFORE the extrusion process. CHOOSE THE NUMBER ONE.
Inline Applications Food Contact Approved Recycling. With highly efficient decontamination BEFORE the extrusion process. CHOOSE THE NUMBER ONE. The modular technology. For your application. Different requirements
More information35 STATION DOUBLE ROTORY COMPRESSION MACHINE
Page 1 of 16 User Requirement Specifications 35 STATION DOUBLE ROTORY Equipment ID: T-35COMP 01 Page 2 of 16 Table of Contents 1.0 APPROVAL SIGNATURES 2.0 OVERVIEW 3.0 PROCESS DESCRIPTION 4.0 PRODUCTIVITY
More informationPlastCoat PC 25/ PC 35
PlastCoat PC 25/ PC 35 The powerful ones Plaster spraying indoors and out with equipment geared to practical use. Quality Offensive! With their plaster spraying units WAGNGER have made it easier to get
More informationPage 1
Engineers to Healthcare Industry INTERTECH EQUIPTECHNOLOGIES PVT. LTD. Company Presentation 2014 www.intertechequip.com Page 1 INTERTECH Production facility Total Fabrication Area 75,000 ft2 & Clean room
More informationCOMPUTERIZED SYSTEM VALIDATION (CSV) IMPLEMENTATION, DEMARCATION AND STRUCTURATION
COMPUTERIZED SYSTEM VALIDATION (CSV) IMPLEMENTATION, DEMARCATION AND STRUCTURATION Audit Security is the high priority for pharmaceutical companies, especially when computerized Systems are used. The everchanging
More informationTECTURA LIFE SCIENCES HIGHLIGHTS
HIGHLIGHTS BATCH AND SERIAL NUMBER MANAGEMENT QUALITY CONTROL VENDOR RATING ELECTRONIC SIGNATURE AND AUDIT TRAIL R&D MODULE MANAGEMENT OF ACTIVE INGREDIENTS SEQUENCE PLANNING MOBILE SCANNER INTEGRATION
More informationValidation. An Easy to Understand Guide Validating Purified Water Systems
Validation Overview Validation Documentation Validation Activities Validation Mistakes Validation Protocols Test Selection Common Verifications When to test Test Layout and Content Validation Protocol
More informationOn the direct way to profitability Injection Molding Compounder IMC. Krauss-Maffei Kunststofftechnik GmbH, 2007
On the direct way to profitability Injection Molding Compounder IMC Krauss-Maffei Kunststofftechnik GmbH, 2007 2 Agenda General principle of the Injection Moulding Compounder Working principle Differences
More informationGAMP5 Validation for Dynamics 365
GAMP5 Validation for Dynamics 365 Prepared by: Michael Webster, Business Development Director, RSM US LLP michael.webster@rsmus.com, +1 617 241 1544 Dynamics 365 is an ideal enterprise resource planning
More informationRisk-based Approach to Part 11 and GxP Compliance
Welcome to our E-Seminar: Risk-based Approach to Part 11 and GxP Compliance 1 Intro Common Discussion Q: Do I really need to do this? Possible Answers A: Of course! (QA) B: Who cares, I have work to do!
More informationOur technology makes an impact. BIG-MIX Model 35 Model 48 Model 60 Model 80 Model 110 Model 120. PUMPE BIG-Mix 1
Dosing technology Our technology makes an impact. BIG-MIX Model 35 Model 48 Model 60 Model 80 Model 110 Model 120 PUMPE BIG-Mix 1 Areas of application Optimal solutions for all requirements. Our experience
More informationAdvances in PVC Compounding Technology with the Oscillating Screw Kneader
Advances in PVC Compounding Technology with the Oscillating Screw Kneader PVC 2008 by Peter Messmer (Speaker) Andreas Niklaus Hans-Ulrich Siegenthaler Introduction Overview of the talk Introduction From
More information800.457.5456 www.albkleinco.com www.palmermfg.com About Alb. Klein Technology Group Inc. If you operate a foundry, use sand and binder to make cores, or if you would like to improve your sand handling
More informationAARBOR COLORANTS CORPORATION
AARBOR COLORANTS CORPORATION Technical Bulletin A/TA/06-2009 AArbor Monopigment Concentrate Flush for Plastics. Phthalocyanine Pigment Flushes for Plastics masterbatches. AArbor s mono-pigment concentrated
More informationComputerised Systems. Inspection Expectations. Paul Moody, Inspector. 18/10/2013 Slide 1. ISPE GAMP COP Ireland Meeting, Dublin, 17 th October 2013
Computerised Systems Inspection Expectations ISPE GAMP COP Ireland Meeting, Dublin, 17 th October 2013 Paul Moody, Inspector Slide 1 Presentation Contents Brief Introduction to the IMB Regulatory References
More informationGMP Pre-Qualification of Separators Ex Works. Flexible and safe on the GEA pharmaceutical test bay
GMP Pre-Qualification of Separators Ex Works Flexible and safe on the GEA pharmaceutical test bay 2 GMP PRE-QUALIFICATION OF SEPARATORS EX WORKS Customer Specific, Economical and Safe For manufacturers
More informationSalmon Filleting Superior filleting with optimum yield
Salmon Filleting Superior filleting with optimum yield Efficient and high-quality filleting Back and Belly trim tools Increased yield Up to 25 fish per minute Small footprint Filleting machines for salmon
More informationRisk Based Validation. Why, How and with what tools?
Risk Based Validation Why, How and with what tools? Tech Talk Agenda History of FDA GMP initiative for the 21 st Century. Industry response to FDA initiative. Harmonisation through ICH. ASTM Standard on
More informationFabrique de Betón prefabriqué SKAKO en liquidation
Fabrique de Betón prefabriqué SKAKO en liquidation Images: Type: Fabricant: SKAKO : : 2006 : Concrete production plant built by SKAKO in 2006, ceased operation in 2012. With an estimated service life of
More information18.H Questionnaire for preparing GMP-inspections
Questionnaire for preparing -inspections Questionnaire for preparing -inspections Here you will find answers to the following questions: What questions are typically asked during inspections based on current
More informationHi-Flex Thermoplastic Polyurethane Hoses
Hi-Flex Thermoplastic Polyurethane Hoses CP Polyester type polyurethane thermoplastic flexible hose. Wire embedded helix offers low force flexibility, expansion and contraction. Clear, corrugated finish
More informationFeeding and weighing
Feeding and weighing Feeding and weighing A correct registration of volume and weight is essential for the preparation of products in the feed, food, pharmaceutical and chemical sectors with a maximum
More informationMulti-column Continuous Capture Chromatography New data confirming significant savings and de-bottlenecking opportunities
Multi-column Continuous Capture Chromatography New data confirming significant savings and de-bottlenecking opportunities Dr.-Ing. Kathleen Mihlbachler, LEWA Bioprocess Repligen Seminar: Advances in Bioprocessing,
More informationFormula Control & Lot Traceability which pays for itself.
Prevent operator hand scaling mistakes from eroding your profit margins! Introduce consistently accurate ingredient weighing by enforcing tolerances. Invest in Vantage Formula Control & Traceability from
More informationDrug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel
Drug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel On February 13th, 2006, the FOOD AND DRUG ADMINISTRATION (FDA) implemented a revision to the Compliance Program Guidance Manual for active
More informationContents. Contents (13) 1 Production (23)
1 Production (23) 1.A Sanitation (27) 1.A.1 Organisational prerequisites (27) 1.A.2 Sources of contamination (28) 1.A.3 Responsibilities and implementation (29) 1.B Personnel hygiene (31) 1.B.1 Clothing
More information