Totally Integrated Solutions for Pharmaceutical Industry

Size: px

Start display at page:

Download "Totally Integrated Solutions for Pharmaceutical Industry"

Christina Peters
6 years ago
Views:

1 Totally Integrated Solutions for Pharmaceutical Industry

ABOUT AUSTAR As a global leading solution provider for the pharmaceutical industry, AUSTAR provides pharmaceutical enterprises with comprehensive products

AUSTAR has globally constituted a gigantic development and research, marketing and service network.

Besides our traditional role as a manufacturer and supplier of technological equipment, AUSTAR supports customer from inception to completion of project.

2 ABOUT AUSTAR As a global leading solution provider for the pharmaceutical industry, AUSTAR provides pharmaceutical enterprises with comprehensive products and services. Headquartered in Beijing, AUSTAR has opened factories, offices and branch companies in Asia and Europe. AUSTAR has globally constituted a gigantic development and research, marketing and service network. AUSTAR products and solutions have been applied to more than 40 countries and regions in the world. Besides our traditional role as a manufacturer and supplier of technological equipment, AUSTAR supports customer from inception to completion of project. AUSTAR is committed to promoting pharmaceutical industry advancement internationally, and becoming your partner in improving human health. AUSTAR HEADQUARTERS Tel: Fax: info@austarunion.com 01 / ABOUT AUSTAR ABOUT AUSTAR / 02

3 40 COUNTRIES AND REGIONS 24 YEARS OF EXPERIENCE AUSTAR IN THE WORLD 03 / AUSTAR IN THE WORLD AUSTAR IN THE WORLD / 04

4 CONTENTS Design Conceptual Design (CD) Basic Design (BD) Detail Design (DD) Production Line Vial Liquid Filling Line Wet Granulation Line for Oral Solid Dosage Soft Bag Production Line GMP Compliance Services Validation Consultancy Pharmaceutical Quality System Consultancy Drug Technology Transfer Engineering Clean Room System Liquid Process System Pharmaceutical Automation Engineering Package Line Blister Packing Line Bottle Counting Line Consumables Personal Protection Cleaning Sterile Packaging 05 / CONTENTS CONTENTS / 06

Drug Technology Transfer Customized drug technology transfer services Design

Study Conceptual Design (CD) Design basis and conceptual design Large Volume

preparation of tender documents Basic Design (BD) Layout development,

Injectables AUSTAR ADVANTAGES Standard Professional Flexible Efficient

standard Process support functions are adaptable for local conditions

Risk-based approach Highly educated, experienced and trained engineers and

weeks on standard equipment of service Total design (CD/BD/DD) 3 mouths for

5 Drug Technology Transfer Customized drug technology transfer services Design THE DESIGN PROCESS Facility URS Project definition, Basis of Design, Concept Study Conceptual Design (CD) Design basis and conceptual design Large Volume Parenteral Oral Solid Dosage Detailed Design (DD) Planning for construction, preparation of tender documents Basic Design (BD) Layout development, utility definition, detailed requirements for DD APIs Small Volume Injectables AUSTAR ADVANTAGES Standard Professional Flexible Efficient Request for Quotation (RFQ) Others Biological Products Process core is standard Process support functions are adaptable for local conditions Equipment manufactured to standard GMP compliance Quality by design Risk-based approach Highly educated, experienced and trained engineers and consultants Flexibility and adaptability to requirements response within 2 weeks on standard equipment of service Total design (CD/BD/DD) 3 mouths for complex process Project completion within budget, quality and predetermined schedule 07 / DRUG TECHNOLOGY TRANSFER DESIGN / 08

CLEAN ROOM SYSTEM Engineering AUSTAR provides complete project management services including designs, manufacturing and installation.

AUSTAR clean room system is flexible and easy to install that accepts changes to design in the field and can be reconfigured for use in

Business Scope Access Control Clean Room Design Project Management Clean Room Partition, Doors, Windows PVC/ Epoxy Floor Clean Room Equipment

6 CLEAN ROOM SYSTEM Engineering AUSTAR provides complete project management services including designs, manufacturing and installation. Our clean room system combines European technology and customized solutions with guaranteed quality and reliable services. AUSTAR clean room system is flexible and easy to install that accepts changes to design in the field and can be reconfigured for use in manufacturing area. Our clean room system meets the requirement of US FDA cgmp, EU GMP, PIC/S and WHO. Business Scope Access Control Clean Room Design Project Management Clean Room Partition, Doors, Windows PVC/ Epoxy Floor Clean Room Equipment HVAC System 09 / ENGINEERING HAVC Automation Control Electrical System 01 Air Flow 02 Wall Panel 03 Door 04 Air Shower 05 HEPA Box 06 Window 07 Return Air Grille 08 Ceiling Panel 09 Light 10 Pass Box 11 PVC/Epoxy Floor ENGINEERING /10

LIQUID PROCESS SYSTEM CIP SKID Preparation Skid WFI Generator Pure Steam Generator Pretreatment PW Generator PW Tank Distribution Skid WFI Tank WFI Distribution Skid AUSTAR provides pharmaceutical

7 LIQUID PROCESS SYSTEM CIP SKID Preparation Skid WFI Generator Pure Steam Generator Pretreatment PW Generator PW Tank Distribution Skid WFI Tank WFI Distribution Skid AUSTAR provides pharmaceutical liquid process technology, international level of AUSTAR will take experience-gained advantages to provide worldwide pharmaceutical design, project management services, manufacturing, installation and validation, as well enterprises with world-class pharmaceutical water system solutions. AUSTAR water as comprehensive integrated service. system meets US FDA cgmp, EU GMP, WHO and other national requirements. 11 / ENGINEERING ENGINEERING / 12

PHARMACEUTICAL AUTOMATION ENGINEERING ONE STOP AUTOMATION SOLUTION INTEGRATOR AUSTAR automation engineering provides integrated process automation lifecycle solutions for pharmaceutical companies.

AUSTAR also provides information system such as BMS, EMS, SCADA, MES, warehouse management system and LIMS.

8 PHARMACEUTICAL AUTOMATION ENGINEERING ONE STOP AUTOMATION SOLUTION INTEGRATOR AUSTAR automation engineering provides integrated process automation lifecycle solutions for pharmaceutical companies. With pharmaceutical industry know-how and excellent abilities of automation application, AUSTAR can provide customized solutions to meet client's requirements. AUSTAR also provides information system such as BMS, EMS, SCADA, MES, warehouse management system and LIMS. 20th More than 20 years experience in pharmaceutical industry 100 More than 100 worldwide clients Process Automation Utility Automation Information System GAMP5 GAMP5 compliant design and Advantages construction procedures 20+ years experience (Focusing on pharmaceutical industry) Highly experienced and qualified engineering team (100+ professional technical experts) World-class system platform (SIEMENS, Rockwell, Emerson) Compliance with FDA, WHO, EMA regulations (System validated to current version of GAMP) Reliable after-sale service (20+ worldwide after-sales service engineers) Process Automation API Process Control System Preparations Process Control System Biopharmaceutical Process Control System Factory Information System Supervisory Control And Data Acquisition (SCADA) Manufacturing Execution System (MES) Laboratory Information Management System (LIMS) Utility Engineering Automation HVAC Control System Environment Monitoring System (EMS) PW / WFI System Light Current System Integration(IT, Access control, telephone, CCTV) 13 / ENGINEERING ENGINEERING / 14

Production Line This production line is integrated in accordance with process requirements.

9 VIAL LIQUID FILLING LINE Vial liquid filling line is composed of rotary or linear washing machine, sterilizing & depyrogenation tunnel, filling & stoppering machine, and capping machine. Production Line This production line is integrated in accordance with process requirements. The vial liquid filling line capacities extend to filling volumes of 2ml-500ml. 15 / PRODUCTION LINE PRODUCTION LINE / 16

ORAL SOLID DOSAGE SOLUTION AUSTAR offers complete solutions for solid processing plant.

AUSTAR process engineers can provide complete production line to customers' requirements.

Movable Drum Lifter Coating Pan Pharma Bin Bin Blender Bin Blender Drum Movable Drum Lifter Capsule Filler Automatic Bin Washing Station IBC Bins High Shear Mixer Fluid Bed Dryer/Granulator Vacuum

10 ORAL SOLID DOSAGE SOLUTION AUSTAR offers complete solutions for solid processing plant. With the process of granulation, drying, WET GRANULATION LINE FOR ORAL SOLID DOSAGE tableting, capsule filling, coating, handling, weight checking, inspection and washing. AUSTAR process engineers can provide complete production line to customers' requirements. Bin Blender Drum Movable Drum Lifter Tablet Press Movable Drum Lifter Coating Pan IBC Bins High Shear Mixer Fluid Bed Dryer/Granulator FBD Bowl Pharma Lifting Mill Bin Blender Bin Bin Tablet Press Movable Drum Lifter Coating Pan Pharma Bin Bin Blender Bin Blender Drum Movable Drum Lifter Capsule Filler Automatic Bin Washing Station IBC Bins High Shear Mixer Fluid Bed Dryer/Granulator Vacuum Lifting Mill Bin Blender Bin Bin Capsule Filler Semi-automatic Bin Washing Station HANDLING Dispensing and Transfer System, Bins, Drums, Lifting Columns, Blenders COATING Perforated Coating Pan for Film and Sugar Coating TABLETING Force Feed Tablet Press Machines and Peripheral Machines INSPECTION Semi Automatic and Automatic Inspection Machine for Tablets and Capsules GRANULATION & DRYING WEIGHT CHECKING CAPSULE FILLING WASHING High Shear Mixer, Fluid Machine for 100% Weight Intermittent and Continuous Wash-In-Place Station, Bed Dryer/Processor Checking of Capsules/Tablets Motion Capsule Filling Machine Semi-Automatic and Fully and Peripheral Machine Automatic Bin Washing Station 17 / PRODUCTION LINE PRODUCTION LINE / 18

SOFT BAG PRODUCTION LINE Non-PVC Soft Bag Complete Production Line Form - Fill - Seal (FFS)

Production Line A high level of flexibility and reliability is reflected in soft bag

Different types of multi-coextruded polypropylene (PP) films and different types of port

The standard bag sizes vary between 50 ml and 3000 ml.

11 SOFT BAG PRODUCTION LINE Non-PVC Soft Bag Complete Production Line Form - Fill - Seal (FFS) Automatic Conveying System Packaging System Sterilizer Pharmaceutical Non-PVC Soft Bag Production Line A high level of flexibility and reliability is reflected in soft bag production line. Different types of multi-coextruded polypropylene (PP) films and different types of port can be processed. This line can produce up to 5000 bags per hour. The standard bag sizes vary between 50 ml and 3000 ml. Air Knife Dryer Visual Inspection Highlight Capacity: 1000 bags/hr-5000 bags/hr Package material: PP bags Bag size: 50ml-3,000ml Bag tube system: versatile Complete production system Customized Design 19 / PRODUCTION LINE PRODUCTION LINE / 20

12 Package Line BLISTER PACKING LINE Blister Packing Machine Cartoner Machine Bundling Machine Semi-automatic Case Packing Machine Application Application Application Application Blister packing machine can be widelyused for talbets, Cartoner machine is suitable for blisters, ampoules All kinds of Pharmaceutical cartons, or similar boxes. Applicable to packs and various kinds of quadrate capsules, pills, vials and ampoules with PVC feeding, heating, forming, sealing batch numbering and automatically cutting functions. Features Wide range for solid dosage products Processing of all film type: PVC, PVCD, Aluminum Camera Inspection blisters, vials, bottles, syringes, cartridges, and similar packaging. Features Multi-purpose use Continuous processing Cartoning packaging in process quality control Features Film feed protection Safeguard door protection Friendly design & Space saving Servo motor segment accuracy guarantee boxes. Features Widely used in pharmaceuticals & food industry Auto & semi-automatic option Sensors control in key segment Cylinder as execution component Continuous flow process: Forming, feeding, identifying mark, bar coding, slitting/cutting 21 / PACKAGE LINE PACKAGE LINE / 22

BOTTLE COUNTING LINE Unscrambler Counter Desiccant Inserter Screw

Solution Maximum speed up to 200bpm CCD scanning sensor with high

of solid Product detecting sensors to avoid incorrect counting

work separately when small count required Pre-count function to

13 BOTTLE COUNTING LINE Unscrambler Counter Desiccant Inserter Screw Capper Sealer Labeler Complete Tablet / Capsule Counting Line Solution Maximum speed up to 200bpm CCD scanning sensor with high accurate counting Modularized design sensor for different types of solid Product detecting sensors to avoid incorrect counting Dipping nozzles to increase speed and prevent jams 12 channel can work separately when small count required Pre-count function to automatically count after buffer stop 23 / PACKAGE LINE PACKAGE LINE / 24

GMP Compliance Services AUSTAR provides integrated solutions for validation compliance covering the whole lifecycle of a pharmaceutical product and provides complete commissioning and validation

14 GMP Compliance Services AUSTAR provides integrated solutions for validation compliance covering the whole lifecycle of a pharmaceutical product and provides complete commissioning and validation services for the successful completion of the project to satisfy the customer, s requirements for such services as consultancy, commissioning, qualification, validation, re-qualification and re-validation at different stages, and help the project to meet the requirements of US FDA, EMA certification or WHO pre-qualification. CONTENT OF INTEGRATED SOLUTION FOR RISK BASED VALIDATION COMPLIANCE Premises,systems,equipment Utilities HVAC system Clean gases Revalidation (Continuous verification) PW and WFI Pure steam API equipment Transportation validation Sterile product equipment Equipment OSD equipment Biological product equipment Blood product equipment Process validation Quality Project Plan (QPP) Validation Master Plan (VMP) Computerized Systems TCM extraction equipment EMS BMS WMS DCS Cleaning validation SCADA Risk Management Plan(QRMP) Analytical instrument QC Lab. Microbial analytical method Physical and chemical analytical method 25 / GMP COMPLIANCE SERVICES GMP COMPLIANCE SERVICES / 26

15 CONTENT OF INTEGRATED SOLUTION FOR Pharmaceutical Quality System AUSTAR is devoted to providing pharmaceutical enterprises with integrated quality system solutions throughout the whole lifecycle of a pharmaceutical product, including quality system establishment, maintenance and training in compliance with EU GMP, WHO GMP, FDA cgmp and ICH Q10 requirements. NEW PQS STRATEGIES (ICH Q8/Q9/Q10) Transfer of personnel training Process Based QM Regulatory Compliance Based On 6 Major Systems documentation in conformity with EU GMP, FDA cgmp and ICH Q10 standards Science Based Approaches Risk Based Approaches 27 / GMP COMPLIANCE SERVICES GMP COMPLIANCE SERVICES / 28

Consumables AUSTAR provides high quality products

protection, sterile packaging and other supplies to

pharmaceutical and life science industries.

market are widely appreciated by our global clients

durability, longer functional life, reliability and

Area 1 The Cleanroom Production area: validated and

personnel) Only cleanroom products allowed.

area reduces the risk of potential source of

1 Area 3 The Controlled Environment 2 Controlled

suitable cleaning regime can prevent up to 80% of

3 Personal Protection Clean room Garments Clean

Goggles Clean room Face Masks Cleaning Polyester

16 Consumables AUSTAR provides high quality products such as cleanroom cleaning tools, personal protection, sterile packaging and other supplies to meet the stringent requirements of the pharmaceutical and life science industries. We offer products suitable for ISO class 5 (Federal class 100) of cleanrooms. The quality-approved products we offer in the market are widely appreciated by our global clients for their immense quality standards such as durability, longer functional life, reliability and their higher performance. Area 1 The Cleanroom Production area: validated and contamination controlled (air, surfaces and personnel) Only cleanroom products allowed. Area 2 The Personnel Entrance/ Gowning room Gowning area reduces the risk of potential source of contamination entering the clean rooms. 1 Area 3 The Controlled Environment 2 Controlled but not classified (CNC) areas include non GMP and packaging areas. These areas may have impact on clean rooms, suitable cleaning regime can prevent up to 80% of contaminants entering the clean room. 3 Personal Protection Clean room Garments Clean room Shoes & Boots Clean room Gloves Clean room Goggles Clean room Face Masks Cleaning Polyester Wiper Non-woven Wiper Microfiber Wiper Cleaning Mop Cleaning System Sterile Packaging Ultraclean PE Bags Cleansteam Bags/Coils Ultraclean Sterile LDPE Freeze-dry Film Bioprocess Vessels(BPV) Powder Transfer Vessels (PTV) 29 / CONSUMABLES CONSUMABLES / 30

17 Offices and Factories AUSTAR Headquaters 18F, Tower B, Chaowai MEN Office Building, No.26 Chaowai Street, Chaoyang District, Beijing, P. R. China Tel: Fax: Beijing Manufacturing Center No.15 Yanqi Road, Yanqi Economic Develpment Zone, Huairou District, Beijing, P. R. China Tel: Fax: Shanghai Manufacturing Center No.799, Yuyang Road, Cangqiao Industry Zone, Songjiang District, Shanghai, P. R. China Tel: Fax: Shijiazhuang Manufacturing Center No.389, Taihang Street, Gaoxin District, Shijiazhuang, Hebei Province, P. R. China Tel: Fax:

Page 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