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Design Service

AUSTAR is committed to providing design service for pharmaceutical projects. With its professional team in the field of processing equipment, civil engineering, public engineering and engineering cost etc., the company provides clients with high-standard engineering design services based on its advanced design concept and rich design experience. Standardized service process for project design and quality control ensures that the design meets the pre-determined functional and advanced requirements under the premise of compliance. In design process, AUSTAR attaches importance to key issues such as safety, environmental protection and energy saving to avoid risks and maximize the economy, maneuverability and enforceability of the project.

Feasibility Study

With economic benefit as the core, AUSTAR demonstrates feasibility of the proposed project in a comprehensive and systematic manner and puts forward all-round assessment & analysis and improvement suggestion by using mass data.

Site Master Planning

Plane and space relations between buildings, structures and other facilities are built on the basis of national norms and land conditions. Building layout, transportation, comprehensive pipelines and green layout etc. are dealt with in a correct manner according to topographic features so that the architectural complex and the facilities integrate organically.

Concept Design

Provide package service for key information of project overview, including project objective, product variety, production scale, processing flow, GMP standard of workshop, labor assignment, list of main processing equipment, processing plan, building structure, public works, project cost estimation and project schedule, etc.
  • Schematic Design
  • Construction Budget

Basic Design

Provide services for overall design, layout design, main processing flow, equipment selection and installation design, civil engineering quantity and cost estimation etc. for the project.
  • Schematic Design
  • Design Optimization
  • Engineering Cost

Detailed Design

Accurate, complete and detailed professional drawings, to provide basis for procurement, installation, construction and commissioning.
  • Schematic Design
  • Design Optimization
  • Engineering Cost
  • Design Review

Production Line Design

For OSD and API projects, provides services range from production simulation, batch capacity evaluation, process equipment selection, energy optimization and balancing, project investment and operational cost evaluation, etc. Through above services, focusing on EHS and cGMP requirements, automation and digitalization purposes, and balancing between project cost and operational cost to realize operational excellence.
  • Bulk Sterile and Non-sterile API Powder System Design
  • High Potent OSD and API Containment Design
  • Flexible API Research and Pilot Production Modular Design
  • Bulk Capacity Intelligent OSD Production System Design
Based on client's requirement for production processing technology, the GEP-based design concept and engineering practice experience is applied to sort out and design the whole-process bioprocessing design, including material balance, processing flow, equipment selection, production planning, material analysis and hybrid integration strategy, etc., providing clients with optimized processing equipment and consumables integration program.
  • Bioprocess Project Design

Process Design

Based on an in-depth understanding of customers' production process, this service can assist customers in developing/evaluating appropriate cleaning (process residue, microbial contamination, rouge) and sterilization process parameters for their cleaning and sterilization systems and equipment on a risk-based basis, thereby accelerating the process validation for cleaning and sterilization, which can prevent contamination and cross contamination, and improve product quality and capacity.
  • Pharmaceutical Processing System and Equipment Cleaning Development
  • Pharmaceutical Processing System and Equipment Sterilization Process Development
  • Pharmaceutical Processing System, Equipment Rust Removal and Microbial Film Process Development
Through in-depth analysis and understanding of production process and operation, reasonable use of diversified single-use system or single-use and stainless steel hybrid system to provide optimization solutions, so as to improve the convenience of system operation and reduce the cost of consumables customization.
  • Hybrid Biological Processing System Design
Based on QbD design concept, Austar, with integration of global high-end technology resources, provides pharmaceutical companies with advanced fluid processing systems that meet the requirements of GMP in China, GMP in the EU, and CGMP in the United States. Such systems include pharmaceutical water system, pharmaceutical liquid preparation system, CIP/SIP system, biological upstream and downstream processing system, etc. The products are applied in various dosage forms such as API (Active Pharmaceutical Ingredient), oral solid preparations, infusion solutions, powder injections and biological preparations etc.
  • Fluid and Biological Processing System Design
The professional analytical instruments and lyophilization equipment of various scales are equipped to allow design of the process parameters for different scales, including the freezing rate, final freezing temperature, shelf temperature, drying time and chamber pressure during primary as well as secondary stages, etc., thereby achieving efficient lyophilization production under the premise of stable quality of the final products.
  • Freeze-drying Technology Development

Consulting Service

AUSTAR is committed to providing clients in the pharmaceutical industry with professional consulting services in line with characteristics and practical needs of enterprises. Senior experts of AUSTAR from abroad & domestic provide clients with cutting-edge knowledge of laws and regulations, business philosophy and management approaches in the aspect of drug life cycle compliance, quality management system, qualification and validation, pharmaceutical production contamination control, laboratory design and compliance verification, lean operation and good project management, helping our clients to improve operation efficiency.

Good Engineering Management Consultation

Provide efficient and high-quality lifecycle management for pharmaceutical engineering project based on client’s requirement, design drawings, general construction specifications, GMP and ISPE implementation guidelines and related pharmaceutical industry standards to ensure that project quality, schedule/progress, cost and EHS meet requirements of the end clients/project investors.
  • Engineering Management Dervices

Lean Operation Consultation

Devoted to providing clients in pharmaceutical industry with digital factory solutions based on lean management concept, experienced lean experts, automation systems team and engineer team specialized in regulation of pharmaceutical industry to help clients realize high efficiency management, improve automation and standardization capability and the over-all factory operation efficiency in addition to making the client's projects conforming to international laws and regulation and cGMP requirements.

Qualification and Validation Consultation

To provide clients with validation compliance solutions covering the full life cycle of drugs to meet clients' needs for commissioning, confirmation, validation and revalidation/revalidation services at different stages. Assist clients to make their projects comply with FDA, EMA, MHRA, PIC/S, NMPA, PMDA certification and WHO pre-confirmation requirements, and provide complete commissioning and validation services for client project completion.

Quality Management System Consultation

On the basis of the ICH Q10 pharmaceutical quality system and taking risk management and scientific analysis as the basic method, AUSTAR helps clients to establish the pharmaceutical quality system that conforms with the FDA, EMA, the MHRA, PIC/S, NMPA, PMDA and the WHO standards within the drug life cycle and guide clients to change from passive management to active management. The quality management helps enterprise to reduce production and operation cost as well as improving client satisfaction and business profits.
  • Drug Research & Development Quality System Management Consultation
  • Drug Production Quality System Management Consultation
  • Management and Evaluation of Single Use Biological Products Supplier

Pharmaceutical Production Contamination Management Consultation

Assist clients to analyze risks in the finished product production technology and defects in the equipment & system, and ensure product quality by developing cleaning and disinfection strategies to reduce microbial contamination and product residual contamination.
  • Cleaning Technology Development Consultation
  • Rust Removal Technology Development Consultation
  • Development of the Microbial Film Removal Consultation
  • Sterile Products Contamination Control Strategy Consulting
  • Management of Processing Water Index Consultation
  • Development of Clean Room Disinfection Approaches Consultation
  • Management Strategy of Microorganism in Clean Environment Consultation
For HPAPI products, OEL value is evaluated in a comprehensive manner and OEB grade evaluation and grade determination of selected facilities will be guided so as to guide the selection of equipment or system airtight rating and confirm the airtight rating of isolation equipment, helping clients to pass EHS regulations, FDA& EU certification, and reduce funds waste due to excessive protection.
  • Management of Cross-contamination Due to Collinear Production of Multi-products Consultation

Process Technology Service

AUSTAR process engineering service provides pharmaceutical clients with cutting-edge technology consulting, product testing, process optimization, process parameter exploration and other services in the R&D stage and production stage based on its process service laboratory to promote innovation and progress of process technology and process equipment. The laboratory is equipped with cutting-edge technology equipment and a professional process development team. At the same time, it has established cooperation with many abroad & domestic university laboratories to continuously build a platform for medical research exchanges and cooperation. AUSTAR introduces advanced products and technology into Chinese market and provides technology transfer services for pharmaceuticals to promote the progress of the industry.

Process Equipment Selection

Integrate both the agent equipment and self-produced equipment, design process route and determine process equipment selection according to client product type, assist clients to improve and supplement production lines and overcome production process difficulties.
  • Selection of Processing Route for Pharmaceutical Research& Development and Equipment Selection
Provide clients with equipment selection services conforming to quality attributes and key process parameters, and help clients to build a process system platform based on quality and derived from the design concept on the basis of the bioprocess equipment and knowledge system platform and deep understanding of client's process route targeting on detailed design and key aspects.
  • Bioprocess Equipment Selection and Configuration Recommendation

Technology Transfer

In pharmaceutical solid dosage product industry, AUSTAR could introduce advanced process for domestic customer, transfer mature process in China to third world country, and shorten the cycle of new product developing. Until now, AUSTAR has thousands of process in soft gel capsule, tablet and hard capsule.
Furthermore, AUSTAR could provide the process developing service in wet granulation, fluid bed top spray granulation, pellet coating, soft gel encapsulation, hot melting extrusion, roller compaction, particle size control.
  • Technology Transfer of Chemical Drugs

Assist clients to carry out the transfer of compliance cleaning process from development phase to production phase and from other factories to client factory, help clients establish risk assessment and transfer plan, etc. for the technology transfer.
  • Cleaning Process Technology Transfer

Freeze-drying Parameters Testing

AUSTAR freeze-drying laboratory uses professional instruments to analyze freeze-drying preparations and obtain key characteristic temperatures of drugs, including collapse temperature, vitrification transition temperature or eutectic temperature, which can be used as the basis for formulation design and process development of freeze-drying preparations.

SMEPAC Testing

Verify OEL value of the equipment according to ISPE guidance documents, provide air permeability performance certification for client's equipment, and provide certification documents for air permeability performance of AUSTAR equipment to meet client's EHS requirements.

Process Optimization

Improve client's existing processing lines and processing flow, help clients improve product development efficiency, shorten process development time, reduce production cost and improve product quality.
  • Solid Preparations Process Optimization
  • Process Optimization of Lipidosome & Microspheres
  • Liquid and Bioprocess Optimization
  • Rust-removal/Microbial Film Development
  • API Crystallization Process Optimization
  • Cleaning Process Optimization
  • Sterilization Process Optimization
  • Freeze-drying Process Optimization
  • Risk Assessment Single Use Products Change
  • Particle Size Control Research and Application Development Services
  • API Filtration, Washing, and Drying Process Parameters and Application Development Services
  • Softgel Capsule Process and Application Development Services
  • Roller Compaction Process and Application Development Services
  • Wet Granulation Process and Application Development Services
  • Fluid-bed Bottom Spray Coating Process and Application Development Services

Product Test

Provide client with product testing and technical consulting services according to client requirements to ensure smooth operation of follow-up business. After the test, test report containing material property, equipment operation parameters, process parameters and other data will be submitted and recommendation on equipment type and model will be delivered to clients.
  • Performance Test of Sanitizer in Clean Room
  • Performance Test of Cleaning Processing of Component Cleaner
  • Performance Test of Processing System Cleaner

Research and Test of Technological Process

To confirm that under the technological conditions, dissolute and precipitates generated by the contact between single use products and materials will not cause adverse effects on patients through scientific compatibility test and reasonable toxicological risk assessment; help clients to complete change and replacement process of single use products.
  • Compatibility Study of Single Use Product
Aiming at potential risks of particulate matter/microorganism and cross-contamination in client's production process system and equipment under routine maintenance and regular cleaning, disinfection and sterilization mechanism, AUSTAR developed pollution testing and verification services in accordance with relevant production quality standards for the client through process analysis, rapid microbial detection and other advanced means. Based on scientific risk assessment, AUSTAR helps its clients realize continuous compliance monitoring and improvement of their production processing systems and equipment.
  • Process System Corrosion Management Studies
  • Disinfection Methods of R & D Laboratory Environment Validation Service
  • Process Contaminants and System Cleanability Studies
  • Instantaneous/On-line Microbial Limit Solution of Pharmaceutical Water
To work closely with clients on the basis of scientific risk management concept and QBD concept, fully consider requirements of all relevant elements, evaluate technical feasibility of SUS and ensure reasonable design, especially to help clients build the single use system reasonably when designing the customized system.
  • Evaluation of Feasibility and Applicability of Single Use Products
Through analysis of clients' sealing requirements for packaging materials, corresponding thermal bonding process is determined and the best thermal bonding scheme is selected for client. 3Q validation will be conducted before thermal bonding scheme is used to ensure that the equipment meets client’s needs; Re-validation of the sealing machine which is in use will be conducted to ensure its safe operation. AUSTAR helps clients choose more suitable thermal bonding process and thermal bonding design according to actual situation to guarantee product quality, reduce quality risk of thermal bonding process to products and ensure compliance and various certification requirements.
  • Sealing Machine Verification

Facility Operations & Maintenance Services

AUSTAR focuses on providing professional Facility management technology and services for customers in the pharmaceutical industry, with the aim of helping them establish a comprehensive and leading concept of equipment and Facility system maintenance and management. It also provides safe and efficient management services for equipment and engineering in the full life cycle, as well as the professional management services for O&M security.
Owning rich experience in project management, installation and commissioning, energy-saving technological transformation and Facility O&M services, our team is composed of professional and senior engineers, process experts and Facility management expert teams. We take customer satisfaction as the core, and devote to providing customers with the most comprehensive, professional, timely and price-friendly services.

Upgrading Service

Provide clients with the latest product and system upgrade scheme according to technology development and new regulations of the industry to ensure compliance of client's equipment, workshop and laboratory with regulation requirements and client’s technology leading position as well as improvement of site safety and work efficiency.
  • Automatic Control and Information Engineering Program Upgrading
  • On-line Environment Monitoring System Upgrading Service
  • Intelligent Warehousing Engineering Upgrading
  • Fluid Technology and Biotechnological System Upgrading
  • HVAC System Installation and Renovation
  • Installation of Water Supply and Drainage Pipelines
  • Electrical Equipment Installation/Electrical Line Laying and Installation
  • Constant Temperature and Humidity System Construction and Installation
  • Purified Eater/Steam/Ciller Equipment and Pipe Installation
  • Cleanroom Renovation
  • Imported and AUSTAR Production Equipment Upgrade, Planning and Implementation

Power and Energy System

  • O&M of HVAC System
  • O&M of Water Purification System

Investigation and Consultation

  • Facility Operation Management Investigation Services
  • Energy-saving Program for Facility and Equipment Systems

Laboratory Construction

Through its in-depth understanding of laboratory construction, AUSTAR provides customers with a series of services ranging from engineering to equipment, software to services, new construction to equipment O&M management. Based on regulations and guided by professional advice, AUSTAR provides powerful project execution teams and experienced engineers to help customers establish compliant, intelligent and efficient laboratories.

Laboratory Engineering

  • Laboratory Construction Drawings Review
  • Laboratory Upgrade Planning and Implementation

Laboratory Instruments and Equipment

  • Laboratory Instruments and Equipment Recommendation
  • Instrument Confirmation and Validation Consultation

Laboratory Informatization

  • R&D Information Management Platform
  • Laboratory Information Management Platform
  • Quality and Risk Management Platform
  • Informatization Consultation

Laboratory Service

  • Analysis Method Validation Consultation
  • Laboratory Relocation Planning and Implementation

Life Cycle Management of Laboratory Instruments/Equipment

  • Asset Utilization Ratio Monitoring
  • Laboratory Assets Inventory and Disposition
  • Simultaneous Validation Service of Multi-brand (instrument)

Laboratory O&M

  • On-site Service/52-week Preventive Maintenance/Regular Inspection/Annual Maintenance.

Digitalization Construction

AUSTAR can provide pharmaceutical enterprises with full lifecycle digital solution services from digital strategy consultation to digital application implementation and after-sales services. It can provide full lifecycle digital solutions for pharmaceutical enterprises of various scales by partnering with top industry players and combining its own extensive experience in process, regulation, lean manufacturing, excellent operation, and validation accumulated in the pharmaceutical industry, which covers various aspects such as warehousing, manufacturing, quality, and equipment maintenance. With decades of experience in digitalization in the pharmaceutical industry, AUSTAR has implemented several digital projects that have won international engineering awards from ISPE.

Enterprise Digital Applications and Services

  • Digital Project Consultation
  • Operational Intelligent Platform
  • Energy Efficiency Analysis and Decision-making

Digitalization of Manufacturing Processes

  • Manufacturing Execution System
  • Advanced Planning and Scheduling
  • Process Control System
  • Building Management System & Environmental Monitoring System
  • Warehouse Management System

Digitization of Equipment and Maintenance

  • Total Productive Maintenance System
  • Equipment Management System
  • O&M System for Intelligent Facilities

Digitization of Quality Compliance

  • Quality Management System
  • Laboratory Management System (LIMS)

After-sales Service

After-sales service provides clients with various kinds of worry-free services such as providing parts and spares for pharmaceutical industry equipment and project and system engineering maintenance etc. The professional senior engineering team of which takes pursuit of client's satisfaction as its core is committed to provide clients with the most intimate and the most timely service.

Calibration

Provide convenient and quick calibration service in accordance with GMP requirements, maintain normal operation of equipment and system, calibrate counting deviation of instruments in the system regularly, and ensure the stability and accuracy of instrument performance.
  • Air Particle Counter
  • Instruments and Apparatus
  • Water Quality Testing
  • On-line Environment Monitoring System
  • Calibration Service for Imported Production Equipment

Service & Maintenance of System and Equipment

In case of system or equipment failure, the professional service team will arrive at the site within 24 hours for servicing and maintenance to help clients restore system or equipment operation in the shortest time and minimize the downtime.

Parts and Spares

Provide selection service for all kinds of pharmaceutical equipment and processing system, parts and spares for instruments and facilities of the clean room engineering and automatic control system, provide clients with emergency parts and spares with the advantage of delivery time and price to ensure normal operation of client's equipment and improve productivity.
  • Cleanroom Engineering Parts and Spares
  • Paid Service for Equipment Spare Part
  • Parts and Spares for Controllers, Meters, Valves and Analytical Instruments

Training and Guidance Service

To improve client's understanding of equipment & system by providing them with training and guidance services through application of standard courses and customized courses settings which are realized through a variety of training models and channels according to client needs.
  • Remote Guidance and On-site Instruction
  • Automatic System Training
  • Equipment Operation Training
  • Equipment Maintenance Training
  • Clean Utility Engineering System Maintenance Training
  • Contamination Control Equipment Operation and Maintenance Training
  • Training on Installation, Operation and Maintenance of Single Use System

Validation

Service for SAT, FAT, IQ, OQ and PQ validation of agency and self-produced equipment to ensure that the equipment and engineering meets FDA, EMA, MHRA, PIC/S, NMPA, PMDA certification and WHO pre-confirmation requirements.
  • Qualification Document Service for API Process Equipment
  • Verification Service for Automatic Control and Information-based Engineering
  • Verification Service for Fluid Technology and Biological Technology
  • Cleaning in Place (CIP) System/Parts Washer PQ & cleaning Validation Service
  • Validation and Verification for the Single Use System
  • Validation and Verification for Imported and AUSTAR Production Equipment

Preventative Maintenance

By signing the annual maintenance and service package technical services to guarantee to provide clients with comprehensive preventive and customized maintenance plan, avoid large downtime caused by minor faults, timely discover potential risks, check the working turntable of vulnerable parts with timely maintenance and replacement so that equipment availability rate can always maintain 100%.
  • Maintenance Service for Biosafety Sewage Treatment System
  • Preventative Maintenance for Liquid and Biotechnological System
  • Maintenance for Automatic Control Engineering System
  • Life Cycle Management of Parts Washer
  • Steam Sterilizer Life Cycle Management
  • Preventative Maintenance for Imported and AUSTAR Production Equipment

Quality Risk Control Service

Risk Assessment of Single Use Product Quality

Evaluate risk of using single use products on the basis of scientific risk management concept and QBD concept and reduce or prevent quality risk of clients' products caused by their own quality problems

Cleanroom Contamination Risks Control

  • Cleanroom VHP Bio-decontamination Service

Pharmaceutical Processing System/Equipment Contamination Risk Control

Provide clients with customized one-stop solutions for contamination control of pharmaceutical process on the basis of scientific risk assessment, help clients establish compliant and effective management system for microorganism, particulate matter and cross contamination control, and reduce contamination risks from the perspective of process, operation and continuous improvement.
  • Process System/Equipment Derouging Service
  • Processing System/Equipment Compliance Clean and Passivation