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Plan and Design

Our experienced and professional design team is dedicated to life sciences projects at home and abroad. By integrating GMP, process, and engineering know-how into engineering services, we provide clients with high-level engineering design and consulting services. With the state of the art of design concepts and rich design experience, we seek to build win-win relationships with our clients.

Feasibility Study

A selected plant location, featuring well-developed supporting facilities and infrastructures, is crucial for the sustainable business success. We will help carry out feasibility study and surveys from a professional perspective, and provide our clients with professional advice for plant location selection & due diligence with the orientation to return maximization and risk minimization.
  • Plant Location and Space Evaluation
  • Power and Utility Work Evaluation
  • Project Schedule Evaluation
  • Project Investment Evaluation
  • Human Resource Evaluation

GMP Front End Design

GMP compliance is the first and most important goal of all design projects. By integrating AUSTAR's comprehensive GMP and engineering design capabilities into the front end design work, we provide clients with an integrated engineering design that complies with NMPA, FDA, EMA, PICs and WHOL GMP standards.
  • Site Master Plan
  • GMP Layout Design
  • Flow Design
  • Validation Plan
  • Contamination Control Strategy
  • URS
  • BIM

Detail Design

A set of clear, complete and detailed construction drawings is the guarantee to control the project quality, cost and schedule in construction. We provide high-quality detail design services with rich engineering project experiences.

GMP Facility Compliance Review

Facilities,system and Equipment that have the potential to impact product quality must be compliance with cGMP regulatory requirements. Based on the principle of Quality by Design (QbD) and ISPE Guideline related to GPG - a systematic approach rooted in quality risk management - AUSTAR implements Design Qualification (DQ) to provides documented verification that the design of a new or modified direct impact system will result in a system that is suitable for the intended purpose. This process ensures that design deliverables are aligned with the URSs, mitigates potential risk, and comply with regulatory requirements by integrating lifecycle management strategies and Good Engineering Practice(GEP).

Design Review

Comply with user requirements and regulatory compliance is critical to the success of design projects. AUSTAR's professional team rigorously verifies the integrity and accuracy of the design to ensure alignment with user requirements and intended functionality.GMP Compliance validation includes adherence to applicable regulations (e.g. EU GMP Annex 1), standards (e.g. ISO 14644) and guidelines with the pharmaceutical industry.
By integrating AUSTAR's GMP-compliant technical team, engineering design resources and subject matter experts (SMEs), we provide efficient, high quality, multi-dimensional design review services to ensure robust project design outcomes and Regulatory compliance.
  • GxP/Non-GxP Regulatory Compliance Review(Including CSA, Process, HVAC, Electrical, BMS/EMS, CCTV, Utilities, Piping, etc.)
  • LEAN
  • Energy Conservation and Consumption Reduction
  • EHS
  • To ensure that the design satisfies user requirements, and ensures that design specifications are specific, measurable, achievable, realistic, and traceable for direct impact and non-direct impact systems. Design review identifies gaps between the design definition and user requirements and recommends remediation for identified gaps.
  • Constructability
  • Operability and Maintainability
  • Material Compliance
  • Space Management

EHS Risk Assessment

Reducing EHS Risks is the long-term mission of every enterprise. With deep understanding of biosafety, high toxicity, and high potent products and process, we provide clients with professional EHS risk assessment to help achieve a safer, healthier and more environment-friendly operating environment;

Project Management

We can provide clients in the life sciences sector with comprehensive and high-quality project management services including project management, engineering management, procurement management, EHS management, and on-site services, etc.

Project Management Service

  • Project Management Consulting Services throughout whole lifecycle of the pharmaceutical project
  • Compliance Consulting Servises for Standard Project Management System of GEP/EQP(Engineering Quality Process)
  • ​Regulatory Compliance Consulting Servises for Engineering Construction Risk Prevention System
  • ​Project Planning and Control
  • Design Management and Technical Support
  • Permits Mangement
  • Procurement Management
  • ​Engineering Quality Management
  • ​Project Risk Managememt
  • EHS (Environmental, Health, Safety) Management
  • ​​Assessment & Review for Engineering Changes
  • ​CQV Validation Management
  • Project files Control
  • ​Engineering Acceptance and Handover Management

Site Technical Service

  • Site BIM Technical Support
  • Design Review & Design Qualification of the Detailed Drawings
  • Cleanroom On-site Construction Management and Technical
  • Support(Including provision of professional personnel such as Project Managers, On-Site MEP Managers, Professional Engineers (includs Process,HVAC,Electrical,BMS/EMS,Piping,CQV Validation),EHS Safety Engineers
  • GEP on-site inspection services for key engineering phases of the project

Procurement Services

  • Procurement Strategy and Planning
  • ​Supplier Audit
  • ​Contract Management
  • ​Supplier Model/Sample Review and Approval
  • Preperation and Review​ of Technical Specifications and URS Documents
  • Technical Support
  • ​Critical Equipment FAT/SAT Support
  • Review and Guidance for Vendors TOP Document for GMP Validation and O&M support)

Operation & Maintenance

With the aim of helping clients establish a comprehensive and leading concept in equipment and facility system maintenance and management, we offer a wide range of professional and comprehensive solutions for facility management, maintenance, and life-cycle operation to clients in the life sciences industry, including safe and efficient management services for equipment and engineering in the full life cycle, and 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 client satisfaction as the core, and devote to providing the most comprehensive, professional, timely and price-friendly services.

Preventive Maintenance

Sign the annual maintenance service agreement to obtain comprehensive and customized preventive maintenance plans. Timely identify faults and hazards, verify the work condition of quick-wear parts, and promptly carry out maintenance and replacement. Provide convenient calibration and verification services for temperature, pressure, wind velocity, humidity verification, water detection, steam quality testing, etc., and carry out regular calibration to enable equipment to conform to GMP requirements.

Upgrading & Renovation & Energy Conservation

In response to evolving industry standards and updated regulations, we provide comprehensive solutions including system upgrades, facility compliance retrofits, energy-saving renovations, and energy management strategies. Our services ensure your equipment, workshops, and laboratories maintain regulatory compliance while adopting cutting-edge technologies, improving onsite safety protocols, and optimizing operational productivity.

Validation Services

Provide clients with compliance validation solutions for pharmaceutical drug full lifecycle to meet clients' requirements for consultation, commissioning, verification, validation and re-verification/re-validation services involved in various stages, as well as complete commissioning and verification services for project consummation., and help achieve complying with FDA, EMA, MHRA, PIC/S, NMPA , PMDA certification requirements and WHO pre-certification.

Instrument Testing and Calibration

Offering calibration services for temperature, pressure, air velocity, and humidity, along with water quality testing, steam quality validation, cleanroom certification, airborne particle counter verification, and other critical measurement services. We ensure instrument performance stability and measurement accuracy in full compliance with international regulatory standards including GMP, FDA requirements, ISO guidelines, and other applicable quality assurance frameworks.

Spare Parts

Provide clients with an extensive selection of various kinds of spare parts for pharmaceutical equipment and process system, clean room, and automatic control system. Emergency spare parts can be delivered without delay by leveraging our global supply chain system to help achieve normal operation of clients’ equipment.
As a well-known brand in the precision machinery industry, FLUITEN offers customized superior mechanical seals. As the sole designated agent of FLUITEN in China, AUSTAR Group provides sales, installation, maintenance, inspection, and other services for the full range of products.
For more product information: www.fluiten.com

Facility Management

Our on-site facility technical team can formulate work plans, establish a specification documentation system, and offer a wide range of services including wroutine point inspection and maintenance services, power facility maintenance, general troubleshooting, energy conservation consultation, consumables procurement and facility management digitization services for all kinds of systems and equipment, prepare project facility repair plans for all categories of problems emerging in the service process and continuously carry out update, operation, maintenance, servicing and other services, with a view to helping clients implement the operation and maintenance management for facility and equipment systems.

Emergency Service

Through real-time monitoring of equipment operational data, we provide intelligent risk alerts. In the event of unexpected failures, our rapid-response team provides 24/7 emergency support, combining remote diagnostics with on-site repair crews. We coordinate resources across all parties to ensure timely supply of mission-critical parts,significantly reducing production losses from unplanned outages.

Compliance and Validation

The compliance and validation service is to provide professional consulting services in line with the client's characteristics and practical needs. 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 achieve improve operation efficiency.

Quality Management System

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.

Risk Control Strategy

Risk management empowers the pharmaceutical enterprise with a necessary tool and a basis upon which it can undertake sound decision-making for various stages in the full life cycle of drug development. The risk control strategy implements a consistent and step-by-step workflow with one metric throughout the drug product lifecycle.. It can trace risks and find an appropriate solution, and can define, assess and convey action plans and efficiently manage the knowledge base of the entire organization.

Technology Transfer Management

Provide clients with consultative management services covering the full life cycle of technology transfer projects. From the perspectives of project design, project evaluation, risk evaluation, and verification of activities and compliance requirements, we can fully coordinate the resources of the technology supplier and recipient of a project. We build unobstructed communication channels as well as knowledge management and transfer bridges to promote project success.

Contamination Control Strategy

The interaction between all key control points and the control measures can be realized through an enhanced quality risk assessment and an overall pharmaceutical quality system. The implementation of CCS help facilitate pharmaceutical business to establish an overall awareness plans for the product and patient contamination risks, which eventually reduces ineffective control endeavors and individual subjectivity of enterprises, in order to realize better resource allocation, optimal benefits and continuous improvement.

Digital Factory

AUSTAR can provide the life sciences sector with full lifecycle digital solutions from digital strategy consulting to digital application implementation and after-sales service. Based on the strategic cooperation with industry-leading enterprises ,and together with 30 years of experience relating to process, laws & regulations, lean manufacturing, operational excellence and validation, AUSTAR can provide different scales with entire life-cycle digital solutions which cover various aspects from warehouse to manufacturing, quality and equipment maintenance etc. , and help clients shorten launch cycles, improve production efficiency , quality and safety.

Digitalization Plan&Blueprint Design

Digitized factory consultation can help clients define project objectives, technical routes and project feasibility, carry out investment practicality and effectiveness analysis, identify risks and conduct risk analysis, as well as provide suggestions related to the labors, equipment, materials and outsourcing services involved in the project implementation, etc., so as to implement effective supplier management and ensure steady implementation of digitalized factory projects.

Data Analysis

With cutting-edge digital technologies, the integration of advanced PAT technology, data acquisition & analysis techniques, adhering to QbD principles, a compliant, efficient and flexible platform are designed specifically for data analysis from lab-scale development to commercial production, building a closed-loop of data collection, transmission, storage, processing and feedback, which help clients achieve smart production, intelligent R&D, digital management and lean operation.

Value Stream Rebuilt &Lean Management

AUSTAR Pharma LeanTec is committed to helping clients to realize excellent production operational management with a view to bring measurable and remarkable benefits in terms of quality, cost, delivery, safety, etc.

Process Engineering Service

Based on the AUSTAR process service laboratory, we provideclients with cutting-edge technology consulting, product testing, process optimization, process parameter exploration and other services in the R&D stage and production stage, to promote innovation and progress of their 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.

SMEPAC Test

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.

API and Oral Drugs

Optimize client's existing process lines and processing flow, help clients improve product development efficiency, shorten process development time, reduce production cost and improve product quality.

Injections and Lyophilization

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.

Cleaning Process Development and Cleaning Validation

Based on process understanding and risk assessment , AUSTAR provides the cleaning process service through the life cycle approach which covering cleaning process development, cleaning process qualification and continuous cleaning process validation for the pharmaceutical enterprise, and with compliant and robust clean process strategies for multi-production quality risk control and batch-to-batch system contamination control to help client speed up product time-to-market.

Bioprocess Development and Validation Consultation

Based on the life-cycle concept of process development PD, process verification PPQ/PV and continuous process validation CPV, and in accordance with the QbD process development path of QTPP - CQA /CMA - CPP/IPC, a process control strategy will be established to help biotechnology companies to successfully pass process validation and enter commercialization stage; Establish and implement the CPV strategy to help continuously produce biological products that meet quality standards.