+ All Categories
Home > Documents > Biotechnology and Pharmaceutical -...

Biotechnology and Pharmaceutical -...

Date post: 17-Mar-2018
Category:
Upload: phungtuyen
View: 224 times
Download: 2 times
Share this document with a friend
36
Biotechnology and Pharmaceutical Bioprocess & Controlled Environments
Transcript

Biotechnology and PharmaceuticalBioprocess & Controlled Environments

Senior ManagementJoe GangiManaging Director Bioprocess & Controlled Environments, Australia and South East Asia

Darren GreenTechnical Director Bioprocess & Controlled Environments, Australia and South East Asia

Frederic JeunetGeneral Manager Bioprocess & Controlled Environments, Australia

Nenad FirezBusiness Development Manager, Bioprocess & Controlled Environments, Australia

Tel: +61 (0) 400 495 885 Email: [email protected]

ContentsCompany overview 1

Beyond Zero 2

Services 3

Project delivery 3

Engineering 5

Architecture 6

Environmentally sustainable design services 7

Procurement and construction management 7

Commissioning services 8

Qualification and validation 9

Client representative / peer reviews 10

Pharmaceutical capability 11

Relevant experience 13

Clients 13

Sterile Manufacturing Facility 14

QA/QC Testing Laboratories 15

Solid Dose Manufacturing Facility 16

Veterinary Medical Research Development Facility 17

Solid Dose Production Facility 18

Liquid Manufacturing Facility 19

Biopharmaceutical Sterile Formulation Facility 20

Other selected project history 21

AMEC international project history 30

Company overview

1 Biotechnology and Pharmaceutical

AMEC is a focused supplier of consultancy, engineering and project management services to its customers in the world’s oil and gas, minerals and metals, clean energy, environment and infrastructure markets. AMEC designs, delivers and maintains strategic and complex assets for its customers.

AMEC’s businesses employ over 29,000 people in more than 40 countries globally. AMEC shares are traded on the London Stock Exchange. The company has a strong reputation for operational excellence, and combining global excellence with local delivery.

In 2011, AMEC and Zektin Engineering combined strengths to improve delivery for our customers by offering combined expertise, wider global coverage and increased scale within the bioprocess and controlled environment sectors within Australia and South East Asia.

AMEC’s Bioprocess & Controlled Environments (BCE) business operates from Australia and China and services a wide variety of related industries:

 Bioprocess

• Biotechnology and pharmaceutical

• Laboratories and research facilities

• Food and beverage

• Biofuels

 Renewables

• Biomass / Bioenergy

• Solar

• Wind

  Industrial / Commercial

• Advanced manufacturing / Heavy industrial

• Waste treatment and emissions control

• Energy efficiency and optimisation

 Government Services / Defence.

AMEC’s global locations

AMEC’s BCE locations

AMEC’s BCE project locations

AMEC’s vision is to achieve sustainable, world class Health, Safety, Security and Environmental (HSSE) performance excellence throughout our global operations.

The AMEC Beyond Zero program aims to create an HSSE culture where strong leadership, personal responsibility and an unyielding commitment to excellence are cornerstones of how we conduct our business. We consistently take HSSE performance beyond the work place and out into the wider community.

Engagement at various levels within the organisation provides an opportunity to influence safety behaviour and create a culture of HSSE commitment greater than self-interest. AMEC has developed engagement tools to support this process, taking our HSSE performance ‘Beyond Zero’.

Beyond Zero

I believe real leadership can only be demonstrated by setting personal standards that capture the hearts and minds of our people, thereby encouraging the right attitudes and behaviours throughout the organisation.’’Neil Bruce, Chief Operating Officer AMEC Natural Resources

Biotechnology and Pharmaceutical 2

ServicesProject delivery

Ensuring the design solutions meet the project and compliance requirements.”

AMEC’s project delivery is based on a proven gate system that ensures the deliverables are appropriate to the relevant project phase.

This system is well aligned with our clients’ requirements for funding approvals and improves our clients’ risk management profile due to our experience with and understanding of all phases of asset life cycles. This knowledge enables our clients to achieve their business objectives by confidently making decisions that provide optimal solutions for profit and sustainability.

3 Biotechnology and Pharmaceutical

Biotechnology and Pharmaceutical 4

Engineering

AMEC offers a multi-disciplined engineering design team, which includes Mechanical, Chemical, Process, Electrical, Instrumentation and Automation Engineers, and associated drafting support.

Our engineers are skilled in providing design in compliance with a wide range of regulatory bodies and codes, relevant to our industries of specialisation.

The knowledge base gained from our widely varying range of speciality projects brings to our clients a source of design solutions that provide innovative and cost effective outcomes.

Our aim is to fully understand our clients’ scope, cost, time and quality requirements, and ensure that our assigned personnel have the experience and resources necessary to exceed our clients’ expectations. Our focus is to deliver

a fully co-ordinated, process driven design with strong emphasis on compliance and safety.

AMEC’s scope of services span the entire asset life cycle from Phase 1 (Feasibility Study) through to Phase 5 (Operation).

We utilise best industry practices in all areas of our business, providing the following service range to our clients:

 Project management (incl. capital cost estimation, cost control and planning)

  Site infrastructure development strategies and planning

 Building services

  Feasibility and conceptual studies

  Schematic design

Phase 1

Feasibility study

� User brief � Concept options � Feasibility analysis

� Modelling � Execution strategy

� Value assessment.

Phase 2

Concept design

� Validation master plan

� User requirements specification

� Concept design documentation

� Design criteria � Site selection � Cost planning � HAZOP 1.

Phase 3

Schematic Design

� Functional specification

� Schematic design documentation

� Design basis � Planning documentation

� Cost estimating � HAZOP 2 � Risk assessments / safety reviews.

Phase 4

Detailed design / tender / execution

� Design specification � Design qualification � Detailed design documentation

� Authorities approval � Cost estimating � HAZOP 3 � Risk assessments / safety reviews

� Tender evaluation / review � Construction supervision / assistance

� FAT / SAT � Commissioning � Installation qualification / operational qualification / performance qualification.

Phase 5

Operations

� Operational assistance

� Process optimisation

� SOP’s � O&M manuals � Value assessment.

Engineering delivery model

5 Biotechnology and Pharmaceutical

 Process design / production modelling

 Project risk analysis

 HAZOP Studies, SIL reviews & safety management studies

 Plant layout

 Detailed design (2D or 3D modelling)

  EPCM services.

Architecture

AMEC is committed to delivering truly exceptional professional design services which are tailored to the specifics of our clients and their projects.

We deliver successful projects through extensive client collaboration from inception to occupation, co-ordinated multi-disciplined integrated design teams, and the implementation of comprehensive consultancy processes.

Phase 1

Predesign

� Brief preparation � Feasibility studies

� Site analysis � Space analysis � Functional relationship diagrams

� Flow diagrams � Block planning � Masterplan.

Phase 2

Schematic design

� Site layout � Schematic design

� Site development options

� Data sheets.

Phase 3

Detailed Design

� Detailed design � Town planning application

� Outline schedules of materials finishes, colours & fixtures

� 3D modelling � 3D animations.

Phase 4

Contract documentation / tender / contract

administration

� Working drawings � Specification � Schedule of materials / finishes / colours

� Building permit application

� Tender process & negotiations

� Contract administration.

Phase 5

Post contract

� Defects liability period

� As-built documentation

� Post occupancy evaluation.

Architectural delivery model

AMEC’s architectural design professionals approach projects with careful analysis, creative and technical skill, innovation, and proven design experience, ensuring project information is continually shared, coordinated and updated across our multi-disciplined teams.

Services include the following:

�Design management, Design co-ordination

�Strategic facility planning, Master planning

�Feasibility studies, Brief formulation

�Schematic design

�Developed design

�Contract documentation

�Contract administration

�Post contract services

�Post occupancy evaluation

�3D animation

�Interior design.

Biotechnology and Pharmaceutical 6

Environmentally sustainable design services

Procurement and construction management

AMEC offers a multi-disciplined and integrated approach to achieving ESD principles and Green Star Ratings to projects.

Sustainability is the base principle in our approach to delivery of projects. With our accredited GBCA Green Star Professionals, which include our Architectural, Process, Mechanical and Electrical disciplines, we deliver successful Green Star projects through extensive design team and client collaboration.

AMEC utilises best sustainable design practices in all areas of our business, providing the following service range to our clients:

�Life cycle cost analysis

�Energy efficient HVAC and building services systems using innovative design solutions

�Ecologically sustainable architectural design

�Water recycling and reuse solutions

�Integration of renewable energy solutions

�Waste treatment and waste products reuse

�Emissions control, Heat recovery systems.

AMEC offers the following procurement and construction management services:

Procurement management

�Identification and approval of suitable contractors

�Development of tender packages and contract conditions

�Assessment and analysis of tender submissions

�Recommendation of tender offers

�Preparation of orders

�Expediting

�Assessment and approval of vendor data

�Inspections

�FAT / SAT.

These tasks can be carried out using AMEC’s proven systems or tailored to our clients’ preferred or existing systems:

Construction management

Construction management can be executed on behalf of our clients, or individual discipline support can also be provided where appropriate and can be in conjunction with client representatives or other service providers.

�Assistance during construction

�Site supervision

�Site management

�Contract management.

7 Biotechnology and Pharmaceutical

Commissioning services

AMEC is widely experienced in the start up and commissioning of complex technical facilities and process systems.

Our inherent understanding of the way things work brings a thorough approach to commissioning, with the use of job specific methods and procedures, delivering safe and incident free start-up. This provides a high degree of confidence for plant operation and validation in regulatory controlled project environments.

Our commissioning services experience includes:

�Preparation of inspection and test plans

�Preparation of commissioning plans

�Preparation of commissioning procedures

�Commissioning management and direct supervision

�Plant start up and performance testing

�Commissioning documentation compilation

�Compliance documentation.

Biotechnology and Pharmaceutical 8

9 Biotechnology and Pharmaceutical

Qualification and validation

AMEC is widely experienced in the qualification and validation of GMP facilities, services and process systems.

Our experience and understanding of the various pharmaceutical regulatory requirements for compliance, allows us to use job specific methods and procedures as well as client templates, where applicable. This approach provides a high degree of confidence that the specific regulatory requirements of a project will be met, and that regulatory approval will be simplified.

Verification or “documentary evidence” of the project’s critical aspects is of prime importance in projects for controlled regulatory environments such as OGTR, AQIS, NATA, SSBA, chemical weapons, HAZCHEM, EPA and TGA.

All compliance documentation is produced under a Project Validation Plan and formatted in a manner that gives forward and backward traceability of critical aspects, in addition to defining specific roles and responsibilities throughout the project stages.

Our core qualification competencies include:

�Preparation of User Requirement Specifications (URS)

�Preparation of Functional Specifications (FS)

�Preparation of Design Specifications (DS)

�Preparation and execution of Design Qualification (DQ) protocols

�Preparation and execution of Installation Qualification (IQ) protocols

�Preparation and execution of Operational Qualification (OQ) protocols

�Qualification management and direct supervision.

Our core validation competencies include:

�Preparation of Project Validation Plans

�Preparation of responsibility matrices

�Preparation of validation protocols

�Protocol execution

�Gap analysis

�Validation management

�Validation risk assessment.

User Requirements

Performance Qualification

Operational Qualification

Functional Requirements

Design Requirements

Installation Qualification

The pharmaceutical industry validation ‘V’ model

Client representative / peer reviews

AMEC has performed the role of peer reviewer or client representative on many projects. We understand the client needs and have a thorough approach in ensuring that client requirements are met in all aspects of the project, from safety to quality, compliance, budget, time and operability.

Our services at various project stages include:

�Representing the client during design, tender, construction and commissioning stages

�Performing design reviews/peer review

�Liaison with all stakeholders and development of user requirements

�Facilitating user brief meetings

�Chair compliance and regulatory committee meetings

�Project risk identification / assessments

�Performing / chairing / facilitating HAZOP studies and safety reviews

�Attending design meetings, review design team progress and schedule

�Assistance with contractor selection and tendering process

�Attending site to inspect and comment on construction works, samples and prototypes

�Performing independent site inspections and prepare defects list at critical milestones

�Reviewing builder’s construction documentation including as-built O&M manuals and commissioning documentation

�Reviewing builder’s quality plan for compliance requirements

�Assisting client in answering construction queries

�Witnessing critical commissioning tests for critical services.

Biotechnology and Pharmaceutical 10

AMEC is an AQIS accredited Third Party Assessor for Quarantine Approved Premisses for PC2/QC2 to PC4/QC4 Containment facilities.”

11 Biotechnology and Pharmaceutical

Pharmaceutical capabilityAMEC has designed and validated facilities for compliance with the code of Good Manufacturing Practice (cGMP) in Australia, USA, China, European Union, South Korea, UAE, Saudi Arabia, Singapore, Malaysia, Thailand and New Zealand. Our project and design documentation is tailored to suit the relevant industry and regulatory requirements, ensuring compliance is maintained at all times.

AMEC’s core competencies in the process, process services, architectural and building design of GMP facility include:

�Solid dose, liquids and creams

�Sterile processing

�Blood plasma and serum processing

�Mammalian and microbial cell culture

�Fermentation

�Cytotoxic / steroids

�Containment facilities (BSL1 to BSL4)

�Medical device

�Clinical trial / pilot plant

�Biosecurity / Biocontainment

�Animal Facilities (QC/BSL-Rated and SPF)

�Laboratories (R&D, QA, QC)

�Biological containment laboratories (microbiology, animals, plants and invertebrates) (PC1 [BSL1] To PC4 [BSL4]) (AQIS & OGTR certified)

�Warehousing, sampling, dispensing

�API manufacturing

�Primary and secondary packaging.

Some of our specific design and compliance certification expertise include:

�Architectural and building services (HVAC, electrical, instrumentation & controls, hydraulics)

�Facility gases (argon, helium, hydrogen, ethylene oxide, carbon dioxide, oxygen, breathing air, compressed air, acetylene, silane)

�Facility water (filtered water, purified water, water for injection)

�Waste treatment (biological liquid waste, chemical waste, toxic waste)

�Process vacuum

�Chemicals and solvents handling and reticulation

�Hazardous and flammable goods handling and storage

�Cryogenic systems

�Stringent environmental conditions control (temperature, humidity, pressure, particles)

�Ventilation and fume extraction

�Dust, vapour and emissions control, odour control, scrubbers

�Fumigation systems

�Explosion proof facilities

�Specialist utilities (pure steam, glycol chilled water, UPS).

Our expertise and services are available for all stages of your project; from concept development through to operational support.’’

Relevant experienceClients

�Acrux

�Akruti (India)

�Alpharma Animal Health

�Australian Defence Science and Technology Organisation (DSTO)

�Australian Department of Industry, Tourism and Resources (DITR)

�Australian Nuclear Science & Technology Organisation (ANSTO)

�Australian Red Cross Blood Services

�Australian Therapeutic Proteins

�AVT (Shenzen, China)

�Biological Therapies

�Bioniche

�BioPharmaceuticals Australia (QLD Government)

�Biota

�Bristol-Myers Squibb Australia

�BTI A*Star (Singapore)

�Buildcorp

�Central Pharmacy QLD

�Cochlear

�Cockram Constructions

�Commonwealth Scientific & Industrial Research

�CSL Ltd

�Fresenius Medical Care (Changshu, China)

�GSK

�Hamilton Laboratories

�Hanseo Pharmaceuticals (Seoul, Korea)

�Herron Pharmaceuticals

�Hydration Pharmaceuticals

�IVF Australia

�Johnstaff Projects

�JRH Biosciences

�Juizhou Pharmaceuticals (Taizhou, China)

�KMUTT (Bangkok, Thailand)

�Kukje Pharmaceuticals (Seoul, Korea)

�Ludwig Institute for Cancer Research

�Melbourne Health

�Merck Sharpe and Dohme

�Murdoch Childrens Research Institute

�New Products Development

�Orica

�Pfizer Animal Health

�Pharmaxis

�Port Moresby Hospital

�Probiotec

�QED Asia

�Quantum Pharmaceuticals

�RMIT University, Victoria

�SAFC

�Saudi Arabian Blood Plasma Group (Riyadh, Saudi Arabia)

�Selborne Biological Services

�Sigma Pharmaceuticals

�Sypharma

�Victorian Department of Primary Industries (DPI)

�Victorian Infectious Diseases Research Laboratories

�Virax

�Virbac

�Walter and Eliza Hall Institute

�William Cook Australia (QLD)

�Watpac

13 Biotechnology and Pharmaceutical

Sterile Manufacturing Facility | Biological Therapies

Phase 1

Feasibility study

Phase 2

Concept design

Phase 3

Schematic Design

Phase 4

Detailed design / tender / execution

Phase 5

Operations

Phases executed by AMEC

Biological Therapies required a modern sterile manufacturing facility for the manufacture, filling and packaging of liquid product into bags and vials.

The new facility is located adjacent existing operations and supplies the local market with injectable vitamins. The key objectives which the facility had to deliver were, compliance with TGA and GMP requirements, increased capacity and operator safety, automation of production, exacting, high tech and innovative, design within compact footprint.

Key Functional Areas

�Sterile Filling Suites with Filling Machine, PTP, PTC, LFWS (Grade A/B)

�Manufacturing (Grade C)

�Preparation with Pass Through Oven, LAF, PTP & future Autoclave (Grade C)

�Materials Air Lock MAL (Grade D/C)

�Personnel Air Locks PAL (Grade B/C/D)

�Dispensary / Sampling with BSC (Grade C)

�Store Room (Grade D)

�Goods Lock Viewing Corridor

�Plant Room - interstitial trafficable space

�Labelling & Office.

AMEC Services

�Project Management

�Design Management

�Architectural Design

�Process Engineering Design

�Mechanical Engineering Design

�Electrical & Data Engineering Design

�Instrumentation Engineering Design.

�Automation Engineering Design

�Building Management Engineering Design

�Hydraulic Engineering Design

�Commissioning

�Qualification Documentation.

Project Outcomes

Quality GMP manufacturing facility of the highest standard. Efficient use of small footprint to achieve optimal materials and personnel flows. Maximum visual communication via internal glazing. Complete proprietary Dagard cleanroom panel system utilized to achieve GMP construction detailing. EMS for HVAC (terminal hepa filtration) continuously monitoring air pressure, supply air, LAFs and facility alarming / indicators. Door interlocking, gases and services. TGA cGMP licensing requirements met. Increased GMP manufacturing capability and product development, improved customer service and cost competitiveness.

Biotechnology and Pharmaceutical 14

QA/QC Testing Laboratories | CSL Ltd

Phase 1

Feasibility study

Phase 2

Concept design

Phase 3

Schematic Design

Phase 4

Detailed design / tender / execution

Phases executed by AMEC

CSL required a modern and consolidated QA/QC testing laboratory facility where samples from various expanding R&D and manufacturing departments could be submitted and tested. The laboratory facility performs testing on finished products, in-process / stability / R&D / validation samples, raw materials, reagents, media and chemicals in the areas of sterility, virology, bacteriology, environmental monitoring, immunochemistry and chemistry. The key objectives which the facility had to deliver were, compliance with TGA, FDA and cGLP, refurbishment and upgrade of existing building, improved sample, material and equipment flows, and increased testing capacity.

Key Functional Areas

�Chemistry Labs

�Immunology Labs

�Bacteriology Labs

�Virology Labs

�Sterility Labs

�Samples Receipt

�Personnel Airlocks (PAL)

�Lab Support / Prep Rooms

�Freezer, Cold & Warm Room

�Dangerous Goods Stores (fire rated)

�Offices, Meeting Rooms & Canteen.

AMEC Services

�Project Management

�Design Management

�Process Engineering Design

�Mechanical Engineering Design

�Electrical & Data Engineering Design

�Fire Service Engineering Design

�Hydraulic Engineering Design.

Project Outcomes

FDA registration for the labs, equipment and testing processes obtained. High grade labs of increased capacity, efficient use of space and improved flow of samples, materials and equipment. Labs contain new and reused lab equipment, isolators, BSCs, LIMS / BPCS points, autoclaves, purpose built lab joinery, safety eye wash / showers and lab services such as natural gas, nitrous oxide, acetylene, nitrogen, argon, helium, hydrogen, carbon dioxide, DI water, PFW, vacuum and compressed air. Improved air quality within labs using filtered HVAC system and provision of segregation of testing operations to prevent sample contamination and protect operators. Facility security access for personnel and samples in accordance with GLP and FDA guidelines.

15 Biotechnology and Pharmaceutical

Biotechnology and Pharmaceutical 16

Solid Dose Manufacturing Facility | Hanseo Pharm

Phases executed by AMEC

Hanseo Pharm required a new solid dose manufacturing facility for the production and packaging of pharmaceuticals. The new facility enables the implementation of Hanseo’s five year plan to increase production capacity to 1,065 batches per year (100 to 300 kg sizes), 569,400,000 tablets and 223,100,000 capsules. The key objectives which the facility had to deliver were, compliance with latest KFDA, FDA, EU regulations, state of the art GMP design for solid dose manufacturing, accommodation of all personnel in one location and provision for future expansion.

Key Functional Areas

�Manufacturing (ISO 8 clean room)

�Dispensaries and sampling (ISO 8 clean room)

�Packaging (ISO 9 clean room) Warehouse

�Micro and Chemical Wet Labs

�Animal Lab (PC2)

�Office and staff amenities

�Plant and Engineering area – interstitial space

�Cafe and outdoor terrace

�Dangerous goods store

�External car parking and tennis court.

AMEC Services

�Project Management

�Design Management

�Architectural Concept Design

�Process Engineering Concept Design

�Mechanical Engineering Concept Design

�Electrical and Data Engineering Concept Design.

Project Outcomes

Efficient and greatly improved material and personnel flows, increased flexibility and productivity. Introduction of technologies to reduce dust generation and improve product quality and operator safety. Innovative engineering principles for process and building services to improve reliability and energy efficiency. Process modelling of the production capacity and budget costing with an implementation strategy for Hanseo to meet its five year plan. Unique, yet functional facility design with expansion options to allow future growth.

Phase 1

Feasibility study

Phase 2

Concept design

Veterinary Medical Research Development Facility | Pfizer

Phases executed by AMEC

Pfizer required a pilot scale manufacturing facility for the development and GLP validation of biological manufacturing technology. The new facility will support their veterinary vaccine manufacturing in Australia and New Zealand by testing and developing manufacturing processes, processing, and formulation of bacterial (1:10 scale) and viral (1:3 scale) vaccines. The key objectives which the facility had to deliver were, multiple product and process testing and development, compliance with HSE regulations, GLP, OGTR and AQIS compliance, refurbishment and upgrade of existing building and exacting engineering design.

Key Functional Areas

�Bacterial Laboratory (PC2)

�Cell Culture Laboratory with LAF (PC2)

�Formulation and filling with LAF (PC2)

�Equipment wash and preparation with Autoclave and FC (C2), Viewing Corridor and Air Locks

�Cold, cool and warm rooms, Administration office and Plant.

AMEC Services

�Project Management

�Design Management

�Process Engineering Design

�Mechanical Engineering Design

�Electrical & Data Engineering Design

�Instrumentation Engineering Design

�Automation Engineering Design

�Building Management Engineering Design

�Fire Service Engineering Design

�Hydraulic Engineering Design.

Project Outcomes

Successful refurbishment through integrated, innovative and high tech architectural and engineering design. GLP construction detailing, optimal materials and personnel flows, maximum visual communication via internal glazing. BMS and EMS for process, HVAC with remote notification, terminal hepa filtration, online particle monitoring, alarmed door interlocking, lab gases and services, waste decontamination and formaldehyde gas fumigation. Increased manufacturing expertise and product development, improved product, customer service and cost competitiveness.

Phase 1

Feasibility study

Phase 2

Concept design

Phase 3

Schematic Design

Phase 4

Detailed design / tender / execution

Phase 5

Operations

17 Biotechnology and Pharmaceutical

Solid Dose Production Facility | Pharmaxis

Phase 1

Feasibility study

Phase 2

Concept design

Phase 3

Schematic Design

Phases executed by AMEC

Pharmaxis required a new manufacturing facility for the manufacturing and packing of solid dose products. The new facility allows the dispensing and preparation of solutions for spray drying, blending, encapsulation and final packaging of capsules to the local and international markets. The key objectives which the facility had to deliver were compliance with TGA and FDA requirements, optimum environmental conditions and water quality to ensure product quality, and reliable state of the art design solutions.

Key Functional Areas

�Manufacturing Rooms (Spray Drier, Blending, Solution Prep, Encapsulation) (ISO 7)

�Primary Packaging (ISO 7)

�Secondary Packaging Dispensary (ISO 7)

�Washbay/Clean Equipment Store (ISO 7)

�Goods & Raw Materials Storage

�Warehouse & Store Plant & Maintenance – interstitial trafficable space

�Materials & Personnel Airlocks (ISO 7)

�Staff Change & Amenitiest.

AMEC Services

�Process Engineering Design

�Mechanical Engineering Design.

Project Outcomes

Quality GMP manufacturing facility of the highest standard with an increase in production capabilities. An efficient and robust HVAC system that maintains a clean environment (ISO 7) and stringent operating conditions (temperature and humidity control). State of the art automated WFI system. Innovative, high tech engineering design with flexibility for future expansion.

Biotechnology and Pharmaceutical 18

Liquid Manufacturing Facility | Sigma Pharmaceuticals

Phases executed by AMEC

Phase 1

Feasibility study

Phase 2

Concept design

Phase 3

Schematic Design

Sigma Pharmaceuticals (now Aspen) required a new liquids manufacturing facility for the manufacture, filling and packaging of liquids and creams. The new facility supplies local and international markets with pharmaceutical liquid products such as, cough and cold mixtures, nasal decongestants, topical creams and ointments, highly potent liquids and creams. The key objectives which the facility had to deliver were, operator safety, consolidation of manufacturing on one site, increased production capacity, compliance with GMP requirements of Australia, Europe and Asia, connection to existing solid dose manufacturing facility, high tech and exacting engineering.

Key Functional Areas

�Liquids, Cream and Ointment Suites (ISO 8)

�Potent Products Suite (ISO 8 containment area)

�Filling and Packaging (ISO 8)

�Materials Airlocks MAL (ISO 8)

�Personnel Airlocks PAL (ISO 8)

�Personnel Change (ISO 8)

�Staff Canteen and Amenities

�Packaging Warehouse

�Utility / Plant Rooms (AHU, waste, boiler, backup generator, substation, chillers, air compressors)

�Plant Room – interstitial trafficable space.

AMEC Services

�Design Management

�Process Engineering Design

�Mechanical Engineering Design

�Electrical & Data Engineering Design

�Instrumentation Engineering Design

�Automation Engineering Design

�Building Management Engineering Design

�Hydraulic Engineering Design

�Commissioning

�Qualification Documentation & Execution

�Validation.

Project Outcomes

Premier liquids and creams facility in Australia. Raw materials, solid dose and liquid manufacturing consolidated on single site. GMP construction detailing, optimal materials and personnel flows, maximum visual communication via internal glazing. BMS, EMS and EBR with remote notification (for process, HVAC and doors), terminal hepa filtration, door interlocking, RO water generation, waste decontamination and heat recovery systems. Integration of electronic batch records with manufacturing processes resulting in paperless manufacturing. Increased operator safety, GMP manufacturing capability / expertise, increased production, improved customer service and cost competitiveness..

19 Biotechnology and Pharmaceutical

Biopharmaceutical Sterile Formulation Facility | CSL and Swinburne University of Technology

Phases executed by AMEC

CSL in collaboration with Swinburne University of Technology (SUT) required a state of the art biopharmaceutical formulation facility. The new facility is used for training of SUT students enrolled in the Good Manufacturing Practice (GMP) course at SUT and for formulation and finishing of liquid pharmaceuticals to be used in human clinical studies. The key objectives which the facility had to deliver were, compliance with GMP requirements of Australia, Europe and the US, connecting to existing Clinical Manufacturing Facility, exacting engineering design and high tech, innovative, yet contextual design.

Key Functional Areas

�Sterile Formulation Suites with PTP, PTC,CFWS & LFWS (Grade A/B)

�Preparation (Grade C)

�Materials Air Locks MAL (Grade B/C)

�Personnel Air Locks PAL (Grade B/C)

�Wash Room (Grade C)

�Cold Room (Grade C)

�Store Room (Grade C)

�Goods Lock (Grade C/D)

�Viewing Corridor (Grade D)

�Autoclave

�Plant Room - interstitial trafficable space

AMEC Services

�Project Management

�Design Management

�Process Engineering Design

�Mechanical Engineering Design

�Electrical & Data Engineering Design

�Instrumentation Engineering Design

�Automation Engineering Design

�Building Management Engineering Design

�Fire Service Engineering Design

�Hydraulic Engineering Design

Project Outcomes

Quality GMP teaching and manufacturing facility of the highest standard. GMP construction detailing, optimal materials and personnel flows, maximum visual communication via internal glazing. BMS and EMS with remote notification (for process, HVAC and doors), terminal hepa filtration, online particle monitoring, door interlocking, lab gases and services, waste decontamination and heat recovery systems. Increased GMP manufacturing expertise, and product development, improved customer service and cost competitiveness. Reinforcement and revitalisation of R&D precinct through innovative, high tech architectural and engineering design. Premier facility on CSL Parkville campus used extensively for marketing purposes.

Phase 1

Feasibility study

Phase 2

Concept design

Phase 3

Schematic Design

Phase 4

Detailed design / tender / execution

Biotechnology and Pharmaceutical 20

Other selected project history

Client Description of services

BPA, Queensland As Lead Consultant, AMEC is currently engaged to carry out the full process, architectural, building services and clean utilities design of a new BSL2 large-scale mammalian cell culture facility. Clean utilities requirements included water for injection (WFI), clean steam, gases and CIP etc, whilst our role in equipment selection centred around state of the art “single use” technology fermentation reactors (2000L), autoclaves, equipment washers and down stream processing equipment. The 6 storey facility includes BSL2 cleanrooms (ISO5 to ISO8), media and buffer preparation areas, QC laboratories, offices and support spaces. In addition we are engaged to provide contract administration assistance during tender, procurement, construction and commissioning.

CSL Ltd, Victoria AMEC recently completed the mechanical services detailed design for a new PC2 Mammalian Cell Culture manufacturing facility (ISO8 and ISO7 rooms), including laboratories, cold storage, site infrastructure and support services. (Project Value AUD$50M).

Australian Red Cross Blood Service, New South Wales

AMEC was engaged as the lead designer for the ARCBS processing cleanroom facility and testing laboratories in Sydney, NSW. AMEC is responsible for the multidiscipline design of the process and services for the new PC2 facility. AMEC was also engaged as validation coordinator responsible for the overall qualification documentation and execution. (Project Value AUD$70M).

Sigma Pharmaceuticals (now Aspen) Australia,Victoria

AMEC completed the design, supervision of construction and commissioning for mechanical, electrical and process disciplines for the new large liquids facility (11,000m2) built on the Dandenong, Victoria site. The project included 3000L, 5000L and 10,000L manufacturing tanks for cough and cold mixtures, nasal decongestants, topical creams & ointments and highly potent liquids and creams. (Project value AUD $55M).

Bristol Myers Squibb,Victoria

AMEC completed the full Design, Project Management, Procurement, Construction and Validation of a new Steroid Manufacturing suite for the Noble Park solid dose facility. The facility was a full containment facility to ISO 7 cleanroom standards and comprised high containment technology and security measures with personnel exposure limits of as low as 0.1 microgram/cubic meter. Services included architecture, mechanical, electrical and process design. AMEC was also engaged to prepare all facility validation documentation, execute qualification protocols and prepare manufacturing SOP’s. (Project Value AUD$6M).

Cochlear, New South Wales

AMEC was engaged as architectural and engineering lead designer for the ISO7 ear implants cleanroom manufacturing, including support during construction and commissioning.

Biota, Victoria AMEC was engaged to provide architectural, mechanical and electrical concept layouts and process design for a new powder inhalant facility, including filling machine specification, development of project schedule and equipment schedules, providing technical support for equipment procurement and validation documentation and execution support.

Glaxo Smith Kline, Victoria AMEC was engaged to provide architectural, mechanical, electrical, hydraulics and fire protection detailed design for the Block 7 Research & Development Blow Fill Seal pilot scale FDA approved facility. Project includes a new Weiler Blow Fill Seal machine, mixing and filling suites and all associated support areas. AMEC is also currently involved in construction assistance.

21 Biotechnology and Pharmaceutical

Client Description of services

Intervet / MSD, Victoria AMEC was engaged to provide a site masterplan for the existing animal health facility. In addition AMEC provided a concept and schematic design for the new seed storage and cell bank area (Grade D).

Virbac, New South Wales AMEC were engaged to provide detailed process, building services and architectural design for the inactivation tank and centrifuge projects both of which were instigated to remove current process bottlenecks in the biological vaccines plant.

Glaxo Smith Kline, Victoria AMEC was engaged to provide architectural, mechanical and electrical detailed design for the Ventolin Multi Dose Inhalant (MDI) line relocation, such that the expansion works in block 2 could commence. AMEC was also engaged to provide a concept design for the Block 2 Ventolin new blow fill seal expansion line, including concept layouts, project scheduling, costing and existing services site survey.

GSK - Port Fairy, Victoria AMEC were selected by GSK Port Fairy to provide ongoing engineering support for the Opiates API facility. The role will see AMEC work through multiple projects to improve the safety and capacity of the facility, including safety upgrades required for the bulk solvent tank farm.

Cochlear, Queensland AMEC was engaged to perform a feasibility study for the upgrade of Cochlear current ear implants cleanroom manufacturing from ISO7 to ISO6.

KMUTT, Thailand AMEC was engaged to provide a full conceptual design for a new PC2 Microbial Cell Culture facility. It included manufacturing process design and process modelling, architectural and services engineering design. (Project Value Undisclosed).

CSL Ltd, Victoria AMEC recently completed the architectural and engineering concept design for a new buffer and chromatography plant aimed to support capacity expansion for CSL Bioplasma’s plasma fractionation. (Project Value Undisclosed).

23 Biotechnology and Pharmaceutical

Client Description of services

Pasteur Institute,Vietnam

AMEC was engaged to complete schematic design for a BSL-3 Laboratories Building to Australian, Canadian, United States and WHO guidelines and standards. The facility acts as Vietnam’s major infectious diseases diagnostic and research centre for the emergence of new diseases such as SARS, H5N1, etc. (Project Value AUD$3M).

JiuzhouPharmaceuticals, China

AMEC was engaged, together with its partner QED Asia, to provide a Concept Design andprocess development for a new antibiotic API facility. (Project Value Undisclosed).

Hanseo Pharma, SouthKorea

AMEC was engaged, together with its partner SeerPharma, to provide a Concept Design and Masterplan for a greenfield multi product solid dose manufacturing facility to meet Korean and US FDA requirements. (Project Value Undisclosed).

Victorian InfectiousDiseases ReferenceLaboratory (VIDRL),Victoria

AMEC is currently engaged as Peer Reviewers and specialist advisors for the construction and regulatory compliance of the new WHO Flu research facility which consists of Gas Fumigable PC2 and PC3 containment Labs and supporting PC2 and PCR facilities. In addition AMEC were engaged as designers for the HIV PC3 laboratory upgrade and recently completed the design and project management of an upgrade to the National High Security PC4 laboratories Liquid waste treatment system. (Project Value Undisclosed).

Pharmaxis, New South Wales

AMEC completed the mechanical and process services engineering design for the new TGA compliant solid dose facility as part of the Hooker Cockram Projects design and construct team. (Project Value Undisclosed).

Fresenius Medical Care, Changshu, China

AMEC was engaged to provide master planning advice, building services & process engineering design for this large scale Dialysis products manufacturing facility. The project consisted of Pilot Scale Liquids Manufacturing of Large Volume Sterile and Non Sterile Liquids, Bloodline and Dialysis Cartridge production facilities and supporting Laboratories. (Project Value Estimated USD$120M).

Gujurat Akruti TCGBiotechnology, Vadadora, India

AMEC completed the Specialist Labs component (Architecture & Engineering) of a schematic design for Multi Tenanted Wet Labs in conjunction with HBO + EMTB Architects as part of a development plan for a technology precinct in a major Technology Park. (Project Value Undisclosed).

Biota, Victoria AMEC completed the detailed architecture for the new Laboratory Complex as part of the Wilkore design and construct team. (Project Value Undisclosed).

Biological Therapies,Victoria

AMEC completed the full facility and services design and assistance during the construction and commissioning of a new Sterile vitamin production facility to TGA compliance. The facility consists of Grade D, C and B Cleanrooms with Grade A laminar flow protection of the filling equipment. (Project Value AUD$2M).

Bristol-Myers Squibb,Victoria

AMEC was engaged to review the various existing dust extraction systems in the facility and prepare a gap analysis report recommending required upgrades to minimise production losses, improve operator safety and ensure compliance to regulatory bodies. We were subsequently engaged to perform the detailed design. (Project Value AUD $1M).

Client Description of services

Bristol-Myers Squibb,Victoria

AMEC was engaged to perform a feasibility study for the upgrade of the existing solid dose facility (change rooms, manufacturing and packing), improving flows and segregation. (Project Value Undisclosed).

Protherics Australasia,Adelaide, South Australia

AMEC was responsible for the design of an ISO7 cleanroom for a Rattlesnake Antivenom Facility Upgrade (Project Value AUD$2M). AMEC also performed procurement, construction and commissioning management.

CSL Ltd, Victoria AMEC completed the architectural, HVAC and electrical detailed design for the refurbishment of the Flu vaccine sterile filling and packing facility. The facility consisted of various Grade D, C and B Cleanrooms. The upgrade included an overall review of the controls and automation to meet FDA standards. (Project Value Undisclosed).

Australian CustomPharmaceuticals, New South Wales

AMEC completed a Masterplan and Concept Design for a large scale Compounding Pharmacy. (Project Value Undisclosed).

Kukje Pharma, SouthKorea

AMEC was engaged, together with its partner SeerPharma, to provide a Concept Design and Masterplan for a greenfield multi product cephalosporin sterile manufacturing facility to meet Korean and US FDA requirements. (Project Value AUD$25M)

BTI A Star, Singapore AMEC completed concept design for a GMP and GTP adult progenitor stem cell processing facility. The scope involved complete facility design including mechanical, electrical, architectural and process. (Project Value Undisclosed).

Selborne BiologicalServices, Tasmania

AMEC completed the concept design for a new Hyperimmune facility for the manufacture of antitoxin and filtered serum. The facility was a greenfields plant with ISO 7 and ISO 8 areas. (Project Value AUD$17M).

25 Biotechnology and Pharmaceutical

Client Description of services

Sigma Pharmaceuticals (now Aspen),Victoria

AMEC completed the design and supervision of construction and commissioning for mechanical, electrical and process disciplines for a new raw materials facility (10,000m2) being built on the Dandenong, Victoria site. The raw materials facility consisted of receipt, sampling, hazardous goods storage, high bay storage, dispensing and powder debagging areas. The key objectives which the facility had to deliver were; operator safety, consolidation of manufacturing on one site, increased production capacity, compliance with GMP requirements of Australia, Europe and Asia, connection to existing solid dose manufacturing facility, high tech and exacting engineering. (Project Value AUD $10M).

Sigma Pharmaceuticals (now Aspen),Victoria

AMEC completed the design and supervision of construction and commissioning for mechanical, electrical and process disciplines for various upgrades of the existing solid dose manufacturing facility including: new 3,000L cone blender, 2 tonne IBC technology, new washbay and equipment drying areas, new packing lines, new finished products warehouse. The project also included the feasibility study for the upgrade of the coating and granulation facilities. (Project Value AUD $7M).

Intec Corporation,Victoria

AMEC completed a preliminary design (all disciplines) for a new veterinary sterile products facility and oral drench facility. The plant was located within an existing warehouse hardstand and comprised sterile filling and manufacturing as well as ISO 8 drench manufacturing areas. (Project Value AUD$8M).

HydrationPharmaceuticals,Victoria

AMEC completed the design and commissioning review for a new TGA compliant liquids production facility for the Hydralyte product range. The facility included Raw Materials Storage, Dispensary, Blending room, two Filling suites, a Packaging suite and Finished Goods warehouse.(Project Value Undisclosed).

CSL R & D, Victoria AMEC completed the design of the New Clinical Formulation Facility for CSL at Parkville, Victoria. The project included an additional wing added to the Clinical Manufacturing Facility to provide two new Sterile Formulation suites each classified Grade A/B in accordance with Annex 1 of the cGMP. In addition new support areas of Grade C classification are included for preparation, washing, drying and cool room storage. The facility also includes a new Autoclave for sterilisation of components. (Project Value AUD$5M).

Acrux DDS, Victoria AMEC completed the design, project management and qualification of a new GMP Phase II / III clinical trial facility for Acrux in Melbourne. The facility consists of an ISO 8 cleanroom (upgradable to ISO 7) and support areas. The cleanroom was designed to manufacture flammable and high potency materials and is an addition to the existing Acrux laboratories. (Project Value AUD$200K).

Advent Pharmaceuticals,Victoria

AMEC completed the development of qualification documentation for the new Advent medical device facility in Melbourne. (Project Value Undisclosed).

Cook Australia, Queensland

AMEC was engaged as preliminary designers for a new greenfield medical device facility for William Cook Australia in Brisbane, QLD. The scope included full architectural, mechanical and electrical design. The facility manufactures human heart stents and grafts under GMP conditions. (Project Value AUD$20M)

Biotechnology and Pharmaceutical 26

Client Description of services

Milpharma, New South Wales

AMEC was engaged as mechanical and electrical building services designers for the refit of an old manufacturing facility. The facility was designed to be capable of GMP manufacture of Liquids, Creams, Ointments, Solid Dose, Effervescents and Flammable Liquids. (Project Value Confidential).

Selborne BiologicalServices, Tasmania

AMEC completed the concept design for a new Lipoprotein facility for Selborne Biological Services in Launceston. The facility comprised ISO 7 and 8 areas and is a Greenfield project. (Project Value AUD$14M).

Herron Pharmaceutical, Queensland

AMEC was engaged to provide a feasibility study and concept design for the retrofit and upgrade of the existing solid dose facility (including QA/QC laboratories) to meet latest TGA requirements. (Project Value Confidential).

Herron Pharmaceutical, Queensland

AMEC was engaged for the concept design of a new solid dose manufacturing suite for glucosamine product, including 1 tonne IBC technology, new sampling, powder debagging, dispensing, IBC handling, coating and capsules area. Services included architecture, mechanical, electrical, process modelling, process equipment selection and process services design. (Project Value Undisclosed).

GlaxoSmithKline,Victoria

AMEC acted as project managers and HVAC designers for the Relenza Line 1 antiviral plant installation. (Project Value Undisclosed).

GlaxoSmithKline,Victoria

AMEC was engaged as project manager for the Relenza Line 2 antiviral plant installation. (Project Value Undisclosed).

Ludwig Institute forCancer Research,Victoria

AMEC completed the design, project management and qualification of an upgrade to the phase II clinical biological processing facility at the Austin Hospital for the LICR. The upgrade brought this sterile manufacturing facility up to the cGMP Grade A, B & C requirements and also converted the facility from a campaign only capability to ‘contained concurrent use’ capability to allow increased throughput. New bioprocessing technologies were also introduced to increase throughput. (Project Value Undisclosed).

27 Biotechnology and Pharmaceutical

Client Description of services

CSL R & D, Victoria AMEC completed the design, project management and qualification of the Clinical Manufacturing Facility Upgrade for CSL at Parkville, Victoria. The project included conversion of existing facilities into a new fumigatable Cell Culture Facility and ISO 8 cleanroom areas. Also included were upgrades to Personnel Change rooms and materials airlocks to achieve cGMP Grade C. (Project Value AUD$1.5M).

CSL R & D, Victoria AMEC completed the design, project management and qualification of the Clinical Manufacturing Facility Upgrade for CSL at Parkville, Victoria. The project included conversion of existing facilities into a new fumigatable Cell Culture Facility and ISO 8 cleanroom areas. Also included were upgrades to Personnel Change rooms and materials airlocks to achieve cGMP Grade C. (Project Value AUD$1.5M).

CSL Ltd, Victoria AMEC completed the mechanical, electrical and hydraulic design for the upgrade to the existing QC testing facilities for CSL at Parkville, Victoria. The facility comprised Chemistry, Immunochemistry, Bacteriology, Virology and sterility testing laboratories, compliant to FDA and TGA. The building is a 4 storey building built in the early 1970’s which required a significant architectural and mechanical upgrade. (Project Value AUD$6M).

CSL R & D, Victoria AMEC was engaged to assist in the documentation and technology transfer of R&D products between CSL Parkville and CSL USA. The project involved production of Process Flow Diagrams and User Requirements Briefs as well as assistance in the selection and specification of process equipment. (Project Value Undisclosed).

CSL R & D, Victoria AMEC completed the design, project management and qualification of a product specific suite for the manufacture of research materials and clinical batches of products manufactured from hazardous, toxic and flammable materials. The suite is cGMP grade C (ISO 7) compliant and is a ‘clean contained’ design. (Project Value Undisclosed).

Bristol Myers Squibb,Victoria

AMEC completed the Basis of Design for an upgrade to dust extraction and vacuum systems including reconfiguration of HVAC in dispensary and sampling facilities for the Noble Park solid dose facility. (Project Value Confidential).

QuantumPharmaceuticals,Victoria

The Quantum Ointments Facility is a greenfield pharmaceutical facility. The facility manufactures an OTC topical ointment and skin conditioner cream as well as a cleansing gel through multiple batch processes. The scope of work designated to AMEC for this project includes: advisory role for the design and manufacture of the 2,500 litre side scraped mixing tanks, detailed process, purified water, mechanical, piping and electrical design and drafting, development of URS/FRS/DS/IQ/OQ documents, equipment selection and procurement assistance, construction supervision, commissioning, validation, training and project management.

Pfizer Animal HealthAustralia, Victoria

AMEC completed the design, project management and construction management of a laboratory upgrade for the VMRD laboratory at Parkville, Melbourne. The scope of work included the architectural, building services, mechanical services, electrical and automation design of a PC2 laboratory complex for the development of veterinary vaccines. The laboratory will house up to 500L fermentation capabilities. (Project Value AUD$2M).

Biotechnology and Pharmaceutical 28

Client Description of services

GlaxoSmithKline,Victoria

AMEC acted as External Project Managers for the Filling Machine 8 project in the Sterile Blow Fill Seal Process at GlaxoSmithKline, Boronia plant. The project involved the design and installation of a new Grade B cleanroom, BFS filling machine and associated packaging equipment. (Project Value AUD$8.9M).

CSL Ltd, Victoria AMEC completed Design Management and Detail Design for the QC Sterility Testing Laboratory Upgrade at CSL, Parkville plant. The project involved the design and installation of a new Grade D / PC2 laboratory to house Grade A sterility testing isolators for final product testing. (Project Value AUD$ 1.2M).

Virax Holdings Ltd,Victoria

AMEC was engaged on behalf of Virax to provide project management and technical services for design and construction management, including the coordination of internal Virax resources and regulatory approval strategy. The project involved the construction of a new GMP PC2 manufacturing facility and a technology center for the development of vector vaccines for Phase II clinical trials. The facility was based on roller bottle incubator technology and consisted of cleanrooms ranging from Grade D to Grade A and includes PC2 containment to OGTR requirements. (Project Value - AUD$3M).

Saudi Arabian PlasmaGroup (SAPG), RiyadhKSA

AMEC completed a Pre Feasibility study and concept design for the Saudi Arabian Plasma Group for a new Greenfield plasma products facility in Riyadh, Saudi Arabia. The plant was designed to be fully compliant to FDA and PIC/S requirements. (Project Value USD$80M).

29 Biotechnology and Pharmaceutical

Client Description of services

JRH Biosciences,Queensland

AMEC completed the Design and Project Management of a new Blood Serum collection, separation and storage facility for JRH Biosciences in Brisbane, QLD. The project involved the architectural and processing fit out of an existing warehouse complex with cleanrooms and HVAC equipment to support processing equipment and storage plant. (Project Value AUD$1.2M).

Agenix, Queensland AMEC completed the design and EPCM of a new cleanroom (Grade C – ISO 7) laboratory (OGTR PC2) for Phase II clinical trials of a new diagnostic product requiring TGA licencing. (Project Value - Confidential).

New productsDevelopment Ltd,Queensland

AMEC was involved in the validation of pharmaceutical Grade D air handling systems and process services at the NPD site in Brisbane. This involved the development of TGA qualification documentation as well as the execution of qualification activities including testing and commissioning. (Project Value - Undisclosed).

CSL Ltd, Victoria AMEC completed the Project Management of a new Raw Materials Sampling & Dispensing Area for the Broadmeadows facility. The new facility was a regulatory requirement and has undergone TGA auditing. AMEC provided conceptual and preliminary design services as well as total project management. (Project Value AUD$1.5M).

CSL Ltd, Victoria AMEC was engaged to provide design and project management services for numerous upgrade projects at Broadmeadows including upgrade of the IG plant, installation of a Salt handling plant, Installation of a UF cleaning plant and the CIP optimization project. (Projects Total Value AUD$5M).

AVT Bioplasma Ltd, China AMEC was engaged as the industrial consultants providing design and engineering services to AVT Holdings Ltd and Neptunus Pharmaceuticals (Schenzen, China) for a plasma products facility in China. The services included process design, automation and control and cleanroom design including building services for various cleanroom classifications from Grade D to sterile filling environments. (Project Value USD$100M).

GlaxoSmithKline,Victoria

AMEC was involved in the Sterile Blow Fill Seal Process Upgrade project at the GlaxoSmithKline Boronia plant providing Design Review, HAZOP and Project Management services to GSK. (Project Value AUD$5M).

CSL Ltd, Victoria AMEC staff was appointed Project Managers on behalf of CSL Ltd for a large cleanroom expansion project at Broadmeadows, Victoria including Grade D and C areas. This involved managing both internal and external design and project teams of technical experts both in Australia and Ireland. (Project Value AUD$30M).

CSL Ltd, Victoria AMEC was responsible for numerous projects during the construction of the new CSL plasma products facility in Melbourne, Australia. The facility is the only plasma facility in Australia and utilizes Chromatography based blood processing technology. The facility is of world class standard and produces the highest purity plasma products available. (Project Value AUD$220M).

Client Description of services

Apotex Inc. Major FDA-compliant three level manufacturing facility, expansion of pharmaceutical manufacturing facility, including warehouse, gravity feed and automated material handling, product manufacturing (ISO Class 5 mainly), packaging, labs, employee facilities, service and support space.

  AMEC provided design of mechanical, electrical and controls/instrumentation.

Project Awards

  FINALIST 2005 ISPE

  “Facility of the Year”

  2004 -Toronto Construction Association – “Best of the Best”.

Apotex Inc. Expansion of pharmaceutical manufacturing facility:

  AMEC provided mechanical, electrical and controls engineering, construction assistance, start-up and commissioning.

Apotex Inc. Various projects in pharmaceutical manufacturing facility:

  AMEC is providing process, mechanical, electrical engineering, support/design as needed.

AstraZenecaCanada

Upgrade of critical plant services in research facility:

  AMEC provided engineering and validation services for the upgrades of the clean utilities, focusing on the clean steam and pure water systems

Biotechnology and Pharmaceutical 30

AMEC international project history

31 Biotechnology and Pharmaceutical

Client Description of services

AstraZeneca Decommissioning of sterile manufacturing and development of new packaging halls:

  AMEC provided all design (A/E), construction management, commissioning and validation.

CIBA Vision Sterile opthalmic solutions facility:

  AMEC is providing architectural and engineering services.

Shire Biologics (IDBiomedical , now GSK)

Major expansion of downstream production process facility to incorporate upstream production of fluviral vaccine:

  AMEC provided owner’s engineer (Director of Engineering) and complete and integrated BOD, preliminary and design engineering for this sterile injectable production project

Sanofi Pasteur Major capital projects to provide global production (polio vaccine and flu vaccine):

  AMEC provided technical assistance and auditing for several projects.

Trillium Health CareProducts

Pharmaceutical manufacturing facility:

  AMEC provides master planning for major plant expansion(s), HVAC upgrades, new sanitation area, warehouse expansion, and new employee entrance.

Trillium Health CareProducts

Upgrades to OSD manufacturing equipment (liquids, nasal liquid line, ointments) for specialized multipurpose solid dose facility:

  AMEC is providing master-planning, design (A/E) and technical services.

University HealthNetwork / Hospital forSick Children

15 storey research and development facility to support medical research:

  AMEC provided all design, programming, planning, architectural (with partners NXL), detailed design, and engineering for interior fit-out of laboratory space.

UniversityHealthNetwork /TorontoMedical Labs

Interior fit-out of laboratory space in research and development facility:

  AMEC provided design, programming, planning, architectural (with partners NXL), detailed design and engineering.

ConfidentialClient “A”

Expansion of pharmaceutical manufacturing facility for a 3-fold increase in output at this API plant:

  AMEC provided validation and commissioning services , as well as start-up assistance

  Phase 3: AMEC is providing validation services.

Find out more at amec.com

Please contact Nenad Firez

Business Development Manager, Australia

Tel: +61 (0) 400 495 885 Email: [email protected]

Melbourne AMEC, Level 15, 300 La Trobe Street Melbourne, Victoria 3000 Tel: +61 3 8480 1000 Fax: +61 3 8480 1055

Sydney AMEC, Level 10, 67 Albert Avenue Chatswood, New South Wales 2067 Tel: +61 (0) 410 083 833

Brisbane AMEC, Level 4, 144 Edward Street Brisbane, Queensland 4000 Tel: +61 7 3013 7700 Fax: +61 7 3013 7755

Perth AMEC, Level 7, 197 St Georges Terrace Perth, Western Australia 6000 Tel: +61 8 9347 4777 Fax: +61 8 9347 4747

Jakarta AMEC Berca Indonesia, CCM Building 4th Floor JI Cikini Raya no. 95 Jakarta 10330 Indonesia Tel: +62 21 315 9040 Fax: +62 21 314 2740

Kuala Lumpur

AMEC Larastia, Suite 10.2 Level 10 East Wing, Rohas Perkasa No. 9 Jalan P. Ramlee 50250 Kuala Lumpur, Malaysia

Tel: +60 3 2162 1230 Fax: +60 3 2163 1231

Muntinlupa City AMEC, Insular Life Corporate Centera Level 22 Tower 1, Corporate Corner Commerce Avenue, Filinvest Corporate City, Alabang Muntinlupa City, Philippines 1780

Tel: +632 7711576 to 78 Fax: +632 7711532

Shanghai AMEC, Unit 3007-3012 Shanghai Information Tower, 211 Century Avenue, Pudong New District, Shanghai 200120 China

Tel: +86 21 3861 5599 Fax: +86 21 5877 0248


Recommended