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Saudi Arabia Plasma Group
 
Saudi Arabia Plasma Group
Blood Plasma Products Facility
Riyadh
Brief
SAPG required a blood plasma processing facility to process up to 250,000 kg/year (250 tpa) of blood donations derived from The Kingdom of Saudi Arabia & other Arab countries.
The new facility is to be located on the King Saudi University Campus & will produce factor VIII factor IX immunoglobulin & albumin products for markets in Arab countries.
The key objectives which the facility had to deliver were, compliance with EU guidelines, bulk large scale plasma processing, worlds best practices, efficient exacting engineering design.

Cost
$250M Estimate

Areas
1F 10,904m²
2F 8,393m²
3F 7,896m²
Total 27,193m²

Key Functional Areas
Goods In / Out
Warehouse & Store
Plant & Maintenance – interstitial trafficable space
Manufacturing & Packaging
Materials & Personnel Airlocks
Staff Change & Amenities
QC Laboratories
Reception & Admin / Office Accommodation
Utility / Plant (ahu, waste, boiler, backup
generator, gases etc)
Carpark

 Zektin Services
Feasibility Study including:
- 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
World class plasma facility complying with international standards.
Logical flow of product, personnel, equipment & waste, sufficient space to carry out all operations, use of pressure differentials & airlocks to protect processing areas, traceability of all components in the process, closed systems where possible, clean room design for all processing areas to appropriate classification, automation for continuous & sequential control for process, interlocks for protection of operators, process & equipment monitoring.
Complex site, building & process services & infrastructure integrated with facility design.
CSL
 
CSL
QA & QC Testing Laboratories
Parkville
Brief
CSL required a modern & consolidated QA & QC testing laboratory facility where samples from various expanding R+D & manufacturing departments could be deposited & tested.
The laboratory facility performs testing on finished products, in process / stability / R&D / validation samples, raw materials, reagents, media & chemicals in the areas of sterility, virology, bacteriology, environmental monitoring, immuno chemistry & chemistry.
The key objectives which the facility had to deliver were, compliance with TGA, FDA & cGLP, refurbishment & upgrade of existing building, improved sample, material & equipment flows & increased testing capacity.

Cost
$6.0M

Areas
GF 579m²
1F 557m²
2F 557m²
3F 541m²
Total 2,234m²

Key Functional Areas
Chemistry Labs
Immunology Labs
Bacteriology Labs
Virology Labs
Sterility Labs
Samples Receipt
Personnel Airlocks (PAL)
Lab Support / Prep Rms
Freezer, Cold & Warm Rms
Dangerous Goods Stores (fire rated)
Offices, Meeting Rms & Canteen

 Zektin 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 & testing processes obtained. High grade labs
of increased capacity, efficient space use & improved flow of samples, materials & equipment. Labs contain, new & reused lab equipment, isolators, BSCs, LIMS / BPCS points, autoclaves, purpose built lab joinery, safety eye wash / showers & lab services such as natural gas, nitrous oxide, acetylene, nitrogen, argon, helium, hydrogen, carbon dioxide, DI water, PFW, vacuum, compressed air. Improved air quality within labs using filtered HVAC system & provision of segregation of testing operations to prevent sample contamination & protect operators. Facility security access for personnel & samples in accordance with GLP & FDA guidelines.
CSL
 
CSL
Biopharmaceutical Formulation Facility
Parkville
Brief
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 & for formulation & 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 & the US, connecting to existing Clinical Manufacturing Facility, exacting engineering design & high tech, innovative, yet contextual design.

Cost
$6.5M

Areas
1F 350m²
2F 320m²
Total 670m²

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 Rm (Grade C)
Cold Rm (Grade C)
Store Rm (Grade C)
Goods Lock (Grade C/D)
Viewing Corridor (Grade D)
Autoclave
Plant Rm - interstitial trafficable space

 Zektin 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 & manufacturing facility of the highest standard.
GMP construction detailing, optimal materials & personnel flows, maximum visual communication via internal glazing.
BMS & EMS with remote notification (for process, HVAC & doors), terminal hepa filtration, online particle monitoring, door interlocking, lab gases & services, waste decontamination & heat recovery systems.
Increased GMP manufacturing expertise, &
product development, improved customer
service & cost competitiveness.
Reinforcement & revitalisation of R+D precinct through innovative, high tech architectural & engineering design.
Premier facility on CSL Parkville campus used extensively for marketing purposes.
Selborne Biological Services
 
Selborne Biological Services
Bovine Lipoprotein Production Facility
Longford
Brief
Selborne Biological Services required a new facility to manufacture Bovine Lipoprotein which is used to increase antibody production in cell culture processes.
The design basis for the new facility was 100,000 L/annum of bulk finished product for dispensing using a batch size of 4,000kg.
The objectives of the facility included provision for increased capacity of lipoprotein production, automated processes which eliminate the need for manual handling & ensuring repeatability & consistency, compliance with regulatory guidelines for the manufacture of API’s & the provision for future product development

Cost
$14M Estimate

Areas
GF 1,814m²
1F 1,248m²
Total 3,062m²

Key Functional Areas
Sterile filling suite (Grade A)
Bottle Prep (Grade C)
Processing Suites (Grade C/D)
Preparation & Wash Rms (Grade C)
Materials Air Locks MAL (Grade D/C)
Personnel Air Locks PAL (Grade D/C)
Dispensary, Packaging & Despatch
Store, Cold & Freezer Rms
Chemical Sore & Plant
Plant Rm - interstitial trafficable space
QC Laboratories (PC2)
Administration offices & staff amenities
Future Expansion

 Zektin Services
Facility Master Planning
Architectural Concept Design
Process Development & Definition
Production Modelling
Process Engineering Concept Design
Mechanical Engineering Concept Design
Cost Planning		 Project Outcomes
Provision of a process plant with full product traceability from raw material to dispensed product. The design flow ensured uni directional product, material & personnel flow reducing the risk of contamination from batch to batch & from personnel to product. State of the art control provisions were specified with innovative solutions for materials handling & process & environmental
monitoring.
The facility was designed to ensure full compliance to cGMP & relevant codes & standards.
Sigma Pharmaceuticals Limited
 
Sigma Pharmaceuticals Limited
Liquid Manufacturing Facility
Dandenong
Brief
Sigma Pharmaceuticals required a new liquid manufacturing facility for the manufacture, filling & packaging of liquids & creams.
The new facility supplies local & international markets with pharmaceutical liquid products such as, cough & cold mixtures, nasal decongestants, topical creams & ointments, highly potent liquids & 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 & Asia, connection to existing solid dose manufacturing facility, high tech, exacting engineering.

Cost
$60M

Areas
GF 10,149m²
1F 5,819m²
Total 15,968m²

Key Functional Areas
Liquids, Cream & Ointment Suites (ISO 8)
Potent Products Suite (ISO 8 containment
area)
Filling & Packaging (ISO 8)
Materials Airlocks MAL (ISO 8)
Personnel Airlocks PAL (ISO 8)
Personnel Change (ISO 8)
Staff Canteen & Amenities
Packaging Warehouse
Utility / Plant Rms (ahu, waste, boiler, backup
generator, substation, chillers, air
compressors)
Plant Rm – interstitial trafficable space

 Zektin 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 & creams facility in Australia.
Raw materials, solid dose & liquid manufacturing consolidated on single site.
GMP construction detailing, optimal materials & personnel flows, maximum visual communication via internal glazing.
BMS, EMS & EBR with remote notification (for process, HVAC & doors), terminal hepa filtration, door interlocking, RO water generation, waste decontamination & 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 & cost competitiveness.
Bristol Myers Squibb
 
Bristol Myers Squibb
Steroid Containment Facility
Noble Park
Brief
BMS required a steroids containment facility for the safe processing & packaging of steroid compounds.
The new facility allows the safe dispensing, blending & compression of steroid powders into tablets which are supplied to the local medical industry.
The key objectives which the facility had to deliver were, achieve containment levels <0.05μg/m3, GMP compliance, OH&S compliance, improved operator safety, efficiency & reliable dust extraction, minimisation of dust, easily accessible plant, improved personnel & materials flow & cleaning & maintenance procedures.

Cost
$4M

Areas
GF 210m²
1F 210m²
Total 420m²

Key Functional Areas
Airlock (ISO 8)
Change In with PTC & SOB (ISO 8)
Change Out with PTC (ISO 8)
PAL In with PTC (ISO 8)
PAL Out with PTC & safety shower (ISO 8)
Dispensing & Granulation with IBC lifter
blender, isolator & downflow booth (ISO 8)
Compression with tablet press, deduster &
downflow booth (ISO 8)
Staging Area, Store & Wash Bay with trade
waste pit (ISO 8)
MAL & MAL Transit (ISO 8)
Plant – Interstitial trafficable space

 Zektin Services
Project Management
Design Management
Architectural Design
Process Engineering Design
Mechanical Engineering Design
Electrical & Data Engineering Design
Building Management Engineering Design
Fire Service Engineering Design
Hydraulic Engineering Design
Equipment Procurement
Commissioning
Qualification Documentation
Validation		 Project Outcomes
Self contained sterile & cleanable facility utilizing prefabricated / prefinished Dagard door, window, wall & ceiling panel system.
GMP construction detailing, optimal materials & personnel flows, maximum visual communication via internal glazing.
Contamination prevention, operator protection, & air quality achieved using sate of the art containment technology, cascading pressure regimes, HVAC system with terminal hepa filtration & local alarmed room monitoring of pressure / temperature / humidity as well as dedicated specialist extraction systems preventing. Other initiatives BMS, EMS, EWIS, door interlocking, process services & waste decontamination systems.
Innovative, high tech architectural & engineering design.
Australian Therapeutic Proteins
 
Australian Therapeutic Proteins
Therapeutic Protein Production Facility
Longford
Brief
ATP required a therapeutic protein production facility for the processing of sheep serum & the manufacture of therapeutic antigens for
use in the pharmaceutical & defence industry.
The new facility receives & processes fresh sheep serum & fractionates target proteins for the purpose of manufacturing purified antigens. The initial batch size was 65kg with provision to increase capacity in future & produce 2000 x 10ml freeze dried bottles per batch.
The key objective was to design & construct a facility which provided state of the art & world’s best practice solutions for blood processing with multiple viral reduction steps & optimum product purification.

Cost
$17M Estimate

Areas
GF 2,550m²
1F 1,580m²
Total 4,130m²

Key Functional Areas
Sterile filling suite (Grade B)
Freeze drying (Grade B)
Processing Suites with LFC (Grade C)
Preparation & Wash Rms (Grade D)
Materials Air Locks MAL (Grade D/C)
Personnel Air Locks PAL (Grade D/C)
Dispensary, Fill, Packaging & Despatch
Store, Cold & Freezer Rms
Viewing Corridor
Plant
Plant Rm - interstitial trafficable space
Laboratories
Administration office & staff amenities
Future Expansion

 Zektin Services
Facility Master Planning
Architectural Concept Design
Process Development & Definition
Production Modelling
Process Engineering Concept Design
Mechanical Engineering Concept Design
Cost Planning		 Project Outcomes
Design of a facility which ensured full product containment & safety. A combination of clean room processing & product containment using differential room pressures to adjacent suites ensured that full personnel & product safety was maintained at every boundary.
The latest equipment & viral clearance concepts were used to ensure optimum processing & product safety.
Unidirectional flows were utilised as the basis for facility layout & room adjacencies were considered when planning for support areas.
Provision for future expansion was also designed into the facility without impact on operations.
Akruti Biotech
 
Akruti Biotech
Multi Tenanted Wet Laboratories (MTWL) Facilities
Akruti Biotech Park, Vadodara, India
Brief
Akruti Biotech required two international standard MTWL facilities which offer high quality, modular & flexible lab workspace to prospective tenants.
The two facilities are an integral part of a 708 acre biotech park comprising of a biotech incubator, research & training institute, loaded lab building, administrative block, services block, common equipment library, pilot plant facility, animal house, green belts & built to suit plots.
The key objectives which the facility had to deliver were, GMP / GLP compliance, facilitation of R+D & commercialisation of biotechnology, world class, modular & easily adaptable design.

Cost
$30M

Areas
MTWL1 MTWL2
GF 4,355m² 1,631m²
1F 4,393m² 1,631m²
2F 1,898m² 560m²

Total 10,646m² 3,822m²
Key Functional Areas
Lab Module
Wet Lab (open plan, BSL2)
Dry Lab (closed plan, fume hoods, BSL2)
Airlocks & Autoclave
Dry Lab (closed plan, BSC, BSL3)
Lab Store & Support
Office
Shared Areas
Goods In / Out, PAL / MAL, Prep Rm, Wash
Rm, Equipt Rm, Cold Rm, Warm Rm, Dark
Rm, Lab Support, Meeting / Seminar Rms,
Café, Plant Rm – interstitial trafficable space

 Zektin Services
Architectural Design
Process Engineering Design
Mechanical Engineering Design		 Project Outcomes
GMP / GLP compliant, high grade modular labs capable of accommodating multiple independent tenants of varying sizes. Open & closed plan modules capable of redesign.
Innovative solution to complex set of project parameters resulting in separate lab tenancies, yet shared support functions whilst maintaining BSLs, security & ensuring efficient space use, optimal flow of samples, materials & equipment.
Lab gases & services, modular joinery, safety showers / eyewashes & UPS. Separate terminally filtered HVAC systems to tenancies to prevent contamination & protect operators.
Signature, hi tech facility attracting & retaining multiple tenants of varying sizes.
Biological Therapies
 
Biological Therapies
Sterile Manufacturing Facility
Braeside
Brief
Biological Therapies required a modern sterile manufacturing facility for the manufacture, filling & packaging of liquid product into bags & vials.
The new facility is located adjacent existing operations & supplies the local market with injectable vitamins.
The key objectives which the facility had to deliver were, compliance with TGA & GMP requirements, increased operator safety, capacity, automation of production, exacting, high tech & innovative, design within compact footprint.

Cost
$1.5M

Areas
GF 199m²
1F 171m²
Total 370m²

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 Rm (Grade D)
Goods Lock
Viewing Corridor
Plant Rm - interstitial trafficable space
Labelling & Office

 Zektin 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 & personnel flows. Maximum visual communication via internal glazing.
Complete propriertary Dagard cleanroom panel system utilized to achieve GMP construction detailing.
EMS for HVAC (terminal hepa filtration) continuously monitoring air pressure, supply air, LAFs & facility alarming / indicators. Door interlocking, gases & services.
TGA cGMP licensing requirements met.
Increased GMP manufacturing capability & product development, improved customer service & cost competitiveness.
Pfizer
 
Pfizer
Veterinary Medical Research Development Facility
Parkville
Brief
Pfizer required a pilot scale manufacturing facility for the development & GLP validation of biological manufacturing technology.
The new facility will support their veterinary vaccine manufacturing in Australia & New Zealand by testing & developing manufacturing processes, processing, & formulation of bacterial (1:10 scale) & viral (1:3 scale) vaccines.
The key objectives which the facility had to deliver were, multiple product & process testing & development, compliance with HSE regulations, GLP, OGTR & AQIS compliance, refurbishment & upgrade of existing building & exacting engineering design.

Cost
$6.0M

Areas
4F 760m²
Total 760m²

Key Functional Areas
Bacterial Laboratory (PC2)
Cell Culture Laboratory with LAF (PC2)
Formulation & fill with LAF (PC2)
Equipment wash & preparation with Autoclave
& FC (PC2)
Viewing corridor
Air Locks
Cold, cool & warm rooms
Administration offices
Plant

 Zektin 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 & high tech architectural & engineering design.
GLP construction detailing, optimal materials & personnel flows, maximum visual communication via internal glazing.
BMS & EMS for process, HVAC with remote notification, terminal hepa filtration, online particle monitoring, alarmed door interlocking, lab gases & services, waste decontamination & formaldehyde gas fumigation.
Increased manufacturing expertise & product development, improved product, customer service & cost competitiveness.
Kukje
 
Kukje
Cephalosporin Manufacturing Facility
Seoul, South Korea
Brief
Kukje required a Cephalosporin manufacturing facility for the production of sterile & non sterile products in the forms of tablets, capsules, dry syrup, sterile injectables & freeze dried injectables.
The new facility replaces an existing redundant, outdated building & supplies local & international markets with numerous pharmaceutical broad spectrum antibiotic products.
The key objectives which the facility had to deliver were, compliance with latest KFDA, FDA, EU regulations, state of the art GMP design, increased production & segregation of Cephalosporin product from other existing manufacturing processes.

Cost
$25M

Areas
1F 1,900m²
2F 1,900m²
3F 1,900m²
4F 1,087m²
Total 6,787m²

Key Functional Areas
Sterile Powder Manufacturing (Grade A/B/C)
Sterile Freeze Dried Manufacturing (Grade
A/B/C)
Solid Dose Manufacturing (ISO8)
Primary & Secondary Packaging (ISO8)
Materials Air Locks MAL
Personnel Air Locks PAL
Warehousing (Controlled Environment)
QC/QA Laboratories
Administration Offices
Plant Rm - interstitial trafficable space

 Zektin Services
Project Management
Design Management
Architectural Concept Design
Process Engineering Concept Design
Mechanical Engineering Concept Design
Electrical & Data Engineering Concept Design		 Project Outcomes
Cephalosporin production segregated from other product manufacturing.
Efficient & greatly improved material & personnel flows, increased flexibility & productivity.
Introduction of technologies to reduce dust generation & improve product quality & operators’ safety.
Innovative engineering principles for process & building services to ensure sterile environment, improve reliability & energy efficiency.
Process modelling of the production capacity & budget costing supporting Kukje implementation strategy.
Unique, yet functional facility design integrated with existing buildings & services on campus style manufacturing site.
Hanseo Pharm
 
Hanseo Pharm
Solid Dose Manufacturing Facility
Gyeonggi-do, South Korea
Brief
Hanseo Pharm required a new solid dose manufacturing facility for the production & packaging of pharmaceuticals.
The new facility enables the implementation of Hanseo’s 5 year plan to increase production capacity to 1,065 batches per year (100 to 300 Kg sizes), 569,400,000 tablets & 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 & provision for future expansion.

Cost
$30M

Areas
GF 6,547m²
1F 3,608m²
Total 10,155m²

Key Functional Areas
Manufacturing (ISO 8 clean room)
Dispensaries & sampling (ISO 8 clean room)
Packaging (ISO 9 clean room)
Warehouse
Micro & Chemical Wet Labs
Animal Lab (PC2)
Office & staff amenities
Plant & Engineering area – interstitial space
Cafe & outdoor terrace
Dangerous goods store
External car parking & tennis court

 Zektin Services
Project Management
Design Management
Architectural Concept Design
Process Engineering Concept Design
Mechanical Engineering Concept Design
Electrical & Data Engineering Concept Design		 Project Outcomes
Efficient & greatly improved material & personnel flows, increased flexibility & productivity.
Introduction of technologies to reduce dust generation & improve product quality & operators’ safety.
Innovative engineering principles for process & building services to improve reliability & energy efficiency.
Process modelling of the production capacity & budget costing with an implementation strategy for Hanseo to meet its 5 year plan.
Unique, yet functional facility design with