Pharmaceutical Production Facility Engineering

Others

From the beginning to the goal of a pharmaceutical facility construction

Obayashi Group will provide total support for our client's projects, utilizing our rich know-how and reliable technology in order to achieve stable production as well as high quality and safety that meet international standards.

The merits of comprehensive service

Improved quality

Quality is improved through total quality management whereby all processes from planning, design and construction to maintenance are implemented under a consistent system.

Shortening of the overall process, project cost reduction

Being able to unify the management of various areas of expertise renders coordination between distributors by the client unnecessary and allows shortening of the overall process, resulting in reduced costs and a reduction in the number of client's staff for the project.

Economical cost allocation

Economical cost allocation is possible as the entire process from planning to maintenance is managed via a consistent system.

We will realize the pharmaceutical facility that meets all aspects of the owner's expectations: functionality, durability, safety and sustainability.

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Project development flow

Project management

 

Comprehensive supervision on site

Comprehensive coordination during project development. Abundant management technologies will be applied.

  • Preparation of master plan.
  • Emancipation from management work such as quality, cost and construction schedule control.
  • Emancipation from coordination work between building constructor and vendors.
  • Reduction of number of personnel in charge of the project.

Various advantages are achieved by comprehensive supervision on site.

  • Advanced quality control.
  • Reduction of construction cost.
  • Reduction of construction time.
  • High-quality safety management.
  • Clarification of scope of work.
  • Common use of the temporary work materials.
  • Recycle of construction waste.
  • Support of commissioning, punch list work.

Rational design

 

After-sales service

Rational and well-balanced design is accomplished taking each design element into account.

  • All sorts of design.
  • Economical structural design.
  • Rational installation of infrastructure.
  • Application of deregulation.
  • Prompt action on permit application.
  • Flexible action on design change and VE.

Long term maintenance of facility is planned by achieving periodic inspection. Extensive organization for maintenance is provided.

  • All sorts of maintenance.
  • Periodic diagnosis and inspection.
  • Quick response to repair work.
  • Action in case of emergency.
  • Reform planning.
  • Future expansion plan.

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Scope of Obayashi Group Service

We will offer engineering, procurement, construction / installation, commissioning / validation and maintenance services of not only building, electrical and HVAC but also process equipment, purified water system, process utility and material handling system. We realize effective facility by harmonizing building with production equipment

Production equipment

Preparation equipment

Preparation equipment

We will construct a production system tailored to the client's various needs to facilitate the production of high-quality pharmaceutical products with greater functionality. We boast rich know-how and extensive experience with biological products, injections, solid dosage forms and API(active pharmaceutical ingredients), etc.

Process water/utility equipment

Purified water System

Purified water System

We provide process water that complies with the strict GMP quality control standards. Utility equipment such as clean steam and compressed air, etc. is constructed under a system optimized for the quality that is required.

Automation/In-plant logistics/MES

We implement systems such as production automation systems aimed at the reduction of labor and prevention of erroneous operation, in-plant logistics systems for easy inventory management and streamlined conveyance and manufacturing execution systems aimed at integrating production information management and production support management, etc.

Auto Guided Transport System

Auto Guided Transport System

Palletizer

Palletizer

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Obayashi Group's Technology to Support Each Phase

Plant survey

3-D wind speed measurement

3-D wind speed measurement

We implement various surveys such as GMP diagnosis, comprehensive plant diagnosis and environmental measurement of the manufacturing area, etc. which are then reflected in the planning for the new plant or plant reconstruction.

Simulation

We will derive optimal solutions utilizing the latest simulation technology, visualize these solutions, making them easy to understand, and incorporate them into the plant design.

BIM (Building Information Modeling)
 
Air flow planning by computer simulation

The maintainability of piping and equipment can be examined from different angles and perspectives.

The most appropriate air flow conditions are determined by using numerical simulation by super computer. The result is then applied to the HVAC design. For example, the simulation such as converting a staircase into a clean room. Another example would be the ventilation caused by the heat emissions from equipment.

3D-CAD

3D-CAD

Air Flow Analysis

Air Flow Analysis

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Anti-insect/rodent measures

We provide comprehensive anti-insect/rodent measures that follow the three general rules:
"do not attract them", "do not let them infest the plant" and "prevent breeding and proliferation".

ISS / ceiling panel system that supports walking

ISS:InterStitial Space

ISS:InterStitial Space

Insulation panels that support walking are adopted as ceiling materials which results in increased operability of interstitial spaces. Our unique HEPA filter box and lighting fixture which can be maintained from above the ceiling without contaminating the manufacturing space.

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Containment Facility

Facilities in which hazardous materials are handled are required to have containment system of equipment and facilities through their lifecycle. Obayashi Group will provide engineering services to realize the most appropriate facility matching its character by following approach.

*1 EPS: Exposure Predictor Solid Band
*2 PPE: Personal Protective Equipment

Room Decontamination

Obayashi Group has technologies of room decontamination with Hydrogen Peroxide (H2O2) to decontaminate process rooms and equipment certainly with more attention to prevent corrosion. We will provide the most appropriate system as a facility's character.

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Connecting Type Vibration Control Technology for AS/RS*
*AS/RS: Automated Storage and Retrieval System

This technology controls vibration of building frame and storage rack which are connected with vibration control damper. It prevents dropping stocks and also controls the earthquake input to the building frame.

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Other technology we possess

  • Containment of hazardous substances
  • Cross-contamination prevention measures
  • Floor concrete cracking control
  • Optimization of floor finishing materials
  • Waste water treatment system construction
  • Soil contamination countermeasures
  • Energy-saving measures
  • CO2 emission-reducing technology
  • Natural energy-utilizing technology
  • Fire and explosion countermeasures
  • Disaster countermeasures
    (Seismic isolation, damping, BCP support)
  • Security measures (facilities, information, personnel)

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Validation Support

Obayashi Group has a lot of experience to support validation work with fully understanding of GMP. We will totally support owner to develop Validation Master Plan, to develop and implement the DQ/IQ/OQ protocol and to assist the PQ.

Work flow

work flow

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Major Project

Adhesive PlasterNichiban Medical Plant No.2 Fukuoka, Japan

Nichiban Medical Plant No.2
Fukuoka, Japan

Pharmaceutical CapsulesQualicaps Plant No.6 Nara, Japan

Qualicaps Plant No.6
Nara, Japan

Reagent ProductsWako Pure Chemical Industries Aichi Plant Aichi, Japan

Wako Pure Chemical Industries Aichi Plant
Aichi, Japan

Reagent ProductsWako Pure Chemical Industries Osaka Plant Hyogo, Japan

Wako Pure Chemical Industries Osaka Plant
Hyogo, Japan

Reagent ProductsTakeda Healthcare Products Pharmaceutical products warehouse Kyoto, Japan

Takeda Healthcare Products Pharmaceutical products warehouse
Kyoto, Japan

Medical ProductsHogy Medical Tsukuba Plant Ibaraki, Japan

Hogy Medical Tsukuba Plant
Ibaraki, Japan

Cosmetic productsShiseido Vietnam Inc. Dong Nai, Vietnam

Shiseido Vietnam Inc.
Dong Nai, Vietnam

Oral Solid Dosage FormsTOA Pharmaceuticals Nishihongo Plant Toyama, Japan

TOA Pharmaceuticals Nishihongo Plant
Toyama, Japan

Clinical reagentWako Pure Chemical Industries Mie Plant Mie, Japan

Wako Pure Chemical Industries Mie Plant
Mie, Japan

Oral Solid Dosage FormsASGEN Pharmaceutical Mizunami Plant Gifu, Japan

ASGEN Pharmaceutical Mizunami Plant
Gifu, Japan

Reagent ProductsWAKO Chemical Miyazaki Plant Miyazaki, Japan

WAKO Chemical Miyazaki Plant
Miyazaki, Japan

Oral Solid Dosage FormsMochida Pharmaceutical Plant No.1 Expansion Tochigi, Japan

Mochida Pharmaceutical Plant No.1 Expansion
Tochigi, Japan

Blood ProductsMeasles Vaccine Production Facilities Hanoi, Vietnam

Measles Vaccine Production Facilities
Hanoi, Vietnam

Blood ProductsJapanese Red Cross Society Tatsumi Building Tokyo, Japan

Japanese Red Cross Society Tatsumi Building
Tokyo, Japan

Cosmetic productsAssuran Group Tosu Factory Saga, Japan

Assuran Group Tosu Factory
Saga, Japan

Biological products / InjectionsThe Research Foundation for Microbial Diseases of Osaka University Kanonji Institute Kagawa, Japan

The Research Foundation for Microbial Diseases of Osaka University Kanonji Institute
Kagawa, Japan


Oral Solid Dosage Forms
Takeda Healthcare Products Plant No.7 Kyoto, Japan

Takeda Healthcare Products Plant No.7
Kyoto, Japan


Ointments / Injections
Mochida Pharmaceutical Plant No.2 Tochigi, Japan

Mochida Pharmaceutical Plant No.2
Tochigi, Japan

Oral Solid Dosage FormsNITTO PHARMACEUTICAL INDUSTRIES, LTD. Ayabe Factory Kyoto, Japan

NITTO PHARMACEUTICAL INDUSTRIES, LTD. Ayabe Factory
Kyoto, Japan

OintmentsFujisawa Pharmaceutical Toyama Plant Toyama, Japan

Fujisawa Pharmaceutical Toyama Plant
Toyama, Japan

InjectionsONO PHARMACEUTICAL Fujiyama Plant Sizuoka, Japan

ONO PHARMACEUTICAL Fujiyama Plant
Sizuoka, Japan

Biological productsONO PHARMACEUTICAL Fujiyama Plant Sizuoka, Japan

Hokkaido Sugar Sapporo Plant Hokkaido, Japan

Cosmetic productsIONA International  Fukushima Plant Fukushima, Japan

IONA International Fukushima Plant
Fukushima, Japan

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