The Study of Decarbonizing Pharmaceutical Plants in Southeast Asia, posted on ISPE’s “Pharmaceutical Engineering.”

The ISPE bi-monthly magazine ‘Pharmaceutical Engineering’ (November/December 2024) has been published with an article contributed by our employees, Mr. Goto, Mr. Tahara, Mr. Inoue and Dr. Hasunuma. The article introduces our efforts to reduce carbon emissions while identifying hazards and assessing risks from a GMP perspective in order to decarbonize pharmaceutical plants in Southeast Asia.   Summary of the article Title "Decarbonizing Pharmaceutical Manufacturing Facilities for Drug Products’ Carbon Footprint Reduction" Authors ・Mr. Koichi GOTO (MSc), Senior General Manager of the Overseas Strategy Office at CM Plus Corporation, ・Mr. Shigehiro TAHARA, Senior advisor about International Pharmaceutical Manufacturing Facility Engineering of CM Plus Corporation, ・Mr. Yoshiyuki Inoue, Corporate Officer at CM Plus Singapore ・Dr. Hideki Hasunuma, HVAC and Carbon Neutral Engineer at CM Plus Corporation. Abstracts Reducing pharmaceutical's carbon footprint has become a management responsibility. This paper introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from the pharmaceutical manufacturing facilities in Southeast Asia. In general drug production facilities, a hazard identification and risk assessment from a GMP perspective should always be performed on the proposed energy efficiency improvements identified from an engineering perspective, and the necessary actions should be considered. In some situations, it is possible that a proposed improvement may not be effective or feasible. Therefore, there are considerable hurdles to reduce carbon emission from drug manufacturing plants compared to general facilities. As an example, we will describe our approach for the decarbonization at an operational pharmaceutical manufacturing facility in Southeast Asia, with key steps along the way. The paper also includes a note on the sustainability aspects of the SDGs (Sustainable Development Goals). Carbon footprint reduction plan also requires a consideration of the manufacturing facility's life cycle. We hope this paper will help to further reduce the carbon footprint...

https://cm-plus.co.jp/en/news/event/2024_1118/

Cross Border Project Management

Home/ Services/ Engineering, Project Management/ Cross Border Project Management Engineering, Project ManagementCross Border Project Management CM Plus will support Project as One-Stop Service Provider. CM Plus will support clients for their construction projects as "One-Stop Service Provider" in Japan including Southeast Asian countries, not only in the fields of pharmaceuticals production / R&D facilities, but also various kinds of production facilities for foods, home cares, cosmetics, datacenter, semiconductor, etc.Our professionals with plentiful experience in overseas projects will take care of such projects, taking into account (1) different languages, (2) different cultures, customs, regulations, and (3) difficulties in communications between remote locations, etc., which are common issues in overseas projects.We will respond to the clients' concerns with overseas project execution, especially about lack of information on the local conditions, such as industrial complex, regulations, cost, construction market situations, and labors wages, etc., and also concerns about government applications. For the foreign investors those who plan to build a factory in Japan, CM Plus provides the same concept of one-stop service from feasibility study and/or land selection to facility commissioning and validations. Project case of Overseas Supporting Work Steps of factory construction project We will execute a project in a flow as shown below. CM Plus will execute a project in a manner to protect the client's interests from the planning phase to the completion for the facilities. Business Concept Conceptual Design Basic Design Procurement Detailed Design Construction Final Inspection Operation STEP01 Business Planning to Basic Planning What the client needs to realize in the project should be documented. We will help the client to build the business plan by incorporating your idea. We can support various surveys in the planning stage, formulation of policies and strategies based on those surveys, and the development of entry plans. Additionally, we can leverage personnel...

https://cm-plus.co.jp/en/service/engineering/overseas_project_support/

Alliance Partners in Southeast Asia

Home/ Services/ Engineering, Project Management/ Cross Border Project Management/ Alliance Partners in Southeast Asia Cross Border Project ManagementAlliance Partners in Southeast Asia CM Plus has formed alliances with companies in Asian countries. The network of each country cooperates and will meet your requests. Map of Alliance partners in Southeast Asia We are planning to expand our partnership with Singapore, Indonesia in the future. MALAYSIA    NEW! Company name Medhini Group Sdn Bhd Address 66-02, Laman Niaga Sunway, Persiaran Medini 3, Bandar Medini Iskandar, 79250 Iskandar Puteri, Johor TEL +6019-239 4855 URL https://medhini.com.my/ Company name VERITAS DESIGN GROUP Address 2nd Floor Bangunan Getah Asli 148 Jalan Ampang 50450 Kuala Lumpur Malaysia TEL +60 3 2162 2300 FAX +60 3 2162 2310 URL https://www.theveritasdesigngroup.com Company name TLC ARCHITECT Address Unit D-3A-6, Megan Avenue 1, 189 Jalan Tun Razak, 50400, Kuala Lumpur Malaysia TEL +60 3 2770 6755 FAX +60 3 2770 6733 e-mail tlcarchitect@yahoo.com INDIA Company name IPS-Mehtalia Pvt. Ltd. Address Unit-B 101-109, First Floor, Kailash Vaibhav Industrial Complex, Park Site, Vikhroli (West), Mumbai 400079, India TEL +91 022 6720 9717 URL https://www.ipsdb.com/southeast-asia/india Global Locations https://www.ipsdb.com/about-ips/locations PHILIPPINES Company name Jonathan O. Gan & Associates Address 10 Saint Paul Street, Horseshoe Village, Quezon City, Metro Manila, Philippines 111 TEL +63 9 175 853 249 URL https://www.jogassociates.com Company name GF & Partners Architects Address 11F BDO Plaza, 8737 Paseo de Roxas Makati City, Philippines TEL +63 917 557 9749 URL https://gfparchitects.com THAILAND Company name SASI D&M Co., Ltd Address G Floor, Ideo Mobi Bangsue Grand Interchange, 571 Pracharat Sai 2 Rd., Bangsue, Bangkok 10800 TEL +668 19132536 e-mail chandrasakha.thaweejit@gmail.com Company name EEC ENGINEERING Address No.40, EEC Academy Building, Soi Ramintra 97, Ramintra Rd., Kannayao Subdistrict, Kannayao District, Bangkok. 10230 TEL +66 2005 -2900-13 FAX +66 2005 -2915 URL https://www.eec.co.th Company name ON GROUND Address 128...

https://cm-plus.co.jp/en/service/engineering/overseas_project_support/partners/

Collaboration Partners in Europe and America

Home/ Services/ Engineering, Project Management/ Cross Border Project Management/ Collaboration Partners in Europe and America Cross Border Project ManagementCollaboration Partners in Europe and America CM Plus collaborates with companies in Europe and North America. The networks in each country work together to meet customer demands. Map of Collaboration Partners in Europe and America UNITED STATES Company name CRB Group, Inc. Address 101 Station Landing, Suite 210 Medford, MA 02155 TEL +1(617) 475-3050 URL https://www.crbgroup.com/ NETHERLANDS Company name Arcadis Address Gustav Mahlerplein 97-103,1082 MS,P.O. Box 7895,1008 AB Amsterdam Netherlands TEL +31 (0) 88 4261 261 URL https://www.arcadis.com/ IRELAND Company name TANDEM Address 11 Nessan House, Mahon Industrial Estate, Blackrock, Cork T12 XN4V TEL +353 (0)21 203 8130 URL https://www.tandempm.ie/ Related Contents Projects Performance by Numbers Other Services Consulting Education/Training Support Technical Information Services [add_part part="sidebar-service"]

https://cm-plus.co.jp/en/service/engineering/overseas_project_support/partners_2/

Technical Information Services

Home/ Services/ Technical Information Services ServicesTechnical Information Services The environment surrounding facilities and equipment requiring advanced environmental control, such as those in the life sciences and semiconductor sectors, is evolving to become more international, diverse in scope, and demanding in terms of information processing.Our company, which thrives on challenges in engineering and life sciences manufacturing quality, offers comprehensive information services to support our clients’ international operations. These services address topics related to GMP (Good Manufacturing Practice), QMS (Quality Management Systems), and the latest technological advancements, including digitalization.In addition, we provide product services that include engineering information tools and education and training related to quality. GMP Platform Aggregating knowledge to solve our clients’ challenges GMP Platform is a free information site established based on CM Plus Corporation’s founding principle of addressing various quality-related issues in life sciences facilities while staying close to our customers. We offer a variety of technical articles and translated and explained guidelines. In addition to GMP (Good Manufacturing Practice), we also share information related to clinical and non-clinical studies, as well as quality and safety for medical devices, cosmetics, and even food products. CM Plus aims not only to disseminate the expertise of our experienced in-house consultants and engineers through this site but also to gather and integrate knowledge from top consultants worldwide to help solve any challenges our clients may face. GMP Platform Internet Virtual Exhibition for Life Science Life Science Company Information Platform Life Science Company Information Platform is a specialized portal site where top suppliers, who constitute the robust supply chain in the life sciences industry, showcase and share extensive information on their latest technologies, products, and services. Those seeking the latest information on technologies, products, and services related to life sciences can access a wealth of information from various perspectives provided by the...

https://cm-plus.co.jp/en/service/technology_information/

Terumo Vietnam

Home/ Portfolio/ Projects/ Terumo Vietnam Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facilities that are safe and environmentally friendly for people and communities Terumo Vietnam Co., Ltd DATA Facility Use Medical device manufacturing facility Summary (Total floor area): More than 30,000㎡ including renovation for existing facility Location Hanoi, Vietnam PREV NEXT 1 / 3 Services we provided 1.Support for preparation of URB (User Requirements Brief) 2.Basic planning 3.Basic design 4.Validation planning 5.Construction company decision support 6.Detailed Design supervision 7.Construction supervision 8.Validation support Project flow Approx. 6 months Basic Plan /Basic DesignInquiry Preparation Approx. 4 months Inquiry for construction quotation Approx. 7 months Detailed Design Approx. 18 months Construction Our contributions to the project Documented required utility conditions, and requirements for facilities and equipment as URB in accordance with the expected product production volume, manufacturing environmental standards, Vietnamese national regulations, Chinese medical device regulations, MDR, 21CFRPart820 (QSR), and the Pharmaceutical Affairs Law. In the basic plan, we organized the flow lines of people and goods, environmental standards, and changing systems, and studied the floor plan and cross-sectional plans, including plans for existing renovations according to the manufacturing operations in each process, We completed the basic design with a structural plan and material selection that matched the actual conditions of the construction site (Vietnam). At the construction inquiry stage, we prepared specifications for quotation inquiries, design documents, and requirement specifications for validation with clear specifications. This made it possible to conduct quotations for multiple companies and to evaluate quotations fairly. During the detailed design and construction phase, our CM and four Vietnamese engineers were stationed at the site to supervise the construction work, including checking the construction progress, checking construction quality, confirming changes, and assessing additional construction costs, thereby contributing to ensuring good construction quality. Smooth start-up of production facilities was...

https://cm-plus.co.jp/en/portfolio/project_details/terumo-vietnam/

Takasago

Home/ Portfolio/ Projects/ Takasago Food／Flavor・Fragrance Facilitate project execution between the Asia headquarters and Japan headquarters Takasago International Singapore Pte. Ltd. DATA Facility use Flavor and fragrance manufacturing factory Summary Total floor area: approx. 10,000㎡ Location Suburban Jakarta, Indonesia PREV NEXT 1 / 3 Services we provided CM Plus provided the following engineering consulting services 1.Feasibility study support 2.Conceptual design (Engineering Management services) 3.Construction contractor selection support (Project Management services) 4.Detailed design management (Project Management services) 5.Construction supervision (Construction Management services) Project flow Approx. 1 year Feasibility study Approx. 6 months Prepare Conceptual Design/ Quotation form 3 months Construction company quotation inquiry stage 14 months Detailed design / construction phase Our contributions to the project A bilingual (Japanese-English) member of CM Plus team participated in the project. We supported smooth communication between the Singapore Asia headquarters, who placed the order, and the Japanese headquarters, who has approval authority. In the feasibility study, we clarified the production workflow by visualizing the movement of people and goods in a flow diagram based on the client's requirements, and were responsible to execute the plan. Following this, we were able to estimate construction costs and calculate the required land area, and the project execution quickly progressed within the client. We also played a role in presenting multiple case studies and gathering internal client opinions. By accurately proceeding with the construction plan, we were able to present costs with few errors and the customer was able to set a budget early. At the construction inquiry stage, we prepared a document for requesting quotation inquiry with clear specifications. This allowed us to conduct inquiries from several construction companies and evaluate estimates fairly, and also helped to minimizing additional changes during construction. We were able to select the best contractor by performing cost and technical evaluations based on...

https://cm-plus.co.jp/en/portfolio/project_details/takasago/

Medreich Limited

Home/ Portfolio/ Projects/ Medreich Limited Pharmaceuticals and Medical Devices Pharmaceutical manufacturing factory: Expansion for manufacturing line Medreich LimitedMeiji Seika Pharma Co., Ltd. Group DATA Facility Pharmaceutical manufacturing factory Location Bangalore, India PREV NEXT 1 / 3 Services we provided The following services were provided as engineering consulting 1.Conceptual Design (Engineering Management services) 2.Contractor selection support (Project Management services) 3.Detailed Design Management (Project Management services) 4.Construction Supervision (Construction Management services) 5.Validation support (Validation Management services) Project flow Approx. 4 months Prepare Conceptual design/ Contract documents 2 months EPC company’s basic design Approx. 3 months EPC company’s detailed design phase 6 months Construction phase Our contributions to the project CMP’s Japanese – English bilingual members participated Prepared documents for concluding a contract with the design and construction company. Reviewed the detailed design of the design and construction company. Two Japanese staff and two Indian staff were stationed at the site to supervise construction and validation, and the project was completed within the scheduled period. Checked the completion of the Validation Final Report and ensured that the necessary documents were in place. Services related to this project Engineering, Project Management Other Projects Pharmaceuticals and Medical Devices Large-scale medical device manufacturing facility equipped with the latest logistics system Terumo Yamaguchi Corporation Pharmaceuticals and Medical Devices Manufacturing facility for bio-based Class IV implantable medical devices CoreTissue BioEngineering Inc. Pharmaceuticals and Medical Devices／Medium-Molecule API Cost reduction through separate sub-contracting Jitsubo CO., LTD. Pharmaceuticals and Medical Devices／Packaging Aiming to create a factory that "responds to rapidly changing customer demands and stay ahead of the competition for 15 years" Iwata Label Co., Ltd.(currently IL Pharma Packaging Co., Ltd.) Cosmetics “Show” cosmetics factory Toyo Beauty Co., Ltd. Data Centers System module type data centerRealizing short construction period and low cost Internet Initiative Japan Inc. Pharmaceuticals and Medical Devices Large-scale...

https://cm-plus.co.jp/en/portfolio/project_details/medreich/