{"id":126,"date":"2024-04-19T16:07:32","date_gmt":"2024-04-19T07:07:32","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=126"},"modified":"2024-09-05T10:41:53","modified_gmt":"2024-09-05T01:41:53","slug":"oral_agent","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/oral_agent\/","title":{"rendered":"Oral Drugs Facility"},"content":{"rendered":"<div id=\"oral_agent\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/\">Home<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\">Services<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/\">Sectors<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/\">Pharmaceuticals and Medical Devices<\/a>\/<\/li>\n<li>Oral Drugs Facility<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Pharmaceuticals and Medical Devices<\/span><br class=\"wpTag\">Oral Drugs Facility<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Pharmaceuticals and Medical Devices Oral Drugs Facility\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service18.webp\" alt=\"Pharmaceuticals and Medical Devices Oral Drugs Facility\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service18.webp\" alt=\"Pharmaceuticals and Medical Devices Oral Drugs Facility\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<section class=\"secBox\">\n<h2 class=\"headLine05\">About Oral Pharmaceuticals<\/h2>\n<p class=\"text\">There are numerous oral preparations taken by mouth, with representative types including tablets, capsules, granules, and powders. Tablets, in particular, can come in forms such as uncoated tablets, film-coated tablets, and sugar-coated tablets. The primary packaging, which directly contacts with the drug, functions to maintain the quality of the drug and ensure user convenience. This primary packaging includes PTP (Press Through Package) blister packaging, strip packaging, sachet packaging, stick packaging, and bottle packaging. Primary packaging products are further wrapped with single or multiple layers of film or paper, carrying regulatory-required labels (such as batch number, expiration date, GS1 barcodes, etc.) to maintain the quality of the product during transportation and prevent errors and ensure convenience during usage.<\/p>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Example of Manufacturing Process for Oral Pharmaceuticals<\/h2>\n<p class=\"text text01\">The following diagram illustrates a process flow chart for a film-coated tablet blister package product as an example of an oral formulation.<\/p>\n<h3 class=\"headLine11\">Process Flow Chart Example: Film-Coated Tablet Blister Packaging<\/h3>\n<div class=\"bigPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/img01.webp\" alt=\"Process Flow Chart Example: Film-Coated Tablet Blister Packaging\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/img01.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<div class=\"awareness\">\n<ul class=\"comRaiList\">\n<li>The preparation process and primary packaging process are conducted in a clean room where temperature, humidity, and particulate matter are controlled to prevent microbial and foreign matter contamination into the products.<\/li>\n<li>During the preparation process, raw materials and intermediate products for each batch are handled using containers between different process stages.<\/li>\n<li>Tablets are engraved or printed with the product name or other information. After they are visually inspected, samples are taken for quality testing.<\/li>\n<li>Lots that pass the quality tests proceed to primary PTP packaging and secondary packaging as pillow packaging, cartoning, printing &#038; inspection and cardboard packing. Unlike the preparation process, where between each stage requires manual handling, the packaging process is normally fully automated. Lots that pass the final quality tests are shipped.<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Key Points of Oral Pharmaceutical Manufacturing Equipment<\/h2>\n<div class=\"comGrayImgBox\">\n<h3 class=\"headLine06\">Handling of High Potency Pharmaceuticals<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark01.webp\" alt=\"Handling of High Potency Pharmaceuticals\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">With the increase in high potency pharmaceuticals such as anticancer drugs, containment performance using isolators and split valves is required for equipment handling particularly dispersive powder raw materials, from the perspective of both product quality and operator safety.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Batch Manufacturing and Equipment Integration<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark02.webp\" alt=\"Batch Manufacturing and Equipment Integration\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">In preparation processes, each batch is handled using containers (with different designs for powders and tablets). This requires design considerations for the integration of lifter or vacuum transfer equipment to manufacturing equipment.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Design of Preparation Equipment Required for Containment<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark03.webp\" alt=\"Design of Preparation Equipment Required for Containment\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">For product requiring containment, split valves are used, necessitating high-precision alignment of equipment horizontally and vertically. This involves complex design considerations including container and valve operation.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Evaluation and Selection of Production Equipment<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn phoInnStyle\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/keypoint23.svg\" alt=\"Evaluation and Selection of Production Equipment\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Production equipment includes mills, granulators, tablet presses, film coaters, capsule filling machines, weight sorting machines, and packaging machines, are evaluated and selected from containment, capabilities, sampling methods, dust collection, cleaning and other various points of view from domestic and international manufacturers. Containers washing machine also required.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Mechanical Flow Diagram<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn phoInnStyle\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/keypoint24.svg\" alt=\"Mechanical Flow Diagram\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Considering these factors, a mechanical flow diagram is created and reviewed with customers during the design phase.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Continuous Manufacturing<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark06.webp\" alt=\"Continuous Manufacturing\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">In place of conventional batch methods using containers, continuous manufacturing equipment automatically transfers raw materials and intermediates between processes is recently developed. Technologies such as Process Analytical Technology (PAT) inline, online, and at-line using NIR sensors or Raman spectroscopy ensure direct product quality monitoring, offering potential for real-time release testing (RTRT).<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Tablet Engraving and Printing<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark07.webp\" alt=\"Tablet Engraving and Printing\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Tablets are used to be engraved during tableting for identification. To improve identification, product names in katakana or other identifiers can be printed directly onto tablets using inkjet or laser printing, with many options available from various mahnufacturers to suit specific needs.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Prevention of Medical Errors and Traceability<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark08.webp\" alt=\"Prevention of Medical Errors and Traceability\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">To prevent medical errors from drug mix-ups and ensure traceability, barcode labeling has been mandated in packaging processes, requiring printing and inspection equipment. For exports, compliance with serialization and other regulations of the target countries is also necessary.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Anti-Counterfeit Technologies<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/oral_agent\/mark09.webp\" alt=\"Anti-Counterfeit Technologies\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">High-cost pharmaceuticals, especially for export, employ various anti-counterfeit technologies in labeling materials.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Contamination Prevention Measures<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"phoInn phoInnStyle\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/keypoint19.svg\" alt=\"Contamination Prevention Measures\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">To prevent cross-contamination of different products, production spaces should be zoned and laid out to facilitate line clearance at the start and end of production. As inspection equipment increases, the number of rejected items rises. Minimizing false positives and planning adequate space for handling rejected items are critical to reducing the risk of contamination. Shared washing areas for re-cleaning containers and considerations for residual checks within product cans during transport are also important.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Strengths of CM Plus<\/h2>\n<div class=\"comImgArea\">\n<div class=\"subArea\">\n<h3 class=\"headLine06\">\u2460Engineering + CM Method<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">The CM method is a project management system that integrates the client\u2019s perspective with designers to operate and manage projects transparently, ensuring success from the aspects of QCD (Quality, Cost, Delivery) + EHS (Environment, Health, Safety). Professionals, including Construction Managers (CMr) who specialize in management, work on behalf of the client.<\/p>\n<div class=\"comLink\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/feature\/\"><span class=\"subSpan\">Construction Managemnet by CM Plus<\/span><\/a><\/div>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo06.webp\" alt=\"\u2460Engineering + CM Method\"><\/div>\n<\/div>\n<div class=\"imgInn imgInnR flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">At CM Plus, we conduct engineering (design) in-house. We have engineers who are well-versed in manufacturing processes, equipment and facilities, construction, and manufacturing support facilities (such as electrical systems, HVAC, and utilities). This allows us to oversee the entire facility from the initial planning stages, enabling the construction of integrated and cohesive layout facilities.<\/p>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img09.webp\" alt=\"\u2460Engineering + CM Method\"><\/div>\n<\/div>\n<\/div>\n<div class=\"subArea\">\n<h3 class=\"headLine06\">\u2461Comprehensive Coordination of Production Equipment and Building Facilities<\/h3>\n<div class=\"imgInn flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">With a focus on designing from the production process perspective, we execute designs that start from the internal aspects like building production equipment lines, layouts, and internal flow\/logistics, leading to the creation of API (Active Pharmaceutical Ingredient) factories that are in harmony with the production system. Our planning extends to the intangible aspects of the production system as well.<\/p>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo14.webp\" alt=\"\u2461Comprehensive Coordination of Production Equipment and Building Facilities\"><\/div>\n<\/div>\n<div class=\"imgInn imgInnR flexB\">\n<div class=\"txtInn\">\n<p class=\"wpTag\">Our team consists of project managers and professional engineers experienced in factory construction across various fields. This allows us to manage the overall project schedule comprehensively, including not only the building and production support facilities but also providing support for the procurement, production management, and coordination of delivery plans of production equipment.<\/p>\n<\/div>\n<div class=\"phoInn\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img11.webp\" alt=\"\u2461Comprehensive Coordination of Production Equipment and Building Facilities\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox comBorBox\">\n<h2 class=\"headLine05\">Services provided by CM Plus<\/h2>\n<div class=\"comFlowListBox\">\n<ul class=\"comFlowList\">\n<li class=\"li01 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\"><span class=\"txtSpan\">Business Concept<\/span><\/a><\/li>\n<li class=\"li02 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\"><span class=\"txtSpan\">Conceptual Design<\/span><\/a><\/li>\n<li class=\"li03 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\"><span class=\"txtSpan\">Basic Design<\/span><\/a><\/li>\n<li class=\"li04 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\"><span class=\"txtSpan\">Procurement<\/span><\/a><\/li>\n<li class=\"li05 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Detailed Design \/ Production Management<\/span><\/a><\/li>\n<li class=\"li06 on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\"><span class=\"txtSpan\">Construction<\/span><\/a><\/li>\n<li class=\"on\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\"><span class=\"txtSpan\">Trial Operation<\/span><\/a><\/li>\n<li class=\"liStyle on\"><a href=\"#\" class=\"no\"><span class=\"txtSpan\">Operation<\/span><\/a><\/li>\n<\/ul>\n<\/div>\n<div class=\"comStepBox\">\n<div class=\"stepBox\">\n<div class=\"lBox\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">01<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img01.webp\" alt=\"Business Concept\"><\/span><\/p>\n<h2 class=\"headLine06\">Business Concept<\/h2>\n<\/div>\n<p class=\"wpTag\">We listen to our clients\u2019 requirements and create deliverables such as a list of key equipment, PFD (Process Flow Diagrams), and conceptual layouts to visualize the investment image. Based on the created deliverables, we calculate an approximate investment amount to support investment decisions (Feasibility Study, F\/S).<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox02\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">02<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img02.webp\" alt=\"Conceptual Design\"><\/span><\/p>\n<h2 class=\"headLine06\">Conceptual Design<\/h2>\n<\/div>\n<p class=\"wpTag\">In the basic planning (concept design) phase, we compile the client\u2019s requirements and requests through discussions and document them as a User Requirement Brief (URB). We also calculate an approximate project cost based on the contents of the URB.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox03\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">03<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img03.webp\" alt=\"Basic Design\"><\/span><\/p>\n<h2 class=\"headLine06\">Basic Design<\/h2>\n<\/div>\n<p class=\"wpTag\">In the basic design phase, based on the contents of the URB, we create the necessary drawings and specifications for effective solicitation. Specifically, in the process design, we produce PFDs, P&#038;IDs (Piping and Instrumentation Diagrams), data sheets, time schedules (OTS), and equipment specifications required for plant design. We also organize regulations and standards related to facility design and construction, government applications, and environmental conditions, support setting up the project\u2019s master schedule and overall execution plan, and assist with preparations and support for prior coordination with relevant government agencies and utility providers.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox04\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">04<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img04.webp\" alt=\"Procurement\"><\/span><\/p>\n<h2 class=\"headLine06\">Procurement<\/h2>\n<\/div>\n<p class=\"wpTag\">In the purocurement phase, to build an optimal execution system tailored to the project\u2019s characteristics, we study the order and service divisions and prepare solicitation specifications and procurement specifications based on these considerations. We then solicit quotations from construction companies. We support the client in selecting a construction company by conducting technical evaluations and quotation assessments on the proposals presented by the construction companies and summarizing them in a report.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox05\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">05<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img05.webp\" alt=\"Detailed Design \/ Production Management\"><\/span><\/p>\n<h2 class=\"headLine06\">Detailed Design \/ Production Management<\/h2>\n<\/div>\n<p class=\"wpTag\">In the detailed design and manufacturing management phase, we perform design supervision to ensure the construction company and production equipment suppliers reflect the URB, basic design documents, and various regulations in their designs and that progress is on schedule.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox06\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">06<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img06.webp\" alt=\"Construction and Installation Phase\"><\/span><\/p>\n<h2 class=\"headLine06\">Construction and Installation Phase<\/h2>\n<\/div>\n<p class=\"wpTag\">In the construction and installation phase, we perform construction supervision to ensure that the construction company reflects the URB, URS, detailed design documents, and various regulations in their work, and manage the quality of facilities and equipment. Additionally, a construction manager will reside on-site to manage construction status, progress, and changes from the client\u2019s perspective.<\/p>\n<\/div>\n<\/div>\n<div class=\"stepBox\">\n<div class=\"lBox lBox07\">\n<p class=\"barlow\">STEP<span class=\"txtSpan\">07<\/span><\/p>\n<\/div>\n<div class=\"rBox\">\n<div class=\"ttl\"><span class=\"img\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_img07.webp\" alt=\"Trial operation\"><\/span><\/p>\n<h2 class=\"headLine06\">Trial operation<\/h2>\n<\/div>\n<p class=\"wpTag\">To carry out high-quality and efficient qualification, we provide services that suit the client\u2019s needs, reducing their burden by supporting the creation of a validation master plan and risk assessment from the planning stage and creating protocols for Qualification (DQ, IQ, OQ, PQ), and supporting the execution phase.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"comTxt operationTtl\">Facility Operation<\/p>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Projects<\/h2>\n<ul class=\"comFooUl comCaseListSml flex\">\n<li>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/jitsubo\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/case_photo03.webp\" alt=\"Pharmaceuticals and Medical Devices\uff0fMedium-Molecule API\"><\/span><br \/>\n<span class=\"textBox\"><br \/>\n<span class=\"tag\"><span class=\"wpTag\">Pharmaceuticals and Medical Devices\uff0fMedium-Molecule API<\/span><\/span><br \/>\n<span class=\"ttl\">Cost reduction through separate sub-contracting<\/span><br \/>\n<span class=\"txt02\">JITSUBO Co., Ltd.<\/span><br \/>\n<\/span><br \/>\n<\/a>\n<\/li>\n<\/ul>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Contents<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/span><br \/>\n<span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/span><br \/>\n<span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section class=\"validation\">\n<h2 class=\"headLine04\">Useful Information<\/h2>\n<p class=\"wpTag\">Please refer to the articles on our information dissemination site, \u201cGMP Platform,\u201d which is operated by our company.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo07.webp\" alt=\"\u201cHow to Build a Pharmaceutical Plant\u201d \"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cHow to Build a Pharmaceutical Plant\u201d <\/h4>\n<p class=\"wpTag\">Aggregating expertise for the successful execution of pharmaceutical plant construction projects. From project structuring and basic planning to basic and detailed design, construction, and validation, we provide detailed explanations and key points for each step of the process.<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=8821\" target=\"_blank\" rel=\"noopener\u00a0noreferrer noopener\">\u201cHow to Build a Pharmaceutical Plant\u201d Table of Contents<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo05.webp\" alt=\"We have published a book in English. Please refer to this news.\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">We have published a book in English. Please refer to this news.<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/news\/event\/2023_0609\/\" rel=\"noopener\u00a0noreferrer noopener\">A presentation at ISPE Indonesia&#8217;s Annual Conference 2023<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"comOtherBox comOtherBox02\">\n<h2 class=\"headLine04\">Other Services<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo02.webp\" alt=\"Consulting\"><\/span><br \/>\n<span class=\"subSpan\">Consulting<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"Education\/Training Support\"><\/span><br \/>\n<span class=\"subSpan\">Education\/Training Support<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/span><br \/>\n<span class=\"subSpan\">Technical Information Services<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<\/article>\n<aside id=\"sideBar\">\r\n\t<p class=\"sideTtl\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\"><span class=\"txtSpan barlow\">Services<\/span><\/a><\/p>\r\n\t<ul id=\"menu-service\" class=\"sideList\"><li id=\"menu-item-238\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-238\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-253\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-253\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/production_facility\/\">One-Stop Service for Production Facilities<\/a><\/li>\n\t<li id=\"menu-item-240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-240\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/construction_management\/\">About Construction Management<\/a><\/li>\n\t<li id=\"menu-item-239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-239\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/feature\/\">Construction Management by CM Plus<\/a><\/li>\n\t<li id=\"menu-item-6143\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-6143\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_management_consultant\/\">Project Management Consultant (PMC)<\/a><\/li>\n\t<li id=\"menu-item-243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-243\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\">Facility Construction<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-245\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\">Business Concept<\/a><\/li>\n\t\t<li id=\"menu-item-246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-246\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\">Conceptual Design<\/a><\/li>\n\t\t<li id=\"menu-item-247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-247\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\">Basic Design<\/a><\/li>\n\t\t<li id=\"menu-item-248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-248\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\">Procurement<\/a><\/li>\n\t\t<li id=\"menu-item-249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-249\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\">Detailed Design \/ Production Management<\/a><\/li>\n\t\t<li id=\"menu-item-244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-244\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\">Trial Operation -Commissioning &#038; 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Tablets, in particular, can come in forms such as uncoated tablets, film-coated tablets, and sugar-coated tablets. The primary packaging, which directly contacts with the drug, functions to maintain the quality of the drug and ensure user convenience. This primary packaging includes PTP (Press Through Package) blister packaging, strip packaging, sachet packaging, stick packaging, and bottle packaging. Primary packaging products are further wrapped with single or multiple layers of film or paper, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":120,"menu_order":36,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[9,11],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Oral Drugs Facility\uff5cProduction Facilities\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"CM Plus provides total support for the construction of production facilities in the pharmaceutical and medical device fields. By adopting the Engineering + CM (Construction Management) method, we coordinate production equipment and building facilities for oral dosage manufacturing facilities. 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