{"id":123,"date":"2024-04-19T16:06:59","date_gmt":"2024-04-19T07:06:59","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=123"},"modified":"2024-09-05T10:41:13","modified_gmt":"2024-09-05T01:41:13","slug":"sterile_medicine","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/sterile_medicine\/","title":{"rendered":"Sterile Pharmaceutical Manufacturing Facility"},"content":{"rendered":"<div id=\"sterile_medicine\">\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>Sterile Pharmaceutical Manufacturing 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\">Sterile Pharmaceutical <br \/>Manufacturing 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 Sterile Pharmaceutical Manufacturing 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-service17.webp\" alt=\"Pharmaceuticals and Medical Devices Sterile Pharmaceutical Manufacturing 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-service17.webp\" alt=\"Pharmaceuticals and Medical Devices Sterile Pharmaceutical Manufacturing 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 Sterile Pharmaceuticals<\/h2>\n<p class=\"text\">Sterile pharmaceuticals include injectable drugs administered by injection, dialysis agents administered through dialysis, and eye drops administered to the eye. Direct containers in contact with the drug have functions to maintain the quality of the drug and to ensure user convenience. These containers include ampoules, vials, cartridges, infusion bags, pre-filled syringes (PFS), blow-fill-seal (BFS), form-fill-seal (FFS), and plastic containers. Sterile pharmaceuticals are manufactured using either terminal sterilization methods or aseptic processing methods to ensure sterility. When handling various containers such as vials and syringes, the supply form of direct containers called NEST, where pre-washed and sterilized direct containers are set in dedicated cases, is sometimes used. In such cases, devices like filling machines are also dedicated to NEST, but they feature easy container switching. Filled products are packed in single or multiple layers of films or paper, labeled with legally mandated information (such as lot numbers, expiration dates, and GS1 barcodes), and maintain the quality of the product during transportation and prevent errors and ensure convenience during use.<\/p>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Example of a Sterile Pharmaceutical Manufacturing Process<\/h2>\n<p class=\"text text01\">The following diagram illustrates the process flow of a vial product using the aseptic method as an example of a sterile pharmaceutical.<\/p>\n<h3 class=\"headLine11\">Example of Process Flow Diagram:<br class=\"sp\">Vial Product Using Aseptic Method<\/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\/sterile_medicine\/img01.webp\" alt=\"\u5de5\u7a0b\u30d5\u30ed\u30fc\u56f3\u306e\u4f8b\uff1a\u30d0\u30a4\u30a2\u30eb\u6db2\u6ce8\u54c1\u306e\u7121\u83cc\u64cd\u4f5c\u6cd5\u3067\u306e\u88fd\u9020\u5de5\u7a0b\u306e\u4f8b\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/sterile_medicine\/img01.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<div class=\"awareness\">\n<ul class=\"comRaiList\">\n<li>Weighing of raw materials, preparation and processes from washing of containers filling\/stoppering\/sealing, these processes are conducted in a clean room controlled for appropriate particle count, temperature, and humidity to prevent microbial and foreign matter contamination. Particularly, the filling and stoppering processes are performed in grade A cleanliness environments, classified as critical areas.<\/li>\n<li>Vials are depyrogenized through a dry heat sterilization tunnel, while rubber stoppers are washed and sterilized using dedicated equipment. The preparation solution is supplied to the filling device via a sterile filtration filter.<\/li>\n<li>Sealed vials are inspected for external and internal foreign substances using visual inspection machines, and quality tests, including sterility testing of sampled products, are conducted.<\/li>\n<li>Filled products that pass the quality tests are labeled with information such as lot numbers and expiration dates. They are then packed into carton printed with the necessary information. Lots that pass final testing are shipped.<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Key Points of Sterile Pharmaceutical Manufacturing Equipment<\/h2>\n<div class=\"comGrayImgBox\">\n<h3 class=\"headLine06\">Manufacturing Process and Cleanliness Class\/Grade Management Concepts<\/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\/sterile_medicine\/mark01.webp\" alt=\"Manufacturing Process and Cleanliness Class\/Grade Management Concepts\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Filling has traditionally been conducted in an aseptic room, however, when introducing new equipment, it is increasingly common to incorporate isolator and Restricted Access Barrier System (RABS) technologies to completely isolate from operator contact, which is one of the highest contamination risks, into grade C\/D environments. Surrounding equipment such as glove leak testers, decontamination devices, and particle monitoring systems are necessary. Coordination with the air conditioning system is also required for decontamination.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Operator Safety<\/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\/sterile_medicine\/mark02.webp\" alt=\"Operator Safety\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">With the increase in high potency product such as biopharmaceuticals, in addition to product quality, containment performance using isolators equipped with HEPA filters in preparation and filling equipment exhausts are demanded from the perspective of operato safety. The design of pressure differentials and airflow inside and outside the isolators and filling rooms during operation and decontamination is necessary. Additionally, external washing devices for cleaning the outer surfaces of containers after filling may be introduced as needed.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Leak Testing\/Integrity Assurance<\/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\/sterile_medicine\/mark03.webp\" alt=\"Leak Testing\/Integrity Assurance\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">For ensuring the integrity of containers, in the case of vials, the opening of the empty vial is inspected with a camera to prevent leaks from the rubber stopper area, and various parameters of the rubber stoppering and sealing devices are monitored for each vial to ensure integrity. Automatic container leak testers from multiple companies can be chosen based on the risk. In the case of containers sealed by melting such as ampoules, 100% inspection is conducted using dry or wet pinhole inspection machines.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Risk Mitigation for Foreign Matter Contamination<\/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\/keypoint14.svg\" alt=\"Risk Mitigation for Foreign Matter Contamination\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Foreign matter contamination poses a significant quality risk, so preventive measures against foreign matter contamination are taken with each equipment until the container is sealed. Monitoring the cleaning functions of washing machines is also necessary. In the event of glass container breakage at the filling supply section, it is important to introduce detection devices and design so that surrounding containers can be recovered through gloves. When introducing visual inspection machines for foreign matter after filling, it is necessary to confirm with the manufacturer in advance that the equipment can distinguish and inspect external foreign matter from bubbles in the solution or the content of the preparation. Minimize the number of false rejections, confirm the detected foreign matter and converting the results into data is to help reduce foreign matter contamination.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Aseptic Connection Devices<\/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\/sterile_medicine\/mark05.webp\" alt=\"Aseptic Connection Devices\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">Rubber stoppers are fed in the vessel with RTP (rapid transfer port) and washed, sterilized and dryed in the vessel on the washing and sterilizing equipmant and then the vessel is transported in filling room and connected to the filling isolater with the lifter and rubber stoppers are fed to the stoppering device aseptically. This machine are available from several manufacturers. Considerations need to be given to the size of the vessel, the frequency of washing and sterilization, whether aluminum caps require sterilization, and the method of installing lifters and the available installation space.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Prevention of Medical Accidents, 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\/sterile_medicine\/mark06.webp\" alt=\"Prevention of Medical Accidents, Traceability\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">To prevent medical accidents caused by misidentification of pharmaceuticals and to ensure traceability, barcode display has been mandated for packaging, requiring printing and inspection device to the packaging process. Additionally, when exporting to overseas, compliance with the labeling regulations of the target country is necessary.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Techniques for Countering Counterfeit Drugs<\/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\/sterile_medicine\/mark07.webp\" alt=\"Techniques for Countering Counterfeit Drugs\"><\/div>\n<div class=\"txtInn\">\n<p class=\"wpTag\">For high-value and exported abroad drugs, anti-counterfeiting technologies may be applied to 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, enough space and compartmentalization of the production layout as well as equipment specifications facilitating line clearance at the start and end of production are essential. Along with the increase in inspection devices, the amount of rejected products will also rise. Therefore, it is crucial to minimize false detections and to plan sufficient space for handling rejected products in order to eliminate the risk of contaminating defective products. Additionally, shared wash areas for re-cleaning containers and consideration of residual confirmation within product trays used to transport containers are necessary.<\/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\/service\/engineering\/industrial_field\/pharma_medical-device_cosmetic\/sterile_medicine\/img02.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; Qualification-<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-254\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-254\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/\">Sectors<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-242\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-242\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/\">Pharmaceuticals and Medical Devices<\/a>\n\t\t<ul class=\"sub-menu\">\n\t\t\t<li id=\"menu-item-263\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-263\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/sterile_medicine\/\">Sterile Pharmaceutical<\/a><\/li>\n\t\t\t<li id=\"menu-item-264\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-264\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/oral_agent\/\">Oral Drugs<\/a><\/li>\n\t\t\t<li id=\"menu-item-256\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-256\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/medium_molecule_drugs\/\">Medium-Molecule API<\/a><\/li>\n\t\t\t<li id=\"menu-item-257\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-257\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/macromolecular_drugs\/\">Large-Molecule (Biopharmaceutical) API<\/a><\/li>\n\t\t\t<li id=\"menu-item-813\" class=\"menu-item menu-item-type-custom menu-item-object-custom menu-item-813\"><a href=\"\/en\/service\/consulting\/regenerative_medicine\/\">Regenerative Medicine<\/a><\/li>\n\t\t<\/ul>\n<\/li>\n\t\t<li id=\"menu-item-265\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-265\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/food\/\">Food<\/a><\/li>\n\t\t<li id=\"menu-item-261\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-261\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/cosmetic\/\">Cosmetics<\/a><\/li>\n\t\t<li id=\"menu-item-260\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-260\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/home-care\/\">Home Care Products<\/a><\/li>\n\t\t<li id=\"menu-item-262\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-262\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/semiconductor\/\">Semiconductors and Electronic Devices<\/a><\/li>\n\t\t<li id=\"menu-item-259\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-259\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/data_center\/\">Data Centers<\/a><\/li>\n\t\t<li id=\"menu-item-258\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-258\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/chemical_plant\/\">Chemical Plants<\/a><\/li>\n\t\t<li id=\"menu-item-5871\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5871\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/logistics\/\">Logistics<\/a><\/li>\n\t\t<li id=\"menu-item-5870\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5870\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/halal\/\">Halal<\/a><\/li>\n\t<\/ul>\n<\/li>\n\t<li id=\"menu-item-250\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-250\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/\">Cross Border Project Management<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-251\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-251\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/partners\/\">Alliance Partners in Southeast Asia<\/a><\/li>\n\t\t<li id=\"menu-item-252\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-252\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/overseas_project_support\/partners_2\/\">Collaboration Partners in Europe and America<\/a><\/li>\n\t<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li id=\"menu-item-266\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-266\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\">Consulting<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-272\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/gmdp_consulting\/\">Pharmaceutical GMP &#038; 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Direct containers in contact with the drug have functions to maintain the quality of the drug and to ensure user convenience. These containers include ampoules, vials, cartridges, infusion bags, pre-filled syringes (PFS), blow-fill-seal (BFS), form-fill-seal (FFS), and plastic containers. Sterile pharmaceuticals are manufactured using either terminal sterilization methods or aseptic processing methods to ensure sterility. When handling various containers such as vials and syringes, the supply [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":120,"menu_order":35,"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>Sterile Pharmaceutical Manufacturing 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 sterile pharmaceutical manufacturing facilities. We meet your requirements for quality, cost, and schedule.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/field\/pharma_medical-device\/sterile_medicine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sterile Pharmaceutical Manufacturing Facility\uff5cProduction Facilities\uff5cCM Plus\" \/>\n<meta property=\"og: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 sterile pharmaceutical manufacturing facilities. 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