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Mangan Biopharm Industry (MBI) is a full service automation integration, commissioning, qualification, and validation services organization. MBI's staff of highly qualified automation and controls engineers design and integrate automation systems that meet the complex control and documentation needs of our clients in this heavily regulated industry. Our commissioning and validation engineers are experienced professionals that understand the regulatory requirements to efficiently qualify facilities and processes.
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We have technical expertise in controls systems, manufacturing equipment, utilities and facilities for all industry applications.
We have technical manufacturing expertise in biotechnology and synthetic API processes, as well as steam sterilization, aseptic processing, and many others.
Our expertise in automation and validation allow us to truly provide turn-key automation control systems to the biotechnology and pharmaceutical industries.
Training
We believe that training and quality are the components necessary to meet the integration and regulatory needs of the biotechnology and pharmaceutical industries. All MBI staff undergo internal training specific to the biopharmaceutical industry prior to working for any customer, regardless of their seniority. We do this to ensure that our standards of quality are maintained and to provide a consistent baseline of knowledge. Internal training is procedurally governed and consists of classroom presentations, individual modules, and testing. In addition to formalized training opportunities, we have integrated senior level degreed engineers—versed by years of experience in biopharm—into our company’s business model for training and success. Many have joined Mangan after years with clients and end-users, making their knowledge base both applicable and desired. |
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We are a full service commissioning, qualification and validation team. Senior staff with 15+ years experience in the biotechnology and pharmaceutical industries posses the knowledge and experience to work with our customers on projects of all sizes—from large scale construction and startup of new facilities to development of SOPs in existing facilities. Our senior engineers lead mid and junior level staff on project teams to ensure customer expectations are being met. Quality documentation is essential. Understanding the needs of our customers allows us to work efficiently to complete project deliverables on time and within budget.
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| Commissioning of New and Modified Facilities |
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(From design through turnover for qualification)
We work with engineering project teams to ensure and document compliance to specifications during procurement, FAT, SAT and startup for automation, equipment and utilities on projects of all sizes. We train our staff internally to ensure that they are familiar with national standards and guidelines by ASME/BPE, ASTM, ISPE, PDA and ISO. |
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o Facility Design & Consultation |
o Integrated Commissioning & Qualification |
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o Validation Master Planning |
o Cleaning & Steaming Qualification |
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o Manufacturing Equipment/System Qualification
(IQ/OQ) |
o Process Validation & Regulatory Filings |
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| System Qualification |
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Process Automation, BAS, Manufacturing Equipment, Laboratory Equipment, Clean Utilities, Controlled Environments (HVAC), Plant Utilities, etc. We have the experience to drive large and small qualification projects for our customers and get things done when others falter. We are very experienced conducting performance qualification of SIP for process systems, autoclave loads and cleaning validation for biotech processes. Our engineers posses a high level of experience and knowledge in biotechnology and synthetic API processing and validation of manufacturing processes in general.
We have experience with the following systems: |
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o Clean Utilities |
o Formulation and Filling |
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o Plant Utilities |
o Aseptic Processes |
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o Media Prep |
o Process Validation & Regulatory Filings |
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o Fermentation |
o Crystallization |
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o Bioreactors |
o Distillation Systems |
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o Centrifugation |
o Cleaning |
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o Homogenization |
o Production and Laboratory Autoclaves |
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o Chromatography |
o CIP |
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o Lyophilization |
o Controlled Environments (HVAC) |
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We provide full facilities integration services from concept to systems installation, commissioning, and qualification for the biotech and pharmaceutical industries. Automation expertise in all industry applications from Utilities, Building Automation Systems, Batch and Continuous Process Control, and Packaging makes Mangan Biopharm Industry an ideal choice for any integration need. The Automation group consists of registered professional engineers and control system specialists located in multiple offices across the USA. Expertise in automation, commissioning, and qualification allow us to provide seamless integration of qualified and documented automated control systems that meet the requirements of the end user.
Fundamental to Mangan’s success is our ability to assess the needs of our clients and meet them in the most effective manner without compromising quality.
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| Proper analysis of end-user requests and project planning ensure regulatory and business needs are met and products get delivered to patients. Our staff of project managers, engineers and technical experts can assist our clients to develop system life cycle documentation and conduct feasibility studies for presentation. We can produce: |
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o User Requirements Specifications |
o Functional Specifications |
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o Detailed Design Specifications |
o Unbiased Business Case Analysis |
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o Bid Documents Preparation |
o Presentations to Client Management |
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| In today’s market, it is no longer enough to provide programming, engineering or qualification services without having a full understanding of the peripheral components employed and the regulatory environment that our customers operate within. Over the past 11 years, our Biopharm Group has performed well over 400 integration projects from concept through completion, including: |
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o Preliminary Engineering Services |
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o Detailed Project Scope Development |
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o Failure Mode Effects Analysis (FMEA) Development and Execution |
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o Engineering Documentation Using GAMP and Client Specifications |
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o Infrastructure Design and Planning |
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o System Design, Engineering, Fabrication, and Coordination Services |
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o Operator Interface Documentation, Design and Planning |
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| MBI has built its reputation developing intuitive solutions for challenging and complex applications. Much of our business is a result of developing solutions for complex programming structures and interfaces necessary to meet client requests. Despite our technical expertise, we understand that in order for our customers to maintain the systems we develop and implement, system design solutions must be as simple as possible to support inevitable future changes and management of those in a heavily regulated environment. We achieve this by maintaining vendor neutrality and a clear focus on end result benefits to the client, their end-user, and the patient. Services available to meet programming needs include: |
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DCS/PLC/HMI Programming and Implementation—Our Biopharm Group
is well versed in many hardware and software platforms, including Allen-Bradley ® /Rockwell Software ® , DeltaV ™ , Siemens ® , Honeywell, GE Fanuc, Wonderware ® , and many others. |
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IT/IS Planning, Configuration and Implementation |
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S-88 Batch Programming |
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Plant Wide Historization and Management |
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Vendor Links
California
Long Beach
(310) 835-8080 | email
Westlake Vilage
(310)735-0466 | email
Colorado
Boulder
(303)951-9343 | email
Texas
Houston
(281)484-0099 | email
Lake Jackson
(979)265-5556 | email
Georgia
Alphareta
(770)569-1684 | email
North Carolina
Cary
(919)249-5932 | email
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