Mangan, Inc. - Overview of BioTech Solutions

Standardized Process Solutions with Different Levels of Automation Available | Part 11 Roadmap | S88 Based Tank Farm Automation Systems

Biotech_Lifescience

Life Science Manufacturing Maturity Begins

The maturation of biotech companies to consistently profitable enterprises is based primarily on their research and development success. After a pipeline of products has been developed, manufacturing excellence becomes the focus. Several internationally recognized firms have reached this point and are focusing on manufacturing processes that are predictable, reliable and cost efficient.

Advanced Automation Project Performance

	Over the last 10 years Mangan has developed biotech facility automation work processes that offer predictable project and system performance. Front End Loading, Define and Select Stages, Full Design and Training Documentation, Software Modularity, FAT, SAT, IQ and OQ Templates are standard tools for project automation performance. Web based project management and unitized and quantifiable work make the project progress visible to all.

S88 MBA Benefits Realized

Biotech_S88

	Application of S88 Batch Technology on several vendor platforms has provided our clients with predictable and modular control. The system documentation is clear. The levels of operation are tailored to each process. The library of process units are standardized, improving reliability. All manufacturing steps are automatically logged, enabling enterprise historians to record them.
Standardized Process Solutions with Different Levels of Automation Available

	Mangan has developed specialized process control solutions for a host of biotech processes. These all have several levels of automation available to select. They can be incorporated into the assortment of control hardware and software platforms, including the ability to be integrated into existing systems that have several vendor products incorporated. The processes include: • Manufacturing Processes • Small Molecule • Buffer Preparation • Purification • Fermentation • Centrifugation • Fill and Finish • Labeling Systems Utilities • Clean Steam Generation • Clean Air • Instrument Air • RO Systems • Glycol Systems • Liquid Nitrogen • WFI Systems • Purified Water • Clean in Place (CIP) • Clean Out of Place (COP) • Chemical Distribution • Labware Washers Equipment Controls and Monitoring • Reactors (Large and Small) • Fermentors • Lyophilizers • Filling Systems • Chromatography Skids • Dilution Skids • Purification Skids • Monitoring Modules • Centrifuge • CIP Systems • COP Systems • Labware Washers • Steam Generators • Ro Systems • WFI Systems • Air Handling Units • Humidifiers • Incubators • Freezers • Refrigerators Building Management • HVAC Controls • Critical Laboratory Equipment Monitoring (CLEMS) • Room pressurization, Humidification and Temperature control [back to top]
Part 11 RoadMap

	With this assortment of work processes, technology and solutions as the basis. Mangan has been able to develop an enterprise wide approach to Part 11 Compliance. These have used existing infrastructure as the foundation, lowering the cost significantly. They have been incremental, offering our clients the ability to migrate at the appropriate pace. Most of all, they have been highly functional, employing the most advanced industry historian features, and providing our clients with compliant systems that benefit their manufacturing processes. [back to top]
S88 Based Tank Farm Automation Systems

	• Automated Daily Schedule development and interface • "Drag & Drop" schedule management tools • Standardized movement structures that guarantee interlocks are performed and contamination is avoided • Extensive library of Tank Farm functions assure consistency and comprehensive application of standardization • Local historians provide auto-prover, auto-meter, auto-ticket and auto-report writing functions [back to top]

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1500 West Carson, Suite 100 • Long Beach, CA 90810
(310) 835-8080 •
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