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Example Clients:
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Abbott
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Acambis |
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Allergan |
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AstraZeneca |
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Bayer |
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B Braun Medical
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BioChem Pharma
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Bristol-Myers Squibb
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Copley
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DuPont-Merck
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Genzyme |
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GlaxoSmithKline
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Johnson & Johnson
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Merck |
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Pfizer
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Regeneron
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Sanofi Pasteur
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Sanofi Winthrop
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Searle
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Theravance
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Wyeth Parmaceuticals
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Example Systems:
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Batch and Formulation Control |
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Electronic Batch Record System |
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Product Tracking and Genealogy System |
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Reactor Temperature Control |
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Toxicology / Inhalation Chamber Control |
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Device Manufacturing and Inspection System |
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Distillation Column Control |
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Steam Sterilizer Control |
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Freeze Dryer Control |
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HVAC Control |
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Fluid Bed-Dryer Control |
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Bottle Washing and Filling Control |
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Animal Room Monitoring and Control |
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WFI & USP Control |
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CIP / SIP Control |
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Tablet Coating |
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Monitoring and Reporting Systems |
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Fermenter Control |
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Granulator Control |
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Mixer and Blender Control |
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Capable and Experienced
With over 20 years of experience in the industry,
Optimation understands the demands of pharmaceutical
and biotechnology projects. We provide a range of services for
some of the best in the business.
GAMP Methodology
Optimation’s experience with GAMP 4 and 5 projects includes
lab system, pilot lines, production systems, high-speed
test systems, flexible dosing, centrifuge / dryer systems,
process air systems, fermentation, sterile filling, batching,
medical testing and more.
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Instrumentation and Controls
Deploying strategies with cascade loops, interlocks
and alarm management for drives, valves and pumps, Optimation's expert process engineers are trained as part of
authorized relationships with world-class suppliers.
Knowledge of modern techniques such as Model Free Adaptive
Controllers (MFA), S95 / S88 batch management and OEE
(Overall Equipment Effectiveness) insure clients operate
at peak performance.
Product Verification and Machine Analysis
Optimation provides high-speed data
acquisition systems to measure product properties
and machine characteristics in real-time. These systems
can verify production results or characterize machine performance
for continuous improvement.
Complete Production Designs
• Operational Layouts
• Air Filtration Systems
• Cleanrooms
• Containment
• HVAC
• Lighting
• Security
• Water and Steam Systems
• Solid and Liquid Process Systems |
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Control and Enterprise Systems
• Electronic Records / Electronic Signature
• S95 / S88 Batch Control and Material Tracking
• Energy Management Systems
• Network Architectures
• Databases and Custom Reports
• SCADA, DCS, PLC Systems
• Data Acquisition
• LIMS, Test and Quality Control Systems
• Performance Metrics (OEE and KPI)
• Legacy System Migration |
Project Execution
Through years of work with pharmaceutical clients, Optimation has a project execution methodology similar to the GAMP V-model for computer validation. Optimation endorses the GAMP V-model and modifies it as required to fulfill the customer's needs while providing a quality project execution strategy.
- User Requirements Preparation: Prepare User Requirements Specification (URS) and bid packages for your project requirements. This typically involves site surveys and customer consultations.
- Functional Specification Preparation: Develop a system Functional Specification (FS) for your project requirements. This typically defines the system object and component functionality.
- Detailed Design Specification Preparation: Develop a system Detailed Design Specification (DDS) for your project requirements. This typically defines the details of the system design enabling software and hardware to be built as well as test protocols to be developed.
- Design: From mechanical and process through electrical and software engineering, Optimation provides a great breadth and depth of design services. Software design uses off-the-shelf or custom software or a combination of both to satisfy the requirements of your application. Our experienced engineering staff will provide you with an efficient, cost effective solution utilizing any combination of PLC's, controllers, DCS's, and computers. All software is fully documented for future reference. Mechanical and E/I Designers and CAD drafters provide drawings and documentation packages to suit any need from system configuration to conduit and cable schedules.
- Fabrication Services: Fully equipped shops, providing a single point of responsibility. Our skilled trades employees are capable of performing all of the tasks required to produce a quality finished product.
- System Simulation: Provide system checkout prior to shipment. Time invested during a simulation is very well spent when measured against time and expense saved at field start-up. All system components and software can be challenged to ensure compliance to system design.
- Installation and Start-Up: Provide system installation, installation assistance and start-up assistance. Our engineers are experienced in making installation and start-up as painless as possible, sensitive to production shut down limitations.
- Validation Services: Provide IQ and OQ protocol development and implementation services for regulated industry clients.
- Training Manuals and Classes: Prepare operational manuals to assist customers in using the system. We can also provide training classes at our facility or at your site.
- Calibration Services: Provide NIST Traceable calibration services for initial instrument installation, as well as calibration services under ongoing contracts.
- Software, Hardware and System Support: Provide continuing support contracts that cover up to 24 / 7 services.
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With over 20 years of experience in the industry,
Optimation understands the demands of pharmaceutical
and biotechnology projects.
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