Services for the Life Sciences and Pharmaceutical Industries

Optimation’s work in life sciences spans our 30+ years of experience providing systems integration, controls and instrumentation services.

Tackling Your Industry Demands

  • Government Regulations
  • Stringent Quality Standards
  • Fast Time to Market
  • Production Management and Efficiency

Optimation helps bear the burden of these demands to keep you focused on your product. With our GAMP project methodology, we’re your partner for pharmaceutical applications.

With over 30 years of experience in the industry, Optimation understands the demands of pharmaceutical and biotechnology projects. We provide a range of engineering services for some of the best in the business.

ServicesPharmaceutical Pressure Vessel

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) ensure clients operate at peak performance. 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
  • Containment
  • HVAC
  • Lighting
  • Security
  • Water and Steam Systems
  • Solid and Liquid Process Systems

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

Test Systems for Medical DevicesMedical Device Test System

Optimation’s knowledge and experience with test systems for medical devices makes us an asset to your team. Our skilled trades personnel are journeymen level with the expertise and experience to fabricate and assemble a test system to meet your requirements.

We can provide engineering and skilled trade services for medical device test systems at any point of your project life cycle. We can:
  • Design a test system concept or assist in the determination of your test system requirements
  • Integrate and/or update an existing test system
  • Provide validation assistance on an installed test system

We are flexible enough to meet your system delivery and custom installation needs for your test system. Upon system delivery, our engineers can provide onsite training to your system operators along with training documentation (i.e. operator manuals).

Example Medical Device Test System Applications

We’ve worked on Class II and Class III Products:
  • Class II Product Examples – syringes, breathing circuits, administration sets for infusion pumps, orthodontic wire and feeding pumps
  • Class III Product examples – Lung ventilator, urethral stent, and contact lens solution

Test System Project Examples:

  • Pulse Generator for High Blood Pressure Treatment
  • Implantable Device for Epilepsy and Depression Treatment
  • Implantable Nanotechnology Devices
  • Research and Development Test Systems
  • Product Final Test

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.

Interested in working together?

When Optimation was approached to work on our project, there were three needs: Cost, Quality and Schedule, which needed to be met for three different simultaneous efforts. Optimation satisfied ALL needs, for each effort, in a professional manner.

– Medtronic Minimed, Inc.
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