Services for the Life Sciences and Pharmaceutical Industries

The life sciences and pharmaceutical industries are highly regulated, with stringent quality standards and fast timelines. Re:Build Optimation has over 30 years of experience providing systems integration, controls, and instrumentation services for manufacturing in the US to help industry leaders  meet these challenges.

Our GAMP (Good Automated Manufacturing Practice) project methodology is designed specifically for pharmaceutical applications and can help you streamline your production management process and improve efficiency.

The Importance of Accuracy and Efficiency

In the life sciences and pharmaceutical industry, accuracy and efficiency are of the utmost importance. Every day, people’s lives depend on the drugs, devices, and products that these industries produce. That’s why it’s so important that every step in the process is carried out with precision and care. From research and development to manufacturing and quality control, every process stage must be conducted with meticulous attention to detail. There is simply no room for error.

That’s why American-made Optimation is such an important partner for life sciences and pharmaceutical companies. We are experts in designing and implementing solutions that help our clients achieve the highest levels of accuracy and efficiency.

Whether it’s optimizing research processes, streamlining manufacturing operations, or improving quality control, we have the experience and expertise to help our clients succeed.

Key Trends in Life Sciences and Pharmaceuticals

• Companies are more patient-centric
• Increased trials
• Improved efficiency
• Increased regulatory and public scrutiny
• Accelerated timelines
• Increased cybersecurity
• Solutions with end-to-end visibility (the level of transparency across an entire supply chain)

Optimation’s Life Science and Pharmaceutical Services

At Optimation, we understand that the life sciences and pharmaceutical industries have unique challenges when it comes to process control. That’s why we’ve developed a range of services specifically designed to help our clients operate at peak performance.

Our expert process engineers and programmers are trained in modern techniques such as:

• Model Free Adaptive Controllers (MFA)
• S95/S88 batch management
• OEE (Overall Equipment Effectiveness)

Optimation’s Complete Production Capabilities

Design

Optimation understands that your success depends on having a well-designed, properly functioning facility – and we take pride in helping our clients achieve that goal. Our team of experts can provide you with the perfect solution for your production needs, whether it is a small or large-scale.

We offer a variety of designs, including:

• Operational Layouts
• Air Filtration Systems
• Containment
• HVAC
• Lighting
• Security
• Water and Steam Systems
• Solid and Liquid Process Systems
• Material Handling
• Conveyance Process Control and Integration

Optimation’s complete production designs are second to none, and we are confident that you will be completely satisfied with the results.

Transforming Operational Data into Trusted Insights

Optimation also has a wealth of experience in designing, developing, and implementing control and enterprise systems across a wide range of industries. We have successfully delivered projects for clients in the following areas:

• 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

Our team of experts have a deep understanding of the latest technologies and trends in the control and enterprise systems landscape, which enables us to provide our clients with comprehensive solutions.

Hence, integrating these solutions provide a more efficient, productive, and quality results for different applications in this industry.

Our Elite Test Systems for Medical Devices

We understand that medical device testing is a critical part of ensuring the quality and safety of these products. That’s why we developed our elite test systems, which are purpose-designed to provide the highest levels of accuracy and precision.

Our team of skilled engineers and tradespeople have the knowledge and experience to custom-design a test system that meets your specific requirements. We can also integrate or update an existing test system, and provide validation assistance on an installed system.

Our systems are designed to meet the specific needs of your project, and our engineers can provide onsite training to ensure that your operators are fully prepared to use the system. With Optimation, you can be confident that your medical devices will meet the highest standards of quality and safety.

Some examples of our medical test systems are as follows:

 

Class II Product Examples	Class III Product Examples
Syringes	Lung ventilator
Breathing circuits	Urethral stent
Administration sets for infusion pumps	Contact lens solution
Orthodontic wire	Insulin Pumps
Feeding pumps
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

How Optimation Helps With Project Execution

The GAMP V-model is a universally accepted standard in validation and verification of computer systems. It begins with identifying user requirements and then proceeds through design, development, testing, implementation, and maintenance phases. Optimation’s project execution methodology closely follows this model, but we tailor it to meet the specific needs of our clients.

This approach ensures that our team understands the criticality of each phase of the project are completed, validated and verified. Our focus on quality at every stage of the project helps to avoid costly mistakes and delays down the road.

We have a team of experienced professionals who are well-versed in the GAMP V-model and can adapt it to fit your project’s unique requirements. We understand the importance of quality at every stage of the project, and we will work with you to ensure that your project is executed flawlessly.

Optimation understands the unique challenges of the life sciences industry, and we are here to help you meet those challenges head-on. Contact us today to learn more!