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Automation Solutions for The Life Sciences and Pharma Industries

In manufacturing of Life Sciences, Pharmaceutical and Biopharmaceutical products, your success depends on quality, compliance, and efficiency. But insufficient control and bottlenecks can impact product safety and profitability. Malisko has completed hundreds of process automation projects for Life Sciences, Pharmaceutical and Biopharmaceutical plants of all sizes over our 25 plus years in operation. Whether you are looking for Automation in the Life Sciences, or Automation in Pharma, our team are the experts that your production plant needs. We know when your plant installs a state-of-the-art automation system, you expect to see a direct return on your investment through efficient, consistent production that ensures safety and quality.

Life Sciences Automation Applications

Aseptic Filling
Buffer Preparation
Centrifuge / Separation
Continuous Blending
High-Shear Mixing
Homogenization and Micronization
Membrane Filtration and Separation
Reactors / Bioreactors
Reformulation and API Production

Validation – An Essential Part of Life Sciences Automation

We believe a complete system sets you up for success, and that includes making sure that your system not only works, but also meets regulations. We take care of all the paperwork to properly validate your system. Your system will be secure. And you will have comprehensive documented evidence to show auditors. We build your system to protect data through a collection of technological and procedural controls. You will have extensive electronic records, and they will be authentic and incorruptible.

Heat Exchangers Offer Big Processing Paybacks

While it may not be as prominent as many other dairy processing technologies, the heat exchanger is far from lowly. The equipment, which is used to transfer heat between two or more fluids during the cooling and heating processes without mixing the fluids together, can have a major impact on processing efficiencies and operating expenses.

Case Study: Pharmaceutical Company Begins Manufacturing New Generic Therapeutic Drug with The Help Of Advanced Process Automation System

A pharmaceutical manufacturer needed to finalize production of a new generic therapeutic drug. As part of their initiative, they wanted to include a state-of-the-art, robust, expandable, and supportable automation system to control, data archive and report on their world-class process.

Case Study: Infant Formula Manufacturer Enhances Its Ability to Capture and Retain Secure Historical Data

A historian collecting manufacturing data on highly critical infant formula is extremely vital for the safe and healthy future of our most prized possessions: babies.

Our Approach to Automation for the Life Sciences Industry

With over 25 years of experience in Automation, we understand that no two production plants are the same. The process needed for your plant may be entirely different than others in your field. Malisko is here to provide expertise for all of your automation needs. Whether you need specific modifications to existing systems or a full design built from the ground up, our team is here to help. We’ll work to assess and meet the needs of your plant.

Our approach to automation in the Life Sciences industry has delivered results, yielding consistent, efficient production, and measurable ROI for our clients. Here’s more information about how we accomplish that.

Site Assessment

Before we can design your new system and implement automation solutions that save you money and improve efficiency, we have to understand your challenges. To achieve this, we can engage with you to perform a site assessment. We listen to your operators, maintenance staff, engineers and operations personnel to fully understand your process, how your business operates, the problems you want to solve and what success means to you. Most important, we take the time to understand the best ways to collaborate with your in-house engineers throughout the automation process as we become familiar with your facility and the systems that make it run.

Our site assessment follows a tried and true process and is the first step in implementing an automation solution. During each site assessment, we will:

  • Identify Existing Automation Controls
  • Identify Potential Cost-Saving Solutions
  • Identify Opportunities
  • Business Justification
  • Presenting Automation Solutions
Front-End Engineering Design (FEED)

Successful engineering has to align everyday production with the big picture. Each processing unit and work cell must come together with your automation system to form not only an efficient production process but also one that matches your business goals and realities. When we present an automation solution to you, we make sure it matches your budget, your timeline, your current production realities and your goals, all while minimizing risk.

Our Front End Engineering Design (FEED) sets the foundation for a successful project accomplished on time, on budget and in a way that fits your in-house team.

If the needs of your business, plant and production line change over time, our systems come ready to change along with them. And if you need, we’ll even tweak the system design to fit the skill sets of your support team. We believe the best systems change for you. It shouldn’t be the other way around.

Once the FEED is completed, you will receive:

  • Outlined Business Objectives
  • Project Timeline & Budget
Detailed Engineering and Design

In our detailed engineering and design service, we transform the conceptual into the final design. We use all the knowledge we gain from the automation solutions site assessment and Front End Engineering Design (FEED) to minimize your risk, get you running quickly, and align our work with your business realities. Here we will also flush out project risks, planning for them by nailing down a realistic project budget, execution plan and timeline.

Malisko both designs your automation system and implements it. Our detailed engineering and design service picks up right after our FEED services leave off, and our system integration execution picks up right after our detailed engineering and design. We can handle the complete package: specification, design, procurement, development, on-site execution, troubleshooting and support of the control, network, security and MES layers.

During this phase, we can provide you with:

Project Execution

After we’ve completed our thorough automation solutions site assessment, Front End Engineering Design and Detailed Engineering Design, we have the information we need to document, code and integrate your automated system. We keep in mind your business goals. We factor in the strengths and limitations of your team, and we prioritize your most important objectives.

We design your system on a foundation of understanding so that we can rapidly implement it with absolute precision. We program each function in your system and set up an intuitive Human Machine Interface (HMI) and reporting that allows your team to adopt your system efficiently. We outfit your system with the reporting you need to stay on top of your production. Prior to installation, we run your system through several rounds of intensive testing in a simulated environment to make sure it works. Once we have programmed your machines, set up your HMI, created a useful reporting program and tested the functionality and performance of your system, it is time to install your system in your facility. When on-site system installation is complete, our team again extensively tests the operation, performance and functionality of the new system holistically from the field devices through to reporting.

During this phase, we can provide you with:

  • Programming & Logic Development
  • Human Machine Interface (HMI) Development
  • Reporting
  • System Integration Testing & Simulation
  • On-Site Process Commissioning

Computer System Validation (CSV) is a must in FDA-regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase, we can provide you with:

  • Computer System Validation Documentation
  • Executed Validation Protocols
  • Electronic Records
Post Project Support

If any troubles emerge with your system, we have you covered, whether it is warranty or support under a formal service contract. When you work with Malisko Engineering, you don’t just get a system, you get a whole team to support it. If you have a full maintenance and system support staff on hand, we will provide assistance to fill the cracks. As much as practical, we can help your team be properly equipped to maintain and troubleshoot your process and automation system. If you need full support services, we are available 24/7 to make sure your system works.

During this phase, we can provide you with:

  • Post-Commissioning Technical Support
  • Remote Support

Contact Malisko for All of Your Automation and Validation Needs

Malisko has decades of experience supporting the automation needs of clients in the Life Sciences, Pharmaceutical and Biopharmaceutical products industries. Contact our team of experts to learn more.

CIP Automation Practices: Mild to Wild

Manufacturers in the process industries can improve their Clean in Place (CIP) operations and efficiencies by effectively utilizing current technologies for CIP process automation. Download our White Paper on CIP Automation Practices now to learn more.

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