Case Studies: Improving Efficiency and Compliance in Pharmaceutical Manufacturing Through Automation by Ruben Pedroza, Director of Automation, Genesis AEC

Automation systems can increase efficiency, reduce time to market, and improve facility and operational performance. Support from a life sciences-focused design firm with experience in cGMP requirements will help you tailor your system to your specific process, facility, and operational needs.

As highlighted in the first article of this three-part series, “Embracing the Power of Automation Design in Pharmaceutical Manufacturing,” the life sciences industry is rapidly evolving. Pharmaceutical, biopharmaceutical, and biotech companies are shifting priorities in order to increase efficiencies in product development and manufacturing and accelerate timelines to commercialization. Despite the benefits of adopting automated processes (often referred to as Pharma 4.0) into drug development and manufacturing workflows, not all companies are responding and implementing automated solutions.

Embracing Pharma 4.0 isn’t an insurmountable goal. With a receptive design partner who understands your requirements, navigates your limitations, and delivers results, it’s not just achievable; it’s a clear and readily attainable path. Companies seeking to expedite and enhance their automation should consider collaborating with a seasoned expert in biopharmaceutical engineering solutions.

Pharma, Biopharma, and Biotech Companies Explain Why Transitioning to Pharma 4.0 is Challenging

• We don’t have an in-house expert and are afraid to make the wrong choice (i.e., invest money in areas that don’t yield the maximum benefit).
• We don’t believe we have the scale/size to benefit from automation.
• We don’t have the financial resources to invest the amount of money needed and the payback on the investment is too long.
• The automated solutions would be too complex or incompatible with our workflows.
• My facility is too complicated. No one firm can help me to automate all of the following areas:
  • Labs
  • Central utilities
  • Manufacturing lines
  • R&D systems
  • HVAC systems

Automation design system planning requires consideration of several elements. Design engineers work with owners to clearly understand objectives and criteria regarding what they wish to achieve from the investment to ensure proper planning and execution. It is essential to consider the roles and responsibilities of systems integrators and automation design engineers (see the second article of this three-part series, “Demystifying Systems Integrators and Automation Design Engineers: Understanding the Differences”) to determine which expert is best suited for their needs.

Systems integrators are typically responsible for programming and implementing an automation system. Automation design engineers focus on how to best apply automation system changes in a way that aligns with the manufacturing process and overall facility purpose. While systems integrators are essential in implementing the technical aspects of the automation system, leveraging the expertise of an automation design engineer ensures your project aligns with your business objectives, regulatory requirements, goals for operational efficiency, future growth, and cost containment/ROI.

DELIVERING FACILITIES FOR LIFE-SAVING THERAPIES

Genesis AEC, a leader in the life sciences industry, provides architectural; engineering; construction management; commissioning, qualification, and validation; and asset management services. Their automation design engineering team provides solutions for seamless, automated operations and quicker, efficient delivery of high-quality products. The following case studies demonstrate Genesis AEC’s role in supporting life science companies with automated solutions to address current system-related issues.

Case Study: Resolving Chemical Dosing Challenges with Improved Automation

CHALLENGE:

A manufacturer faced issues with their continuous emissions monitoring (CEM) system and thermal oxidizer (TOX) for reducing harmful chemicals in their effluent gas stream. The TOX, designed with fixed flow rates and unverified design conditions, inaccurately dosed chemicals, leading to high nitrogen oxide (NOx) levels and substantial fines from the air quality management district (AQMD). Despite previous efforts and investments with a systems integrator, the system still failed to meet the client’s requirements.

SOLUTION:

The client collaborated with a Genesis AEC automation team to develop a solution. The approach involved modifying the existing system by measuring NOx levels in multiple locations within the TOX and adjusting the dosing chemical flow rate based on the highest measured value. Detailed drawings, specifications, and a sequence of operations were provided to ensure seamless integration.

RESULTS:

With the improved automation solution, the TOX operation improved significantly, achieving compliance with AQMD standards. During the initial three weeks of operation, the system was fine-tuned, resulting in a substantial reduction in chemical consumption. This optimization led to quarterly savings exceeding $80,000.

Whether you hire a systems integrator or an automation design engineer, you need to evaluate your needs. Below are some questions to ask:

• Does the firm have strong experience within the life sciences industry and with cGMP requirements?
• What is the firm’s expertise, and specifically that of the personnel executing the work?
• What level of customer service do you need? How responsive should your partner be?
• Does the firm provide all the services (process and automation design) in-house, or will you need to outsource services?
• Will the firm’s automation approach be forward thinking (eg, aid in developing new products/expanding future manufacturing capacity)?
• Does the firm have the experience and expertise with various automation platforms and software within the industry to select and specify the right solution for my facility?
• Does the firm have experience throughout the project lifecycle—from planning and design to oversight and validation?
• Is the firm able to consider potential site-wide impacts to the whole plant?
• Does the firm have the design experience to integrate different platforms into a single solution?
• Will the firm be able to ensure that the design meets all facility requirements and needs?

By addressing the dosing challenges through enhanced automation, the company achieved consistent compliance, minimized fines, and realized substantial cost savings. This case study highlights the value of a tailored automation solution in overcoming operational inefficiencies and achieving long-term success in emissions control.

Case Study: Optimizing Production Capacity with a Waste Holding Tank

CHALLENGE:

A pharmaceutical manufacturer was unable to increase its production capacity due to the limitations of its existing waste neutralization systems. The company generated a significant volume of clean-in-place (CIP) wastewater requiring neutralization before disposal. The existing systems were unable to handle the increased volume, preventing the addition of production capacity. The client desired a solution that would avoid replacing or upgrading the existing waste neutralization system while complying with state and local regulations.

SOLUTION:

To address the challenge, the manufacturer collaborated with a Genesis AEC automation engineer. They worked together to design and specify a control system for a holding tank with sufficient volume to accommodate the increased CIP wastewater. This allowed the client to add one additional batch of product per week, thereby increasing production capacity. The larger tank size also extended the time between emptying, reducing the frequency of disposal to once per month. Throughout the project, collaboration with the client’s environmental, health, and safety (EHS) department ensured adherence to design requirements and considerations for personnel health and safety. This involved incorporating redundant instrumentation, external tank level notification, and visualization.

RESULTS:

This solution allowed the manufacturing company to achieve higher production levels and increases to the number of batches produced per month. The addition of a weekly batch resulted in a $40,000 increase in revenue per week. By optimizing the waste holding tank and aligning it with regulatory requirements, the company successfully expanded production capacity while maintaining compliance and generating significant financial gains.

Case Study: Transforming Pharmaceutical API Manufacturing by Navigating Challenges and Achieving Success through Automation

CHALLENGE:

An active pharmaceutical ingredient (API) manufacturer aimed to enhance its manufacturing capabilities through automation, facing four significant challenges:

1. Market demands pressured them to optimize production processes, requiring increased output in shorter timeframes.
2. Their aging facility employed a mix of manual and automatic control processes, necessitating a study to explore automation options and associated costs.
3. Prior projects initiated by a previous engineering team were plagued by incomplete execution and cost overruns, prompting the leadership to take corrective action.
4. Corporate leadership imposed two critical constraints: (1) the manufacturing standard operating procedures (SOPs) couldn’t undergo radical changes, and (2) automation solutions should maximize ROI and lay the groundwork for future improvements.

SOLUTION:

Spanning a city block, the campus offered numerous opportunities for a transformative impact. Working with the owner and their designated representatives, a Genesis AEC automation team identified areas with significant cost implications and high potential for automation-driven returns.

With the client consensus, the focus was narrowed to a specific building and a targeted manufacturing line. Within the targeted manufacturing line, a pilot reactor was designated by the owner as the focus for a feasibility study. Genesis AEC, in partnership with the owner, delved into automation options, studying personnel-equipment interactions, while preserving approved SOPs. The primary objective was to ensure client alignment with any potential changes while clarifying why some options were not feasible based on constraints from upper management.

RESULTS:

Leveraging information gained in the feasibility study, Genesis AEC assisted the client in developing a preliminary cost estimate. The study’s findings proved indispensable in generating accurate cost projections, as much of the design requirement and associated information was well-developed. Currently, the project awaits capital funding approval, with Genesis contributing through the feasibility study, cost estimating, and presentation material.

Previously, the owner had an unfavorable experience engaging a local systems integrator for a similar project. The costs were higher than promised, the schedule ran longer than forecasted, and the client’s perception was that the systems integrator was inattentive to their concerns. Consequently, they were hesitant regarding engaging another system integrator for a feasibility study. Instead, they chose to work with an engineering firm to represent them and protect their interests.

Benefits of Implementing an Automation Design System into Your Workflow4-8

• High Throughput
• Increased Overall Equipment Effectiveness
• Increased Flexibility
• Reduced Changeover Times
• Quality Consistency and Improvements
• Traceability and Serialization
• Digital Monitoring and Process Control
• Improved Sterility
• Optimized Production Cost

SUMMARY

Automation projects enhance efficiency, reduce time to market, and optimize facility performance. You can seek support from either system integrators, automation design engineers, or a combination of both.

For a consultation with a Genesis AEC automation design engineer who can help you develop cost-effective and industry-specific solutions, please visit genesisaec1stg.wpenginepowered.com.