Mitigating Risk in Your Hardware and Single-Use Products Selection Process

Selecting the right equipment and single-use products is a non-negotiable step for manufacturers aiming for efficiency, quality compliance and customer satisfaction. For those in the biopharmaceutical industry, stringent regulatory guidelines can make it very difficult to revalidate new equipment or materials. Beyond the cost of revalidation, concerns of loss of material, labor cost, and lost time are risks associated with wrong equipment choice.
 
This article aims to provide a framework for reducing risk when selecting equipment and consumables. Understanding fit, function, supply chain resilience and company values are some of the first steps to a successful selection process.

Fit and Function

Hardware compatibility within your existing infrastructure is essential for optimal performance and cost-effectiveness. A mismatch in dimensions, material, or sterilization requirements can lead to costly delays, reduced productivity and increased contamination risks. This holds true for your selection of single-use components. Choosing materials with chemical compatibility, along with designing a consumable to fit your process are key factors in producing efficacious treatments for patients.
 
To reduce the risk of those challenges, manufacturers must evaluate equipment, consumable specifications and compatibility. Validation guides, compatibility charts, and technical guidance are great resources for this evaluation.
 
For facilities with existing cleanroom infrastructure, adding new equipment can be complex. Solutions like the AdvantaPass clean room pass-through portal, which require minimal changes to the room’s interface may be advantageous in minimizing disruptions and reducing the costs associated with change.
 
By prioritizing fit and function, processes can be optimized, downtime reduced, and overall efficiency enhanced.

Supply Chain Resilience

Disruptions in the supply chain can negatively impact biopharmaceutical manufacturing. From missed deadlines and production delays to increased costs and reputational damage, these all can be highly impactful. To reduce the risks, manufacturers would do well to prioritize suppliers with geographic diversification, robust inventory management, supplier risk assessment programming and business continuity planning in place.
 
The ideal partner for supply chain disruption mitigation would have manufacturing sites in different regions and locales to reduce the risks associated with natural disasters, economic instability, local epidemics and more. The supplier would also have a method of qualifying their suppliers to ensure their supply chain is as reliable as possible. Additionally, ensuring optimal inventory levels would go a long way to reduce supply chain disruptions. Lastly, this supplier should have a strong and transparent business continuity model that addresses plans for interruptions that may affect shipment and operations.
 
By partnering with suppliers with a strong commitment to supply chain efficiency, you can ensure product availability even in the face of disruptions.

Company Values and Sustainability

While often overlooked, shared values between your organization and suppliers can cultivate long-lasting partnerships. Beyond product quality and performance, factors like sustainability practices, corporate social responsibility, and ethical sourcing can help form the foundation of a successful collaboration.
 
Whenever possible, consider the company culture and how it aligns with your company values, how robust customer support is, internal training programs and sustainability initiatives. A company with efficient and technically savvy customer support is better equipped to solve challenges and maximize uptime. A dedication to comprehensive training programs often indicates a commitment to operational excellence.
 
A collaboration with such a company can be very advantageous as one can expect continuous quality and innovation for the lifetime of that partnership.

Conclusion 

Carefully considering fit, function, supply chain resilience and company values can position the manufacturing company optimally. It can reduce immediate and future costs while also opening the door for future innovation and increased quality performance.
 

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Carrie Lloyd brings 20+ years of experience in the biopharmaceutical industry to her role as an Account Executive at NewAge Industries/AdvantaPure. Throughout her career, she has honed her skills at industry leaders like Biogen and Sartorius, developing a deep understanding of bioprocess manufacturing, design and consultation, and technical sales.