By Scott Ferguson, groninger USA
The biopharmaceutical filling and packaging segment has experienced significant growth over the past five years. In this evolving business environment, it is critical to identify and select a vendor who can provide not only innovative and robust machinery, but understands and aligns with the buyer’s quality and business and goals.
1. Focus on Quality
Due to the growing market, many new vendors are offering filling solutions. While newcomers will usually offer some attractive features, challenges can occur with scaling up, leading to inconsistent quality levels and delays. Manufacturers should make sure a new vendor has the financial strength to ‘weather a storm.’
Growing pains are presently worsened by a shortage of experienced talent. When evaluating a vendor, evaluate at company tenure of key resources. Look for established procedures and work instructions. Are they available, and is staff trained on them?
2. Innovation and Regulatory Approvals
While innovation is welcome, it must be based on proven technology with appropriate risk assessments and data driven studies. Without data and regulatory support, innovations run the risk of rejection. A vendor with years of successful risk based engineering advances along with well-defined documentation packages will greatly aid in regulatory approval.
Innovation should be approached with solid criteria. E.g. At what increase of flexibility am I willing to accept higher cost, lower speed and more challenging cleaning?
3. Reduced Lead Time
Time to market … time to market … time to market! Companies now desire for vendors to deliver in 9-12 months, which requires greater acceptance of standards and less request for customization. With the advent of RTU (ready-to-use) objects, standard lines and TOP’s (turn-over-packages) are becoming a reality.
4. Ability to Support, Long-Term
It is critical for vendors to offer an established local service group. Without it, the chances of success are at risk. Are the listed service resources really trained for pharma fills and finishes? Is field service staff supported by local back-office engineers? Is remote support available to avoid costly trips? Can spare parts be made in the US? And finally: Will the machine vendor likely still be there a decade or more down the road?
Total cost of ownership is determined by many more factors than hardware price. The main question here, and one that may be rarely asked: Can you afford the cheaper machine?
Scott Ferguson is a Business Development Manager with groninger USA, LLC (Healthcare Packaging EXPO 2019 Booth #N-107), a German provider of fill/finish equipment. He has been with groninger for 10 years with previous experience designing, building and validating biopharmaceutical facilities as well as bench work in the lab. He has an Undergraduate Degree in Biology from North Carolina State University and a Masters’ Degree in Biotechnology and Finance from Johns Hopkins University.