No supplier is immune from taking part in this evolution. From the perspective of a fluid system component supplier, there is tremendous need to augment product supply with services that make an end user's life easier.
DOCUMENTATION Leading suppliers are providing comprehensive documentation with components as an important convenience to biopharm manufacturers whose systems must pass FDA validation. Documentation containing heat, lot, and part numbers for traceability, chemical analysis from the heat, and a physical inspection log, should be accurate, tightly controlled, user friendly, and supplied with the products.In addition, by providing third-party inspected and verified products, ensuring that products meet ASME-BPE requirements at delivery, costs for the owner company can be reduced with minimized failures and returns.
Leading suppliers also maintain documentation online, allowing owner companies to obtain information conveniently and easily 24 hours a day. Through this online function, owner companies can input heat or lot numbers and retrieve material test reports and inspection documentation.
SALES AND TECHNICAL SUPPORT Owner companies should seek suppliers who provide a broad product offering since it is not desirable to deal with multiple suppliers for components. Further, suppliers who move beyond components to value-added services such as vendor-managed inventory, just-in-time deliveries, and training can greatly enhance their value. End users can save time on orders and bring down costs by shifting management of component inventory to the supplier, which reduces overstock and understock situations.
More manufacturers and system fabricators are recognizing the value of using custom fabrications for solutions to unique assembly requirements for their processing systems. End users often attempt to design or build systems within a rigid framework, only to encounter problems during the actual construction phase. In such cases, a supplier who makes an on-site visit may be able to help develop a less costly or more efficient design solution. End users should look to suppliers who provide custom work as a standard service.
PRODUCT INNOVATION Leading suppliers are recognizing the need to develop products to help enhance cleanability and drainability. For example, elbow fittings angled 88 and 92 deg (with a tight tolerance of ±0.5 deg) ensure accuracy and reliability for cleaning and draining. The alternatives are standard 90-deg fittings modified by manual methods of achieving drainable angles, which entail hand bending or mitering, neither of which is desirable. Fittings installed with incorrect angles because of a variable tolerance or manual methods of assembly can put an entire system at risk for contamination.
Another example is an orbital welding system that provides real-time and comprehensive data readings that document welding processes and procedures, thereby simplifying the amount of time — and money — spent to document and validate welds.
Suppliers must rise to the occasion, and those who know the needs of the industry will be in the best position to service owner companies. Suppliers who cultivate relationships with owner companies will bring the most value and will play a key role in helping them to bring products to market faster
Mike Sullivan is president of Swagelok Biopharm Services Company, 107-111 Goundry Street, North Tonawanda, NY 14120, 716.743.9735 ext 1105, fax 800.523.4165,