The checklist challenge:
Considerations when Choosing Silicone Tubing for Pharmaceutical and Biotechnology Manufacturing Applications

Written by Don Jahn, Pharma Processing Segment Leader Dow Corning Corporation

Silicone tubing is often used in pharmaceutical and biotechnology manufacturing processes to transfer fluids from one point to another, such as from tank-to-tank or from tank-to-filling machine. Since the tubing has direct product contact, it is critical that users understand what impact the tubing might have on their product.

While it would seem that selecting a supplier of silicone tubing should not be difficult, the wide-range of tubing offerings and producers can make for a difficult choice. In selecting a supplier, the user should consider the following:

• What is known about the extraction profile of the tubing? Is there a risk of chemicals leaching from the tubing into the drug product? If so, what chemicals and what levels?

• What quality system does the manufacturer have in place? Do they follow appropriate Good Manufacturing Practices (GMPs)? Are they registered with the FDA or other regulatory agencies?

• What controls are in place over the silicone elastomers used to produce tubing? Does the tubing extruder produce their own silicone elastomers or purchase them? Are the silicone elastomers produced under principles of GMPs (with traceability, change management and contamination control) in a facility dedicated to the production of materials for the health care industry or are they produced in an industrial facility?

• What physical attributes are important? Will the tubing be under conditions where high or low pressure-resistance is required?

• What technical and regulatory expertise can the supplier offer? In other words, how can they ease the validation burden?

Once you have narrowed your choice to silicone tubing, cost and quality are important considerations. Where purity is a concern and regulatory compliance is a must, selection of a supplier that follows principles of GMPs and produces the tubing from silicone elastomers intended for health care applications may be the best course of action. And cost-effectiveness is still possible without sacrificing long-term risk management.

Answers to the checklist above may encourage some discussion between users and suppliers-who together can meet the challenges of optimizing safety and productivity in pharmaceutical fluid transfer applications.