Spalling and Sorption of Tubing for Peristaltic Pumps

Abstract

Available tubing for peristaltic pumps tend to shed particulates into the solution due to their poor abrasion characteristics. Most commonly used flexible tubing is silicone rubber or polyvinyl chloride (Tygon) tubing. Two newly available tubing are manufactured from a composite of expanded polytetrafluoroethylene (Teflon PTFE) with platinum-cured silicone rubber (Sta-Pure) and a tubing composite of PTFE with fluoroelastomer (Chem-Sure). These are claimed to resist spalling and deliver constant volume when used in peristaltic pumps. The four tubing were compared for spallation. They were also compared for sorption of methylparaben, propylparaben, and benzyl alcohol over a 72 hr study. Spallation studies indicate that Tygon and silicone tubing are prone to damage and shedding of particulates due to abrasion during use in peristaltic pumps while the Chem-Sure and Sta-Pure tubing are resistant to abrasion and spalling and show negligible shedding of particulates over 72 hr use in the peristaltic pump. Chem-Sure shows no spalling after 48 hr. Decrease in volume delivered is expected using Tygon and silicone tubing only. Chem-Sure tubing did not show any preservative losses. Tygon sorbed all preservatives tested to the greatest extent, followed by Silastic and Sta-Pure tubing, in decreasing order of sorption. Propylparaben was sorbed to the greatest extent. The tubing used appear to approach saturation in 24-48 hr. Chem-Sure and Sta-Pure tubing are ideal for use in peristaltic pumps or for general use for any demanding pharmaceutical applications.

Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing

“…24 Silicone tubing was shown to be more prone for particle shedding as compared with tubing made from polyvinyl chloride and polytetrafluoroethylene composites. 25 Despite these findings, silicone tubing remains the standard material for operation in peristaltic pumps because of the above-mentioned advantages.…”

“…Presently, particle shedding and tubing wear have mainly been investigated in the context of medical use, as silicone tubing is employed, for example, during hemodialysis and in cardiopulmonary bypass operations . Silicone tubing was shown to be more prone for particle shedding as compared with tubing made from polyvinyl chloride and polytetrafluoroethylene composites . Despite these findings, silicone tubing remains the standard material for operation in peristaltic pumps because of the above‐mentioned advantages.…”

Developing a Smart Infusion Pump Dedicated to Infusion Safety

“…However, drawbacks such as blood hemolysis, mechanical tubing degradation, and variable flow accuracy due to changing flow conditions are inherent to this approach (Bahal & Romansky, 2002;Pronk Technologies, 2020;Stull et al, 1988;Wilson et al, 2016). The Ivenix pump uses a pneumatically driven silicone diaphragm to pull fluid from a bag, fill an internal chamber, and then push the fluid to through tubing toward the patient as shown in Figure 2.…”

Potential of Continuous Manufacturing for Liposomal Drug Products

“…[61] Additionally, extended use of flexible tubing in pumping systems can lead to spalling and breaches as well. [62] Beyond building in sterility assurance through designing a durable integral boundary, the ability to maintain an aseptic process must be demonstrated through simulations and validations. Assuming the process is set up using pre-sterilized componentry and/or steam-in-place (SIP) equipment, any feed solutions (API containing aqueous solution, lipid containing organic solution, or buffer) must enter the system through sterilizing filters containing a pore size of typically 0.2 μm or less.…”

“…Use of single‐use componentry can increase the risk to the integrity of that boundary as bags and tubing assemblies can have a higher probability of leaks (especially if custom) than more robust reusable systems such as stainless steel . Additionally, extended use of flexible tubing in pumping systems can lead to spalling and breaches as well …”