Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing

Influence of particle shedding from silicone tubing on antibody stability

“…The employed platinum‐cured silicone tubing with an ID of 6.0 mm is commercially available from Saint‐Gobain (Saint‐Gobain Performance Plastics Corporation, Charny, France). Tubing sets were prepared and rinsed as described earlier and subsequently autoclaved at 121°C and 2 bar for 15 min.…”

“…Recirculates – containing particles shed from peristaltic silicone tubing – were prepared as described earlier . Autoclaved tubing sets were operated using a Flexicon PD 12 peristaltic pump.…”

“…An earlier study revealed a flattening of turbidity monitoring graphs with increasing recirculation time (after approx. 8 h) indicating that with time of use, less additional particles are worn away from the tubing . Therefore, the ‘low’ spiking level of 280 : 1 was chosen due to the reduced extent of particle shedding expected for these later time points during the filling process.…”

“…Rotary piston pumps (with steel cylinders) were suggested to possibly shed stainless steel particles that end up in the final product . However, previous studies revealed that peristaltic pumping may also lead to the generation of particles, although to a rather limited extent, likely due to abrasion of particulates from the tubing. It was shown that different types of silicone tubing shed particles of similar characteristics, but at varying quantities.…”

Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients

“…Other secondary sources are silicone particles which could be shed from the silicone tubing used to fill containers [83] or could migrate directly from infusion sets into infusion solutions [84]. Environmental exposure to silicone and/or the pH of some infused drugs (alkaline drugs) can account for silicone plastic particles found in animals.…”