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Application GuideSelection Guides18 min read

Peristaltic Pump Tubing Spallation: How to Evaluate Particle Shedding Before You Buy

A peristaltic pump can deliver the right volume and still add particles to a sensitive process. This guide explains spallation, how to separate polymer wear from formulation particles, and how to compare low-shedding tubing under your own pumping conditions.

Updated September 23, 2026How Equipvia researches
Chemical metering pumps at a water purification plant
Spallation testing compares the exact tubing grade, size and pump setup over the intended run: blank controls, particle identification and post-run tube inspection turn a particle count into a diagnosis. Photograph of chemical pumps via Wikimedia Commons (CC BY-SA 3.0). View current Landto listing.

Disclosure: We may earn a commission if you purchase through links on this page, at no additional cost to you.

A peristaltic pump can deliver the right volume and still add particles to a sensitive process. Every roller repeatedly compresses the same section of tubing. Under some conditions, the inner wall sheds material into the fluid path. This is spallation, or tubing particle shedding. In protein processing, pumping may also generate particles made from the formulation, even when the tube itself sheds relatively little. Those are different mechanisms and need different tests. [E01, E02]

For a buyer, the useful comparison is not a material label or an unqualified “low spallation” claim. It is the particle burden from the exact tubing grade, size and pump setup over the intended run, compared with the process limit and an appropriate control.

Affiliate disclosure: The Alibaba inquiry links below are CPS links. Equipvia may earn a commission from an eligible transaction at no additional cost to the buyer. Neither their inclusion nor a correct landing page verifies low particle shedding, original-manufacturer identity, or commission tracking.

Where does the particulate come from?

Tubing particles may result from repeated compression, shear and abrasion at the pump head. A 2015 study compared three commercial silicone tubes pumping water and buffer and found that shedding differed among them; the authors advised testing individual tubing during qualification rather than predicting performance from generic specifications. [E01]

A separate 2022 study compared five tubings with a monoclonal antibody formulation. It distinguished particles from tube wear from protein particles generated during pumping. Low tube shedding correlated with low roughness and high abrasion resistance in that experiment; protein particle formation also depended on tube hardness and surface chemistry. The study's observation that a harder silicone performed well is not a universal instruction to buy the hardest tube: fit, occlusion, pressure, dosing accuracy and the actual formulation still have to work together. [E02]

Think in three streams:

Observation Possible source Follow-up
New particles in a water or placebo pump run Tubing wear, assembly, upstream contamination or sampling artifact Compare a no-pump blank, unused tubing and pumped tubing; identify particle material
Particles increase only with protein formulation Product/interface effects, aggregation or tube-associated stress Compare formulation controls and use suitable protein-particle analytics
Large particles or visible debris after a long run Tube damage or another fluid-path component Stop the run as required by your process; investigate the full fluid path and tube surface

Particle count alone cannot identify the source. A blank and material identification are what turn a count into a diagnosis. This test design is a proposed qualification approach based on the cited studies, not a universal regulatory protocol. [E01, E02]

Does silicone tubing always shed more than TPE?

No reliable universal ranking follows from the polymer family alone. In a 2002 comparative study, tested Tygon and silicone products showed more abrasion-related particulate shedding than the particular Chem-Sure and Sta-Pure products tested over a 72-hour pump study. The result belongs to those products and conditions, and should not be generalized to every modern silicone or TPE grade. [E03]

The 2015 work likewise found meaningful differences within silicone tubing. A manufacturer study of five platinum-cured silicone pump tubes reported different spallation outcomes before and after pumping and gamma irradiation; its anonymized competitors, methods and commercial interest should be considered before using it as a purchasing ranking. [E01, E04]

Saint-Gobain markets PharMed BPT and PharmaPure as low-spallation products and offers product-family datasheets and validation materials. These are worthwhile technical candidates for testing, but manufacturer claims do not establish the result for a reseller's untraced marketplace tube. Obtain the exact grade, part number, size, lot history and current supporting report. [E05, E06]

Which operating conditions change the comparison?

A supplier chart only helps when its conditions resemble yours. Record at least:

  • the pump and head model, roller count, tubing ID and wall thickness;
  • occlusion or loading setting, speed, acceleration and run duration;
  • inlet condition, discharge pressure, temperature and fluid viscosity;
  • solution or formulation, pre-use rinse, sterilization method and dose or cycle;
  • sampled volume, collection times, blanks and particle-sizing method.

The Saint-Gobain silicone comparison, for example, used a specified 1/16-inch ID by 3/16-inch OD size, a particular filler, 300 RPM in its spallation run and a defined recirculation sequence. Its measured counts cannot simply be transferred to a different tube size, pump head, fluid or run time. [E04]

If the tubing is sterilized, compare the condition that will actually enter production. The same manufacturer compared non-irradiated and gamma-irradiated samples; its separate PharmaPure material notes that an initial increase in counted particles after gamma exposure may have a different source from polymer wear. A changed count calls for identification, not an automatic spallation diagnosis. [E04, E06]

How should particle shedding be tested?

For a prospective replacement tube, write a small, reproducible protocol before asking suppliers for samples:

  1. Define the decision. Set an application-specific particle acceptance criterion with Quality and Process Engineering. For an injectable product, the applicable finished-product requirements and the point of final filtration matter; do not invent a universal acceptable count for pump tubing.
  2. Lock the setup. Compare candidates at the same size, head, loading, speed, pressure, fluid, sterilization history and expected runtime. Record lot and part numbers.
  3. Run controls. Measure test fluid, collection container and assembly blanks. Where possible include a no-pump circulation or transfer control and a current approved tube.
  4. Sample over time. Capture the initial run and later windows through the expected duty cycle. Report particle concentration and distribution by size, not only a total count. Normalize to sampled volume and record the time window.
  5. Identify material when the decision requires it. Imaging and microscopy can show morphology; appropriate spectroscopy or other material methods can help distinguish polymer debris from protein or external contamination. Choose methods with the analytical team for the sample matrix.
  6. Inspect the used tube. Document inner-wall condition, wear track, cracks, wall change and flow performance. A tube with low measured particles but unacceptable flow drift is still the wrong replacement.

ISO/TR 19727:2017 describes a general procedure for measuring, analyzing and assessing shedding from an infusion pump set during pumping. Its scope should be checked before adapting it to a laboratory or bioprocess line. It is a technical report, not proof that a given product has passed an unspecified “ISO spallation certification.” [E07]

For injection applications, USP ⟨788⟩ addresses subvisible particulate matter in injections; it is a finished-product context and does not by itself certify a tube. FDA's guidance on visible particles calls for a risk-based control program across product development, manufacturing, inspection and investigation. Apply current product requirements with your quality team. [E08, E09]

Can a low-spallation claim replace your own process trial?

No. Ask the manufacturer or authorized channel for the original test report and compare its test article and conditions against your process. Useful questions include:

Which exact formulation, catalog part and size were tested? Was the sample sterilized? Which pump head, loading, speed, pressure, fluid and duration were used? What were the blank-corrected particle counts by size and time? How was the particle material identified? Were multiple lots tested? What changed in flow and tube condition after the run?

Then trial the shortlisted grade in your application. The 2015 comparative study specifically cautions that specifications alone cannot predict shedding for a given tubing type. [E01]

One 2018 study found that spiking two antibody formulations with shed silicone particles at the tested levels did not add measurable degradation over its accelerated stability study. That is useful context for risk assessment, not permission to accept particles in another formulation or to waive applicable quality limits. [E10]

Alibaba sourcing candidates: request the particle evidence

The purpose of these links is to let a buyer ask for samples and documents, not to present either tube as approved for a low-particle process. Listed in order of appearance; no ranking is implied. The CPS links were previously checked during Article 14 verification, and the user independently confirmed on 2026-09-23 that both currently land on their stated Product IDs. The automated recheck timed out; the user confirmation resolves the landing-identity question for this check. Affiliate Reports tracking is not accessible here and must be checked separately. [E11, E12]

Sourcing Candidate A — Landto “USA imported Pharmed” tubing

Inquire about the listed tube on Alibaba · Product ID 1600114007799.

Stated: Baoding Landto Electronic Technology Co., Ltd.; Landto branded listing that describes an “USA imported Pharmed” tube; inquiry route. Not independently verified: Saint-Gobain original part number, size/lot chain, authorized sourcing or a particle-shedding report for the exact supplied variant. Buyer question: Can you provide original package and part-number traceability, then a blank-corrected spallation report for this tube size under stated pump conditions? [E13]

Sourcing Candidate B — LeiRong BPT-16# tubing

Inquire about the listed tube on Alibaba · Product ID 10000035297946.

Stated: Lei Rong Fluid Tech (Shanghai) Co., Ltd.; model BPT-16#, size variations and one-meter MOQ on the visible listing. Not independently verified: original Saint-Gobain identity or low-spallation data for the selected variation. Buyer question: Is this an original PharMed BPT tube or a different BPT-style formulation? Supply the maker, grade, exact ID/wall, lot and particle test method/results for the material actually quoted. [E12]

Screening decision (2026-09-23): These are VERIFY / inquiry only. JIHPUMP Product ID 62073518767 was excluded because its listing calls the product PharMed BPT but gives “Santoprene” as the material, an unresolved identity inconsistency. Equipment bundles and generic silicone tubes without suitable particle evidence were also excluded as a poor fit for this tubing-specific decision. Merchant, Product and CPS scores remain UNKNOWN where required evidence is missing; neither inquiry lead is PRIMARY or APPROVED. We did not create new CPS links: the two above were supplied by the user for the previous article and already mapped to their Product IDs. If the supplier resolves identity and test evidence, score the product under the Alibaba SOP, recheck the landing at publication and verify the click in Affiliate Reports before treating it as a final offer. [E11, E12, E13]

A purchase specification you can send today

Application: [fluid and downstream use]; tubing: exact manufacturer, grade, catalog part, ID × wall/OD and quantity; pump: drive, head and loading; duty: speed, pressure, temperature, run duration and replacement interval; pre-use treatment: sterilization method and cycle; particle evidence requested: full method, blanks, size bins, time points, lots, post-run tube images and material identification; documents: datasheet, certificate/validation summary, lot traceability and change notification; acceptance: buyer-defined particle and flow criteria under the intended conditions.

A sample order is useful only if the supplier can connect the sample, test record and subsequent production lot to the same grade. For critical applications, approve the tube and the operating window together.

Related Equipvia guides: When to Replace Peristaltic Pump Tubing covers maintenance end points; Can You Autoclave Peristaltic Pump Tubing? covers sterilization; FDA, USP Class VI & ISO 10993 for Peristaltic Pump Tubing covers documentation claims.

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