The vascular access port body is the implantable reservoir that receives a needle through a self-sealing septum and delivers drug or nutrition into a catheter. Buyers struggle with thin-wall leakage, inconsistent septum seating depth, and radiographic wall variation that fails incoming inspection. Ningbo Ruican casts the body near net shape and machines the septum seat, floor radius and outlet bore on one controlled datum scheme, holding ±0.03 mm on the sealing land so septum compression stays within the validated window across lots.
Specifications
| Casting process | Material options | Dimensional tolerance (ISO 8062-3 CT grade) | Machining | Surface finish (Ra) | Weight range | Typical lead time |
|---|---|---|---|---|---|---|
| Silica sol lost-wax investment casting (water glass line for cost-optimised volumes) | AISI 316L, 17-4PH (H900 / H1025) | CT5–CT6 as cast; CT4 on machined datum, septum seat and outlet bore | 4-axis and 5-axis CNC milling, turning, precision drilling and tapping | Ra 0.4 um as cast; Ra 0.2 um after electropolishing | 3–25 g | 30–45 days including First Article Inspection report |
Scope and options
Key features
- Near-net-shape casting of the reservoir cavity removes deep-pocket tool paths and lowers per-piece cost against bar-stock machining.
- Moreover, Control of the septum seat flatness within 0.02 mm stabilises needle-puncture cycle life in the customer’s validation testing.
- Full radiographic (ASTM E446 / E505) coverage port option available for the cast-to-cast transition zones.
- Clean-room-compatible final cleaning, passivation per ASTM A967, and individual poly-bagging on request.
- Heat-lot traceability from melt to finished part through a single traveller document number.
- Design-for-manufacture review including draft, wall-thickness and gating recommendations returned before tooling release.
Applications
- Implantable venous access ports for oncology chemotherapy delivery
- Arterial hepatic chemo-infusion ports
- Intraperitoneal ports used in peritoneal dialysis and palliative care
- Intrathecal and epidural drug-delivery access ports
- Tunnelled catheter reservoir bodies for long-term parenteral nutrition
- External ambulatory infusion pump reservoir housings
Quality & compliance
Ningbo Ruican is not an ISO 13485 contract manufacturer. It supplies cast and CNC-machined components in 17-4PH (H900/H1025), AISI 420 and AISI 316L together with project-level documentation under the customer’s Quality Agreement, including material traceability and ISO 10993-5 biocompatibility test support. Every port body ships with a melt certificate tied to the heat lot, dimensional reporting on the sealing features called out on the print, and passivation records; the customer retains regulatory responsibility for the finished device.
Do you hold ISO 13485 certification?
Moreover, Ningbo Ruican is not an ISO 13485 contract manufacturer. We operate under IATF 16949 process controls and deliver components in 316L, 17-4PH and AISI 420 with project-level documentation under your Quality Agreement, including material traceability and ISO 10993-5 test support. Generally, regulatory responsibility for the finished device remains with you, the device manufacturer.
What wall thickness can you cast reliably in 316L?
For port reservoir walls we routinely hold 0.8 mm to 1.2 mm in 316L using silica sol shells and vacuum-assisted pouring, depending on section length and local heat mass. Below about 0.7 mm we recommend a design review, because shell-metal reaction and misrun risk rise sharply. We will flag every thin section on your drawing during the quotation stage.
Can you machine the septum seat to a sealing surface finish?
Yes. We machine the septum landing face and its blend radius against a single datum scheme, typically achieving Ra 0.2 um after electropolishing and flatness inside 0.02 mm. That combination stabilises needle-puncture cycling and reduces the risk of septum extrusion that appears when the seat is cut from bar stock with tool deflection.
What documents arrive with the first shipment?
The First Article Inspection package contains a fully ballooned dimensional report, EN 10204 3.1 material certificate with heat-lot cross-reference, passivation record per ASTM A967, NDT report where specified, and photographs of the packaging configuration. Any additional format required by your Quality Agreement, such as PPAP-style elements, can be added at quotation time.
How do you control biocompatibility expectations?
We supply the ISO 10993-5 cytotoxicity test support at project level through accredited third-party laboratories, and we never re-use cleaning media or electropolishing baths between material families. Cleaning agent residues, lubrication chemistry and handling gloves are documented in the process traveller so your incoming validation team sees the full chain.
CTA
Send us your port body drawing, target annual volume and septum specification, and we will return a tooling quote, DFM notes and a First Article timeline within three working days. Contact Wendy She — sales@cnsandcasting.com — WhatsApp +86-13777124360 for samples, material certifications or a confidentiality agreement before you release files.
