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Medical & Diagnostic Product Applications
Medical and diagnostic disposables run in the millions, need the same part from every cavity on every shot, and leave no room for black specks, flash or short shots. TK’s medical molds are built around modular mold design, short cycle times, stable production and fast pilot development for new products.
Medical Parts TK Builds Molds For
- Laboratory consumables: blood test tubes and caps, pipette tips, 96 well PCR plates, 0.2 ml PCR tubes and tube strips, sampling tubes.
- Syringes and needles: syringe barrels and plungers, needle hubs, safety needle handles and covers, insulin syringe parts, blood collection needles and Luer connectors.
- Infusion: syringe connectors, needle sleeve joints, drip chambers, blood filters and Huber needle parts.
- Hemodialysis and devices: dialyzer housings and cylinder caps, blood glucose meter housings and urinary catheter parts.
Hot Valve Gates Direct on the Part
Most of TK’s high volume medical molds feed every cavity through a hot runner and a valve gate placed directly on the part. There is no cold runner to cut off, regrind or contaminate, every shot is finished parts, and the valve pin closes flush with the part to leave a small, clean gate mark. Long medical parts such as syringe barrels and blood test tubes are gated at the closed end, so the melt flows down both walls evenly and the long core stays centered. They also set the press stroke: the mold has to open more than twice the part length so the cores clear the cavity plate, and a stripper plate, driven by the ejector plates through stripper rods tied on with shoulder bolts, pushes on the flange of every part at once to strip it off the core without marking it.
Gating on TK Medical Molds
- 128 cavity blood test tube: fully hot half with valve gates, concentricity held to 0.1 mm.
- 64 cavity hemostatic clip: hot valve gate direct onto the part in a compact mold that runs on a 230 ton press at a 9.6 s cycle.
- 32 cavity PC syringe connector: hot side gate direct onto the part with no black spots, yellowing or peeling, and servo driven unscrewing for the thread.
- 8 cavity PC needle sleeve joint: fully hot runner valve gates.
For the design reviews behind these choices, see our DFM and Moldflow review and our high cavitation and stack molds.
Medical Tool Shops and Large Launches
TK runs three tool shops dedicated to medical molds, covering laboratory consumables, infusion, hemodialysis and syringe series, with capacity for projects of 50 molds. Medical programs often launch many identical molds at once, and TK has delivered them that way:
Quality System
TK has held ISO 13485 since 2010, ISO 9001 since 1999 and a GMP statement since 2019, along with UL, ISO 14001, ISO 45001 and IATF 16949. TK can also mold the parts; see our contract injection molding page.
Comprehensive IQ / OQ / PQ Validation
Before a medical mold ships, TK proves it out in its mold testing center with a data driven qualification that follows scientific molding practice, so the process window is set from measured data rather than guesswork.
IQ, OQ and PQ for Medical Programs
For medical and healthcare programs, TK’s development process includes IQ, OQ and PQ validation after tooling trial, first article inspection and product and process qualification. In general terms, installation qualification confirms the mold and equipment are installed and documented as specified, operational qualification proves the process window, and performance qualification shows the process makes good parts consistently over production runs.
First Article Metrology and Testing
TK’s inspection team covers GD&T, process validation testing and failure analysis, with 100% CMM measurement and a 99.8% or better pass rate on critical dimensions, and CPK above 1.67 on more than 200 dimensions. Functional tests include tensile, torque, sealing and leak testing, plus high temperature, low temperature, negative pressure and shelf life testing. See our mold trials and quality verification page.
Medical Molds Built by TK
A selection of TK medical and diagnostic molds. Data is from TK’s medical tooling case records.
| Part | Cavities | Resin, Weight | Press | Cycle | Notes |
|---|---|---|---|---|---|
| Blood test tube, ø19 x 102 mm | 128 | PP, 4.3 g | 580 T | 10 s | Fully hot half valve gate, 0.1 mm concentricity, North America |
| Test tube cap, ø21.5 x 14.8 mm | 128 | HDPE, 2.3 g | 360 T | 10 to 13 s | Fully hot half valve gate, North America |
| Hemostatic clip | 64 | PP, 1.1 g | 230 T | 9.6 s | Hot valve gate direct onto the part |
| Syringe connector | 32 | PC, 0.56 g | 130 T | 11 s | Hot side gate onto the part, servo unscrewing |
| Medical device front cover | 32 | PS, 1.99 g | 250 T | 14 s | Hot nozzle to cold runner and sub gate, USA |
| Blood filter | 16 | PP, 0.8 g | 100 T | 9 to 11 s | 0.6 mm average wall, core inserts held to 0.005 to 0.008 mm |
| 0.2 ml PCR tube | 8 | Clear PP | 100 T | 12 s | 0.25 mm wall, Europe |
| 96 well PCR plate | 1 | Clear PP | 100 T | 16 s | 0.25 mm wall, special overflow runner for 96 tubes, Europe |
Interactive Medical Mold Cavitation Planner
Pick a part type to start from a real TK medical mold, then enter your annual volume and cycle. The planner works out how many cavities your volume needs, the mold layout and how many molds to build, and compares it with what TK has built for that part. Open “Show the math” to see every step.
Show the math
Cavity counts are rounded up to common layouts (1, 2, 4, 8, 16, 24, 32, 48, 64, 96, 128). The real cavitation also depends on part size, gate and ejection, press size and your validation plan, which TK confirms in DFM. Reference data is from TK’s medical tooling case records. Default numbers are an example only.
Technical Sourcing FAQ: Medical Tooling
Developing a Medical Device or Diagnostic Program?
Send your part files, volumes and validation requirements to Brandon Henderson, Technical Sales Support Manager for the Americas. He will review cavitation, gating, press size and timeline with TK’s medical tool shops.