What is included in the quotation?

DFM, tooling, all trial rounds, OQ and PQ, in one figure. Trial rounds and validation are the two items most often quoted separately in this industry and most often invoiced later as change orders. They are inside our number.

What cleanroom class do you operate?

ISO 7 / Class 10,000 throughout, with localized ISO 6 where the application requires it. A significant part of the medical molding market operates at ISO 8 / Class 100,000 — ten times the permitted particle count — for the same categories of regulated device.

Do you support European medical device manufacturers looking at localization?

Yes. ISO 7 cleanrooms under ISO 13485 with FDA registration, already running multi-year programs for regulated products at millions of units per quarter. Project management, design reviews and documentation are handled in English from San Diego.

Do you only mold microfluidics?

No. Microfluidics is where the finest feature capability sits, but the majority of molding work is precision medical components above 200 µm — housings, cartridges, surgical components and consumables.

What is your minimum feature size?

2 µm at the finest, using proprietary MEMS mold fabrication. Routine molded channels are 100 µm and above; selected low-aspect-ratio features reach 20 µm after DFM review.

Which materials do you mold?

Any injection-moldable thermoplastic. COC, COP, PC, PMMA, PS and PP are held as standard; ABS, PEEK, PEI and others are quoted on request.

Why is the minimum order 500 units?

Five hundred units is the smallest run we tool for, and below approximately 500 parts a month tooling rarely amortizes within the program. For lower volumes, CNC micro milling and PDMS casting both accept quantity one.

Service \ Scale-up manufacturing \ Cleanroom injection molding

CLEANROOM INJECTION MOLDING

Precision and micro injection molding of medical device components and microfluidic chips in an ISO 7 cleanroom.

MATERIAL

COC · COP · PC · PMMA · PS · PP and more

MINIMUM ORDER

500 units

LEAD TIME

DFM in 1 week · T1 samples in 8–10 weeks

Get a quote

Book a design review

\ OVERVIEW

Cleanroom injection molding

Our injection molding for medical devices, diagnostics and microfluidics runs in a cleanroom that is ISO 7 / Class 10,000 throughout, with localized ISO 6, under an ISO 13485 quality system. The facility produces regulated product at millions of units per quarter. Two kinds of work share the same cleanroom. Precision medical molding covers housings, cartridges, surgical components and consumables. Micro molding replicates sub-200 µm microfluidic channels and arrays, down to 2 µm, from molds we fabricate ourselves.

Injection molding presses in HiComp's ISO 7 cleanroom

2 µm

finest moldable feature

±0.025 mm

standard dimensional tolerance

ISO 7

Class 10,000 cleanroom · localized ISO 6

6–8 weeks

tooling to first trial · one all-inclusive quotation

ISO 13485

certified · FDA registered

\ CAPABILITIES

Capabilities and technical specifications

The mold is made here — CNC to 20 µm, MEMS molds to 2 µm — with tooling to first trial in six to eight weeks and one all-inclusive quotation covering DFM, tooling, every trial round, OQ and PQ. ISO 7 across the molding floor, localized ISO 6 where needed, under ISO 13485.

Precision medical molding vs. micro molding

The two differ in feature size, tooling route, qualification requirement and metrology. Both run in the same cleanroom under the same quality system.

ASPECT

PRECISION MEDICAL MOLDING

MICRO MOLDING

Feature size

Above 200 µm — housings, cartridges, surgical components, consumables

Sub-200 µm microfluidic channels and arrays

Selection criteria

Cleanroom class, quality system, validation support, lead time, quotation transparency

Achievable feature size, replication fidelity, metrology capability

Tooling route

Conventional precision molds

High-speed CNC and proprietary MEMS mold fabrication

Typical development path

Direct to tooling from a released drawing

Prototyping in PDMS or CNC first, transferring to tooling at design freeze

Metrology

CMM and optical microscopy

White-light interferometry, profilometry and SEM, plus functional testing

Micro molding programs rarely begin at tooling.

Sub-200 µm devices are normally prototyped in PDMS or CNC-machined plastic and transferred to injection molding once the design is frozen and volume justifies a tool. If your program is at that earlier stage, start with PDMS manufacturing or CNC micro milling.

Feature size by tooling route

FEATURE

CAPABILITY

TOOLING ROUTE

Routine channels and functional features

≥ 100 µm

Standard precision mold

Selected low-aspect-ratio features

Down to 20 µm after DFM review

High-speed CNC

Fine features

Below 5 µm

Proprietary MEMS mold fabrication

Finest achievable feature

2 µm

MEMS mold, validated conditions

Dimensional and surface

Standard dimensional tolerance

±0.025 mm

Critical dimensional tolerance

Down to ±0.002 mm, depending on feature size, material, mold design and measurement method

Minimum wall thickness

≥ 1.0 mm nominal; local walls and ribs to 0.6 mm subject to flow length and DFM

Draft angle

1–2° external walls, 0.5–1° selected microfeatures. Zero draft evaluated for short, shallow features

Aspect ratio

Routine 2:1; selected localized features to 3:1

Surface roughness

Ra ≤ 0.02 µm on polished surfaces; standard replicated channels Ra ≤ 0.20 µm

Special processes

Two-shot molding · silicone overmolding · insert molding · micropillar and microwell array replication

Mold types

The mold sets the feature size. All four categories are designed and built in house; MEMS mold fabrication is described on the MEMS manufacturing page.

Single-cavity molds

Small-batch production and process testing

Multi-cavity molds

Large-scale production — the route for consumables such as PCR tubes and 96- and 384-well plates

Precision molds

Channel dimensions below 100 µm with strict surface-roughness requirements; generally high-precision CNC metal molds

MEMS-fabricated molds

Features below 5 µm, to 2 µm under validated conditions, by our proprietary MEMS mold fabrication

\ MATERIALS

Materials

Any thermoplastic that can be injection molded. The six below are the most frequently requested and are held as standard in medical, optical and low-autofluorescence grades. Others are quoted on request; the constraint is the resin's processability, not our material list.

COC

OPTICAL

Tɢ / SERVICE TEMPERATURE

~91–92% visible; good UV

~65–180 °C by grade

WATER ABSORPTION

CHEMICAL RESISTANCE

< 0.01%

Good to acids, bases, alcohols. Swells in non-polar solvents

TYPICAL USE

Optical detection, fluorescence, PCR consumables, microplates

COP

OPTICAL

Tɢ

~92% visible; low birefringence

~100–163 °C by grade

WATER ABSORPTION

CHEMICAL RESISTANCE

< 0.01%

As COC

TYPICAL USE

Fluorescence and interferometric detection; optical-grade chips

PMMA

OPTICAL

Tɢ

~92% — best visible clarity

~105 °C

WATER ABSORPTION

CHEMICAL RESISTANCE

~0.3%

Poor to many solvents; dissolved by acetone

TYPICAL USE

Manifolds, structural chips, cost-sensitive devices

PC

OPTICAL

Tɢ

~88–90%; poor UV

~145–150 °C; autoclavable

WATER ABSORPTION

CHEMICAL RESISTANCE

~0.2–0.35%

Poor to bases; stress-cracks with alcohols

TYPICAL USE

High-temperature or high-toughness parts; autoclaved devices

PS

OPTICAL

Tɢ

~90%; poor UV

~100 °C

WATER ABSORPTION

CHEMICAL RESISTANCE

~0.05%

Poor — attacked by many solvents

TYPICAL USE

Cell-culture consumables with TC treatment; disposables

PP

OPTICAL

Tɢ

Translucent, not clear

Melts ~160 °C

WATER ABSORPTION

CHEMICAL RESISTANCE

Very low

Excellent — solvents, acids, bases

TYPICAL USE

Reagent contact and storage; fluid handling

Choose the resin by the readout first.

COC and COP are the low-autofluorescence, low-water-absorption choices for fluorescence and interferometric detection. PC autoclaves but transmits UV poorly and stress-cracks with alcohols. PS, once tissue-culture treated, is the cell-culture resin. PP is the resin for reagent contact and storage where clarity does not matter.

Not limited to these six.

ABS, PEEK, PEI (Ultem), TPE and other engineering thermoplastics are quoted on request. Send the resin and grade, and we will confirm processability and any DFM implications before you design around it. The full comparison, grade by grade, is in the Materials guide.

\ PROCESS

Molding process

One route from released drawing to packaged part; every step in house.

DFM review

Product drawings, tolerances and acceptance criteria in; a written manufacturability report back — wall thickness, draft, gating, sink and weld-line risk.

Report within 1 week of order

Validation — OQ and PQ

Operational and performance qualification executed; written process and inspection plan agreed before release. IQ supported where the program requires it.

OQ and PQ included

Mold design

Cavity count matched to volume — single-cavity for small batches and process testing, multi-cavity for scale — gate and runner layout, Moldflow filling analysis.

Draft 1–2° external walls

Production

Scheduled release under ISO 13485 in the ISO 7 cleanroom; programs running at millions of units per quarter.

ISO 7 · localized ISO 6

Mold making

Conventional precision molds for medical components; high-speed CNC for features to 20 µm; proprietary MEMS mold fabrication below 5 µm.

6–8 weeks to first trial

Downstream processes

Bonding and sealing, surface functionalization, reagent storage and lyophilization, assembly and automation — in house, so the molded part never waits at a vendor boundary.

4 downstream processes in house

Trials — T0 to T1

First shots, dimensional verification and process-window development. Every trial round is inside the quotation.

T1 samples 8–10 weeks after DFM

\ QUALITY CONTROL

Quality control

Inspection requirements differ by product class. Both classes are supported in house.

↓ MEDICAL DEVICE COMPONENTS

↓ MICROFLUIDIC DEVICES

Dimensional

White-light interferometry and stylus profilometry

CMM and optical microscopy

Surface and feature

SEM for replication fidelity and sub-micron feature verification

Optical microscopy

Functional

Burst and pressure, leak, tensile and pull-force, fluidic performance, protein adsorption

Dimensional and visual to drawing

Why it differs

Channels below 100 µm and surfaces at Ra 0.02 µm cannot be verified by CMM or caliper

Features are visible and measurable by contact methods

Acceptance criteria

Methods, sample quantities and criteria agreed at DFM or project kickoff

Environment

ISO 7 / Class 10,000 throughout, with localized ISO 6 where required

Validation

IQ, OQ and PQ supported; OQ and PQ included in the quotation

Quality system

ISO 13485 certified · FDA registered

The cleanroom

Five views inside the cleanroom, from presses to packing.

\ LEAD TIME & MOQ

Lead time & MOQ

DFM report

Within one week of order placement or contract signing

Tool life

Project-specific — mold material, resin, geometry, feature size and maintenance

Tooling and samples

Tooling to T0 in 6–8 weeks after design approval — industry norm is 10–16. T1 samples 8–10 weeks after DFM confirmation

Indicative pricing

NRE from $15,000 — design, DFM, tooling, trials and first-article validation; a variant of a part we already build sits at the floor, a novel geometry above it. Unit price is quoted per geometry and volume

Minimum order

500 units. Economic quantity is above approximately 500 parts per month, with a frozen design

Packaging and delivery

PE bags standard; blister packs or sterile pouches on request. Sterilization available

What the quotation covers.

One all-inclusive figure: DFM, tooling, all trial rounds, OQ and PQ. Trial rounds and validation are the two line items most commonly quoted separately in this industry, and the two that most often appear later as change orders. They are inside our number from the start.

Below 500 units a month.

CNC micro milling accepts quantity one at ±0.05 mm on channel dimensions; PDMS casting has no minimum. Both are normal routes to a molded program later.

\ SHOWCASE

Case studies and applications

Sample parts

24-well open-bottom plate for optical assays
Design-for-manufacturing optimization on a precision biological device with glass integration.

Draft-angle verification across the cavity before tool cutting.

Filling simulation confirming no short shot across the four-point gate layout.

REQUIREMENT

Customer specification

Open-bottom 24-well plate requiring thin optical interface compatibility
Risk of sink marks from thick wall regions
Tight dimensional control for glass bonding alignment
Need to ensure uniform filling without short shot
Weld lines and air traps expected due to multi-cavity geometry

ENGINEERING APPROACH

DFM output

Optimized wall thickness distribution to reduce shrinkage defects
Increased draft angles (1.5° → up to 5°) fo reliable demolding
Added locating features for glass alignment and assembly
Designed four-point gate cold-runner system for uniform filling
Verified moldability using Moldflow simulation: no short shot detected, controlled shrinkage (~0.74%), deformation <0.32 mm

AS MANUFACTURED

Production parameters

Material: GPPS (SECCO GPPS123 equivalent)
Part volume: 53 g
Cycle time: ~50 s
Mold: three-plate tooling (S136 steel)
Machine: 100-ton injection platform
Tool lifetime: 100,000 shots
Surface finish: Ra ≤ 0.02 µm achievable
Gate vestige controlled <0.25 mm

Other programs.

Precision microfluidic chips for single-cell sequencing, direct ELISA and flow cytometry; life-science consumables including 96- and 384-well plates and PCR tubes; over 500 customer projects completed.

Application

At-home & POC tests

Microplates & microwell arrays

\ TESTIMONIALS

“

HiComp has manufactured the injection-molded components of our cartridges for four years, now at millions of units each quarter in their ISO-certified facilities. Consistency at that volume is difficult, and they have delivered it. They stay engaged through every design change.

Dr. Hong Tan

Founder and CEO, ET Healthcare, Palo Alto, California

FAQ

It follows the feature size. Precision molding covers medical devices with features above 200 µm — housings, cartridges, surgical devices and consumables — and is chosen on cleanroom class, quality system, validation support, lead time and quotation transparency; it goes direct to tooling from a released drawing. Micro molding covers microfluidic devices with features below 200 µm and is chosen on achievable feature size, replication fidelity and metrology. Micro molding programs rarely begin at tooling: they are normally prototyped in PDMS or CNC-machined plastic and transferred to a mold once the design is frozen and volume justifies it — if you are at that stage, start with PDMS manufacturing or CNC micro milling.

By the readout first. COC and COP are the low-autofluorescence, low-water-absorption choices (under 0.01%) for fluorescence and interferometric detection, at about 92% visible transmission with good UV; COC grades run from about 65 to 180 °C Tg, and both swell in non-polar solvents. PMMA has the best visible clarity but absorbs about 0.3% water and is dissolved by acetone. PC autoclaves (Tg about 145–150 °C) but transmits UV poorly and stress-cracks with alcohols. PS, once tissue-culture treated, is the cell-culture resin. PP is translucent rather than clear, with excellent resistance to solvents, acids and bases — the resin for reagent contact and storage. Grade-level data is in the Materials guide.

By product class. Medical devices are measured by CMM and optical microscopy, dimensionally and visually to the drawing. Microfluidic devices need white-light interferometry, profilometry and SEM, plus functional tests — burst and pressure, leak, tensile and pull-force, fluidic performance, protein adsorption — because channels below 100 µm cannot be verified by CMM or caliper. Methods, sample quantities and acceptance criteria are agreed at DFM or project kickoff; IQ, OQ and PQ are supported, and OQ and PQ are in the quotation.