Process Guide

Medical Device Assembly

ISO-compliant wiping protocols for implants, surgical instruments, and diagnostic equipment.

The Objective

What are we trying to achieve?

Guarantee bio-compatibility and zero particulate contamination before final sterilization and packaging.

Any foreign particulate (fibers, skin cells, binder residue) on an implantable device can trigger a severe immune response in the patient.

Common Challenges

Types of Contamination

✕ Bio-burden ✕ Machining oils ✕ Skin cells/Hair ✕ Airborne particulates ✕ Packaging dust

Material Specs

Critical Requirements

✓

ISO Class 4 Laundered

Processed in a cleanroom to guarantee extremely low particle counts.

✓

Laser Sealed Edges

Prevents any loose fibers from shedding during the wiping process.

✓

Double Bagged

Ensures the wipes themselves don't introduce contamination into the cleanroom.

The Fix

Recommended Products

SOP

Standard Cleaning Procedure

STEP 1

Donning

Ensure proper cleanroom gowning and double-gloving before handling wipes.

STEP 2

Quarter Fold

Fold the wipe into quarters. This provides 8 clean surfaces for wiping.

STEP 3

Wipe

Wipe the device with firm, overlapping strokes. Turn to a clean quarter of the wipe for each stroke.

STEP 4

Discard

Do not re-use a wipe once all 8 surfaces have been utilized.

✓

Best Practices

✓ Use the quarter-fold technique
✓ Double bag all materials entering the cleanroom
✓ Use pre-wetted wipes to reduce airborne particles

Avoid These Mistakes

✕ Shaking wipes (releases particles)
✕ Leaving wipes exposed on benches
✕ Wiping back-and-forth

Related Resources

Need Custom Manufacturing?

✓ Custom GSM ✓ Cleanroom Packaging ✓ OEM Branding

We engineer wipes to fit your exact standard operating procedure.

Explore Manufacturing

Frequently Asked Questions

Do you provide a Certificate of Analysis (COA)?

Yes, full lot traceability and COAs are available for all cleanroom-grade products.