Medical Device

Cleanroom behavior

Cleanroom gowning, entry, and material transfer procedures exist because particles and microbes matter. A contamination event is a quality event that can shut down production. Before you enter the room, know the gowning sequence for that classification. Know the material transfer procedures. Know the escalation path if something goes wrong. Improvisation is not welcome.

Sterilizers and cycle control

Ethylene oxide and hydrogen peroxide sterilizers have specific cycle requirements. A cycle deviation is an investigation. Vacuum leaks, temperature drift, humidity control, and gas delivery all have to be within spec. Before you touch the machine, read the last cycle chart. The chart tells you exactly where the cycle deviated.

Precision assembly equipment

Medical device assembly uses very precise equipment.

• Micro-molders run tolerances tighter than commercial molders. Parameter discipline matters.
• Laser welders need beam path and energy delivery verification on every production run.
• Vision systems need calibration maintenance. An out-of-cal vision system passes bad parts.
• Bonding and adhesive dispensers need flow verification. Uncontrolled bead size is a quality failure.

Document, document, document

Every maintenance action goes into the device history record. Every. Single. One. It is not enough to fix the problem. You have to document the problem, the cause, the corrective action, the verification, and the closure. If it is not in the record, it did not happen as far as the audit is concerned.