A particle on an implant surface is not a quality statistic. It is a patient outcome.

Medical device contamination control demands evidence that the assembly environment protected the product — not a certification that the room was capable of doing so.

Medical device and implant manufacturing operates at the intersection of contamination control and regulatory obligation. ISO 13485 requires a quality management system that controls the contamination risk throughout the manufacturing process. ISO 14644-1 provides the cleanroom classification framework. What neither standard addresses directly is whether the operational cleanroom environment — with personnel present, with processes running, with equipment vibrating — actually delivers the contamination protection the product requires during the specific exposure windows when it is vulnerable.

The product-oriented contamination control approach developed by Koos Agricola and formalised in ISO 14644-17 starts from the product. What is the critical particle size for this device? What is the vulnerable surface area? How long is the product exposed during the critical assembly step? From these inputs, the maximum allowable particle deposition rate is calculated — and that limit becomes the monitoring target. For a cardiovascular implant with a critical particle size of 25 μm, the calculation gives a specific deposition rate limit that the cleanroom must not exceed during the implant’s exposure. APMON measures whether it does.

Surface cleanliness adds the contact transfer pathway. Surgical instruments, implant carriers, handling fixtures, and packaging surfaces can transfer particles directly to the product surface by contact — particles that arrived from the personnel and environment during previous operations, between cleaning cycles. SUMON measures the particle fall-out level on these surfaces before product contact, per IEST-STD-CC1246E, providing objective documentation that the contact surface was within specification at the time of use. Together, APMON and SUMON provide the evidence base that the product was protected from both airborne deposition and contact transfer throughout assembly.

What you can Count on

in Medical Device Contamination Control.

APMON Live — continuous deposition rate monitoring at the product assembly location, with alarm limits calculated from the critical particle size, vulnerable area, and exposure time of the specific device or implant.
SUMON — surface cleanliness measurement of implant carriers, handling fixtures, surgical instrument trays, and packaging surfaces, providing pre-use evidence of surface cleanliness per IEST-STD-CC1246E.
Regulatory documentation — timestamped APMON event logs and SUMON measurement records that demonstrate operational contamination control for inclusion in technical files and quality management records.
Cleaning validation support — SUMON before and after cleaning provides objective evidence that cleaning procedures achieve the required surface cleanliness level for critical contact surfaces.
Risk-based monitoring program design — ISO 14644-17 product analysis to derive deposition rate limits for each device type, ensuring monitoring alarm limits are based on patient risk, not convention.

Medical device contamination control is an evidence discipline. The cleanroom class is the starting point. The product deposition rate during assembly is the evidence that the patient was protected.

APMON Live — continuous deposition rate monitoring at the product assembly location, with alarm limits calculated from the critical particle size, vulnerable area, and exposure time of the specific device or implant.
SUMON — surface cleanliness measurement of implant carriers, handling fixtures, surgical instrument trays, and packaging surfaces, providing pre-use evidence of surface cleanliness per IEST-STD-CC1246E.
Regulatory documentation — timestamped APMON event logs and SUMON measurement records that demonstrate operational contamination control for inclusion in technical files and quality management records.
Cleaning validation support — SUMON before and after cleaning provides objective evidence that cleaning procedures achieve the required surface cleanliness level for critical contact surfaces.
Risk-based monitoring program design — ISO 14644-17 product analysis to derive deposition rate limits for each device type, ensuring monitoring alarm limits are based on patient risk, not convention.

Medical device contamination control is an evidence discipline. The cleanroom class is the starting point. The product deposition rate during assembly is the evidence that the patient was protected.

APMON Live — continuous deposition rate monitoring at the product assembly location, with alarm limits calculated from the critical particle size, vulnerable area, and exposure time of the specific device or implant.
SUMON — surface cleanliness measurement of implant carriers, handling fixtures, surgical instrument trays, and packaging surfaces, providing pre-use evidence of surface cleanliness per IEST-STD-CC1246E.
Regulatory documentation — timestamped APMON event logs and SUMON measurement records that demonstrate operational contamination control for inclusion in technical files and quality management records.
Cleaning validation support — SUMON before and after cleaning provides objective evidence that cleaning procedures achieve the required surface cleanliness level for critical contact surfaces.
Risk-based monitoring program design — ISO 14644-17 product analysis to derive deposition rate limits for each device type, ensuring monitoring alarm limits are based on patient risk, not convention.

Medical device contamination control is an evidence discipline. The cleanroom class is the starting point. The product deposition rate during assembly is the evidence that the patient was protected.

From cleanroom class to patient risk

ISO 14644-1 classification tells a regulator that a cleanroom was capable of achieving a certain air cleanliness level at rest. It does not tell them that the product was protected during the assembly operations where contamination risk was highest. ISO 14644-17 monitoring with APMON provides that evidence: the deposition rate at the product location, during active production, for every interval of the manufacturing process. This is the contamination control record that supports a 510(k) submission, a CE technical file, or an FDA audit.

Discover

measurement solutions.

Patient-risk-based deposition rate monitoring for medical device assembly

Surface cleanliness for implant carriers and surgical contact surfaces

Patient-risk-based deposition rate monitoring for medical device assembly

Surface cleanliness for implant carriers and surgical contact surfaces

For in-depth knowledge on contamination measurement,
explore the Brookhuis Academy.

For in-depth knowledge on contamination measurement,
explore the Brookhuis Academy.

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whitepapers.

Particle Deposition

Surface Cleanliness

Particle Deposition

Surface Cleanliness