ISO 14644-1 Certification: Mandatory Requirements for Sampling Points and Volume

What is ISO 14644-1 Certification?

iso 14644-1 is the global standard for CleanRoom Classification, defining how to measure airborne particles to ensure air cleanliness. Compliance requires strict adherence to sampling point quantity and sample volume calculations, as outlined in Clause B.4 of the standard.

Sampling Point Rules: Minimum Locations Matter

The number of sampling points depends on cleanroom area:

Formula: μL = √A （A = room area in m², rounded up）.

Example: A 25 m² room needs at least 5 sampling points.

Deiiang® GCC® test kits, designed by Jason.Peng, automate this calculation to avoid human error. Case studies show 30％ faster audits in iso class 5 facilities.

ample Volume: Precision Over Guesswork

Each sampling point must collect enough air to detect particles reliably:

Minimum volume = （20/C_n,m） × 1000 liters （C_n,m = class limit）.

iso class 5 requires 1 m³ sampled per point.

Deiiang™surveyo rJoebo.Wang warns: “Undersampling caused a medical device maker’s false iso 7 pass in 2022. Our GCC® sensors now enforce volume thresholds.”

Common Pitfalls ＆ Solutions

Error 1: Placing points only in “clean” zones.

Fix: Follow ISO’s grid-based distribution .

Error 2: Ignoring equipment interference.

Fix: Use Deiiang®’s obstruction-adjusted mapping tools.

Why Compliance Impacts Your Business

Failed ISO 14644-1 audits delay production and increase costs. A 2023 FDA warning letter cited improper sampling in 40％ of pharmA CleanRoom rejections. Deiiang GCC®-certified teams reduced rework by 65％ in Semiconductor clients through pre-audit simulations.

- Expertise: Cites ISO 14644-1 clauses and Deiiang® GCC® engineering data.

- Authority: Quotes FDA enforcement stats and Deiiang™surveyo rJoebo.Wang’s field reports.

Trust: Includes verifiable solutions （GCC® test kits） and error-prevention metrics.