(ISO 14644, EU GMP Annex 1, and application-specific needs)

Who this is for: teams in pharma/biotech, medical device, semiconductor/electronics, and labs who need a practical, correct way to match glove choice to cleanroom class and process risk.

1. What “cleanroom class” actually controls (and what it doesn’t)

• ISO 14644-1 classifies cleanrooms by maximum allowable airborne particle concentrations (ISO 1 = cleanest … ISO 9 = least clean). It does not prescribe the glove; it sets the air cleanliness target your process controls (including gowning and gloves) must help you meet.

• For regulated aseptic manufacturing, EU GMP Annex 1 overlays Grades A–D with explicit expectations. Grade A/B is used for aseptic core work; C/D for background/support areas.

2. Quick map: typical glove expectations by environment

• A. Aseptic pharma/biotech (EU GMP Grades A–D): Grade A/B operations (e.g., aseptic filling, RABS/isolators) use sterile cleanroom gloves with validated sterilization (typically SAL 10⁻⁶), low particles, and low extractables/endotoxin. Double-gloving and sterile donning are standard. Grade C/D background may use non-sterile clean-processed gloves that still meet low particulation and disinfectant compatibility.

• B. Medical device cleanrooms (ISO 14644): Choose clean-processed, powder-free gloves with low particles/extractables. If the device or pack will be terminally sterilized, ensure glove residues do not challenge sterilization/biocompatibility.

• C. Semiconductor/electronics (ISO 3–7): Prioritize ultra-low particles/ions/silicone and ESD-safe properties. Verify in-use resistance with relevant ESD test methods. Sterility is usually not required unless your process demands it.

3. Sterile glove specifics (when asepsis matters)

• Sterility target: Many sterile cleanroom gloves are validated to SAL 10⁻⁶ (≤ 1 non-sterile item per 1,000,000). Keep the sterilization certificate/lot records.

• Endotoxin control: For low endotoxin claims, verify the endotoxin specification and method if your process is pyrogen-sensitive.

• Powder-free & residues: Powder is incompatible with cleanrooms. Control residues in line with your biocompatibility plan.

4. What to check on a glove datasheet (minimum due diligence)

• Cleanroom compatibility: documented clean-processing and particle/ion extractables data.

• Sterility (if needed): process (gamma/e-beam), SAL, sterilization certificate, and bioburden controls.

• Biological risks: biological evaluation and low endotoxin data if applicable.

• ESD suitability (electronics): in-use resistance testing evidence for your ESD control program.

• Chemical/disinfectant compatibility: ensure no swelling/cracking that increases shedding; validate on site.

5. Choosing gloves by cleanroom context (decision snapshots)

• Aseptic fill/finish (Grade A/B): Sterile, SAL 10⁻⁶, low endotoxin; validated donning; disinfectant-compatible; documented particulate cleanliness.

• Non-aseptic but classified support (Grade C/D): Clean-processed, powder-free gloves with particle/extractables data; no powder/silicone; disinfectant-compatible.

• Electronics wafer line (ISO 3–5): Ultra-low particle/ion gloves, silicone-free, and ESD-dissipative as specified by your process.

• Device assembly (ISO 7–8): Clean-processed, biocompatible; ensure glove residues will not compromise downstream sterilization validation.

6. Testing & standards you’ll see referenced

• ISO 14644-1/-2 — cleanroom classification & monitoring (airborne non-viable particles).

• EU GMP Annex 1 — sterile products; Grades A–D; links particle monitoring to ISO classes.

• IEST recommended practices for gloves/finger cots — cleanliness, integrity, selection guidelines.

• ANSI/ESD methods for in-use resistance when gloves are part of ESD control.

• ISO 11137 — radiation sterilization validation (SAL 10⁻⁶ as a common target).

• EN 455-3 — biological evaluation of medical gloves; endotoxin considerations for sterile product use.

7. Common pitfalls (and how to avoid them)

• Assuming ISO class dictates sterility — it doesn’t. Sterility is a product requirement; ISO class is air cleanliness.

• Relying only on material name — ‘nitrile’ or ‘latex’ alone does not guarantee low particles/ions or ESD suitability.

• Ignoring endotoxin when it matters — for pyrogen-sensitive operations, specify low endotoxin gloves and verify the method.