Question 1

Which cleanroom classes are these gloves recommended for?

Accepted Answer

They are recommended for use in ISO Class 3 or higher cleanrooms and in Grade A and Grade B areas.

Question 2

Are the gloves sterile, and to what assurance level?

Accepted Answer

Yes. They are sterilised to a Sterility Assurance Level of 10-6 in compliance with ISO 11137.

Question 3

What is the particle count?

Accepted Answer

Fewer than 1200 particles per cm2 at 0.5 micron and above, tested per IEST RP-CC005.

Question 4

What is the endotoxin level?

Accepted Answer

The maximum endotoxin level is below 7.5 EU per pair.

Question 5

Are these gloves DNase and RNase free?

Accepted Answer

Yes, they are certified DNase free and RNase free.

Question 6

Can they be used for handling hazardous drugs?

Accepted Answer

They have been tested against 14 chemotherapy drugs per ASTM D6978 and against fentanyl citrate, and meet USP <800> guidelines. Breakthrough times vary by drug, so review the validation guide for your intended use.

Question 7

Are they powder-free and silicone-free?

Accepted Answer

Yes. They are powder-free and silicone-free, with undetectable residual accelerator and other contact sensitizers.

Atelier de mise en œuvre de l’annexe 1 de la PDA 2026 – Édition Europe

Date & heure

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