Cleanroom garment systems for Pharmaceutical and Medical Device applications

Pharmaceutical and Medical Device

The introduction of human contamination into manufacturing processes utilizing cleanrooms and cleanroom garments is one the greatest concern for companies in the Pharmaceutical and Medical Device industries. The proper selection of cleanroom garments is critical in preventing contaminants carried by employees from entering into the cleanroom. 

Managing the cleanroom garment system for Pharmaceutical and Medical Device cleanroom applications can be complicated due to the exacting requirements and production challenges of your industry.

The first step is to identify your production requirements and the ISO classification of the cleanroom to ISO standard 14644-1. In most cases this classification will determine your proper gowning. Here are some recommendations based upon the rooms classification.

ISO Class 4: (Class 10)
-    Disposable Bouffant/Hair Cover
-    Hood
-    Facial shield or goggles
-    Beard Cover(If necessary)
-    Face Mask
-    Coverall
-    Gloves 
-    Disposable shoe covers
-    Boots

ISO Class 5: (Class 100)
-    Hair Cover
-    Hood
-    Beard Cover (If necessary)
-    Face Mask
-    Coverall
-    Disposable shoe covers
-    Boots
-    Gloves

ISO Class 6: (Class 1000)
-    Hair Cover/Bouffant
-    Beard Cover(If necessary)
-    Coverall 
-    Shoe Covers/Boots
-    Gloves

ISO Class 7: (Class 10,000)
-    Bouffant
-    Beard Cover(If necessary)
-    Frock
-    Shoe Covers