Cart 0 Product Products (empty)
No products
To be determined Shipping
$0.00 Total
Product successfully added to your shopping cart
Quantity
Total
There are 0 items in your cart. There is 1 item in your cart.
Total products
Total shipping To be determined
Total
New Sale! 
View larger
View larger ISO 8871-3:2003
New product
ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count
standard by International Organization for Standardization, 08/01/2003
More info
Full Description
Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle.
Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.
ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.
It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.