1125358

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

📝 Amendments Available

View all product details

Most Recent

Track It

Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $54.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $89.00
    • Add to Cart

Customers Who Bought This Also Bought

Identical Versions Available

 

About This Item

 

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.

 

Product Details

Published:
08/01/2003
Number of Pages:
6
File Size:
1 file , 150 KB
Same As:
BS EN ISO 8871-3:2004, BS EN ISO 8871-3:2004
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Amendments, rulings, supplements, and errata

  1. ISO 8871-3:2003/Amd1:2018


    - Amendment 1