What is ISO 88713 - Determination of released-particle count in elastomeric parts about?
BS EN ISO 8871 discusses elastomeric parts for parenteral and devices for pharmaceutical use. ISO 8871-3 provides the best industry guidance on the determination of released-particle count in elastomeric parts to mitigate unexpected risk to product quality.
ISO 8871-3 is the third part of a multi-part series that outlines methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.
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.
Note: ISO 88713 does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.
Who is ISO 88713 - Determination of released-particle count in elastomeric parts for?
ISO 88713 on the determination of released-particle count in elastomeric parts is relevant to:
- Elastomeric parts Manufacturer
- Pharmaceutical laboratory and industries
Why should you use ISO 88713 - Determination of released-particle count in elastomeric parts?
It is important to all sources in particle evaluation, the occurrence of particles in drug products that can originate from the delivery systems or packaging component has always been a big concern that is why the Contribution of each component as a system and individually, should be determined during formulation studies to mitigate unexpected risk to product quality.
Finding the source of the sub-visible particle at the onset of formulation development and throughout a product’s lifecycle is an important factor to ensure product quality.
ISO 88713 guideline assists you by providing methods determination of visible-particle count and determination of subvisible-particle count for the determination of released-particle count.
With compliance and obedience to ISO 88713, you can evaluate the performance of elastomeric parts by collecting and counting the particles when detached from electrometric parts. In addition, assist in, manufacturing a standardized product of high quality to minimize risks at maximum.