The particulate levels found on supplier microcleaned rubber closures were compared to
those of stoppers processed by a pharmaceutical manufacturer. The particle monitoring was …

The effect of sterilization on the number of particles released from five different types of
rubber stoppers, as well as on their surface roughness and elemental composition before …

Elastomeric closures are an essential packaging for parenteral drug products and they
represent a possible source of particulate matter. The purpose of this study was to analyze …

This report summarizes the development and validation of an analytical procedure to
support cleaning validation of pharmaceutical closures (stoppers). Based on current …

Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …

In the pharmaceutical industry, cleaning is a vital area that needs special focus before,
during, and after any batch of manufacturing to prevent contamination and …

Siliconized stoppers, when used with parenteral drug products, have been shown to be a
source of particulate contamination. In this study, five different variables: pH of the solution …

Purpose: Coring of a medication vial's rubber stopper has been reported as a major cause of
visible particle presence in injectable preparations. In this study, we investigated and …

Parenteral drugs are drugs that are administered directly or indirectly into the bloodstream
with a syringe, usually in sterile single-dose or multiple-dose form, such as ampoules or …

Conventional aseptic filling of drug product into vials ultimately includes a step that requires
time and travel from the stoppering stage to the capping/crimping stage. Lyophilized product …