In the ISO 8871-3 standard developed by the International Standards Organization (ISO), methods for the determination of the number of particles released in the elastomeric parts of the devices used for the purpose of intravenous (parenteral) administration of drugs or serums (pharmaceutical) are explained. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 8871-3 Elastomeric parts for parenteral and pharmaceutical use devices - Part 3: Determination of the number of released particles.
Elastomeric caps can be superficially contaminated with visible and invisible particles, and particles may be released when the cap is punctured with a needle. If these particles are transferred to pharmaceutical preparations in contact with the elastomeric parts, they affect the quality of such preparations. The ISO 8871-3 standard provides methods for determining the number of visible and invisible particles, respectively, separated from elastomeric parts by rinsing. However, this standard does not provide particle contamination limits. These must be agreed upon between the manufacturer and the user.
In short, when elastomeric caps are used as primary packaging materials in direct contact with pharmaceutical preparations, the pharmaceutical industry has to request detailed information from the rubber producing company about the presence of the particles. Because the caps become particle injectable. The test methods described in the third and fourth clauses of the standard make it possible to meet this demand.
The standard that is referred to as normative in the application of this standard and indispensable for its implementation is the following: TS EN ISO 3696 Water - Properties and test methods used in the analytical laboratory.
Within the scope of laboratory services, our organization also provides services for the determination of the number of particles released in the elastomeric parts of the devices used for the purpose of intravenous administration of drugs or serums (parenteral) and medicated treatment (pharmaceutical), in accordance with ISO 8871-3 standard.
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