What is ISO 8871-2 about?
ISO 8871 discusses elastomeric parts for parenterals and for devices for pharmaceutical use. ISO 8871-2 layouts identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in ISO 8871-2 permits the determination of the typical characteristics of elastomeric parts including coatings and surface treatments. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
Who is ISO 8871-2 for?
ISO 8871-2 on Elastomeric parts for pharmaceutical use is useful for:
- Manufacturers of elastomeric parts for parenteral
- Manufacturers of elastomeric parts devices for pharmaceutical use
- Pharmacies and medical laboratories
- Regulatory authorities
Why should you use ISO 8871-2?
The elastomer base polymer is converted into rubber by vulcanization. The base elastomer and the type of vulcanization have a major influence on the principal characteristics of an individual rubber material. The effectiveness, purity, stability, and safe handling of a drug preparation can be affected adversely if the rubber part used has not been properly selected and validated.
ISO 8871-2 guideline provides requirements for samples for testing, Reagents, materials, and identification of elastomeric material. ISO 8871-2 also provides tests for hardness, density, compression set, swelling, Development of a fingerprint by gas chromatography, detection of volatile substances by gas chromatography, Determination of residual moisture, and more. This helps you with proper assessments and provides reliable results for elastomeric parts for parenterals and for devices for pharmaceutical use.
What’s changed since the last update?
BS EN ISO 8871-2:2020 supersedes ISO 8871-2:2003, which has been withdrawn. BS EN ISO 8871-2:2020 has some technical changes with respect to ISO 8871-2:2003.
These include:
- Expansion of the scope to include coated stoppers
- Addition of terms and definitions
- Addition of 6 on the interpretation of results for ATR
