ISO 8362-4 PDF

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies. (ISO member bodies). The work. INTERNATIONAL. STANDARD. ISO. Second edition. Injection containers and accessories —. Part 4: Injection vials made of moulded glass. Find the most up-to-date version of ISO at Engineering

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Amber glass Type II. Business cases Top quality vials for highly sensitive drugs: Quality assurance – general topics. It also specifies the material from which such containers shall be made and the performance requirements for the containers. Tuberculosis programme – fixed-dose combinations. Plungers and discs for dental local anaesthetic cartridges. Appendix 4 – International standards on packaging A list is given below of the standards on packaging issued by the International Organization for Standardization ISOas of 10 Octoberstarting with the four main standards, after which they are listed in numerical order.


Basic tests for pharmaceutical substances and dosage forms.

ISO 8362-4:2003

Harmonization of regulatory requirements. Click on the product reference to get product features Ref. Freeze-drying closures for injection vials.

Annex 4 – Considerations for requesting analysis of drug samples 1. Information on reference materials for pharmacopoeial analysis. Add to Alert PDF.

To make the most of sio site thank you to update your browser click here. Calibration, validation and verification of equipment, instruments and other devices. Although we endeavour to maintain an up-to-date catalogue, on occasion we may not have the latest version of a document, including where it has not yet been provided through an international feed.

Quality systems for national GMP inspectorates. Clear glass Type I. Quality control – specifications and tests. Aluminium caps for injection vials. Glass cylinders for pen-injectors for medical use.

Injection containers for injectables and accessories.

BS EN ISO – Injection containers and accessories. Injection vials made of moulded glass

Quality systems – model for quality assurance in final inspection and test. Nomenclature and computerized systems.


Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production. Finished cartridges – requirements and test methods. Proceed to Checkout Continue Shopping. Information on general publications. Quality management and quality systems elements. Already Subscribed to this document.

ISO injectable vials – Ref. Good manufacturing practices for sterile pharmaceutical products.

Subscription pricing is determined by: Annex 7 – Guidelines on pre-approval inspections. Closures for injection vials. Nasal U-Save vials, a unique design for nasal sprays. Preparation for the inspection. Know-how A worldwide technical expertise Molded glass process Tubular glass conversion.

Measures to combat counterfeit drugs. Protection of the environment. Manufacture of sterile preparations.