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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Quality control – pharmaceutical control laboratories. Requirements in The international pharmacopoeia. Information on reference materials for pharmacopoeial analysis. Plungers and discs for dental local anaesthetic cartridges.
BS EN ISO 8362-4:2011
Annex 8 – Quality systems requirements sio national good manufacturing practice inspectorates. Packaging materials and closures. If the document is revised or amended, you will be notified by email. Information on general publications.
Get in touch with your local sales manager. Aluminium caps for transfusion, infusion and injection bottles – general requirements and test methods.
It also specifies the material from which such containers shall be made and the performance requirements for the containers. Transfusion equipment for medical use.
Manufacture of sterile preparations. They trust us A relationship built on trust: 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.
Harmonization of regulatory requirements.
ISO injectable vials – SGD-Pharma
Finishing of sterile products. Requests for analysis of drug samples. As the voice of the U. Already Subscribed to this document.
Calibration, validation and verification of equipment, instruments and other devices. Internal audit and periodic review. Caps made of aluminium-plastics combinations for injection vials.
Quality assurance – packaging. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products.
Infusion equipment for medical use. Materials and setting-up of equipment, instruments and other devices.
ISO injectable vials
Screw-neck bottles for syrups. Quality assurance – inspection. Appendix 3 – Self-inspection and quality audits 1.
Quality management and quality systems elements.
Our experts and commercial agencies You need information about our company or products? Appendix 1 – Storage areas 1. It applies to colourless or amber glass containers moulded from borosilicate or soda-lime glass, with or without an internal surface treatment, and intended to be used in the 832-4, storage or transportation of products intended for injection.
Preparation for the inspection. Repacking, relabelling and dispensing. Basic tests for pharmaceutical substances and dosage forms.
Pen-injectors for medical use. Quality control – reference materials.