Compendial Testing

Reference chapters:

* 3.1.3 Polyolefins

* 3.1.4 Polyethylene without Additives for Containers for Parenteral Preparations and Ophthalmic Preparations

* 3.1.5 Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations

* 3.1.6 Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations

* 3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations

* 3.1.8 Silicone oil used as a lubricant

* 3.1.9 Silicone Elastomer for Closures and Tubing

* 3.1.10 Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions

* 3.1.11 Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration:

* 3.1.14 Materials Based on Plasticized Poly(Vinyl Chloride) for Containers for Aqueous Solutions for Intravenous Infusion

* 3.1.15 Polyethylene Terephthalate for Containers not for Parenteral Use:

* 3.2.1 Glass Containers for Pharmaceutical Use

* 3.2.9 Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders

* 3.2.2.1 Plastic Containers for Aqueous Solutions for Infusion

* 3.3.2 Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components

* 3.3.3 Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components

Reference chapters:

* 661 Plastic packaging systems and their materials of construction

* 661.1 Plastic materials of construction

* 660 Containers-Glass

* 381 Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems

* 661.2 Plastic Packaging Systems for Pharmaceutical Use

* 670 Auxiliary Packaging Components

Reference chapters

* 7.01 Test for Glass Containers for Injections

* 7.02 Test Methods for Plastic Containers

* 7.03 Test for Rubber Closure for Aqueous Infusions

Atomic Absorption Spectroscopy (AAS): The technique is used to determine the amount Zinc in rubber closures or in plastic materials. The determination of Arsenic in the glass containers is performed with coupling of Flow Injection for Atomic Spectroscopy System (FIAS).
ICP-OES/ICP-MS: The techniques is used to determine the presence of elemental impurities from the manufacturing process of plastic material (e.g. Ti; Al; Cr; V, Zr).
UV-Vis: the technique is used to assess the conformity of the material of construction or of the packaging system or its component with the limit for unspecific absorbing extractables. It is used moreover to determine the compliance of light resistant container for spectral transmission.
TOC: The technique is used to assess the conformity of the material of construction or of the packaging system or its component with the limit for unspecific organic extractables.
HPLC coupled with UV: The technique is used to determine the conformity of the plastic material to the maximum limit of the additives used to optimise the processing or the chemical, physical and mechanical properties of the polymer.
ATR-FTIR: The technique used to identify the material by comparison with the IR spectra of certified reference standard.
Dynamometer: The instrument is used to determine the force for piercing an elastomeric closure with hypodermic needle.
Gas chromatography coupled with mass spectrometry: The technique used to determine the conformity of the plastic material to the maximum limit for volatile chemical species (e.g. plastic additive 1 in Materials based on plasticized poly(vinyl chloride)).
Potentiometric titration: The technique used to assess the buffering capacity of a plastic container intended to hold a liquid product.