ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables

This document specifies a) a method for determining the hydrolytic resistance of glass grains at 98 °C. The resistance is measured and expressed by the volume of acid required for titration of the alkali extracted from the unit mass of glass, and can also be expressed by the amount of sodium oxide equivalent to this volume of acid, and b) a classification of glass according to the hydrolytic resistance determined by the method of this document. This document is intended for use on the less resistant types of glass, such as soda-lime glass. NOTE 1 For the more resistant glasses, e.g. borosilicate glass, the method specified in ISO 720 is more suited. NOTE 2 It is emphasized that there is no exact correlation between the classification laid down in this document and that laid down in ISO 720, and it is, therefore, essential to identify which classification is being used.

This document specifies a) a method for determining the hydrolytic resistance of glass grains at 121 °C. The resistance is measured and expressed by the volume of acid required for titration of the alkali extracted from the unit mass of glass, and can also be expressed by the amount of sodium oxide equivalent to this volume of acid, and b) a classification of glass according to the hydrolytic resistance determined by the method of this document. This document is intended for use on the more resistant types of glass, e.g. borosilicate glass. NOTE 1 For the less resistant glasses, e.g. soda-lime, the method specified in ISO 719 is more suited. NOTE 2 It is emphasized that there is no exact correlation between the classification laid down in this document and that laid down in ISO 719, and it is, therefore, essential to identify which classification is being used.

This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

This document specifies the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

This document specifies the design, materials, performance and test methods, and gives recommendations for dimensions for glass cylinders used with pen-injectors for medical use. It applies to the primary containers used in direct contact with the drug.

This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers. This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.

ISO 11418-3:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

ISO 11418-1:2016 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

ISO 11418-2:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‑4 or ISO 11040‑6, together with ISO 11040‑5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods. Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.

ISO 4802-1:2016 specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1 min. The resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in ISO 4802-1:2016.

ISO 4802-2:2016 specifies: a) methods for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in ISO 4802-2:2016. The test method specified in ISO 4802-2:2016 might not be applicable to containers whose surfaces have been treated with silicon (e.g. containers that are ready for direct filling).

ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug. It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

ISO 11040-7:2015 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests. Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of ISO 11040-7:2015.

ISO 11040-4:2015 applies to tubing-glass barrels (single-chamber design) for injection preparations, and sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.

ISO 8362-4:2011 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements for the containers. ISO 8362-4:2011 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 packaging, storage or transportation of products intended for injection.

ISO 8536-1:2011 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.

ISO 9187-1:2010 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. ISO 9187-1:2010 is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user. Ampoules complying with ISO 9187-1:2010 are intended for single use only.

ISO 9187-2:2010 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B, C and D) for injectables. Ampoules complying with ISO 9187-2:2010 are intended for single use only.

ISO 15375:2010 specifies requirements for permanent suspension devices, fixed to infusion racks or set-up devices, for infusion bottles that confirm to the requirements of ISO 8536‑1. The suspension devices are intended for multiple use. The purpose of ISO 15375:2010 is to establish a safe suspension device for infusion bottles during administering of their contents.

ISO 15137:2005 specifies requirements and test methods for self-adhesive hanging devices (SAHD) used in combination with infusion containers, e.g. infusion glass bottles (see ISO 8536-1). The purpose of ISO 15137:2005 is to establish a safe SAHD for prescribed infusion containers while administering their content so as to ensure a safe application for the patient and for the user.

ISO 11418-4:2005 specifies the design, dimensions, material and requirements of tablet glass bottles. Tablet glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-4:2005 is applicable to tablet glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

ISO 8362-1:2009 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers. ISO 8362-1:2009 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.

ISO 11418-3:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-3:2005 is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

ISO 11418-1:2005 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-1:2005 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

ISO 11418-2:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-2:2005 is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

ISO 13926-1:2004 specifies the design, dimensions, materials, performance and test methods for glass cylinders used with pen-injectors for medical use. It applies to the primary container used in direct contact with the drug.

ISO 8362-1:2003 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers. ISO 8362-1:2003 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, in the form of glass tubing, whether internally surface-treated or not, and intended for use in the packaging, storage or transportation of products intended for injection.

ISO 8362-4:2003 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements for the containers. 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 packaging, storage or transportation of products intended for injection.

Applies to tubing-glass barrels (single-chamber design) for injection preparations and specifies materials, dimensions and performance details.

Specifies the design, dimensions, materials and requirements of drop-dispensing bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

Specifies the design, dimensions, materials and requirements of screw-neck bottles used for pharmaceutical preparations in liquid form (sirups). Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

Specifies the design, dimensions, materials and requirements of screw-neck bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of solid and liquid pharmaceutical preparations which are not intended for parenteral use.

Specifies materials, dimensions and requirements (hydrolytic resistance, annealing quality, breaking force, position and stability of point, delivery, packaging, marking) for forms of one-point-cut ampoules (forms B, C and D) for injectables. Ampoules complying with this part of the standard are intended for single use only.

Specifies the dimensions, capacity, type of glass material, form and requirements of glas vails for medical use. It includes procedures for the measurement of the chemical resistivity of the inner surface of vails and, thus, enables a classification in accordance with their propper category of application.

Specification of form, dimensions, material, designations, performance and capacity of injection vails made of colourless or amber-coloured glass tubing which are used for packaging, storage or transport of products intended for injections.

The principle, reagents, apparatus and the procedure are specified. The resistance is expressed by the volume of acid required for titration of the alkali extracted from the unit mass of glass. The permissible range of the values obtained and the limit values in the hydrolytic resistance grain test are listed.

The principle, reagents, apparatus and procedure are specified. The resistance is expressed by the volume of acid required for titration of the alkali extracted from the unit mass of glass. For five classes of grain the limit values in the test are listed.