EUROLAB laboratory provides testing and compliance services within the scope of ISO 11040-6 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 11040 standard specifies material, size, quality and performance requirements, as well as test methods for ready-to-fill polymer barrels and sterilized sub-assembled syringes intended for single use only.
This standard also specifies components that are a ready-to-fill part of the sterilized lower-assembled syringe. Ready-to-fill polymer barrels and sterilized bottom-mount syringes are designed for single use only.
Ampoules and injection vials have been used mainly as primary packaging material for the administration of injectables. However, for the injection of liquid medicinal products stored in these containers, a hypodermic syringe combined with the appropriate injection cannula is also required. This requires transferring the medicinal product to the hypodermic syringe prior to its final use. This procedure is not only time consuming; it can also easily cause confusion and possible contamination.
In combination with appropriate sealing components, prefilled disposable syringes conforming to this document form a safe system for drug handling, storage, and administration. Due to their relatively simple processing procedures, they allow rapid injection of the medicinal products they contain.
Such prefilled syringes allow immediate injection of the contained product after relatively simple use. These syringes can also be used in injectors with automatic functions where more and special requirements apply.
In more recent years, new technological developments have been made to provide prefilled syringes based on polymers as a material for the body of a prefilled syringe system; These developments have been supported by progress in polymer science and the introduction of new polymers.
This standard can also be used by engineers as a basis for the development and marketing of standardized filling and processing equipment, eg. so-called tub and nest filling presentations. Manufacturers of filling equipment and ancillary processing equipment can use this document to achieve a degree of unity regarding the design of these standardized pieces of equipment.
Depending on the dimensions of the prefilled syringes, suitable components such as rubber plungers, end caps, needle guards and other closure systems can also be standardized. Together with the right sealing components, they offer a system for (parenteral) injectable use. It is recommended to contact the component and system provider to verify component compatibility, eg. for silicone-free or oil-free systems, or if components need to be specifically matched. Filling machine manufacturers can implement this standard to provide some degree of standardization in the equipment of the machines.
For ready-to-fill sterilized sub-assembled syringes, the responsibility for the injectable product handling steps remains with the manufacturer1. After assembly of the needle guard for syringes with needles or syringes with end caps for the Luer cone version, the lower assembled syringes are inserted into the slots. The nests, in turn, are placed in a plastic tub. The syringes in the housing are protected by a snap liner, and the cuvette itself is closed with a sealing cap (this has now and until now been achieved mainly using a porous material).
Therefore, the cuvette, properly closed with a sealed lid, represents the “sterile barrier system”. The sealed tub is then wrapped in a sealable bag so it is ready for sterilization. Various sterilization methods can be applied with polymer syringes; Gamma, E-ray, X-Ray irradiation, Moist Heat (autoclave), ethylene oxide.
Sterilized sub-assembled syringes ready to be filled are delivered to pharmaceutical companies as sterile and processed in appropriate machines.
Components to complete the subassembled syringe, such as the plunger and rod, are not specified in this document.
Prefilled syringes can be produced on specialized and specially designed processing equipment such as inline molding and filling. This document is not valid but may also be used for such special prefilled syringes.
Among the services provided by our organization within the framework of material testing services, there are also ISO 11040-6 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
