EUROLAB laboratory provides testing and compliance services within the scope of ISO 11040-7 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 11040 standard specifies the packaging system used to deliver sterilized sub-assembled syringes ready to be filled into tubes and receptacles.
At the beginning of prefilled syringe processing by the pharmaceutical industry, syringes made of tubular glass were delivered to pharmaceutical companies only as non-sterile "bulk goods". Then, process steps such as washing, drying, internal lubrication, closing the syringe with the closing system, sterilization, filling and closing were carried out in pharmaceutical companies. Bulk processing is still done in this way today. Partially sterilized bottom-assembled syringes have replaced non-sterile "bulk articles".
In the case of sterilized bottom-assembled syringes ready to be filled, the responsibility for the above-mentioned processing steps for the injectable product lies with the manufacturer of the primary packaging material. Following assembly of the needle guard for syringes with needles or syringes with end caps for the Luer cone version, the bottom-mounted syringes are inserted into the so-called 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 cuvette is then wrapped in a sealable bag so it is ready for sterilization now and thus far.
In this form, sterilized sub-assembled syringes are prepared for filling, processed in appropriate machines and delivered to pharmaceutical companies in sterile condition.
The packaging design and material must ensure sterility and be compatible with the customer's process. The packaging properties, material, thickness, shape and resistance to deformation, among others, are such that it maintains the integrity of the product up to the point of use and an approved barrier against particulate and bacterial contamination. Packaging materials must meet regional and national regulatory requirements.
Subsequent processes (post-fill, such as in-home/out-of-door shipping, reprocessing) may result in special requirements on the packaging system used to deliver sterilized sub-assembled syringes ready to fill. However, these requirements are not covered by ISO 11040-7.
Ready-to-eat glass drums and plastic drums for sterilized sub-assembled syringes, plungers and injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.
Among the services provided by our organization within the framework of material testing services, there are also ISO 11040-7 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.
