ISO 11040-8 Prefilled Syringes - Part 8: Requirements and Test Methods for Finished Prefilled Syringes

EUROLAB laboratory provides testing and compliance services within the scope of ISO 11040-8 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 11040 standard is aseptically filled or finally sterilized according to ISO 11040-4 or ISO 11040-5 in conjunction with ISO 11040-4 or ISO 11040-6 for quality-focused parenteral injection preparations. Applicable to pre-filled syringes (single use only).

Finished prefilled syringes that have undergone an additional step of preparation by the user prior to injection (for example, diluent syringes that are emptied for reconstitution and aspirated reconstituted drug solution after reconstitution) are outside the scope of this part of ISO 11040.

Historically, injectable (parenteral) liquid pharmaceutical products have been provided primarily in primary containers (i.e. ampoules and vials) that required the liquid to be transferred into a hypodermic syringe and combined with the appropriate injection needle before final use. This procedure is not only time consuming but also offers numerous possibilities for contamination and handling errors.

In the past few years, the presentation of liquid pharmaceutical products in single-use prefilled syringes, many with piled needles, has become more common. The ease of use provided not only benefits their use in the clinical setting, but also allows them to be used by ordinary users in the home environment.

The standardization of prefilled syringe requirements has been addressed by ISO/TC 76 in two ways:

• The characteristics of the components of the prefilled syringe prior to filling are covered earlier in the ISO 11040 series;
• The requirements for the final prefilled syringe available to the user as a finished product are addressed in this section of ISO 11040.

Finished pre-filled syringes require marketing authorization as a drug, combination product or medical device in some jurisdictions, depending on the content and intended use. The syringe plays a dual role in the prefilled syringe product as a container closure system and an delivery device. Safety, performance and usability must also be considered in the case of pre-assembly, co-packing or label reference intended for use with other devices and equipment. This part of ISO 11040 considers the contents and syringe as a system to ensure successful performance for its intended purpose.

There are other international and national standards and guidance publications, and in some countries national regulations that apply to medical devices and drugs. Its requirements may replace or supplement this part of ISO 11040. Developers and manufacturers of finished prefilled syringes are encouraged to investigate and determine if there are other requirements regarding the safety or marketability of their products.

This part of ISO 11040 can also be used as a guide for other types, designs and/or sizes of prefilled syringes, eg dual chamber prefilled syringes.

So-called borderline products, for example, finished prefilled syringes containing hyaluronic acid, are covered by this part of ISO 11040, although they are not always regulated as a pharmaceutical product.

Among the services provided by our organization within the framework of material testing services, there are also ISO 11040-8 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.