Whitehouse Laboratories has a dedicated unit focused on providing support and testing for compliance with ISO 11608, “Needle-Based Injection Systems for Medical Use — Requirements and Test Methods”.
ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. ISO 11608 comprises seven parts, under the general title Needle-based injection systems for medical use — Requirements and test methods Whitehouse currently provides testing for include:
— Part 1: Needle-based injection systems
— Part 2: Needles
— Part 3: Finished containers
— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
— Part 5: Automated functions
In the FDA Guidance document entitled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, it is recommended that performance testing for general use injectors be with the final injector for marketing and should take into account the characteristics of the wide range of drugs/biological products in their final approved dosing form with which an injector is intended to be used. When conducting performance testing, it is recommend that the most current version of the standards recognized by FDA are followed, which includes the ISO 11608 series. In addition to ISO 11608 testing, Whitehouse Labs provides complimentary testing for drug delivery and combination products, such as container integrity closure (CCI) and package and distribution testing.
Whitehouse Labs in addition to ISO 11608 testing provides complimentary testing for drug delivery and combination products such as container integrity closure (CCI) and package and distribution testing.
Using an outside, independent testing laboratory to prove compliance to regulatory requirements can free up precious resources for companies to concentrate on product development.
Syringes are used in a variety of applications, including administration of medication, measurement of fluid and in the application of compounds such as lubrication. Syringes are typically made of plastic or glass.
ISO 7886 and ISO 8537 are two of the major syringe testing standards. We provide many different syringe testing services to ensure your product is ready for submission to the appropriate regulatory agency.
We specialize in syringe testing for all types of applications. We are capable of measuring the force to operate, freedom from air and liquid leakage and many other standard tests.
Shown below are a few of the standards that are applicable to syringe testing –
ISO 7886 Sterile, hypodermic syringes for single use
ISO 8537 Sterile single-use syringes, with or without needle for insulin
ISO 594-1 Conical fittings with 6% (Luer) taper – Part 1: General Requirements
ISO 594-2 Concial fittings with 6% (Luer) taper – Part 2: Lock Fittings