Test of syringes and safety boxes for vaccination programs
Test and documentation of syringes and safety boxes to ensure that your product meets the requirements of the relevant PQS performance specification.
To be able to supply syringes and safety boxes for vaccination to WHO member states and UN purchasing agencies your products must be prequalified and added to the WHO PQS database (Performance, Quality and Safety).
How do you get your syringes and safety boxes registered to the PQS database?
However, before a product or device can be added to the PQS database, it must be tested. Verification establishes whether a specific product from a manufacturer meets the requirements of the relevant PQS performance specification.
WHO has divided the approach into three parts:
- Independent type-testing
- Full Quality Assurance.
An accredited testing laboratory is an organisation, which can perform one or more of the functions outlined above.
A WHO accredited laboratory for syringes and safety boxes
FORCE Technology is an WHO accredited laboratory for testing the following product categories:
- E008: Single-use injection devices and Jet injectors
- E010: Safety boxes and Needle cutters
- E013: Therapeutic injection devices.
Apart from currently being the only WHO accredited laboratory for testing of syringes (E08) we are authorised to test safety boxes (E10) and therapeutic injection devices (E13) as well as material testing and counselling within material testing etc.
Once your syringes and/or safety boxes are tested and approved they can be added to the WHO PQS Device Catalogue.
How well do you know your product – and what about documentation?
Apart from the actual test of syringes and safety boxes required according to the WHO standards, we are also able to assist you on material technical issues.
You might experience that your products fail your internal production control, or you have doubts whether you have received the proper quality of raw materials. We can help examining your products and raw materials and determine whether they fulfil your specifications.
To minimise this problem, we conduct production quality testing, which is a supplement to our customers’ own internal quality control. Some of the tests, besides the ones stated in the standards, are e.g. FTIR-ATR (Fourier Transform InfraRed - Attenuated Total Reflectance) spectroscopy, which will verify the material type and identify possible degradation or TGA (Thermogravimetric Analysis), which determine the amount of polymer and fillers.
Based on our experience of testing syringes and safety boxes, we have often seen products fail retest which is mandated to be performed every 5 years. The main issue is change of material properties. Consequently, your company may be left with a serious commercial impact if you lose tenders due to inadequate raw materials.
FORCE Technology is among the leading European testing laboratories. We are accredited for a wide range of tests and trials as well as being a notified body within different product categories.