Sinopharm - Single use hypodermic syringe and needle (for a la carte vaccine products)
A factory audit and final random inspection and testing of finished products will be performed by a Bank nominated independent inspection agency. The inspection contract will be let by Sinopharm to the approved inspection agency with costs passed through to the Borrower to pay.
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission (SASAC) of the State Council, with 128,000 employees and a full chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business and financial services.
For further enquiries, please contact
Sinopharm Fortune International Trading Corp.
Address: Fortune Tower, No.4, Hui Xin Dongjie, Chao Yang District, Beijing 100029, China
Tel.: +86-10-8466 3076/ +86-13269815298
SINGLE-USE HYPODERMIC SYRINGE AND NEEDLE
Purpose: The purpose of a single-use hypodermic syringe and needle is to inject fluid into or withdraw fluid from the body for medical purposes.
Description: The World Bank seeks to procure single-use hypodermic syringes and needles that meet the specifications below. Single-use hypodermic syringes come in a variety of volumes and may or may not be sold as a set with a hypodermic needle. Syringes proposed shall have fixed needles and auto-disable features.
1. Proposed syringe and needle shall be classified as a medical device and have approval by the US FDA, CE Mark or equivalent (e.g., FDA Class 2, 510(k)).
2. Device shall be disposable and intended for single patient use.
3. Device shall be supplied sterile and packaged in individual units.
4. Syringe shall meet the requirements of ISO 7886-1:2017.
5. Hypodermic needle shall meet material requirements of ISO 9626:2016.
6. Hypodermic needle shall meet the requirements of ISO 7864:2016.
7. Hypodermic needle shall meet the color code requirements per ISO 6009:2016.
8. Device shall have an auto-disable feature that complies with ISO 7886-3. The syringe must be passively and automatically rendered unusable upon delivering the intended dose. It must be impossible to re-use the syringe under normal conditions of use.
9. Syringe shall be 1ml or 3 ml in volume.
10. Needle size shall be:
a. Adults, 22-25 gauge with a length of 25-38mm (1-1.5”)b. Children ages 3-18, 22-25 gauge with a length of 16-25mm (5/8 – 1”)
11. Syringe shall be latex free.
12. Syringe barrel must be translucent.
13. Device shall be capable of being filled either directly or indirectly through a vial adapter or other transfer mechanism from a vaccine vial or ampoule, or from a needle.
14. Device shall be equally useable by left and right-handed health workers.
15. Syringes designed as low dead space or low dead volume are preferred.