The Germany-made plastic COP syringes are suitable for demanding, sensitive medications such as cancer drugs and biologicals
Gerresheimer has released the first product in its newly developed line of Gx RTF Clear-Ject COP syringes.
The prefillable, high-performance plastic COP (Cyclo-Olefin-Polymer) syringes are suitable for demanding, sensitive medications and high-viscosity agents, the firm says.
In future Gerresheimer will offer American and European customers a portfolio of COP syringes from a single production location in Germany. The new development combines the know-how of experts in prefillable glass syringes in Bünde, Germany and plastic specialists at the firm's Technical Competence Centre in Wackersdorf, Germany.
Gerresheimer currently offers a range of prefillable COP syringes produced by long-time partner Taisei Medical in Japan. The firm is now assuming the sales and technical consulting roles for ClearJect syringes for customers in Europe and the US.
The first product in the range is a 1ml long syringe with integrated cannula
The company is expanding its range of COP syringes and is combining the tried-and-tested RTF (ready-to-fill) concept of glass syringes with ClearJect to create the new Gx RTF ClearJect brand. In cooperation with Taisei Medical, the new syringes will be produced by Gerresheimer.
The first product in the range is a 1ml long syringe with integrated cannula. It is equipped with a 27-gauge, 1/2in (12.7mm), thin-walled stainless-steel cannula with three bevels.
COP is a plastic alternative to glass syringes that is resistant to breaking, as transparent as glass and hardly interacts with the packaged medications, Gerresheimer says. Thanks to the use of injection moulding, the design boasts especially tight tolerances. Its precise geometry also reduces dead volume, leaving behind less of the expensive medication in the syringe.
The new Gx RTF ClearJect syringe with cannula offers key advantages with regard to the primary packaging of demanding medications, says Gerresheimer, especially when it comes to biocompatibility. The COP material does not release metal ions into the medication solution.
Since the entire syringe, including the insert-moulded cannula, is produced in a single step, the product is also free of tungsten and adhesives.
COP has a high pH tolerance and, unlike glass, does not change the pH value while in storage. The oxygen permeation rate is low compared with other plastics, as are the values for extractables and leachables.