FILLING IS A MATTER OF TRUST
A logical, albeit not a common step for a manufacturer of medical devices and pharmaceutical primary packaging is to also provide the filling of these products. Our spectrum in this sector currently ranges from in-vitro diagnostic medical devices to the ready to use syringe. Hence, we develop custom containers for auto-sterile solutions, design and construct an appropriate filling station and fill on our premises. The filling medium can be provided by the customer or be formulated in our adjacent laboratory.
In the aseptic filling sector, the best quality, upmost safety and flexibility in order to meet diverse customer requirements are also a matter of course. Our certification according to ISO 13408 and GMP environments of Class A and B allows us to fill liquids of different viscosities in volumes from small series up to batch sizes of several hundred litres. The packaging thereof is predominantly produced and sterilised in-house.
Aseptic filling, as a particularly critical procedure, requires exhaustive qualification and validation. Transcoject guarantees this throughout all process steps and safeguards this by incorporating regular ”media fills”. Specially selected and trained staff safeguard that our customers’ trust in these sensitive products is always justified, especially as the microbiological monitoring is accomplished in-house.
Our packet is rounded-off with comprehensive support, which we offer our customers in order to aid them with obtaining the certification or authorisation to different markets. Transcoject offers an extensive and customer-focused one-stop service.