REGULATION, LEGISLATION: EVERYTHING IN VIEW.
With regulation in mind - for you.
GMP, FDA, governments. Standards, regulations, laws. We provide our customers with solutions tailored to their needs and meeting all current requirements, and adaptable to meet new requirements at any time.
Track&Trace example: Legislation on serialization - always keep up-to-date
Inspection example: Annex 1 for capping of lyophilised vials
On 1 March 2010 the transition period of Annex 1 for the capping of lyophilised vials ended; para.121 reads:
121. Containers with missing or incorrectly seated stoppers should be rejected before caps are fitted. Where human intervention is necessary at the capping station, appropriate technology should be used to prevent direct contact with the containers and minimise microbiological contamination.
Seidenader supports its customers in relation to compliance with this Annex 1 with a number of inspection solutions adapted to the special requirements:
- High stopper detection
- Crimp-cap inspection
- All solutions also suitable for isolators or clean rooms
- Stations with gas-resistant design (e.g. H2O2-resistant)
- Customised solutions with one or more cameras
The highly accurate inspection stations can be integrated into existing filling and sealing machines. In addition, Seidenader also offers its own platform for stopper inspection, including product handling and a reject system, in the form of a compact machine. The solutions access either the customer's already integrated product handling system or their own system, thereby fulfilling the Annex 1 requirements specifying no product contact.
The camera station can, for example, be inserted before crimping takes place, to ensure a perfect stopper seal. An additional post-crimping camera checks whether this is perfect. The applied inspection technology has already proved its worth in many Seidenader inspection machines successfully installed worldwide.
- Procedure accepted by the authorities for compliance with Annex 1, para. 121
- Documentation and test runs corresponding to the level required by the FDA