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

Worldwide, pharmaceutical companies have to consider existing and expected legislation on anti-counterfeiting and traceability of drugs. Many governments opt for the implementation of serialization regulations. To keep you informed of governmental track & trace programs we regularly update our Roadmap of Regulations. For information just click on the respective country or region in below map.

United States of America

  • Serialization (11.2017)
  • Aggregation (11.2019)
  • GS1 Datamatrix

Brazil

  • Serialization (12.2021)
  • Aggregation (12.2021)
  • GS1 Datamatrix

Argentina

  • Serialization (06.2012)
  • Aggregation (not req.)
  • GS1 Datamatrix

Turkey

  • Serialization (01.2010)
  • Aggregation (11.2012)
  • GS1 Datamatrix

India

  • Serialization (01.2013)
  • Aggregation (04.2016)
  • GS1 Datamatrix, Code 128

Saudi Arabia

  • Serialization (03.2016)
  • Aggregation (not req.)
  • GS1 Datamatrix

China

  • Serialization (12.2015)
  • Aggregation (12.2015)
  • Code 128

South Korea, Republic of Korea

  • Serialization (01.2015)
  • Aggregation (not req.)
  • GS1 Datamatrix, Code 128

Russia

  • Serialization (01.2019)
  • Aggregation (01.2019)
  • GS1 Datamatrix

Europe

  • Serialization (12.2019)
  • Aggregation (not req.)
  • GS1 Datamatrix

Read more

More information on EU FMD February 2019

It's time to serialize for Europe

Inspection example: Annex 1 for capping of lyophilised vials

The requirement

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.

The solution

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.

The advantages

  • Procedure accepted by the authorities for compliance with Annex 1, para. 121
  • Documentation and test runs corresponding to the level required by the FDA

Talk to us!

We look forward to finding the optimal solution for you. Your personal contact will gladly answer your individual questions. Call us. Or contact us using the contact form.

 

 

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Seidenader Maschinenbau GmbH

Phone: +49 8121 802-0

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