Beta Bag, the Transfer Solution via RTP Port

Under article 4.11 of the new EU GMP Annex 1, the introduction of material or components into an environment under barrier technology must be studied particularly carefully so as not to introduce contamination.

STERIGENE supports you in implementing RTP port transfer solutions for packaging components (stoppers, inserts, caps, etc.) and for the equipment required for cleaning operations in isolator technology:

1. Feasibility study

2. Establishment of the analytical approach with a certified laboratory:
• Validation of the microbiological analytical methods in accordance with the annexes to standard NF EN ISO 11737
• Bioburden analysis, definition of the verification dose, treatment and then sterility testing
• Treatment at maximum dose for gamma sterilisation
• Performance qualification in accordance with standard 11137-3

3. Filling of the sterile beta bags in our cleanroom

4. Deliveries can be scheduled by production batch

5. Supply of a regulatory validation file (analytical, sterilising dose, etc.)

Together, let us find the solutions that suit your production processes.
The simplest way is to have a sales engineer visit your site so that we can familiarise ourselves with your challenges. At STERIGENE, we are confident we can help you choose and implement the solutions that will secure, future-proof and sustain your production area.