Aseptic filling of I.V. bags

Aseptic filling of I.V. bags : New opportunities for the packaging of sensitive molecules

New aseptic filling opportunities for I.V. bags are in increasing demand world-wide. Bioluz pharmaceutical laboratories, specialized in the filling of IV drugs in flexible bags, is the first independent Contract Manufacturing Organization (CMO) to offer this service in the EU. Bioluz is bringing a solution to companies looking for contract filling of sensitive molecules in flexible bags. Bioluz designed a brand new, state of the art, high capacity aseptic filling line that is fully automated in order to reduce the risk of possible human contamination.  

Thanks to aseptic filling, Bioluz brings the standards of drug delivery in infusion bags up to the highest industry level.

This technique offers a greater control over safety issues and avoids the risks of product contamination. 

The company is now in a position to enter a new part of the market such as heat sensitive products, antibiotics, analgesics, solutions for cardiology, contrast media, deactivated biological products...

The current practice on the market for filling IV drugs in flexible bags is to use terminal sterilization.

Our new process will add to the existing standards the following advantages:

• Aseptic filling: The filling of the drugs into the flexible bags is done aseptically in A class environment which will satisfy proposed higher regulatory standards.
• Automated process: The process is fully automated from the loading of pre-sterilized bags up to the overwrapping of the bags to reduce operator contamination potential.
• High capacity: The capacity of this new filling line is much higher than for our previous equipment to increase efficiency and bring down cost
• This new process offers greater flexibility: the aseptic filling will be followed by terminal sterilization when possible, depending on the molecule tolerability; and PVC or non-PVC bags will be processed and will be overwrapped either before or after terminal sterilization.

The quality norms that defined this process are the GMP, ISO 13485 norms and the FDA CFR 21 norms.