Bags versus bottles for bulk drug substance shipping

Fluoropolymer bottles: a durable and safe solution for shipping BDS

Shipping bulk drug substance (BDS) or other critical products and process solutions requires very durable packaging. Common single-use technologies are bag-based, which require additional protection because they’re vulnerable to material loss and contamination due to punctures, cracking, seam separation and material delamination.

Integrity testing of bags is difficult and time consuming due to the complexity of the system. After all, bags can’t be filled or dispensed without multiple tubing paths and connection points, which are also susceptible to leaks.

Bottles, on the other hand, are durable, free standing, and have little vulnerability to punctures. This makes them ideally suited to standard storage and shipping processes.

Shipping validation and container closure integrity testing (CCIT) for bottles is simple and straightforward.  Another advantage is that bottles can be leak tested to much higher pressures than bags – up to 15 psig or more.

Purillex bottles: The ideal BDS shipping technology

Savillex created its line of Purillex^® ready-to-use bottles and vials for critical applications – including product shipping. Our bottles are made from the highest purity grade virgin PFA (Perfluoroalkoxy alkane), FEP (Fluorinated ethylene propylene) and ETFE (Ethylene tetrafluoroethylene) resins – with zero added fillers or release agents.

These materials are not only well suited for shipping, but also pure, clean, and non-reactive for the ultimate assurance that your drug substance will be safe. Purillex bottles are also offered pre-sterilized for convenience and ease of use.

When it comes to transporting your materials, our bottles have successfully passed multiple product shipping validation protocols and CCIT testing to ensure the greatest possible protection. Bottle closure torque specifications are available for standard shipping as well as data on flash freezing and shipping down to liquid nitrogen temperatures.

To bring it all home, here’s a quick summary of Purillex bottle benefits:

• Validated for shipping and CCIT
• Made from stable, inert, highest purity fluoropolymer resins
• Available sterile and ready to use for ultimate convenience
• Five-year shelf life

Want the ultimate in protection for shipping and storing BDS and other critical products? Explore our full lineup of Purillex bottles and get in touch with us to discuss your specific needs.