FluroTec® Barrier Film: An Investment in Drug Protection, Purity and Patient Safety
Getting a drug through the development and approval process is a monumental achievement in its own right. Years of dedicated and collaborative research coming together and culminating in a potentially life-changing medication fit for the public.
At every step of the way, in addition to adhering to the rigorous testing and procedural standards set by the Food and Drug Administration, safety for the end-user – the patient – is the most critical consideration next to the efficacy of the drug.
Given that, once your drug has been approved, protection becomes the next mission. That doesn’t mean patents though, it means protecting the drug itself. It means carefully selecting primary packaging components that safeguard the purity of the medication and ensure the safety of the patients you’ve invested so much in already.
The Benefits of FluroTec® Barrier Technology in Medicine
There are a number of benefits that FluroTec® Barrier technology brings to the table, some obvious and some on the more unexpected side.
The clear advantages of FluroTec coated stoppers are:
- Protection of sensitive drugs
- Improved shelf life of a packaged drug
- Reduction of visual and subvisual particulates
Some of the more surprising positives go beyond mere protection and actively improve certain medical processes:
- Ensuring predictable piston release in syringe systems
- Reduction of stopper clumping during autoclave sterilization
- Preventing stoppered vials from sticking to shelves in lyo chambers
In combination with B2-coating, it provides lubricity without the use of free silicone oil
The Importance of Reliable Drug Packaging
Nothing is an afterthought when it comes to the medical field in general and drug development in particular. Every decision is infused with more gravity because other people’s lives are in the balance with every choice you make.
In that context, packaging plays a decidedly large role. Once your drug leaves the manufacturing plant, it’s solely the job of that packaging to not just be protective and tamperproof but also remain free from influencing the medication itself.
Of course, there are plenty of packaging options out there, what does getting it right mean for you in terms of reliability?
Consider it as a preventative measure that helps with:
- Mitigating reformulation and/or product replacement cost
- Reducing time-to-market issues related to contamination and recalls – note that impurities and degradation of the medication are among the major causes of drug recalls
- Lowering downtime
- Increasing operational efficiency
It’s also worth thinking about the cost a recall has not only on your bottom line but the residual effects it can have on your reputation and status as a market leader. Recovering your good name is no easy task and comes with a price.
Considering Purity and Patient Safety in Drug Packaging
Last but not least is the purity and safety element; it bears repeating that this is the crux of what packaging is all about.
A cardboard box or plastic bag are technically containers and packaging, but you intuitively know they’re not enough to shield patients from environmental dangers or keep the drug free from contamination.
Effective drug packaging can and does do that. It plays a big part in:
- Reducing the accumulation of leachables in the drug formulation
- Reducing the interaction of extractables from the rubber
- Minimizing the interaction between the elastomeric closure and the drug ingredients – it’s true, the packaging itself can cause issues with the drug
This is such a profoundly crucial part of the drug-making process that the World Health Organization put together a 38-page guide for “packaging pharmaceutical products”. Likewise, the Food and Drug Administration has a 56-page guide for “container closure systems for packaging human drugs and biologics”.
What Is the FluroTec® Barrier Film?
Above all else, FluroTec® Barrier Film delivers all the above, striving to surpass the exacting standards set forth by regulatory bodies.
The FluroTec® Barrier Film is a fluoropolymer film that first and foremost serves to protect your drug – reducing the absorption and adsorption of the medication – and affording you the peace of mind that what you developed is exactly what gets delivered.
Maintaining the integrity of your drug’s ingredients is of paramount importance and an investment in protection is truly a continuation of the professional commitment to excellence and safety you already operate with.