FluroTec Barrier Film and the importance of packaging in drug safety.
For medical professionals, maintaining the stability, integrity, and potency of drugs is critical to supplying safe and effective drugs to patients.
Impure, degraded, or damaged drugs cause serious problems that can put patients (and your reputation) at risk. Improper drug packaging increases susceptibility to impurities, accelerates drug degradation, and increases risk of product damage during manufacturing and transport. These factors can cause drug recalls, risks to patients, operational inefficiencies, and increased costs, among other detriments.
Purity and patient safety in drug packaging
Drug purity is critical to patient safety, and proper drug packaging must be implemented to maintain the purity and quality of drugs. Proper drug packaging also extends shelf life, reduces risks, and provides other performance benefits. According to Soumyanath Mishra, head of packaging development at Mankind Research Centre, due to drug formulation limitations, some products can even be stabilized by the use of innovative packaging design solutions.
Addressing drug packaging design during the drug development phase is critical not only for drug safety, but for cost and other manufacturing considerations as well. Early in the development process, packaging choices can be made that ensure the best result when the product is manufactured and distributed. Packaging materials must be able to maintain the purity, potency, and quality of the drug product in order to keep patients safe. Problems arise when drug packaging causes drug degradation, leaches toxins, or has other negative reactions when placed in contact with a drug product. These interactions between the packaging and its contents can significantly impact the purity of a drug and put the safety of patients at risk. Additionally, according to an FDA presentation from May 2013, drug impurities and drug degradation are among the top three causes of drug recalls.
When packaging is considered early in the drug development process, medical professionals can be assured that the packaging used is compatible with the drug, so patients as well as your business are protected.
The importance of barrier film in minimizing impurities and drug degradation
With improper or insufficient packaging, drugs can begin to degrade in quality and effectiveness before they are received by the patient. Barrier films are a solution for optimal drug protection. Barrier film helps to maintain the integrity and stability of drugs with minimal degradation between manufacturing, distribution, and receipt by the patient.
Barrier films with FluroTec coatings such as stoppers and plungers allow pharmaceutical manufacturers to:
- Package drugs effectively to preserve drug purity and quality
- Package drugs with a protective barrier that does not cause negative interactions with the drug formula
- Fully seal a drug so that the drug remains stable and potent
- Block impurities to supply pure, safe products to patients
Drug packaging supply chain management
Barrier films are an investment in drug packaging that provide many benefits from a supply chain management perspective. West FluroTec Barrier Film may help by:
- Providing an effective barrier against extractables from rubber and leachables in the drug formation
- Improving compatibility between the drug and the elastomeric closure
- Minimizing interaction between the drug ingredients and elastomer
- Eliminating a potential source of particulate contamination
- Reducing stopper clumping during autoclave sterilization
- Preventing stoppered vials from sticking to shelves in lyo chambers
- Minimizing use of silicone oil while enabling excellent machinability
Product packaging needs to be safe, effective, and cost-efficient. Smart packaging plays a critical role in successful, timely supply chain management in the pharmaceutical industry.
The benefits of effective drug packaging are many, including:
- Protecting drugs from damage during transportation
- Ensuring packaging materials are compatible with drugs to prevent adsorption and absorption
- Reducing time-to-market issues from recalls or contamination
- Minimizing patient risk by maintaining drug stability and quality
- Preventing reformulation or product replacement costs
- Reducing packaging-related failures and associated costs
- Improving shelf life of packaged drugs
Logistically, manufacturers face supply chain challenges in processes, cost, production, and regulations, among others. Therefore, it’s critical to choose suppliers and products wisely to avoid manufacturing problems, development delays, or recalls.
What is FluroTec coating?
FluroTec coating or barrier film provides a barrier between a drug and its container closure to help protect drugs and patients. FluroTec’s fluoropolymer film coating reduces the absorption and adsorption of a drug product to maintain the quality and extend the shelf-life of most drugs.
FluroTec barrier film uses B2-coating technology that maintains closure integrity and minimizes contact between drugs and the closure to maintain stability and strength of drugs. This is critical to cost savings and preserving the integrity of drugs from manufacturing through patient receipt.
Talk to your Farris Labs representative today for more information on choosing the right option for your product and your patients.