PremiumFill^®: elevating your contamination control strategy

As advances in the pharmaceutical industry continue to raise the standards of patient care, operating pharmaceutical manufacturing environments that provide cleaner and more controlled environments has become critical to meeting the latest EMA GMP Annex-1 revisions. Drug filling operations can introduce extrinsic contamination. Any particle, fiber or biological contaminant present on the primary packaging could have contact the drug. Ensuring that your operation remains as contaminant-free as possible is essential to avoiding costly sterile product recalls, especially when involving high-value vaccines or biologics.

To address this concern, Aptar Pharma developed PremiumFill^®, an advanced technology solution that leverages ISO clean room manufacturing and advanced robotization to minimize the risks of human contamination or extrinsic particle contamination of rubber stopper or syringe components. PremiumFill^® injection components offer improved specifications  regarding key contamination criteria (particles, fibers, biological contaminants) to derisk filling operations and ensure patients receive safe injections.

Improved operational efficiency

As the pharmaceutical market shifts toward higher value drugs and increases its focus on patient safety, particulate contamination and product defects rates are highly scrutinized on manufacturing lines. Choosing the right Annex-1 compliant packaging components is crucial not only for managing these risks but also for maintaining profitable fill-finish operations.

PremiumFill^® vial stoppers and pre-filled syringe plungers are engineered to meet enhanced particulate specifications and other contamination criteria. This improved cleanliness can help reduce drug product rejection rates produced on fill-finish lines, decrease scrap rates and lower the risk of recalls, all of which can contribute to significant cost savings and improved manufacturing efficiency.

By simply switching from standard injectable components to our PremiumFill^® line, an Aptar Pharma customer demonstrated a decrease in reject rates of over 20% on their fill-finish lines.