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Reach New Heights of Particulate Cleanliness and Operational Efficiency

 

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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.

Aptar Pharma’s advanced parenteral closures include liquid and lyophilized vial stoppers.

Supporting your compliance with EMA GMP Annex 1 revision standards

The 2022 revision of the European Medicines Agency (EMA) Good Manufacturing Practice (GMP) Annex-1 mandates rigorous standards regarding sterility and particulate contamination. Annex-1 requires that pharmaceutical manufacturers implement a robust Pharmaceutical Quality System along with a comprehensive Contamination Control Strategy (CCS), covering every operational stage, from supply to the final product delivery, to promote injectable product safety. Ensuring that parenteral packaging components comply with these stringent requirements, including particulate reduction criteria, are essential for pharmaceutical manufacturers in order to strengthen their manufacturing operations and support patient safety.

PremiumFill® particulate reduced components emerged as a strategic response to supporting compliance with the revised Annex-1 requirements. All PremiumFill® components benefit from a specific manufacturing process that delivers improved stopper or plunger specifications with regard to key contamination criteria, such as particulate contamination, as defined in section 10.2.

Learn more about how primary packaging is impacted by the revision of EMA GMP Annex 1.

Aptar Pharma grey rubber vial stoppers manufactured in ISO cleanroom for consistent high quality and Annex-1 compliance.

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.

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Upgrade to PremiumFill® without regulatory reapproval

PremiumFill® low particulate injection components solutions represent an upgrade over our well-established conventional vial stoppers and syringe plungers by featuring:

  • Identical component designs
  • Identical rubber formulations
  • Identical Ultraclean 6 finishing process

For Aptar solutions users, adopting PremiumFill® is a straightforward process that does not require regulatory re-approval. This ensures a seamless integration into existing pharmaceutical manufacturing processes and helps manufacturers to support compliance with the new EMA GMP Annex-1 regulatory demands while boosting their operational efficiency.

Product Details

 

PremiumFill® vial stoppers are available with in 13mm, 20mm and 32mm sizes.

Special designs are available upon request.

Syringe plungers are available in 0.5mL, 1mL, 1-3mL and 10mL formats.

Cartridge plungers are available in 1.5 and 3mL format.

Additional standard plunger sizes are available and special designs are available upon request.

Our market-proven formulations are validated sterile with gamma sterilization.

All sterilized products are supplied in poly-ethylene-only (Tyvek-free) bags to miminize the risk of Tyvek related particulate contamination.

Learn more about Ready-to-Use (RTU) Gamma-sterilized components

Various packaging options, including Getinge or Sartorius formats, are available with 105, 110 or 190 mm port sizes for all of our advanced parenteral closure components.

Available with Tyvek bags (for steam sterilization) or Poly-ethylene bags (for Ready-to-Use gamma sterilized solutions).

RTP bags help ensure aseptic transfer on filling lines, when used with isolators or Restricted Access Barrier Systems (RABS), as recommended in the 2022 EMA GMP Annex-1 revision.

Learn more about Rapid Transfer Port (RTP) bags

Contact Aptar Pharma’s Parenteral Expert Team Today

Learn more about how we can support your compliance with Annex-1 revision requirements and optimize your operations with our Advanced Parenteral Packaging Solutions.

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