PremiumFill® for Improved Particulate Specification

Vial Containment Solutions & Syringe Components

Pharma

Particulate contamination and product cleanliness are primary concerns in the pharmaceutical market. The latest EMA GMP Annex 1 revision requires that pharmaceutical companies establish more stringent contamination control strategies (CCS) that encompass their operations and suppliers.

Aptar Pharma’s PremiumFill^® solutions offer improved specifications regarding key contamination criteria as defined in Annex 1 such as particulates, biological or fiber contamination. PremiumFill^® contribute to enhanced patient safety while promoting operational efficiency.

Reach New Heights of Particulate Cleanliness and Operational Efficiency

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.

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.

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.

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.

Premiumfill®: Molding and Trimming in ISO 7 Cleanroom

All key manufacturing steps for PremiumFill^® components take place in ISO-classified cleanrooms. Molding and trimming are conducted in ISO-7 cleanrooms, which are equipped with state-of-the-art robotic automation. This ensures reproducible molding and minimizes the risk of extrinsic and human-borne contamination.

Enhanced Packaging Process with Metal Detection

Packaging of Aptar Pharma vial stoppers and syringe plungers takes place within an ISO-5 classified cleanroom environment. To further enhance quality, all PremiumFill^® injectable components are processed through metal detection equipment to minimize the risk of accidental metallic contamination.

Stringent Quality Control (QC) Standards

PremiumFill^® employs a meticulously implemented release control strategy, using a level 2 sampling approach, as defined by ISO 2859-2 to certify high standards of quality.

PremiumFill® Vial Stoppers

Vial stoppers for liquid and lyophilization: Bromobutyl and Chlorobutyl rubber formulations

PremiumFill® Pre-filled Syringe Plungers

Pre-filled syringe (PFS) and cartridge plungers: Bromobutyl and Chlorobutyl rubber formulations

Ready-to-Use (RTU) Gamma-sterilized components

PFS plungers vial stoppers for liquid and lyophilization.

Rapid Transfer Port (RTP) bags

RTP bags for PFS plungers and Vial stoppers – Getinge/Sartorius

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.

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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