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Gerresheimer 6R / 6 mL Amber Sterile Vials – ISO Standard Type I

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Items must be purchased in nests of 48 units.

The Gerresheimer 6R / 6 mL Amber Sterile Vial, made from premium ISO Standard Type I Borosilicate Gx® Elite glass, is purpose-built for sterile compounding excellence. Its amber tonality ensures optimal protection for light-sensitive formulations, while Ready-To-Fill (RTF®) processing guarantees that every vial is washed, depyrogenated, sterilized (ETO or VHP), and packaged under cGMP cleanroom conditions.

Delivered in double-bagged EZ-fill® trays with nest & tub packaging , these vials minimize glass-to-glass contact, streamline aseptic workflows, and reduce breakage rates. Combined with Gx® Elite glass technology—offering superior strength, flawless cosmetic quality, and validated regulatory compliance—they are the trusted choice for 503A/503B compounding pharmacies, biopharmaceutical manufacturers, and clinical fill-finish operations.

1 Nest & Tub = 48 units; 5 packs = 240 units (10 less than a complete 250-unit batch). These vials provide nearly a full 250-unit batch while minimizing glass-to-glass contact.

SKU: 921020600009

Relevant Industries

• Sterile Compounding Pharmacies (503A / 503B)
• Biopharmaceutical Manufacturing
• Clinical Research & Fill-Finish Facilities
• Vaccine and Biologics Production

Applications

• Aseptic preparation of sterile injectables
• Packaging of light-sensitive biologics (hormones, peptides, vaccines)
• Ready-to-Fill use in laminar flow isolators
• Batch sterile compounding requiring consistent vial quality

• Volume Capacity: 5 mL nominal (Brimful ~6.68 mL)
• Neck Finish: ISO 20 mm crimp neck
• Color: Amber – protects against UV/light degradation
• Material: ISO Standard Type I Borosilicate Glass (high chemical resistance)
• Packaging Configuration:
a) 1 Nest & Tub = 48 Vials
b) 5 Packs = 240 Vials (10 less than a 250-unit full batch)
• Sterilization Method: Ready-to-Fill (ETO or VHP)
• Dimensions: Ø 22.0 mm × H 40.0 mm (ISO 8362-1 Standard)
• Compatibility: Suitable with 20mm stoppers & seals

• Sterility Assurance: Compliant with USP <71> Sterility Tests
• Endotoxin Control: Meets USP <85> Bacterial Endotoxin requirements
• Residual Testing: Verified per ISO 10993-7 (ETO residuals)
• Glass Standards: Complies with USP <660>, Ph. Eur. 3.2.1, and JP for hydrolytic resistance
• Container Closure Integrity (CCI): Fully validated for sterile compounding workflows
• Defect Rate: Cosmetic defect reduction >90% with Gx® Elite glass inspection
• Documentation Supplied: Certificate of Conformance (CoC), Certificate of Analysis (CoA), Sterility & Endotoxin Reports
• Shelf Life: 3 years under recommended storage

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Component Material Properties / Features
Transparent Peelable Polymer Lid Opaque HDPE/PE
  • - Ensures sterility with a hermetic seal for ultimate product protection
  • - Easy-to-remove peelable design streamlines operations
  • - Reduces particulate contamination during opening
Gx® Elite Glass Vials Type I Borosilicate Glass
  • - Flawless appearance and unmatched mechanical strength
  • - Virtually no lot-to-lot or intra-lot variation
  • - Optimized for efficiency and low reject rates
Nest Polypropylene Homopolymer
  • - Prevents glass-to-glass contact for breakage protection
  • - Universal fit with standard fill-finish lines
  • - Simplifies production with easy integration
Tyvek Stripes HDPE
  • - Permeable barrier supports multiple sterilization methods
  • - Hermetic sealing maintains sterility
  • - Seamless integration with standard equipment
Tub High Impact Polypropylene Peterophasic Copolyme
  • - ISO 11040-7 compliant
  • - 3-inch tub suitable for all vial sizes and cartridges
  • - Holds Tyvek barrier for gas sterilization
Boxes Polypropylene
  • - Protects packages during handling and transport
  • - Compatible with ETO and VHP terminal sterilization
Sterilization ETO
  • - Terminal sterilization ensures SAL
  • - Validated sterility per ISO standards

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