USP Type I borosilicate glass vials for our injectable medicine packaging line. We are a licensed pharmaceutical manufacturer expanding our sterile product range.

Specifications:

• Type I borosilicate glass (USP/EP compliant)
• 10ml capacity with 20mm neck finish
• Ready-to-use (washed, siliconized, sterilized)
• Tray-packed in clean room packaging
• CoA and DMF documentation required
• Must pass particulate matter and extractable tests

Applicable Standards & Compliance

The glass vials shall comply with the latest editions of the following standards:

USP <660> / <660.1> – Containers, Glass

European Pharmacopoeia (EP) 3.2.1 – Glass Containers for Pharmaceutical Use

ISO 8362 Series – Injection vials and accessories

Japanese Pharmacopoeia (JP) (where applicable)

cGMP requirements

FDA & EMA regulatory compliance

DMF (Type III) availability preferred

Glass Type & Composition

Glass Type: Type I – Neutral Borosilicate Glass

Hydrolytic Resistance: Class I (highest resistance)

Manufacturing Process:

• Tubular glass (preferred)
• Molded glass (if applicable)

Vial Configuration

Nominal Fill Volume: ___ mL (e.g., 2 mL, 5 mL, 10 mL, 20 mL, 50 mL)

Neck Finish:

•  ISO standard (e.g., 13 mm / 20 mm)

Vial Type:

• Serum vial
• Lyophilization vial

Bottom Shape:

• Flat
• Concave

Packaging & Cleanliness

Supplied in cleanroom-controlled packaging

Packaging suitable for aseptic processing environments

Protection against particulate contamination and mechanical damage

Packaging configuration:

• Nest & tub
• Tray
• Bulk (specify)

Documentation & Quality Requirements

• Supplier shall provide:
• Certificate of Analysis (CoA)
• Certificate of Conformance (CoC)
• Batch/Lot traceability
• Change notification policy
• Regulatory support documentation (DMF, compliance letters)