Primary Container
Sterile RTU Glass Vials
- Type I borosilicate, ISO 8362 compliant
- 2R · 6R · 10R · 20R formats
- RTU sterile, depyrogenated
- EU blowback geometry compatible
- Injectable & lyophilisation applications
Sterile Primary Packaging
Sterile Packaging Solutions for Injectable Pharmaceuticals.
LBS International supplies sterile ready-to-use primary packaging components for pharmaceutical and biotech manufacturing environments worldwide.
Borosilicate Glass
Type I
Manufacturing Standard
ISO 15378
Controlled Distribution
GDP
Sterile · Depyrogenated
RTU
ISO 15378ISO 9001USP / EPDMF SupportedGDP DistributionChange Control
Why LBS International
A technical partner for sterile injectable packaging.
Eight pillars that define our approach to supplying primary packaging into regulated pharmaceutical and biotech manufacturing environments.
Sterile RTU Packaging Solutions
Tub & nest components washed, depyrogenated and sterilised by qualified manufacturing partners — ready for direct introduction to aseptic filling.
Type I Borosilicate Glass Systems
Pharmaceutical-grade glass evaluated against USP <660> and EP 3.2.1 for chemical resistance and injectable suitability.
Lyophilisation Packaging Expertise
Lyo-slot stopper geometries and matched vial formats engineered for stable freeze-drying cycles and reliable closure integrity.
Technical Qualification Support
Documentation packages aligned to internal qualification protocols — supporting evaluation, sampling and validation activities.
Supply Continuity Support
Dual-sourcing strategies, buffer stock programmes and project-aligned delivery scheduling for commercial fill-finish operations.
Low Particulate Packaging Systems
Fluoropolymer-coated bromobutyl elastomers and controlled cleanroom packaging to minimise sub-visible particulate contribution.
ISO Standard Packaging Formats
Components produced in accordance with ISO 8362 vial dimensional standards for compatibility with standard filling platforms.
Pharmaceutical Traceability Controls
End-to-end lot-level genealogy from manufacturing partner batch through GDP-controlled distribution to customer site.
Our Solutions
A complete sterile primary packaging system.
Three core component families engineered to integrate cleanly on standard pharmaceutical filling and lyophilisation platforms.
Closures
Lyophilisation Stoppers
- 13mm and 20mm formats
- Premium bromobutyl elastomer
- Fluoropolymer-coated surface
- Low particulate profile
- RTU sterile · freeze-dry compatible
Sealing System
Flip-Off Seals
- Pharma-grade aluminium
- 13mm and 20mm formats
- Standard vial system compatibility
- Cleanroom-compatible packaging
- Color-coded options available
Quality & Compliance
Built on a controlled, qualified supply chain.
LBS International operates as a GDP-controlled distribution partner. All manufacturing, sterilisation, depyrogenation and RTU processing are performed by qualified manufacturing partners operating under ISO 15378 / ISO 9001 quality systems.
ISO 15378
Primary packaging materials manufactured under recognised pharma standard.
ISO 9001
Quality management systems applied across the supply chain.
USP / EP Compliance
Materials evaluated against USP <660>, <381>, EP 3.2.1 / 3.2.9.
RTU Sterile Processing
Washed, depyrogenated, sterilised — ready for aseptic filling.
DMF-Supported Supply
Drug Master File coverage available for regulatory submissions.
GDP Distribution
Good Distribution Practice principles across European logistics.
Change Control
Formal change notification protocols with end customers.
Traceability
Lot-level batch traceability across the controlled supply chain.
Compatibility Statement
"Components are manufactured in accordance with applicable ISO vial and stopper dimensional standards and are intended for evaluation and qualification on standard pharmaceutical filling and lyophilisation equipment platforms."
Technical Expertise
Supporting Critical Pharma Projects.
From early development to commercial-scale fill-finish, LBS International acts as a technical packaging partner — closing supply gaps, mitigating shortages and supporting qualification activities on aseptic filling and lyophilisation lines.
- Alternate Supplier SupportValidated second-source supply for primary packaging continuity.
- Engineering Batch SupplyComponents for SAT, OQ, PQ runs and process characterisation.
- Project Execution SupportCoordinated supply against project milestones and timelines.
- Supply Continuity MitigationBuffer stock strategies and dual-sourcing programmes.
- Qualification SupportDocumentation packages aligned to internal qualification protocols.
+200M
Components / yr capacity
48h
Documentation response
100%
Lot traceability
Supplier Qualification Support
A technical pharmaceutical packaging partner.
We work alongside pharmaceutical and biotech quality teams from initial supplier assessment through to ongoing supply, aligning documentation and protocols to internal qualification frameworks.
Read the qualification frameworkSupplier onboarding support
Technical documentation packages
Sample supply for evaluation
Lot-level traceability management
Change notification protocols
Quality agreement readiness
Qualification protocol support
Dedicated technical contact
Get in touch
Discuss your sterile packaging requirement with our technical team.
Products are supplied for customer-specific technical evaluation, qualification and validation activities. Final suitability for commercial use remains subject to customer qualification and GMP validation requirements.