Rubber Stopper for Liquid Powder Vial
13mm Blue Rubber Stopper, Round, Serum Stopper
Ready To Sterile, Ready To Use
We Manufacture Variety Rubber Stopper For Pharmaceutical Applications
The Stoppers Are Suitable For The Seals Of Antibiotics, Powder, Infusion, Chemisty Lab
- Fast Delievery
- Quality Assurance
- 24/7 Customer Service
Full Customization
Description
Product description
13mm Blue Rubber Stopper, Round, Serum Stopper
Ready To Sterile, Ready To Use
We Manufacture Variety Rubber Stopper For Pharmaceutical Applications
The Stoppers Are Suitable For The Seals Of Antibiotics, Powder, Infusion, Chemisty Lab
|
Specification |
Head diameter |
Head thickness |
Plug diameter |
Height |
|
13-A |
12.5 ± 0.2 |
2.0 ± 0.25 |
7.5 ± 0.1 |
6.7 ± 0.3 |
|
13-D1 |
12.5 ± 0.2 |
2.2 ± 0.25 |
12.1 ± 0.1 |
12.7 ± 0.3 |
|
13-D2 |
12.5 ± 0.2 |
2.2 ± 0.25 |
7.7 ± 0.1 |
11.1 ± 0.3 |
|
13-D4 |
12.6 ± 0.2 |
2.5 ± 0.25 |
9.3 ± 0.1 |
10.5 ± 0.3 |
rubber stopper for liquid powder vial · lyophilization
lyophilization two-leg stopper · moisture seal
Rubber stopper for liquid powder vial · lyophilization
rubber stoppers for powder vials · two-leg structure
Rubber Stopper
for Liquid / Powder Vial
Lyophilization Two-Leg Structure · Powder Moisture Seal · Formulation Compatibility
Standard serum stopper · Two-leg lyophilization stopper · powder moisture barrier · bromobutyl elastomer
|
liquid standard stopper |
powder lyophilization type |
two-leg lyo structure |
moisture seal powder protection |
bromobutyl elastomer |
13/20/28mm sizes |
LYOPHILIZATION STOPPER - TWO - LEG STRUCTURE
Two-leg stopper - engineered for the lyophilization cycle
Lyophilization (freeze-drying) removes moisture from a filled vial by sublimation - converting frozen water directly to vapour under vacuum, then pumping it away. During this process, the vial cannot be fully sealed or the vapour cannot escape. The two-leg stopper solves this by sitting partially inserted during the freeze-dry cycle, with its channel gap open for vapour passage, then being pressed fully home afterward to create a permanent hermetic seal.
two - leg
Lyophilization stopper ★
Channel gap · vapor escape during lyo
The two-leg (or two-prong) structure creates a defined channel between the legs through which water vapour escapes during the freeze-drying process. After lyophilization, the stoppering press pushes the stopper fully home, collapsing the channel and creating a hermetic powder seal.
standard
Serum/injection stopper
Flat base · liquid sealing
The standard serum stopper has a solid flat base - appropriate for liquid formulations where an immediate complete seal is required from the moment of stoppering. Not designed for lyophilization, as vapour cannot escape a fully sealed vial during freeze-drying.
four - leg
Multi-leg lyophilization variant
Extended channel network
A four-leg variant provides a more distributed channel network around the stopper circumference - used where the lyophilization cycle's vapour flow rate is higher, or where the vial geometry benefits from a more symmetric vapour escape path during freeze-drying.
Two-leg is the most common lyophilization stopper format - confirm your cycle before specifying
The two-leg stopper is the industry standard for most pharmaceutical lyophilization processes. The channel gap geometry (width, depth, and spacing) is defined by the stopper manufacturer and determines the vapour conductance during freeze-drying. Confirm your lyophilizer shelf stoppering mechanism configuration and target cycle residual moisture level when specifying - these determine whether a two-leg or four-leg stopper is more appropriate for your process.
SEALINGPRESURE - POWDER MOISTURE PROTECTION
Post-lyo sealing - how the stopper protects your dry powder
After lyophilization is complete, the stoppering press closes the stopper fully into the vial neck under controlled force - creating the moisture-tight seal that protects the dry powder for the product's entire shelf life. This final sealing step is what justifies the complexity of the two-leg design.
1
Freeze-drying complete - shelf stoppering initiated
At the end of the lyophilization cycle, the lyophilizer's heated shelf plates move upward, pressing each stopper fully into its vial neck under a defined stoppering force. This force closes the two-leg channel gap, compressing the elastomer against the vial neck walls on all sides simultaneously.
2
Channel closed - radial and axial compression established
As the stopper seats fully, the leg structures deform and close the gap between them, while the plug head and skirt compress against the vial neck geometry - generating both radial seal force (outward against the glass neck wall) and axial seal force (downward into the neck shoulder). Together these create the hermetic moisture barrier.
3
Crimped under nitrogen - inert atmosphere preserved
The stoppered vial is typically removed from the lyophilizer and immediately crimp-sealed with an aluminum cap, ideally under a nitrogen or inert atmosphere, to maintain the low-moisture, oxygen-reduced headspace created inside the lyophilizer during the freeze-drying cycle - preserving the dry powder's stability from sealing through to end of shelf life.
4
Moisture vapour transmission rate - the ongoing seal metric
Once sealed, the stopper's moisture vapour transmission rate (MVTR) through the elastomer itself becomes the ongoing seal performance metric - bromobutyl has the lowest MVTR of common pharmaceutical elastomers, making it the correct material choice for dry powder and lyophilized products where moisture ingress over a multi-year shelf life is the primary packaging risk.
FORMULATIONCOMPATIBILITY
Formulation Compatibility - stopper type selection by formulation
Not every stopper type suits every formulation. The table below maps formulation characteristics to the appropriate stopper type, elastomer grade, and key compatibility considerations.
| Formulation type | Standard serum stopper | Two-leg lyo stopper | Key consideration |
|---|---|---|---|
| Liquid formulations | |||
| Aqueous injectable solution | ✓ Primary choice | ✗ Not required | Standard serum stopper fully adequate |
| Oil-based injectable | ✓ With oil-compatible elastomer | ✗ Not required | Confirm elastomer compatibility with specific oil carrier |
| High-concentration protein solution | ✓ Low-extractable grade | ✗ Not required | Select low-extractable bromobutyl for biologics |
| Powder & lyophilized formulations | |||
| Lyophilized (freeze-dried) powder | ✗ Not suitable | ✓ Primary choice ★ | Two-leg required - allows vapour escape during lyo cycle |
| Spray-dried powder (pre-filled) | ~ Terminal sealing only | ✓ Where moisture control critical | Confirm filling method - aseptic powder fill uses two-leg |
| Lyophilized biologics / mAb | ✗ Not suitable | ✓ Low-extractable lyo grade | Critical: specify low-extractable lyo stopper for biologics |
| Reconstitutable antibiotic powder | ✗ Not suitable for fill | ✓ Standard lyo grade | Classic lyophilized antibiotic vial application |
| Special applications | |||
| Radioactive / diagnostic agent | ~ Confirm radiation tolerance | ~ Confirm radiation tolerance | Elastomer radiation stability must be validated |
| Cytotoxic drug (lyophilized) | ✗ Not suitable | ✓ Confirm chemical resistance | Extractables profile critical - specify for cytotoxic use |
| Peptide vial (lyophilized) | ✗ Not suitable | ✓ Low-extractable lyo grade | Standard lyophilization stopper application |
This table is a selection guide - confirm with extractables data for your specific formulation
Formulation compatibility is ultimately confirmed through specific compatibility testing - extractables/leachables study, container closure integrity testing, and accelerated stability studies - not by stopper type selection alone. Use this table as an initial selection guide and confirm against your specific formulation's requirements before finalising a stopper specification.
LYOPHILIZATION STOPPER - ENGINEERINGDETAIL
What the lyophilization stopper must do - three demands
The lyophilization stopper has a more demanding functional profile than a standard liquid stopper - it must perform correctly across three distinct phases of the product's life.
during lyo
Vapour conductance - open phase
Channel gap must remain open under vacuum
During freeze-drying, the stopper sits partially inserted with the channel gap held open by the vial neck geometry - under the process vacuum, water vapour sublimates from the frozen cake and must exit through this channel unimpeded. Any stopper that prematurely collapses the channel under vacuum will trap moisture and produce a failed lyo cycle.
at sealing
Full compression - channel closed phase
Shelf stoppering force - controlled compression
The sealing force applied by the lyophilizer shelf mechanism must be calibrated to fully close the two-leg channel without over-compressing the elastomer to a compression set failure. The stopper's Shore A hardness and two-leg geometry are designed to close cleanly and reproducibly within the stoppering system's defined force range.
shelf life
Moisture barrier - storage phase
MVTR · long-term hermetic seal · compression set resistance
After sealing, the stopper must maintain its compression against the glass neck throughout the product's shelf life - often two to three years or more. Compression set resistance (the stopper's resistance to permanent deformation under load) is the primary material property governing long-term seal force maintenance for the dry powder moisture barrier.
COMPLETE SPECIFICATIONS
Rubber stopper for liquid/powder vial - full specification reference
Reference specifications for the standard serum stopper and two-leg lyophilization stopper.
| Parameter | Standard serum stopper | Two-leg lyo stopper |
|---|---|---|
| Material | ||
| Elastomer base | Bromobutyl rubber | Bromobutyl rubber ★ |
| Hardness (Shore A) | 40–55 typical | 40–50 typical (softer for channel closure) |
| Test reference | USP <381> | USP <381> · lyo grade validated |
| Structure | ||
| Bottom geometry | Flat / continuous base | Two-leg with channel gap ★ |
| Channel function | N/A | Vapour escape during lyo |
| Post-seal geometry | Sealed at stoppering | Sealed after shelf stoppering |
| Sizing & supply | ||
| Standard sizes | 13mm · 20mm · 28mm | 13mm · 20mm · 28mm |
| Siliconized option | Available | Available |
| Sample available | Yes - free sample | Yes - free sample |
WHO ORDERS THIS STOPPER
Rubber stoppers for liquid / powder vials - across the pharmaceutical supply chain
Liquid and lyophilization stoppers are specified wherever injectable drug products require the appropriate container closure system for their fill format.
lyophilization drug manufacturers
Antibiotics · biologics · peptides · mAb
Manufacturers filling lyophilized injectable products requiring two-leg stoppers compatible with their specific lyophilizer shelf stoppering system.
biologics & biosimilar producers
Lyophilized mAb · lyo-grade low extractables
Biologics producers specifying low-extractable lyophilization stoppers for lyophilized monoclonal antibody and biosimilar products where extractables risk is particularly stringent.
peptide manufacturers
Lyophilized peptide vials
Peptide producers lyophilizing their products for improved stability and shelf life, requiring two-leg stoppers matched to their lyophilizer configuration.
CDMOs with lyophilization capability
Multi-client lyo services
Contract development and manufacturing organisations offering lyophilization services for multiple clients, needing validated lyo stopper stock compatible with their equipment.
biotech R & D clinical supply
Early-phase lyo development
Biotech clinical supply teams developing lyophilization processes for early-phase clinical products, needing appropriate lyo stoppers for process development and clinical batches.
packaging component distributors
B2B · both stopper types stocked
Pharmaceutical packaging distributors stocking both standard serum and two-leg lyophilization stoppers to serve customers across liquid and powder vial product lines.
Open During Lyo. Sealed After.
The two-leg stopper, engineered for both.
Request a free sample of the two-leg lyophilization stopper or standard serum stopper - with formulation compatibility data and elastomer documentation for your specific application.
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