Glass Serum Bottle Vials with Rubber Stopper
Technology: Vulcanization/ Halogenated
Material: Butyl/ Silicone
Packing: Double PE Bag+Carton
FTS Bag+Carton (Ready To Sterilize Packing)
Color: Grey
Storage: Dry Place
- Fast Delievery
- Quality Assurance
- 24/7 Customer Service
Full Customization
Description
Product description
|
Technology |
Vulcanization/ Halogenated |
|
Material |
Butyl/ Silicone |
|
Packing |
Double PE Bag+Carton FTS Bag+Carton (Ready To Sterilize Packing) |
|
Color |
Grey |
|
Storage |
Dry Place |
|
Size |
13mm 20mm 26mm 28mm 32mm |
Pharmaceutical Rubber Stopper Data sheet
|
|
TOP DIA. |
TOP THK |
NECK DIA. |
TOTAL H. |
|
13-A |
12.5±0.02 |
2.0±0.25 |
7.5±0.1 |
7.0±0.3 |
|
13-A2 |
12.7±0.02 |
2.0±0.25 |
7.5±0.1 |
7.0±0.3 |
|
20-A |
18.8±0.02 |
3.3±0.25 |
13.2±0.1 |
8.8±0.3 |
|
20-B2 |
19.5±0.02 |
3.0±0.25 |
13.0±0.1 |
8.7±0.3 |
|
26-B3 |
25.5±0.03 |
3.8±0.3 |
15.8±0.2 |
10.9±0.4 |
|
28-B |
26.6±0.03 |
3.8±0.3 |
18.0±0.2 |
11.8±0.4 |
|
28-C |
27.0±0.03 |
3.8±0.3 |
18.0±0.2 |
11.8±0.4 |
|
32-A2 |
30.8±0.03 |
4.0±0.3 |
23.6±0.2 |
12.2±0.4 |
|
32-A3 |
30.8±0.03 |
5.0±0.3 |
24.2±0.2 |
16.0±0.4 |
Glass Serum Vials with Rubber Stopper · Combination Kits
Neutral & Low Borosilicate · Opening Force · Seal Data
Glass serum bottle vials with rubber stopper · serum vial and stopper combination kits
neutral / low borosilicate glass - bromobutyl stopper
opening force & seal data
technical data sheet
serum vial and stopper combination kits
matched glass grade and elastomer · pharmaceutical injectable use
neutral & low
borosilicate glass *
CCIT tested
seal integrity
≤ 20N
opening force
TDS
data sheet available
Neutral borosilicate vs low borosilicate - choosing the right glass for your application
The serum vial and stopper combination kit is available with two glass grades. The choice determines the vial's chemical resistance, hydrolytic resistance class, and suitability for specific regulatory frameworks - and it must be matched to the formulation's pH sensitivity and the applicable pharmacopoeial requirements.
Type 1 / Hydrolytic Class I
Primary pharmaceutical injectable grade ★
Neutral borosilicate glass (also referred to as borosilicate glass Type 1) has the highest hydrolytic resistance of the three pharmacopoeial glass types - meaning it releases the lowest level of alkali ions into contact liquids over time. This makes it the required glass type for all parenteral (injectable) drug products under USP, EP, and JP specifications, and the standard grade for most pharmaceutical serum vials.
Class I
Hydrolytic class
Type 1
USP/EP designation
≤ 0.1ml
NaOH equiv./100ml (typ.)
> 6% B₂O₃
Boron oxide content
Type 2–3 / Hydrolytic Class II–III
Cost-effective alternative for lower-criticality use
Low borosilicate glass has lower boron oxide content and correspondingly lower hydrolytic resistance than neutral borosilicate. While less expensive, it is typically restricted to oral or topical liquid products, or non-pharmaceutical laboratory use, where the stricter hydrolytic resistance requirement of Type 1 glass does not apply. Not recommended for parenteral injectable products without specific regulatory justification.
Class II–III
Hydrolytic class
Type 2–3
USP/EP designation
Cost
Lower than neutral boro
Non-injectable
Typical application
For injectable products, neutral borosilicate (Type 1) is the correct choice in virtually all cases
USP <660> Containers - Glass and its pharmacopoeial equivalents (EP 3.2.1, JP General Tests) require Type 1 neutral borosilicate glass for parenteral (injectable) preparations. Specifying low borosilicate glass for an injectable product would require additional justification and testing to demonstrate suitability - the default specification should always be neutral borosilicate for injectables unless you have a specific reason otherwise.
KIT PARAMETERS - STOPPER MATERIAL
Rubber stopper elastomer options - matched to your formulation and process
The stopper elastomer is selected to match the formulation's chemical environment, the required cleanliness level, and whether the stopper needs to accommodate lyophilization. Three elastomer grades are available for the serum vial combination kit.
Bromobutyl ★
Primary pharmaceutical grade
Lowest MVTR · broadest chemical resistance
Bromobutyl rubber is the standard first choice for pharmaceutical injectable stoppers - lowest moisture vapour transmission rate, excellent chemical resistance to a wide range of aqueous formulations, and lowest extractable profile of the common injectable stopper elastomers. Compatible with most pH ranges encountered in injectable formulations.
Chlorobutyl
Alternative halogenated butyl
Similar profile to bromobutyl · some formulation preference
Chlorobutyl rubber provides comparable performance to bromobutyl for most pharmaceutical applications - marginally different extractable profile and vulcanisation chemistry that makes it the preferred option for some specific formulations where compatibility screening has indicated a preference. An alternative rather than a default upgrade or downgrade.
natural rubber
Legacy / specific applications only
Latex allergy risk · limited modern use
Natural rubber stoppers are largely phased out of modern pharmaceutical injectable use due to latex protein allergen concerns and higher extractables compared to synthetic halogenated butyls. Occasionally specified for legacy products or specific non-injectable laboratory applications. Not recommended for new product development.
PHYSICAL DATA - OPENING FORCE & SEAL INTEGRITY
Physical data - what the numbers mean for your closure system
Physical test data on a vial closure system lets you make informed decisions about usability at the point of care and regulatory compliance of the sealed package. Below are the primary physical parameters reported for this kit
≤ 20N
Flip-off cap opening force
USP <381> removal test reference
The force required to flip open the plastic tab of the flip-off cap - what a healthcare professional or patient experiences when opening the vial. USP <381> references that this should be achievable by thumb pressure without tools. A cap opening force above this range indicates a manufacturing defect or incorrect crimp force. Measured in Newtons (N) on a calibrated force gauge.
CCIT
Container closure integrity test
Helium leak / dye ingress / pressure decay
Container closure integrity testing (CCIT) confirms the sealed vial does not allow ingress of microorganisms, liquids, or gases from the external environment. Methods include helium leak test, vacuum/pressure decay, laser headspace analysis, or dye ingress - the appropriate method depending on the product and required sensitivity. CCIT is now the preferred method replacing sterility testing for closure validation under USP <1207>.
≤ 15N
Stopper removal (withdrawal) force
Post-crimp stopper extraction test
The force required to pull the rubber stopper out of the vial neck after crimping - confirms the stopper is seated with sufficient compression to maintain the seal, but not so tightly that it would present problems during pharmaceutical processing. Measured after a defined conditioning period to allow creep to stabilise. An upper limit defined by the stopper specification prevents over-compression that could damage the vial neck or stopper.
TECHNICAL DATA SHEET · TDS
Glass Serum Vial + Rubber Stopper Combination Kit - Full Technical Data Sheet
Complete physical data, glass hydrolytic resistance class, elastomer extractables summary, dimensional specifications, and test method references for the serum vial and stopper combination kit. Available in PDF format on request - contact us with your specific kit configuration (glass grade, stopper type, and vial size) for the relevant TDS.
Physical data values shown are representative - request the TDS for your exact kit configuration
Opening force, withdrawal force, and seal integrity test results vary by stopper formulation, vial neck geometry, crimp tooling, and siliconization status. The values above are representative reference ranges for standard configurations. The Technical Data Sheet for your specific combination (glass grade + stopper type + vial size + crimp specification) provides the applicable tested values for your qualification documentation.
AVAILABLE KIT COMBINATIONS
Serum vial and stopper combination kits - standard configurations
Four standard kit configurations cover the most common serum vial and stopper combinations for pharmaceutical injectable, laboratory, and veterinary applications.
1
KIT A - INJECTABLE
Neutral borosilicate + bromobutyl stopper
◆Glass: Type 1 neutral borosilicate, hydrolytic Class I
◆Stopper: Bromobutyl rubber, USP <381> compliant
◆Sizes: 2ml, 5ml, 10ml, 20ml
◆Use: Aqueous injectables, biologics, hormone oils, multi-dose
2
KIT B - LYOPHILIZATION
Neutral borosilicate + two-leg bromobutyl stopper
◆Glass: Type 1 neutral borosilicate, hydrolytic Class I
◆Stopper: Two-leg bromobutyl, lyophilization grade
◆Sizes: 5ml, 10ml, 20ml
◆Use: Freeze-dried powder, lyophilized biologics and peptides
3
KIT C - LAB / DIAGNOSTIC
Low borosilicate + bromobutyl stopper
◆Glass: Low borosilicate, Type 2–3
◆Stopper: Bromobutyl rubber, lab grade
◆Sizes: 2ml, 5ml, 10ml
◆Use: Laboratory reagents, diagnostics, non-injectable use
4
KIT D - VATERINARY
Neutral borosilicate + bromobutyl, larger volumes
◆Glass: Type 1 neutral borosilicate
◆Stopper: Bromobutyl rubber, 20mm or 28mm
◆Sizes: 20ml, 50ml, 100ml
◆Use: Veterinary injectable, livestock hormone and antibiotic products
COMPLETE SPECIFICATIONS
Serum vial + stopper combination kit - full specification reference
Reference specifications across both glass grades and stopper types for the serum vial and stopper combination kit.
| Parameter | Neutral borosilicate | Stopper (bromobutyl) |
|---|---|---|
| Glass vial | ||
| Glass grade | Neutral borosilicate ★ | - |
| Type / Class | Type 1 / Hydrolytic Class I | - |
| Standard | USP <660> / EP 3.2.1 | - |
| Volume range | 2ml – 100ml | - |
| Rubber stopper | ||
| Elastomer | - | Bromobutyl rubber ★ |
| Test standard | - | USP <381> |
| Hardness | - | 40–55 Shore A |
| Physical data | ||
| Flip-off opening force | ≤ 20N (representative) | - |
| Stopper withdrawal force | - | ≤ 15N (representative) |
| Seal integrity | CCIT tested - method on request | - |
| Technical Data Sheet | Available on request (PDF) | Available on request (PDF) |
WHO ORDERS THIS KIT
Serum vial and stopper combination kits - across the pharmaceutical supply chain
Glass serum vials with rubber stoppers are specified across the pharmaceutical, veterinary, and laboratory supply chain wherever sealed injectable or sample containers are needed.
pharmaceutical manufacturers
Injectable · multi-dose · lyophilized
Manufacturers requiring neutral borosilicate glass vials with matched bromobutyl stoppers and documented physical data for regulatory submissions and production validation.
compounding pharmacies
Sterile compounding · USP <797>
Compounding pharmacies specifying combination kits with the appropriate glass grade and stopper type for their injectable preparations under sterile compounding requirements.
biotech & clinical supply
IND / CTA packaging development
Biotech clinical supply teams selecting and qualifying closure systems for investigational drug products, needing TDS documentation for container/closure sections of regulatory submissions.
CDMOs & fill - finish
Multi-client vial kit supply
Contract fill-finish organisations sourcing matched vial and stopper kits for multiple client products across different glass grades and stopper types.
veterinary pharmaceutical producers
Livestock & companion animal injectables
Veterinary producers requiring larger-volume serum vial and stopper combinations for livestock injectable products, using Kit D configuration in 20–100ml sizes.
research & diagnostic laboratories
Low borosilicate kit C · reagent storage
Research and diagnostic laboratories using the lower-cost low borosilicate kit configuration for reagent and sample storage where Type 1 glass is not required.
Right Glass. Right Stopper. Right Data.
Complete serum vial and stopper combination kits.
Tell us your glass grade requirement, stopper type, and vial size - we'll confirm the kit configuration, provide the Technical Data Sheet with physical test data, and arrange a free sample within 48 hours.
Hot Tags: glass serum bottle vials with rubber stopper, China glass serum bottle vials with rubber stopper manufacturers, suppliers, Vial Rubber Stoppers, 20mm Butyl Vial Rubber Stopper, Glass Vial with Cap Rubber Stopper, Rubber Stopper for Liquid Powder Vial, 13mm 20mm Coated Bromobutyl Vial Rubber Stopper, Medical Bottle Glass Vials Use Rubber Stopper
Send Inquiry
You Might Also Like
