Medical Silicone Bottle Stopper
Uses: suitable for the sealing of injection liquid
Packing: inner packing is double-layer high density polyethlene bags, outer packing is corrugated box
Industry standard: YBB00042005-2015
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Description
Uses: suitable for the sealing of injection liquid
Packing: inner packing is double-layer high density polyethlene bags, outer packing is corrugated box
Industry standard: YBB00042005-2015
|
Item |
Feature |
Size |
|
20-V |
one needled hole four points |
head dia: 18.8±0.2 plug dia: 13.2±0.1 height: 7.0±0.3 head thickness: 3.3±0.2 |
|
20-A |
double needled circles |
head dia: 18.8±0.2 plug dia: 13.2±0.1 height: 8.8±0.3 head thickness: 3.3±0.2 |
|
24-B |
three arcs two needled holes |
head dia: 23.9±0.3 plug dia: 13.9±0.2 height: 10.2±0.4 head thickness: 3.8±0.25 |
|
26-B |
three arcs two needled holes |
head dia: 25.5±0.3 plug dia: 15.5±0.2 height: 10.0±0.4 head thickness: 3.8±0.25 |
|
28-B |
single crcle one needled hole |
head dia: 27.1±0.3 plug dia: 17.8±0.2 height: 10.2±0.4 head thickness: 3.4±0.25 |
|
28-B3 |
single needled circle three rays |
head dia: 26.9±0.3 plug dia: 18.0±0.2 height: 11.8±0.4 head thickness: 3.8±0.25 |
|
32-A |
four needled holes three arcs four rays |
head dia: 30.8±0.3 plug dia: 23.6±0.2 height: 12.2±0.4 head thickness: 4.0±0.25 |
|
32-A1 |
four needled holes three arcs four rays |
head dia: 30.8±0.3 plug dia: 24.0±0.2 height: 16.0±0.4 head thickness: 5.0±0.25 |
|
34-A |
one needled hole four rays |
head dia: 32.6±0.3 plug dia: 26.5±0.2 height: 14.5±0.3 head thickness: 4.3±0.25 |
Translucent Medical Silicone Stopper
Non-Toxic · Odorless · Biocompatible · Inert
Medical silicone bottle stopper · translucent · inert bottle seals · Shore A hardness
Medical Silicone
Bottle Stopper
Translucent · Non-Toxic · Odorless · Biocompatible · Shore A Hardness Data · Silicone vs Butyl
Inert elastomer bottle seal · translucent medical silicone · physicochemical-certified
|
Translucent Optical clarity |
Non-toxic Physicochemical |
Odorless No off-gassing |
Inert Chemically stable |
40-60 Shore A Hardness range |
USP VI Biocompatibility |
Non-toxic, odorless, biocompatible - what the data shows
Medical-grade silicone is characterised by a small set of physicochemical and biological properties that together establish its suitability for direct contact with pharmaceutical and biological products. Each property below is independently tested and documented.
non-toxic
Non-toxic - no harmful extractables
Extractables & leachables testing
Medical-grade silicone is formulated without toxic plasticisers, heavy metal catalysts, or other harmful additives commonly found in industrial-grade silicone. Extractables and leachables (E&L) testing confirms that substances migrating from the stopper into a contacting liquid remain below pharmacopoeial safety thresholds across the product's intended contact duration.
✓ No toxic plasticisers or heavy metal catalysts
✓ E&L levels below pharmacopoeial thresholds
✓ Suitable for direct drug product contact
odorless
Odorless - no off-gassing or taste transfer
Sensory testing · no formulation interference
Medical-grade silicone has no detectable odour and does not release volatile compounds during normal storage or sterilisation. This matters specifically for oral liquid and ophthalmic formulations, where any odour or taste transfer from the stopper material would be immediately noticeable to the patient and could be mistaken for product degradation.
✓ No detectable odour at rest or under heat
✓ No taste transfer to oral liquid formulations
✓ No volatile off-gassing during sterilisation
USP VI
Biocompatibility - USP Class VI
In vivo biological reactivity testing
USP Plastics Class VI is the most stringent biological reactivity classification in the USP <88> biocompatibility framework, requiring in vivo testing (systemic injection, intracutaneous, and implantation studies) in addition to the in vitro cytotoxicity testing required for lower classes. Medical-grade silicone formulated to Class VI standard has passed this full testing battery.
✓ Systemic toxicity testing passed
✓ Intracutaneous reactivity testing passed
✓ Implantation study testing passed
Inert bottle seals - what "inert" means in practice
"Inert" describes a material that does not chemically react with, absorb into, or release substances into the product it contacts. For a bottle stopper, this means the silicone neither alters the formulation's chemical composition nor takes up active ingredients from it - preserving both the product's potency and its safety profile across the shelf-life storage period. This inertness is the practical basis for why silicone is selected for sensitive and high-value formulations.
Hardness - Shore A data
Shore A hardness - how it's measured and what it means
Shore A hardness is measured using a durometer - a spring-loaded indenter pressed into the rubber surface, with the resistance to penetration read on a 0–100 scale. Medical silicone bottle stoppers are typically specified within a defined hardness window, balanced between sealing compliance and dimensional stability.
20-30
Very soft
Specialty seals · gentle compression applications
40-60 ★
Standard medical range
Most common range for medical silicone bottle stoppers
50
Typical default
Standard catalogue specification, most bottle formats
60-70
Firmer
Higher dimensional stability · larger format bottles
70-90
Hard
Not typical for stoppers · rigid component applications
Why 40-60 Shore A is the standard range
Below 40 Shore A, the stopper may be too soft to maintain its sealing geometry under the sustained compression of a crimped or screw cap closure - risking long-term sealing force loss. Above 60 Shore A, the stopper becomes more difficult to compress reliably and can require higher insertion/crimping forces, increasing the risk of cracking or uneven seating during the capping process. 40–60 Shore A balances reliable seal compliance against dimensional and handling stability for most bottle stopper applications.
Hardness is a controlled, specified parameter
Shore A hardness is tested on every production lot using a calibrated durometer per ASTM D2240 or equivalent standard, and reported on the lot's certificate of analysis. We can confirm the exact target hardness for your specific bottle closure system and supply lot-specific hardness test data on request.
Silicone vs Butyl
Silicone vs Butyl - side-by-side comparison
Silicone and bromobutyl rubber are the two most common elastomer choices for pharmaceutical bottle stoppers - each with a different property profile suited to different formulation requirements.
| Property | Medical Silicone | Bromobutyl Rubber |
|---|---|---|
| Gas / moisture permeability | Higher - weaker barrier | Lowest of common elastomers |
| Extractables / leachables | Very low | Low |
| Biocompatibility | USP Class VI - excellent | USP Class VI - good |
| Thermal range | −60°C to +200°C+ | −20°C to ~150°C |
| Optical clarity | Translucent/clear available | Opaque only |
| Compression set resistance | Good | Excellent - industry standard |
| Cost (typical) | Higher | Lower - cost-efficient |
| Best suited to | Sensitive biologics, oral/topical, low-barrier needs | Injectables, oxygen/moisture-sensitive formulations |
There is no universally "better" elastomer
Silicone and bromobutyl solve different problems. Choose silicone where biocompatibility, thermal range, or optical clarity is the priority and the formulation does not require a strong gas/moisture barrier. Choose bromobutyl where barrier performance against oxygen and moisture is critical - most injectable and oxygen-sensitive products. Many formulation teams test both against their specific product before finalising the closure system.
Medical silicone bottle stopper - full specification reference
Reference specifications for the translucent medical silicone bottle stopper.
| Parameter | Specification |
|---|---|
| Physicochemical & biological | |
| Toxicity | Non-toxic ★ - E&L tested |
| Odour | Odorless ★ |
| Biocompatibility | USP Plastics Class VI |
| Chemical character | Inert - chemically stable |
| Physical properties | |
| Hardness (Shore A) | 40–60 typical · 50 default ★ |
| Optical clarity | Translucent / clear available |
| Thermal range | −60°C to +200°C+ typical |
| Hardness test standard | ASTM D2240 / equivalent |
| Sizing & ordering | |
| Standard sizes | 13mm · 20mm · 28mm · custom |
| Custom hardness | Available within material limits |
| Sample available | Yes - free sample on request |
| Lot documentation | CoA with hardness + biocompatibility data |
who orders this stopper
Medical silicone stoppers - across the pharmaceutical supply chain
Translucent medical silicone bottle stoppers are specified wherever biocompatibility, thermal range, or optical clarity outweigh the need for maximum gas/moisture barrier performance.
Biologics & biosimilar producers
Sensitive formulation · low extractables
Producers of protein-based and other sensitive biologic formulations requiring the very low extractables profile of medical silicone over standard barrier requirements.
touch and atmosphere
Oral & topical liquid formulators
Taste/odour sensitive · syrups, oral solutions
Manufacturers of oral liquid medicines and topical formulations where any odour or taste transfer from the stopper would be immediately noticeable - using odorless medical silicone to eliminate this risk.
Compounding pharmacies
Custom Rx · biocompatibility priority
Compounding pharmacies preparing custom liquid formulations - selecting medical silicone for its biocompatibility and inertness when barrier performance is not the primary concern.
CDMOs & fill-finish
Multi-protocol thermal range
Contract fill-finish organisations needing one elastomer that performs across an unusually wide thermal range, simplifying material selection across multiple client sterilisation protocols.
Biotech & clinical supply
USP Class VI documentation
Biotech clinical supply teams requiring full USP Plastics Class VI biocompatibility documentation and hardness certificates of analysis for investigational product packaging submissions.
Packaging component distributors
B2B · silicone + butyl stock
Pharmaceutical component distributors stocking both silicone and bromobutyl stopper ranges to advise customers on the appropriate elastomer for their specific formulation.
Translucent. Inert. Certified.
Medical silicone, properly documented.
Request a free sample of the medical silicone bottle stopper - with biocompatibility certificate and Shore A hardness test data for your specific bottle format. We confirm fit and material compatibility within 48 hours.
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