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Clear 3ml Glass Vial For Packaging Freeze-dried Powders

3ml tubular glass vial
Freeze drying
USP Type I
±0.05mm tolerance
Depyrogenated
Flat bottom
Clear · Borosilicate

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Description

3ML TUBULAR GLASS VIAL FOR FREEZE DRYING · USP TYPE 1

Clear · Tubular · Borosilicate · Lyophilization optimised

3 mL
Clear Glass
Vial for
Freeze-Dried
Powders

USP Type I · ±0.05mm tolerance · Flat bottom · Depyrogenated

A 3 ml clear tubular glass vial engineered for pharmaceutical freeze-dried powder packaging - biologics, vaccines, peptides, and lyophilised APIs. USP Type I borosilicate glass, ±0.05 mm dimensional tolerance, flat-bottom geometry for lyophilizer shelf contact, and full pharmacopoeial documentation. The precision vial for demanding lyophilisation applications.

3ml tubular glass vial

Freeze drying

USP Type I
±0.05mm tolerance

Clear · Borosilicate

Depyrogenated

Flat bottom

3 ml

capacity

flat

bottom geometry

±0.05mm

Tolerance

RTD

Ready-to-deliver

PRODUCT SPECIFICATIONS

3 ml clear tubular glass vial -
complete specification

A precision-manufactured 3 ml tubular borosilicate glass vial for pharmaceutical lyophilisation applications. Every dimensional parameter is held to ±0.05 mm tolerances - ensuring consistent fill volumes, reliable stopper insertion, and reproducible freeze-drying performance lot after lot.

Product drawing

technical specifications

product	3 ml clear tubular glass vial
capacity	3 ml nominal
glass type	tubular borosilicate
Outer diameter (OD)	16.0 mm ± 0.05 mm
Inner diameter (ID)	14.3 mm ± 0.05 mm
Wall thickness	0.85 mm ± 0.05 mm
Overall height	45.0 mm ± 0.2 mm
Neck diameter	11.0 mm ± 0.05 mm
Open-mouth	13 mm or 20 mm (specify)

Bottom type	Flat · ≤ 0.1 mm flatness
Surface treatment	Plain / siliconised (specify)
Depyrogenation	≥ 300°C dry-heat tunnel

Endotoxin limit	≤ 0.25 EU/vial
Delivery state	RTD · depyrogenated
CoA	Included per lot

USP Type I borosilicate - hydrolytic class I

USP Type I (Hydrolytic Class I) borosilicate glass is the highest-specification pharmaceutical glass grade, with the lowest extractables profile and the best chemical resistance of any glass type. Essential for biologics, proteins, peptides, and vaccines where glass-drug interaction could impact potency, stability, or patient safety. Complies with USP <660>, EP 3.2.1, and JP G4.

±0.05 mm dimensional tolerance - why it matters

In lyophilisation, dimensional precision impacts every stage: fill volume consistency (OD/ID tolerance), stopper insertion force reproducibility (neck diameter tolerance), and heat transfer uniformity during drying (bottom flatness). A ±0.05 mm tolerance is the tightest achievable in commercial tubular glass vial production and the standard required for high-speed automated filling and in-situ stoppering.

Clear glass - visual inspection during lyophilisation

Clear (uncoated) borosilicate allows visual and near-infrared monitoring of the product throughout the freeze-drying cycle - including observation of the frozen product, monitoring of the sublimation front, and end-of-drying confirmation. Critical for early cycle development and PAT (Process Analytical Technology) implementations.

RTD - ready-to-deliver, depyrogenated

Supplied depyrogenated (≥ 300°C dry-heat tunnel, LRE ≥ 3-log), triple WFI-washed, and packaged in a cleanroom-controlled environment. Ready for direct use on your lyophilisation filling line without additional washing or depyrogenation steps at your site.

The dimensional specification below defines every measurable parameter of the 3 ml tubular glass vial, with the tolerance held on each dimension. All tolerances are production guarantees confirmed in the Certificate of Analysis - not nominal targets

Dimension	Nominal value	Tolerance	Measured by
products
Outer diameter (OD)	16.0 mm	± 0.05 mm	Laser micrometer / 100%
Inner diameter (ID)	14.3 mm	± 0.05 mm	Air gauge / sampling
Wall thickness	0.85 mm	± 0.05 mm	Ultrasonic / laser
Neck outer diameter	11.0 mm	± 0.05 mm	Plug/ring gauge
Neck inner diameter	9.5 mm	± 0.05 mm	Pin gauge / sampling
Overall height	45.0 mm	± 0.2 mm	Height gauge / AQL
Bottom flatness	≤ 0.10 mm	Max 0.10 mm deviation	Surface plate / CMM
Bottom wall thickness	1.0 mm	± 0.10 mm	Ultrasonic / sampling
Shoulder height	8.0 mm	± 0.3 mm	Height gauge / AQL
Ovality (OD roundness)	-	≤ 0.1 mm	Multi-point laser scan

Highlighted rows = lyophilisation-critical dimensions

Dimensions highlighted in blue directly impact lyophilisation process performance: OD/ID/wall thickness determine heat transfer Kv uniformity; neck dimensions determine stopper fit and in-situ stoppering force; bottom flatness determines shelf contact area and sublimation uniformity.

PRECISION CONTROL

Six dimensions. Six tolerances. All guaranteed.

Dimensional precision in tubular glass vials is not a single measurement - it is a system of interdependent tolerances that together determine filling accuracy, stopper fit, heat transfer performance, and container integrity. Our Precision Control programme monitors all six critical parameters at every stage of production.

±0.05 mm

Outer diameter (OD) control

Laser micrometer · 100% inline

The OD is measured 100% inline using a non-contact laser micrometer on every vial during tube forming. The OD determines the crimp fit of the 13/20 mm aluminium-plastic cap - an OD outside tolerance produces either a loose seal or a cap that cannot be applied. 100% inspection eliminates dimensional outliers before the vial reaches your filling line.

100% inspection - laser micrometer

Critical for cap crimp seal integrity

SPC charts available in CoA

±0.05 mm

Wall thickness uniformity

Ultrasonic · laser shadow · multi-point

Wall thickness determines both the mechanical strength of the vial and - critically for lyophilisation - the thermal resistance (R) between the shelf and the product. Thicker walls mean higher thermal resistance and slower heat transfer; wall thickness variation creates non-uniform sublimation fronts across a shelf. ±0.05 mm wall control minimises batch-to-batch Kv variability.

Multi-point ultrasonic measurement

Direct impact on heat transfer Kv

Uniform sublimation - reduced process variability

≤0.10 mm

Bottom flatness (key lyo spec)

Surface plate · CMM · AQL sampling

The bottom flatness specification is the most critical parameter for lyophilisation. A non-flat vial bottom creates an air gap between the glass and the lyophilizer shelf - dramatically reducing the contact heat transfer coefficient (Kc) and introducing batch non-uniformity. A flatness of ≤ 0.10 mm maximises shelf contact, minimises air gap, and produces the most uniform heat transfer across the vial batch.

≤ 0.10 mm - commercial lyo standard

Maximises shelf contact area and Kc

Reduces edge effect and sublimation non-uniformity

±0.05 mm

Neck inner diameter control

Pin gauge · air gauge · AQL

The neck inner diameter governs stopper insertion force during in-situ stoppering - the critical step where the lyophilizer shelves press down to seat the stopper into the vial under vacuum. A neck too tight causes stopper deformation or vial cracking; too loose causes stopper leakage after stoppering. ±0.05 mm neck ID control ensures reliable stoppering across all major equipment platforms.

Critical for in-situ stoppering force

Compatible with 13/20 mm lyo stoppers

Consistent across all vials in a batch

100%

Visual inspection

AVI · manual · particulate check

Every vial undergoes 100% automated visual inspection (AVI) for cosmetic defects - cracks, chips, seeds, stones, inclusions, and surface contamination - followed by particulate matter checking. Defect categories are classified per ISO 8362-1 and USP <1790> requirements. Defect rate statistics are reported in the Certificate of Analysis.

100% AVI - cracks, chips, seeds, stones

ISO 8362-1 defect classification

Defect AQL per USP <1790>

SPC

Statistical Process Control

Cpk ≥ 1.33 · X-bar/R charts

All six critical dimensions are monitored using Statistical Process Control (SPC) with X-bar/R control charts throughout the production run. Process capability index Cpk ≥ 1.33 is maintained for OD, ID, and wall thickness - confirming the process is centred and capable of holding the ±0.05 mm tolerance with < 64 ppm defect rate. Control chart data is archived and available for customer process qualification audits.

Cpk ≥ 1.33 on all critical dimensions

X-bar/R charts archived per lot

Available for supplier qualification audit

The 3 ml tubular glass vial is engineered from the bottom up for lyophilisation process performance - every geometric and material decision is made with the freeze-drying cycle in mind.

Flat bottom heat transfer

Kv · shelf contact · sublimation

The ≤ 0.10 mm flat bottom specification maximises the contact area between the vial base and the lyophilizer shelf. The overall vial heat transfer coefficient (Kv) has three components: shelf-to-vial contact conduction (Kc), gas conduction through the gap (Kg), and radiation (Kr). A flat bottom minimises the air gap, maximising Kc - the most controllable component at typical chamber pressures.

Maximises Kc (contact conduction) contribution to Kv

Reduces batch non-uniformity from bottom variation

Measurable by gravimetric Kv testing

Thermal cycling stability

−60°C to +60°C · no microcrack

Borosilicate glass CTE (~3.3 × 10⁻⁶/°C) is the lowest of any commercial glass composition - providing exceptional resistance to thermal shock during the rapid freezing phase (product temperature drop from +5°C to −45°C in 30–60 min) and the secondary drying phase (ramp to +20–40°C under vacuum). No microcracking across the full lyo cycle thermal range.

CTE ~3.3 × 10⁻⁶/°C - lowest of any glass

Validated: −60°C to +60°C without microcracking

Stable through rapid freeze rate ≥ 1°C/min

Depyrogenation & validation

≥300°C · LRE ≥3 log · USP/EP

Vials are depyrogenated by dry-heat tunnel at ≥ 300°C, achieving LRE ≥ 3-log (USP <1211>, EP 5.1.1). Depyrogenation validation data, temperature mapping records, tunnel calibration certificates, and endotoxin challenge study reports are available as part of the Validation Support Package - covering all documentation your QA team needs to qualify these vials in your lyophilisation process filing.

≥ 300°C dry-heat depyrogenation - LRE ≥ 3-log

USP <1211> and EP 5.1.1 validated

Full validation package: IQ/OQ/PQ data available

Chemical inertness at low temperature

No extractables · stable pH · no delamination

Borosilicate glass maintains its hydrolytic resistance (USP Type I) across the full lyo cycle temperature range - the freezing process does not increase extraction rates or promote glass surface delamination. No pH shift is introduced by glass dissolution at any stage of the freeze-drying cycle, critical for pH-sensitive biologics and proteins formulated at narrow pH ranges.

Hydrolytic Class I maintained at −60°C to +40°C

No pH shift from glass at any lyo cycle stage

No delamination risk under lyo thermal cycling

Visual & NIR monitoring

Clear glass · PAT · cycle development

Clear borosilicate glass is transparent to visible and near-infrared (NIR) wavelengths - enabling real-time visual observation of product state during freeze-drying and NIR spectroscopy for moisture content monitoring (PAT). During cycle development, the clear vial allows direct observation of ice formation, sublimation front progression, and cake collapse - critical information for primary drying endpoint determination.

Visible range: full transparency for visual monitoring

NIR transparent for moisture PAT sensors

Essential for cycle development and scale-up

In-situ stoppering fit

Neck tolerance · stoppering force

In-situ stoppering occurs under chamber vacuum or nitrogen backfill - the shelves descend simultaneously to seat every stopper in one press. The ±0.05 mm neck ID tolerance ensures consistent stopper insertion force across every vial in the batch, eliminating the risk of partially-seated stoppers (leak path) or over-stressed stoppering (vial cracking) that results from neck diameter variation.

Neck height ±0.2 mm for uniform shelf press

Consistent stopper insertion force across batch

Compatible with all major lyo equipment (Millrock, IMA, Telstar)

APPLICATIONS & COMPLIANCE

Built for biologics, vaccines, and peptides

The 3 ml tubular glass vial for freeze drying covers the widest range of lyophilised pharmaceutical product types - from the most delicate protein biologics to stable small-molecule APIs.

Biologics & monoclonal antibodies (mAbs)

Lyophilised mAbs, antibody-drug conjugates (ADCs), fusion proteins, and other large-molecule biologics requiring long-term solid-state storage. Type I glass ensures no protein adsorption or metal ion-catalysed degradation from glass contact.

Vaccines (live attenuated & recombinant)

Lyophilised viral, bacterial, and recombinant vaccines. The 3 ml format matches the standard single-dose or multi-dose vaccine vial size. RTD depyrogenated supply reduces manufacturing preparation time at vaccine filling sites.

Peptide APIs & hormones

Growth hormone (rhGH), GLP-1 peptide analogues, oxytocin, vasopressin, and other peptide APIs requiring lyophilisation for stability. The narrow 3 ml format is ideal for unit-dose peptide presentations.

Lyophilised small-molecule APIs

Antibiotics, cytotoxics, antimalarials, and small-molecule APIs supplied as lyophilised powders for reconstitution. The clear glass enables visual inspection of the cake quality and reconstitution completeness.

3 mL

Capacity

Tubular borosilicate

±0.05

mm tolerance

OD · ID · wall · neck

≤0.1mm

Flat bottom

Max Kv · uniform sublimation

USP I

Glass type

Hydrolytic Class I · lowest E&L

300°C

Depyrogenation

LRE ≥3 log · RTD

Cpk≥1.33

SPC control

All critical dimensions

Precision to ±0.05 mm.
Ready for your lyophilizer.

Request dimension data sheets, CoA samples, Kv test reports, or a production quote. Validation Support Package - IQ/OQ/PQ data and depyrogenation records - available on request. Factory direct, 24-hour response.