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Lyophilization Vial

RTS glass vials
Lyophilization
Depyrogenated
Three-stage wash
USP / EP compliant
RTD · Ready to deliver

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Description

RTS · DEPYROGENATED · READY-TO-DELIVER

RTD / DEPYRO / USP-EP / LYO

RTS
Glass
Vials for
Lyophilization

Depyrogenated · Three-stage washed · USP / EP compliant · RTD

Ready-to-sterilise (RTS) depyrogenated glass vials for pharmaceutical lyophilisation applications - triple-purified water washed, heat-depyrogenated, and delivered as ready-to-deliver (RTD) components. Compliant with USP and EP standards. Paired with pre-washed bromobutyl rubber stoppers, third-party endotoxin and bioburden tested, with full validation support documentation available.

RTS glass vials

Lyophilization

RTD · Ready to deliver

USP / EP compliant

3-Stage

Water wash

300°C

Depyrogenation

RTD

Ready to deliver

3rd Party

Tested · CoA available

CLEAN & DEPYROGENATION PROCESS

From raw glass to pharmaceutical-grade clean

Every vial undergoes a validated three-stage purified water washing sequence followed by high-temperature depyrogenation, achieving the cleanliness and endotoxin reduction standards required for lyophilisation applications.

Recirculated purified water (PW)

Initial rinse with recirculated pharmaceutical-grade purified water (USP Purified Water). Removes gross particulate matter, dust, and processing residues from the internal and external glass surfaces. Water is monitored for conductivity and microbial limits throughout the cycle.

USP Purified Water

Water for Injection (WFI)

The primary wash cycle uses Water for Injection (WFI) - the highest purity water grade in pharmaceutical processing, with endotoxin limits of ≤ 0.25 EU/mL (USP/EP). This stage eliminates ionic contamination, organic residues, and the majority of endotoxin burden from glass surfaces.

WFI · ≤0.25 EU/mL

Final WFI flush

A final fresh WFI flush cycle ensures no carry-over from previous stages and confirms a clean rinse water profile on the last pass. Rinse water samples are retained and tested for endotoxin, conductivity, and TOC (Total Organic Carbon) as part of the process qualification record.

Final WFI flush · TOC tested

≥ 300 °C dry-heat tunnel

Washed vials pass through a dry-heat depyrogenation tunnel at ≥ 300 °C. This achieves a minimum 3-log reduction in bacterial endotoxin (LRE ≥ 3), compliant with the USP <1211> and EP 5.1.1 depyrogenation validation requirements. The heat exposure also provides simultaneous sterilisation. Temperature mapping and challenge studies are documented and available.

≥300 °C · LRE ≥3 log

Vial specifications

RTS glass vials - product detail

Depyrogenated Type I borosilicate glass vials for lyophilisation, supplied ready-to-deliver. Available in standard pharmaceutical formats matched to common lyophilisation equipment tray configurations.

size	outer diameter	vial height	nest box		PP soft box
size	outer diameter	vial height	pcs/box	pcs/CTN	pcs/box	pcs/CTN
2R/2ml	16+0.15mm	35±0.5mm	120	1200	500	2500
4R/4ml	16+0.15mm	45±0.5mm	120	1200	500	2000
6R/6ml	22+0.2mm	40±0.5mm	56	560	266	1064
8R/8ml	22+0.2mm	45±0.5mm	56	560	266	1064
10R/10ml	24+0.2mm	45±0.5mm	56	560	228	912
15R/15ml	24+0.2mm	60±0.5mm	56	560	228	684
20R/20ml	30+0.25mm	55±0.5mm	30	300	140	420
25R/25ml	30+0.25mm	65±0.5mm	30	300	140	420
30R/30ml	30+0.25mm	75±0.5mm	30	300	140	420
2ml	16+0.15mm	31±0.5mm	120	1200	500	2500
10ml	22+0.2mm	50±0.5mm	56	560	266	1064
8ml	24+0.2mm	40±0.5mm	56	560	228	912
20ml	28+0.3mm	55±0.5mm	30	300	160	480
25ml	28+0.3mm	65±0.5mm	30	300	160	480
30ml	32+0.3mm	70±0.5mm	30	300	113	339

Product name	RTS Lyo Glass Vials
Designation	Ready-to-Sterilise (RTS) / RTD
Glass material	Type I borosilicate
Hydrolytic class	Class I (USP) / Type I (EP)
Application	Lyophilisation (freeze-drying)
Washing	Three-stage PW + WFI
Depyrogenation	≥ 300 °C dry-heat tunnel
Endotoxin limit	≤ 0.25 EU/vial (post-process)
Particulate matter	USP <788> / EP 2.9.19 compliant
Surface treatment	Siliconised (if specified)
Delivery condition	RTD - ready to deliver
Packaging	Nested tray or pp bag
Lot traceability	Full lot documentation included
CoA	Available with each shipment

Purpose-built for lyophilisation

The vial geometry - neck diameter, body height, and bottom profile - is optimised for lyophilisation process requirements: heat transfer uniformity across the shelf surface, consistent headspace for sublimation, and compatibility with standard lyo stopper insertion and stoppering mechanisms.

Type I borosilicate - pharmacopoeial grade

Type I borosilicate glass provides the lowest extractable and leachable profile of any pharmaceutical glass type - meeting the chemical resistance requirements of USP Type I and EP Type I classification. Safe for injectable preparations, pH-sensitive formulations, and protein biologics.

RTD - no further preparation required

RTS vials are supplied in a ready-to-deliver (RTD) condition - washed, depyrogenated, and packaged under cleanroom conditions. They can proceed directly to your lyo filling line without additional washing or depyrogenation steps, subject to your site's incoming inspection process.

VALIDATION SUPPORT

1. documentation that supports

your regulatory filing

we provide a comprehensive validation support package with each product lot-covering the documentation your QA and requlatory teams need to quality our components as a supplier and incorporate them into your pharmaceutical batch records

2. Certificate of Analysis (CoA)

Lot-level · Test results · Specs

A full Certificate of Analysis is issued for every production lot, confirming compliance with all applicable USP and EP requirements including hydrolytic resistance, particulate matter, dimensional specification, and endotoxin test results.

Hydrolytic resistance (USP Type I / EP Type I)

Particulate matter (USP <788> / EP 2.9.19)

Endotoxin (BET - LAL method)

Dimensional inspection report

Lot number and traceability chain

3. Depyrogenation Validation

Process qualification · LRE data

The dry-heat depyrogenation tunnel process is fully validated, with documented temperature mapping studies, challenge studies using Lipopolysaccharide (LPS) endotoxin, and demonstrated ≥ 3-log reduction in endotoxin (LRE ≥ 3) - meeting USP <1211> and EP 5.1.1 requirements.

Temperature mapping (IQ/OQ/PQ documented)

LRE ≥ 3-log challenge study data

USP <1211> compliance statement

EP 5.1.1 compliance statement

Tunnel calibration and maintenance records

4. Supplier Qualification Package

Audit support · DMF · Quality agreement

Our supplier qualification package supports your incoming inspection, approved supplier list maintenance, and audit programme. Available documentation includes a Drug Master File (DMF) reference, quality agreement template, and site master file information on request.

Drug Master File (DMF) reference

Quality agreement available

Site audit questionnaire

Manufacturing site information

Change notification procedure