Prefilled syringes

Commercial-scale prefilled syringe (PFS) filling, validated manufacturing technologies and the flexibility to support complex injectable medicines, backed by decades of aseptic experience.

Get in touch

Expertise in every PFS dose.

Flexible aseptic filling for prefilled syringes from 0.5 mL to 20 mL, supported by 12 aseptic filling lines, with a combination of highly flexible and cost-effective restricted access barrier system (RABS) lines, for rapid changeover, and the latest isolator technology. Every filling line is qualified to EU and US regulatory requirements and ISO certification standards, with terminal sterilization available where needed.

PFS filling capability at a glance

12

PFS aseptic filling lines

700m

PFS capacity per year

0.5mL to 20mL

PFS formats 0.5mL to 20mL

0.16mL to 20mL

Filling volume

Technology transfer to commercial manufacture

From technology transfer to commercial manufacture, every prefilled syringe program benefits from the experience, capability and partnership needed for program success.

Multiple formats

0.5 mL to 20 mL formats, each validated across multiple fill volumes

Fast to market

FDA- and EMA-approved bracketing strategy, reducing time-to-market

Flexible filling technologies

Isolator and O-RABS technologies matched to your product requirements

WFI solutions

Multiple formats including 0.5mL, 1.0mL, 3mL, 10mL, 20mL with CTD

The ROIS standard

Partnership
Collaborating with clients as strategic partners, with flexible, adaptable models
Impact
Strengthening the supply of medicine to patients through reliable manufacturing
Integrity
Steadfast standards in every submission, batch and conversation
Responsibility
Operating in a way that demonstrates responsibility to people, communities and the planet

FAQs

ROIS supports four validated prefilled syringe formats covering fill volumes from 0.5 mL to 20 mL. An FDA- and EMA-approved bracketing strategy covers the full fill range within each syringe size, reducing validation requirements across multiple fill volumes while supporting regulatory compliance.

Water for injection and diluents

Our injectable plants also offer pre-filled water for injection (WFI) syringes in different sizes and volumes, produced according to European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) requirements. Prefilled syringe programs are supported by a four-year shelf life, providing the stability data needed for long-term commercial supply and inventory planning across global markets.

Technical details – Module 3 Common Technical Document (CTD) dossiers and Drug Master Files (DMF) are available to our WFI clients at no additional cost to facilitate the registration process.

Bracketing: 0.5 (.54) mL to 1 (1.05) mL in 1.25 mL syringe
1.16 mL in 1.25 mL syringe
2 (2.18) mL in 3 mL syringe
5 (5.2 – 5.44) mL in 10 mL syringe
Bracketing: 5 (5.2) mL to 10 (10.47) mL in 1.25 mL syringe
10 (10.47) mL in 10 mL syringe

Labeled volume (mL)	Filled volume with overfill (mL)	Syringe size	Syringe	Plunger stopper	Batch size	Stability data	DMF
.5	0.54	1.25 mL	BD 47409810 PRTC 7025/65	BD 47198410 FM457 bromobutyl	72,000 PFS	48 months	DMF 037945
1	1.05	1.25 mL	BD 47409810 PRTC 7025/65	BD 47198410 FM457 bromobutyl	72,000 PFS	48 months	DMF 037945
2	2.18	3 mL	BD 47203010 PRTC 7025/65	BD 47198410 FM457 bromobutyl	36,000 PFS	48 months	DMF 30419
5	5.2 – 5.44	10 mL	BD 47179819 PRTC 7025/65	BD 47178410 FM457 bromobutyl	18,000 PFS	48 months	DMF 25234
10	10.47	10 mL	BD 47179819 PRTC 7025/65	BD 47178410 FM457 bromobutyl	18,000 PFS	48 months	DMF 26758