Fill-finish for prefilled syringes, cartridges and vials
Siegfried is a leading sterile injectable CDMO providing end-to-end aseptic and sterile fill-finish solutions for pharmaceutical and biotechnology companies worldwide. From development and technology transfer to commercial manufacturing, we support the complete lifecycle of injectable drug products.
Our state-of-the-art facilities and experienced teams deliver sterile fill-finish services for prefilled syringes, cartridges and vials, ensuring the highest standards of quality, compliance and supply reliability.
Your trusted partner for sterile and aseptic contract development and manufacturing
Our wide range of services for sterile and aseptic fill-finish
Development services for sterile injectable drug products
- Our flexible development platform supports sterile and aseptic injectable drug products in vials, cartridges and prefilled syringes for both small molecules and biologics. From formulation development to commercial readiness, our experts help optimize product performance, manufacturability and regulatory compliance. Evaluating primary packaging systems, container closure integrity and compatibility for prefilled syringes, cartridges and vials
- Selecting and optimizing filtration strategies for sterile manufacturing processes
- Improving formulation stability and product performance for injectable drug products
- Identifying optimal mixing, filling and dosing technologies
- Assessing product-contact materials, packaging interactions and extractables and leachables
- Developing terminal sterilization cycles and evaluating sterilization impact on product quality
- Producing laboratory-scale and non-GMP development batches to support early-stage programs
Analytical development
Our experienced analytical development team supports sterile and aseptic injectable drug product programs with cGMP-compliant analytical testing throughout the product lifecycle. Working closely with our drug substance experts and leveraging the capabilities of Siegfried’s global network, we provide integrated analytical support from early-stage development through commercial manufacturing.
Our analytical services include method development, method validation and qualification, formulation support, stability studies, GMP batch release testing and ongoing quality control. We also offer specialized bioanalytical capabilities through our development center in Hameln, supporting both small molecules and biologics.
Scale-up and clinical manufacturing
We seamlessly scale sterile and aseptic injectable drug products from development to clinical and commercial manufacturing. Whether starting with a new formulation, a transferred process or a product developed by Siegfried’s drug product development teams, we ensure a smooth and efficient transition to the next stage of manufacturing.
Siegfried provides cGMP manufacturing of sterile injectable products from pilot-scale batches through commercial production, tailored to the requirements of each development phase.
Our facilities in Irvine and Hameln support global clinical supply with cGMP-compliant manufacturing of clinical trial materials for small molecules and biologics. Leveraging both fixed and single-use technologies, we manufacture clinical batches from 1-liter scale and support customers throughout the clinical development journey.
Technology and analytical method transfer
Siegfried designs manufacturing processes with commercial readiness in mind, enabling efficient scale-up, technology transfer and successful progression to commercial manufacturing.
Our flexible and scalable solutions support a broad range of sterile and aseptic injectable drug products, including both NDA and ANDA programs. With extensive expertise in process design, manufacturing technologies and regulatory requirements, we ensure seamless transfer and scale-up across our global manufacturing network.
Siegfried supports complete technology transfer of your product to our U.S. and European manufacturing sites, providing continuity from development through commercial supply. Services include:
- Transfer and qualification of analytical methods, including cleaning validation
- Process transfer, scale-up and manufacturing readiness assessments
- Process qualification and validation
- Manufacture and release of registration and validation batches
- Packaging according to customer specifications
- Stability studies in accordance with ICH guidelines
- Regulatory and registration support
- Product lifecycle management and continuous process improvement
Commercial fill-finish and packaging
Siegfried provides commercial sterile and aseptic fill-finish services for injectable drug products, delivering market-ready products in compliance with global cGMP requirements and customer specifications. Our integrated manufacturing and packaging capabilities support reliable commercial supply across international markets.
Primary packaging
- Vials (2–250 ml), including standard glass, pre-siliconized and RTU configurations
- Ampoules (1–30 ml)
- Cartridges (0.5-3 ml)
- Prefilled syringes (0.5-5 ml)
- Multiple filling technologies, including single-use systems, peristatic pumps and piston pumps
Visual inspection and secondary packaging
- Manual, semi-automated and fully automated visual inspection
- Crack detection and defect identification
- Labeling of vials, ampoules, cartridges and prefilled syringes
- Packaging in thermoformed blisters and tamper-evident serialized cartons
Tertiary packaging and supply chain support
- Bundling and aggregation
- Shipper and pallet aggregation
- Market-specific packaging and serialization requirements
- Global commercial supply and distribution readiness
Technical capabilities
Siegfried’s sterile and aseptic manufacturing capabilities support a broad range of injectable drug products, including small molecules, biologics and vaccines. Our integrated infrastructure, advanced manufacturing technologies and experienced technical teams enable efficient development, fill-finish and commercial supply for global pharmaceutical markets.
Our technical capabilities include:
- Sterile and aseptic fill-finish of small molecules, biologics and vaccines
- Cold-chain storage, management and distribution
- In-house microbiological, chemical and analytical testing laboratories
- Raw material, in-process and finished product testing
- Stability studies and quality control services
- Final packaging in market-ready configurations, including serialization and aggregation for global supply
Our manufacturing facilities are equipped with industry-leading technologies from trusted partners including Bosch, Steriline, Innoscan, Groninger, Bausch + Ströbel, Seidenader and Uhlmann.
Facilities
Storage facilities for raw materials and finished products are available at temperatures down to –78°C. All facilities are routinely inspected by national and international regulatory authorities and operate in accordance with global cGMP requirements. Siegfried also holds national licenses for the handling of controlled substances.
Siegfried's centers of excellence for sterile and aseptic fill finish
Europe
Zofingen
Zofingen is the headquarters of the Siegfried Group and one of Siegfried’s two launch sites for newly developed processes. The production site specializes in the development and commercial manufacturing of active pharmaceutical ingredients (APIs) and intermediates, including high potency APIs. Founded in 1873, the site has a broad portfolio of technological capabilities including hydrogenation, organometallic and hydride chemistry, halogenation, methylation, milling and micronization and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Highly active and controlled substances
- Custom synthesis

4800 Zofingen Switzerland
Evionnaz
Siegfried Evionnaz is one of Siegfried’s two launch sites for newly developed processes. It specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. With an R&D Center housing advanced chemical and analytical facilities, state-of-the-art laboratories, and cutting-edge technologies, it offers chemical process R&D and analytical development services for Siegfried’s global Drug Substances network. Established in 1957, the site has a broad portfolio of technologies including micronization, azide chemistry, hydrogenation, halogenation, organometallics, cryogenics, and more. Focused on niche technologies, the facility possesses development capacity from 1 gram to industrial-scale production. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Custom synthesis

1902 Evionnaz
Switzerland
Zurich
DINAMIQS, a Siegfried company, is a science-driven Contract Development and Manufacturing Organization offering end-to-end viral vector manufacturing solutions to accelerate gene therapy projects from DNA design to commercial scale. DINAMIQS offers a comprehensive and customized range of manufacturing services, process development, quality control and analytics solutions for genetic medicine companies.
Competencies
- Viral vectors

Hameln
Siegfried Hameln is one of Siegfried’s six Drug Products sites globally. It is a leading manufacturer of parenteral solutions, producing a wide range of aseptic and terminally sterilized products in ampoules and vials, with a dedicated development center for sterile injectables. Its specialization lies in the production of complex formulations, including anesthetics, flammable substances, oxygen-sensitive liquids, and cold chain products, all while ensuring strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards. The site has a broad portfolio of technological capabilities including cold-chain handling, automated visual inspection and packing and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Sterile and aseptic filling of ampoules and vials
- Biologics and small molecules

Minden
Siegfried Minden is one of Siegfried’s five run and deliver sites for established processes. It specializes in synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 1935 and focused on efficient operations and special technologies, the facility possesses production capacity from approximately 25 kilograms to multi-100-ton-scale production. The site has a broad portfolio of technological capabilities such as hydrogenation, organometallic and hydride chemistry, milling and micronization, halogenation and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Highly active and controlled substances
- Custom synthesis

Karlstrasse 15
32423 Minden
Germany
St.Vulbas
Siegfried St.Vulbas is one of Siegfried’s five run and deliver sites for established processes. It specializes in synthesis of active ingredients, intermediates and custom synthesis for the pharmaceutical industry. Established in 1993, the site has a broad portfolio of technological capabilities such as organometallic and hydride chemistry, phosgenation, hydrogenation, halogenation and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Custom synthesis

530 Allée de la Luye
01150 Saint Vulbas
France
Hal Far
Siegfried Malta is one of six Siegfried’s Drug Products sites globally. It specializes in the manufacturing of oral solid dosage forms (OSD), encompassing tablet and capsule formulations with diverse release profiles (IR, SR, DR), formulations and technologies. Established in 2007 as one of the first OSD sites within the Siegfried network, technologies range from dry blends, aqueous and organic – wet/dry granulation (bottom with Wurster technology and top spray), tableting, encapsulation, coating and blister packaging. The facility has the ability to produce manufacturing batch sizes on a mid – large scale, with a focus on tech transfer and scale up activities. All operations comply strictly with quality standards (GxPs), safety, health protection and environmental standards.
Competencies
- Bulk manufacturing and packaging of solid dosage forms for oral applications

Hal Far BBG 3000
Malta
Barberà del Vallès
Siegfried Barberà is one of Siegfried’s six Drug Products sites globally. It specializes in manufacturing and packaging solid oral dosage forms (OSD), including high-potency and inhalation capsules for treating respiratory diseases. Established in 1994, the site supplies products worldwide including Japan and the USA. It has a dedicated Development Center offering development and scale-up services for solid dosage forms and inhalation capules. The site has a wide range of equipment to produce solid formulations on a small and large scale, with blister, bottle and wallet/Shellpak packaging forms. Its state-of-the-art production equipment integrates Industry 4.0 technologies, such as digitization, system integration, robotics, and automation, ensuring precise processes. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Bulk manufacturing and packaging of solid dosage forms for oral applications including high potency
- Inhalation capsules for medical devices to treat respiratory diseases

08210 Barberà del Vallès (Barcelona)
Spain
El Masnou
Siegfried El Masnou is one of Siegfried’s six Drug Products sites globally. It has a long track record of expertise in manufacturing aseptic products, with the site established in 1925. It is the largest factory in Spain specialized in ophthalmic products, both eye drops and sterile eye care ointments, as well as products for nasal and otic use. It has a dedicated Development Center offering development and scale up services focused on sterile ophthalmic products. The site’s technological capabilities include ball milling molturation, pre-use post sterilization integrity testing, and multi-dose round, oval and preservative-free bottles. Processes are fully automated and use cutting-edge technology, embracing Industry 4.0 technologies like system integration, robotics, and extensive automation. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Bulk manufacturing and packaging of sterile ophthalmic products, including eye drops, eye ointments, otic/nasal sprays

08320 El Masnou (Barcelona)
Spain
USA
Pennsville
Siegfried Pennsville is one of Siegfried’s five run and deliver sites for established processes. It is Siegfried’s drug substance manufacturing site for the US market and provides spray drying operations globally. Established in 1928, its main activities are pilot and commercial manufacturing of drug substances (APIs) and intermediates, in a fully cGMP and SHE compliant manner. The site has a broad portfolio of technological capabilities including spray drying, organometallic and hydride chemistry, hydrogenation, milling and micronization and more.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Highly active and controlled substances
- Custom synthesis

Pennsville, NJ 08070
USA
Irvine
Siegfried Irvine is one of Siegfried’s six Drug Product sites globally. It is a sterile drug product manufacturing site, specializing in innovative and difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices. It provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels in a fully compliant manner. Established in 2002, the site’s technological capabilities include state-of-the-art filling lines for vials, droptainers and prefilled syringes; bulk filling capabilities; and low oxygen, light sensitivity, low humidity and non-aqueous product handling. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Sterile and aseptic filling of large and small molecules

Grafton
The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing. Established in 1998, the site offers phase-appropriate analytical and development services, regulatory expertise, and regulatory-compliant quality systems — all with the capability to manage highly potent and controlled substances. The Acceleration Hub provides end-to-end life cycle management with services from preclinical through commercial, including scale-up, tech transfer, validation and launch, with seamless transfer into Siegfried’s global network. The site has a broad portfolio of technologies and capabilities, including phase-appropriate preclinical process development, advanced filtration technologies, CMC sections of DMFs, alternate synthesis, route scouting and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Athens

Wilmington
Siegfried Wilmington, is one of Siegfried’s five run and deliver sites for established processes. It is a large-scale commercial manufacturing facility for innovative products and controlled substances, supporting a wide range of therapeutic applications. Established in 1979, the multi-purpose site today offers 150 cubic meters of reactor capacity with a wide range of technologies, operating to the highest regulatory and quality standards.
Competencies
- Active pharmaceutical ingredients (API), Intermediates, Controlled Substances

Wilmington, DE 19801
USA
Asia
Nantong
Siegfried Nantong is one of Siegfried’s five run and deliver sites for established processes. It specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 2013, the chemical plant’s technological capabilities include organometallic chemistry, hydrogenation, alkylation, amination, chlorination and milling. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Custom synthesis

Nantong City, Jiangsu Province
P.R.C. (post code: 226017)
Australia
Westbury

FAQ: Sterile and aseptic fill-finish
What is aseptic fill finish manufacturing?
Aseptic fill-finish manufacturing is the process of filling sterile drug products into final containers, such as vials, cartridges or prefilled syringes, under controlled conditions that prevent contamination. The process can include sterile filtration, filling, stoppering or sealing, visual inspection and packaging, all performed under cGMP requirements to ensure product quality and patient safety.
What is the difference between sterile and aseptic?
Sterile means that a product is free from viable microorganisms. Aseptic refers to the controlled process used to maintain sterility throughout manufacturing, filling and packaging. In pharmaceutical manufacturing, aseptic processing is typically used for products that cannot be terminally sterilized.
What is aseptic processing in pharmaceutical manufacturing?
Aseptic processing is the manufacture of sterile drug products in controlled cleanroom environments using validated procedures to prevent contamination. Product, containers and closures are sterilized separately and then brought together under aseptic conditions. This approach is essential for heat-sensitive or complex injectable drug products that cannot undergo terminal sterilization.
What types of products can Siegfried manufacture aseptically?
Siegfried supports a broad range of sterile injectable drug products, including small molecules, biologics and vaccines. Our capabilities cover clinical and commercial supply and are designed for complex and sensitive products requiring a high level of sterility assurance.
What container formats does Siegfried support?
Siegfried provides sterile and aseptic fill-finish services for vials, cartridges and prefilled syringes. Our manufacturing and packaging capabilities support a broad range of product requirements, from clinical trial material to global commercial supply.
Can Siegfried support both clinical and commercial aseptic fill-finish?
Yes. As an experienced sterile injectable CDMO, Siegfried provides end-to-end support from development and clinical manufacturing through commercial fill-finish and supply. Our flexible capacity, global network and harmonized quality systems enable smooth transitions across product lifecycle stages.
Does Siegfried support technology transfer and scale-up?
Yes. We support technology transfer, process scale-up, validation and commercial readiness activities to ensure a seamless transition from development to clinical and commercial manufacturing. Our teams work closely with customers to accelerate timelines while maintaining quality and regulatory compliance.
What are the advantages of working with a sterile injectable CDMO?
Partnering with a specialized sterile injectable CDMO provides access to development expertise, aseptic manufacturing capabilities, regulatory know-how and established quality systems. This helps pharmaceutical and biotechnology companies reduce complexity, mitigate risk and accelerate the path to market.
What is sterile fill-finish?
Sterile fill-finish is the final stage of sterile drug product manufacturing in which the product is filled into its final container and prepared for distribution. Depending on the product characteristics, sterile fill-finish may involve either aseptic processing or terminal sterilization, followed by inspection, packaging and release.
Why are pre-filled syringes, cartridges and vials used for injectable drug products?
Prefilled syringes, cartridges and vials are widely used because they provide flexibility across different therapies and delivery systems. The choice of container depends on factors such as product stability, administration requirements, patient convenience and commercial considerations.



