Life Sciences
Products to Enable World-Class Medical Devices and Medicines
Swagelok supports medical device, pharmaceutical, biopharmaceutical, and biotechnology companies with fluid system products and services that promote a safe, reliable operation in the most sanitary and sterile production environments. We offer leak-tight components and assemblies that are easy to install, disassemble for cleaning, and reassemble, all without compromising quality.
Our specialists can help you manage the pressures that come with building the devices and manufacturing the medicines that support human wellness, including:
- Providing design and assembly services tailored to your business to help get your medical device or pharmaceutical drug to market quickly
- Maintaining a high degree of accuracy and purity throughout manufacturing processes and clinical procedures to enable optimal results
- Navigating a complex range of fluid system components and industry compliance standards like ISO 9001, 13485 and 14971
- Improving operational efficiency and reducing costs despite demanding lead times and mounting logistics challenges related to products and materials
We connect manufacturers to components and assemblies that help their machines and equipment operate dependably. Your local authorized Swagelok sales and service center is the place to start for products and technical advice.
Swagelok is for Companies that Care for People
Our products and services support the life sciences market in the design and manufacturing of:
- Pharmaceuticals and biopharmaceuticals
- Biotechnologies
- Cosmetics
- Gas delivery and control systems within health care facilities and research laboratories
- Healthcare equipment for critical heart and brain surgeries
- Medical devices such as respirators and water purifiers
How We Support Life Sciences
New Product Development
By investing time and resources in early-stage R&D for concept medical devices and pharmaceuticals, we become a core resource on the path to your successful project outcome. Our collaborative sales and engineering process allow you to focus on the development of new technologies while remaining flexible and agile. This also helps to avoid spending for new infrastructure before it is required to support serial production.
- Within this model, the customer develops intellectual property, software, design, and regulatory documentation, and Swagelok provides the fluid control and containment expertise along with the infrastructure to support limited-scale manufacturing and testing. We also support the growth of customer personnel through knowledge transfer.
- Our approach helps you avoid the significant effort and expense that come with making changes to already approved medical devices and technologies, whereby modifications to design, component selection, form, or function require reassessment.
- By matching our sales cycle to your new product development cycle, we create project synergies from concept to creation, so you go to market faster.
Meeting Quality Expectations
We understand the stringent expectations global health care manufacturers have for validation and change controls. That’s why we never rest when it comes to quality. For more than seven decades, we have demonstrated our commitment to designing, manufacturing, and delivering reliable fluid system components. Today, customers are asking us to expand our offerings and find new ways to help them solve emerging challenges.
Our authorized sales and service centers help to develop these new products that must meet high standards of excellence. The Swagelok Quality System (SQS) is a business management system that enables process improvements throughout our supply chain.
- SQS offers a faster and easier way to introduce new products and services and to establish new initiatives and processes. With SQS, we are in a better position to anticipate your changing needs and consistently deliver high-quality outcomes.
- Most global health care manufacturer audits are focused on ISO 9001 and ISO 13485. SQS positions us to meet or exceed these requirements.
Achieving Compliance Standards
We know everything that is required to maintain an appropriate quality standard. We help medical device and pharmaceuticals manufacturers consistently meet customer and regulatory requirements like ISO 13485:2016 and ISO 14971:2019.
- Achieving and maintaining ISO compliance can require significant additional working practices, documentation, and cost. By engaging companies early in the planning process, we develop a thorough understanding of their needs. This helps us deliver products and solutions that are harmonized with applicable regulations and risk acceptability criteria.
- We are well-versed in FDA established Quality System Regulations (QSR) addressing medical device design and validation as well as good manufacturing practices. We can help with the ins and outs of compliant investigations and device performance.