Life Sciences

Products and Services that Facilitate Efforts to Improve Lives

Medical device, pharmaceutical, biotechnology and bio pharm production companies rely on Swagelok for fluid system products and services that promote a safe, reliable operation with leak-tight components and assemblies that are easy to install, disassemble for cleaning, and reassemble, all without compromising quality. Our commitment to quality and safety is extremely strong and aligns with that of the life sciences market, especially when considering pharmaceutical and biopharmaceutical production, adding further value and relevance to the manufacturing process.

The go-to-market timeline can be long for manufacturers of medical devices and medicines. Any changes found to be required at the product build phase must go back through the cycle of being submitted for re-patenting, additional clinical studies, and FDA approval. By engaging early on during the prototyping and development of new concept devices and drugs, we become a core partner and a key element on the critical path to a successful project outcome, ensuring minimal disruption prior to a device being slated for clinical studies.

Expedite the design and prototyping stage more quickly and go to market sooner with expertise to design and build functional subsystems and gas delivery and control systems for health care facilities and research laboratories that reduce parts and leak points while keeping footprints to a minimum when space is limited. We work hand-in-hand with customers on prototype builds, moving quickly to keep projects on track with validation builds and finalized drawings, to ensure minimal disruption prior to a device being slated for clinical studies.

By taking a consultative approach to understand long-term goals and provide resources and product selection recommendations for specific applications, we help during the R&D concept stage to identify suitable components based on requirements, vetting out future opportunities to identify and provide additional resources and engineering support that may needed to support ramping for future needs to fulfill demand.

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Meeting Quality Expectations & Achieving Compliance Standards

Most global health care manufacturer audits are focused on ISO 9001 and ISO 13485. The Swagelok Quality System (SQS) enables process improvements throughout our supply chain and positions us to meet or exceed these requirements by offering 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.

We help medical device and pharmaceuticals manufacturers consistently meet customer and regulatory requirements like ISO 13485:2016 and ISO 14971:2019 and are well-versed in FDA established Quality System Regulations (QSR) addressing medical device design and validation as well as good manufacturing practices to navigate the ins and outs of compliance investigations and device performance.

Areas Where We Support Life Sciences

Biotechnology/Bio Pharm (Human)

• Chemical, biological, and radioactive substances used in diagnosing or monitoring the state of human health by identifying and measuring normal or abnormal constituents of body fluids or tissues
• Construction of biotechnology and biopharmaceutical processing facilities
• Development and manufacturing of machinery and equipment used in this industry

Biotechnology/Bio Pharm/Pharmeceutical - Veterinary & Agricultural (Non-Human)

• Manufacturing, fabricating, or processing drugs in pharmaceutical preparations for veterinary use, finished in the form for final consumption
• Development and manufacturing of machinery and equipment used in this industry
• Construction of processing facilities for veterinary and agricultural bio pharm products

Cosmetic, Cosmetic-Medical, Beauty Products

• Preparing, blending, compounding, and packaging of toiletries, such as perfumes, shaving creams, hair products, facial moisturizers, and lotions (including sunscreens)
• Cosmetic-Medical includes ointments, hydroxy, creams, and eye solution
• Development and manufacturing of machinery and industrial equipment
• Construction of cosmetic processing facilities

Pharmaceutical (Human)

• Manufacturing and processing bulk medicinal chemicals, their derivatives, and processing botanical drugs and herbs
• Manufacturing, fabricating, or processing drugs in pharmaceutical preparations for human use, finished in the form for final consumption
• Manufacturing pharmaceutical machinery
• Development and manufacturing of machinery and equipment used in this industry
• Construction of pharmaceutical processing facilities

Medical Devices

• Establishments primarily engaged in manufacturing medical equipment and supplies such as laboratory apparatus and medical instruments
• Establishments primarily engaged in manufacturing medical and surgical apparatus such as anesthesia apparatus and blood transfusion equipment
• Hospitals, clinics, and other healthcare establishments
• Construction of medical and healthcare facilities

As a local authorized Swagelok sales and service center for Alabama, Florida and Tennessee, we connect manufacturers to components and assemblies that help their machines and equipment operate dependably. Contact us to learn more about products and technical advice.