CUSTOMER CHALLENGES

DEMANDING APPLICATION. LIMITED OPTIONS.

Active Pharmaceutical Ingredient production requires process equipment capable of meeting demanding regulatory, safety and operational requirements.

For this application, key customer needs included FDA compliance, anti-static performance for hazardous areas, rapid product changeovers and greater supplier availability.

The challenge created an opportunity for XOMOX to respond directly to customer feedback and develop an alternative solution for pharmaceutical API applications

APPLICATION

WHY API MANUFACTURING MATTERS

Active Pharmaceutical Ingredients (APIs) are the active substances used in finished pharmaceutical products. Their production can involve chemical synthesis or biotechnology processes, followed by purification, isolation, quality testing and regulatory verification.

These tightly controlled processes place demanding regulatory, safety and operational requirements on the process equipment used throughout production, defining the application requirements addressed by XOMOX.

XOMOX SOLUTION



TURNING CUSTOMER REQUIREMENTS INTO A SOLUTION

The solution began with the customer.

Through extensive Voice of Customer engagement, XOMOX identified the requirements and developed its response around the specific needs of pharmaceutical API applications.

XOMOX has successfully introduced FDA-compliant anti-static lined valve technology by qualifying an FDA-approved anti-static PFA resin, validating the manufacturing processes, and establishing the documentation and compliance framework required to support FDA-conforming applications.

The result is an XOMOX FDA-compliant anti-static lined valve solution addressing critical FDA compliance and anti-static requirements while providing customers with an additional qualified supplier option.

IMPACT

FROM CUSTOMER NEED TO MARKET OPPORTUNITY

QUALIFIED SOLUTION

Established XOMOX as a qualified supplier for pharmaceutical API and Peptides applications.

GROWTH PLATFORM

Created opportunities across pharmaceutical, biotech and life sciences markets.

STRATEGIC INVESTMENT

Validated the investment in FDA-approved anti-static liner technology.