Ensure Production Integrity and GMP Compliance

Every component of a production line that contacts a drug substance or product must be characterized and documented to ensure it does not compromise the finished product’s safety or quality. This is a fundamental requirement of Good Manufacturing Practice (GMP). SAXOCON provides the technical evidence and testing strategies necessary to prove that your manufacturing systems—from stainless steel infrastructure to single-use technologies—remain inert and compliant.

SAXOCON provides the end-to-end expertise required to document the safety of your manufacturing systems, including:

• Material Characterization:
  Selecting and evaluating construction materials to minimize chemical interaction with the drug product.
• Standards-Based Risk Analysis:
  Conducting comprehensive assessments in accordance with European and US Pharmacopoeia standards.
• Extractables Strategy:
  Designing and managing extractables testing protocols tailored to the specific contact time and conditions of your process.
• Technical Oversight:
  Reviewing laboratory protocols and providing active monitoring of extractables studies to ensure data quality.
• Toxicological Risk Assessment:
  Final expert evaluation of analytical results to confirm the safety of the equipment-product interface.

Why Choose SAXOCON?

Our equipment safety services provide the technical depth required to maintain a compliant manufacturing environment:

• Multidisciplinary Insight:
  A specialized team of toxicologists and material scientists who understand the chemical leaching risks of manufacturing hardware.
• Exclusive Supplier Data:
  Safety evaluations informed by proprietary material information from our global network of equipment and component suppliers.
• Proven Safety Expertise:
  Extensive experience in state-of-the-art safety assessments that align with the latest international regulatory guidelines.
• Strategic Development:
  Smart, cost-effective test strategies designed to satisfy auditors while maintaining operational efficiency.

Delivery

SAXOCON compiles all necessary evidence into a definitive technical report. This document is specifically formatted for inclusion in your Good Manufacturing Practice (GMP) file, providing the rigorous justification needed to support equipment qualification and manufacturing audits.