WHY SterRx

Quality Control

SterRx provides complete end product testing for sterility, potency and endotoxin.
Every lot. Every time. But we don’t stop there.

From SOPs to environmental and personnel controls to product quality verification, SterRx employs rigorous QA controls throughout the facility and from the beginning of the manufacturing process to shipment of the final product.

SOPs
  • SOP in place for every process, from receiving incoming materials to shipping
  • Each product preparation documented in master batch records
  • Experienced QA professionals complete, collect and review documentation detailing every facet of operations
Environmental Controls
  • All equipment validated, calibrated, certified
  • Clean rooms and fill zones routinely certified to ensure ISO 14644 compliance
Personnel Controls
  • Multilevel training program— procedural review, task-based training, proficiency evaluation and verification of training
  • Media fills performed for each process to ensure proper aseptic controls
Finished Product Controls
  • Rigorous stability program ensures that a product meets specifications in every stage of the product life cycle
  • Multilayered verification process ensures each unit meets the highest standards
  • Final product verification ensures all preparations meet all specifications
Validation Programs
  • Equipment qualified (IQ, OQ, PQ) to ensure proper performance
  • Ongoing validation of cleaning procedures, manufacturing processes, critical utilities per FDA guidelines
Certificate of Analysis
A CoA, confirming the testing of the finished product in its final container, accompanies every product and is sent with each shipment. It affirms the product specifications and details testing of potency, sterility, endotoxin, labeling and expiry dating.