The Axia Pharmaceutical Facility

Our state-of-the-art facility contains all of the modern technology necessary to provide our clients with pure injectable pharmaceutical agents of the highest quality.

Our laboratory includes:

• A completely sterile workspace with badge-only access, with barrier separation between internal and external environments
• A USP800 clean room that has been installed for the preparation of hazardous medications well before the the 2018 FDA-mandated deadline
• Five ISO5 laminar horizontal flow hoods; the cleanest rating available
• Continuous environmental monitoring, including wireless transmitters that detect particle counts, temperature, humidity, and differential pressure throughout our facility
• Quarantine zones to segregate all finished batches from those in process until sterility and environmental testing results are confirmed negative
• HEPA-filtered powder contained hoods
• A PennTech automated vial filling machine
• Semi-automated visual inspection and labeling system to ensure consistent product packaging quality
• Stability testing chamber
• ScanRDI® laser scanner cytometer (cell counter)
• Turbidimetric endotoxin testing
• BacT/ALERT® microbial detection system
• Automated filter integrity testing system
• Ultra-High-Performance Liquid Chromatography (U-HPLC)
• A barcode verification system

Why choose us?

Most contract manufacturer outsourcing facilities do not perform all stability and sterility testing in-house. This makes it difficult to ensure that optimal, reproducible, and reliable protocols are followed, and can also increase cost to the client.

At Axia Pharmaceutical, we believe that the best way to ensure that our customers receive quality medications every single time is to keep all manufacturing and quality control procedures in-house. After manufacturing is complete, all of our products undergo the following testing before leaving our facility:

• Sterility testing. We confirm the purity of our products by testing for bacterial and fungal contamination and endotoxins. All products are held in quarantine until all testing is complete and the results are confirmed negative.
• Stability testing. Thorough stability testing is performed in-house to ensure that our expiration dates are accurate.
• Potency testing. Although this is not required by the FDA, we believe in giving our clients the best quality products and keeping our standards similar to those of large pharmaceutical companies. We test the potency of all of our products prior to release.