Maintaining sterility and microbial safety is paramount in pharmaceutical manufacturing, especially for injectables and high-risk formulations. At Abiozen, our contamination control and microbial testing services are engineered to identify, mitigate, and prevent microbial risks throughout the production lifecycle. These services are critical to ensuring patient safety and meeting stringent global regulatory requirements.

Endotoxin and Sterility Testing

We employ the Limulus Amebocyte Lysate (LAL) assay to detect bacterial endotoxins in injectable products, ensuring they are free from harmful pyrogens. Sterility testing is conducted in ISO Class 5 cleanroom environments using validated methodologies that confirm the absence of viable microorganisms. These tests are fundamental for regulatory compliance and the release of aseptically manufactured products.

Particulate Matter Analysis

Our particulate testing protocols safeguard against both visible and subvisible contamination. Using high-precision laser-based particle counters and microscopy, we adhere to USP <788> and EP 2.9.19 standards for particulate matter in parenteral products. This ensures that all batches meet safety specifications before release, particularly for critical care and injectable therapies.

Microbial Identification and Environmental Monitoring

Rapid identification of microbial contaminants is achieved using advanced techniques such as PCR and MALDI-TOF mass spectrometry. Our environmental monitoring program includes comprehensive air and surface testing to detect potential sources of contamination within cleanrooms and production areas. This proactive approach ensures a controlled manufacturing environment and supports ongoing GMP compliance.

Industry Alignment

Abiozen’s contamination control strategy is informed by best practices from Thermo Fisher Patheon’s sterile manufacturing protocols and Curia Global’s high-containment facilities. By aligning with these benchmarks, we deliver world-class microbial assurance to clients developing sterile and high-sensitivity pharmaceutical products.