INSIGHTS ON QUALITY CONTROL

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production

  Get strategies for meeting the updated GMP Annex 1 in small-batch aseptic filling. Learn about contamination control, quality management, and equipment design for high-value liquid and powder products.

• Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements

  Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

• Effect Of X-Ray Inspection On Pharmaceutical Products

  Explore the use of X-ray inspection systems for the internal examination of pharmaceutical products, particularly non-transparent packaged drugs.

• The Scalability Of Depth Filters For CHO Cell Culture Clarification

  7/19/2024

  Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  6/19/2024

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• Water Activity: A Better Approach For Lyo Moisture Determination

  3/24/2025

  Explore why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

• Data-Driven Methods for Ensuring Container Closure Integrity

  12/18/2024

  An integral component to a robust quality control program is container closure integrity testing (CCIT), which helps ensure the prevention of contamination and/or the degradation of a product.

• Thermal Analysis In The Pharmaceutical Industry

  12/30/2024

  Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.