Manufacturing

Articles

The agency cited Emcure Pharmaceuticals with CGMP violations.

FDA Issues Warning Letter to Indian Facility

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Best Practices for Handling Antibody Drug Conjugates

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

Best Practice: The Importance of Removing Sporicidal and Disinfectant Residue

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

Best Practices: Using Single-Use Systems in Aseptic Processing

Sensaphone's monitoring system provides low-cost, 24/7 remote monitoring of unattended freezers and coolers.

System Monitors Temperature-Controlled Storage

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.

Parenteral Packaging: 2021

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

Using Deterministic Container Closure Integrity Testing

Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.

Overcoming Challenges in Implementing Single-Use Systems

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

Aseptic/Sterile Processing