Manufacturing

Articles

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

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

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.

Achieving Balance in Sterile Product Manufacturing

Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

All openings and potential apertures for air penetration must be considered when designing a cleanroom so that the HVAC system can maintain the desired negative or positive pressure.

Preventing Room Pressurization Failures

Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.

Using Dynamic Thermal Imaging to Correct Sealing Problems

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

Aseptic/Sterile Processing