Aseptic/Sterile Processing

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

The Class 100 cleanroom oven from Grieve is used for a variety of heat processes such as sterilizing, depyrogenation, curing, and drying workloads.

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

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

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

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

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

The revised USP Chapter 1207 gives best practices for obtaining reliable data in 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.

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

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.

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

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.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

Walker Barrier Systems extended-width mobile cleanroom provides 1350 square feet of workable space.

Bill Hartzel, Director Strategic Execution, Advanced Delivery Technologies at Catalent Pharma Solutions, spoke with Pharmaceutical Technology about blow-fill-seal for aseptic processes.

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Experts at Eppendorf discuss common challenges in cell culture and share insights on possible solutions.

Groninger has developed FlexPro 50, an isolator system for aseptic processing of nested syringes, cartridges, and vials. FlexPro 50 is capable of achieving outputs of up to 5000 containers per hour.

Bosch’s market launches at the show include a new bioreactor for laboratory-scale API development, a water-for-injection unit, and a new generation of pure steam generators with high yields.

Telstar has developed an innovative in-line vial management system for recognition and marshaling of vials in automatic loading and unloading systems.

Machine manufacturer IMA is showcasing a number of technological advances for the processing and packaging of pharmaceutical products at ACHEMA 2015.