Aseptic/Sterile Processing

Challenges encountered when implementing a continuous monitoring system are reviewed.

sterilization approach-cycles controlled by differential pressure-is described.

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Application of single-use technology in a parenteral facility for syringe filling.

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

The AdvantaPass wall pass-through system from AdvantaPure permits aseptic transfer of fluids between suites.

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.

Measuring headspace gas composition and pressure allows sterile product manufacturers to simultaneously monitor important quality parameters rapidly and nondestructively.

Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Report outlines recommended practices for control and evaluation of operations.

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

Adoption of single-use systems and more flexible systems drive innovation.

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

As an important method for improving the stability of parenterals, lyophilization is fairly well understood, but can still benefit from several advancements in the technology.

The FPC50W is an aseptic filling system with full or partial stoppering and crimp capping of vials, delivering fill volumes ranging 0.1ml to 100ml and filling accuracy of +/- 0.5%.

PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Room-temperature sterilization using nitrogen dioxide gas provides benefits for sterilizing the external surfaces of single-dose, parenteral drug containers.

An efficient cleaning cycle begins with equipment and automation-system design.

How to avoid invisible and airborne contamination.

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

Henrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.

The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.

The author describes the benefits and challenges inherent to cleaning in place (CIP). The article also describes the development and validation of a CIP cycle.

To help you get up to speed with the ins and outs of the amended version of Annex 11, which will come into effect on 30 June 2011, PTE brings you two articles that take a close look at the amendments.