A3P

Log in

Design of a production isolator. From user need to construction.From user need to construction. (La Vague 52)

It is an absolute truth that all sterile production line installations must be associated with an appropriate means of protection of the product and the environment. When this choice relates to isolator technology, very particular attention must be paid to its design. This must be based on a perfect match between user need and the current state-of-the-art of this cutting-edge technology, culminating in an optimised solution for future production. The installation of a new injectables production line at the Aspen site at Notre-Dame-de-Bondeville (76) is an example. The site, located in Normandy close to Rouen, has specialised in the production of prefilled syringes for many years and produces almost 180 million syringes each year destined for more than 30 international markets including the USA.

Read more...

The European approach to disinfectant qualification. (La Vague 52)

Contamination control is of great importance to healthcare facilities and to pharmaceutical cleanrooms. One way of ensuring the hygiene is maintained through a cleaning and disinfection regime. After a disinfectant has been chosen based on its chemical properties and expected performance/effectiveness, each disinfectant should be validated to ensure its efficacy.

Read more...

Advanced vaporized H2O2 decontamination technology for pharmaceutical isolators. Reduction of H2O2 decontamination cycle time using direct injection nozzles. (La Vague 52)

For the purpose of protecting pharmaceuticals from contamination with microbes or nonviable particles filling and closing machinery are equipped with isolators or other barrier systems. It is not only the Sterility Assurance Level (SAL) which is focused upon but also the non-productive time for decontamination processes between batches which has to be taken into account.
This article describes and evaluates a new technology to reduce the cycle time of isolators.

Read more...

Analytical Quality by Design: the required integration for Quality by Design. (La Vague 52)

What performance requirements are needed for analytical procedures to ensure an alignment with the enhanced approach of Quality by Design for product/process?
An analytical procedure should be followed during the life cycle of the product to continually assure that it remains fit for its intended purpose.

Read more...