- Vetter Pharma - Information

- Major differences between dual-chamber systems and vials

- Motivation to select a dual-chamber systems

- Correlation between middle stopper and residual moisture of the freeze-dried cake

- Approach for a “typical” product life-cycle development from vial to dual-chamber system

- Conclusions

A common technology to decontaminate rooms and isolators is the H2O2 decontamination method. A typical decontamination of an isolator is divided in four steps: The preconditioning, conditioning, decontamination and aeration.

The H2O2 decontamination is a surface decontamination, therefore materials and their surface used in an isolator, is of importance as shown in the material studies.

Another well accepted surface decontamination is the E-Beam method. Electron beams are directed towards the object to be decontaminated and damages the DNA of any pathogen. This method is mainly used to decontaminate the surface of tubs before they enter the class A zone in an isolator.

EZ-fill: sterile syringes and vials for biodrugs

Representing over four decades as a market leader in parenteral packaging, Helvoet Pharma has applied its expertise in Ready-for-Sterilization (RfS) solutions to a platform of Ready-To-Use (RTU) components. By doing this, Helvoet Pharma will now also take full ownership of the sterilization of its high quality rubber and alu/plastic components prior to their shipment.

By turning over the responsibility for component sterilization, Helvoet Pharma brings to its customers a total solution that allows them to redirect their resources to their core business – the manufacturing and filling of drug products.

Produced, controlled and tested under the most stringent conditions, Helvoet Pharma’s RTU products guarantee the highest degree of confidence. In this presentation we will focus on the market trends and drivers, the RTU product offer and a detailed view on the product, process and packaging validation.

Bausch + Ströbel, one of the world’s leading manufacturers of pharmaceutical equipment, will present their new concepts for aseptic processing of syringes. Today’s principal topics will be the processing of syringes in bulk and in nests.

The processing in bulk with an individual transport system comprises the following steps: removal of syringes from the trays, washing, sterilizing, filling, closing and insertion of syringes into trays.

The high speed processing in nests comprises the steps: tub debagging, removal of foil lid and liner, filling and closing of syringes. Further processing of syringes consists of labelling, plunger rod insertion, assembly of safety devices and back stops.