Injectable products inevitably contain very small amounts of subvisible particulate matter (i.e., synthetic polymers, starch, metal ions, insoluble degradation products, etc.) as a consequence of the low pH of the vehicles.

This process decreases solubility of component and thus increases production of particulates, and enhances the capacity to extract metal ions from contact surfaces such as vials, iv bags, rubber stopper, and the presence of metal ions (particularly zinc) that forms insoluble complexes with many active components due to charge interactions.

Guidelines to the assessment and control of such contaminants are reported in the U.S. Pharmacopoeia (USP) and in the European Pharmacopoeia (EP).

An excessive quantity of particulate matter could cause adverse drug reactions (ADRs), including phlebitis, pulmonary granulomas and dysfunctions, local tissue infarction and death, due to mechanical occlusion of small-diameter arterioles and capillaries, activation of platelets and/or neutrophils (generation of occlusive microthrombi), and indirect effects on vasomotor activity.

Therefore it is essential that stringent quality systems in place at Plant Operation are supported by process equipment, non-process equipment and primary components fully in compliance with product formulation.

Glass containers are the primary packaging of choice for drugs and vaccines in the U.S. and European pharmaceutical markets. Although vials continue to be the most popular container, cartridges and syringes, which are typically used in prefill applications, are growing most rapidly.

This is due to the inherent benefits of prefills for the end-user; most importantly for the convenience and ease of use and for the marketing objectives of pharmaceutical companies to differentiate their products through packaging and delivery systems. Q

uality requirements for primary packaging are steadily increasing.

The partnership with the supplier of the primary packaging plays a central role for the pharmaceutical company to ensure high quality levels.

For the containers themselves, a very high level of controls (flange, self-adjusting, tip control, inspection systems) is needed to meet dimensional, cosmetic and mechanical criteria.

Regulatory support by the container manufacturer is also very important for the pharmaceutical company to bring their drugs or vaccines to market, especially in a timely manner. Conforming to USP, EP and JP are critical as are providing access to DMFs (U.S) or Technical Files (Europe).

Prefilled Systems are gaining popularity and wide acceptance globally.

This presentation explains the drivers leading to this change and the criteria for selection as well as the evaluation process of the elastomeric closures for the prefilled systems.

The characteristics of a clean elastomeric closure, the formulations as well as the use of barrier coating are also explained. The US guidances and regulatory drivers are reviewed.

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Ulrich Steuerer is talking about one of the big issues in the US and european hospitals , regarding patient safety. In the rush of every hospital today,we find many critical situations wich could lead to medical errors. How can we prevent or reduce this problems?

Today's market holds several challenges for pharmaceutical companies, regardless whether in NCE's or Generics. In particular spray products are facing an increasing demand from the regulatory bodies in both Europe and the US.

Pfeiffer and Valois, device manufacturers with a substantial experience in the field, show new approaches on how to face this challenges and overcome regulatory hurdles.

Bausch + Stroebel, one of the world's leading manufacturers of pharmaceutical equipment, will now present you their latest developments from the syringe processing' sector! Today's principal topic will be the processing of pre-cleaned syringes in nests.

The nests are unpacked and opened and then the syringes are filled, sealed and labelled on Bausch + Stroebel machines.The Sales and Marketing Director from Bausch + Stroebel, Mr Hans Thomas will explain the individual working steps from unpacking through to labelling in detail now.

The market trend has been to integrate delivery system earlier in the drug development process. They are no longer an afterthought, but are now integrated into the drug product as a method for addressing unique customer needs and/or extending the life cycle for established drugs.

These systems include pre-filled syringes (with and without needle safety), disposable and reusable pens, and prefilled nasal and oral delivery systems, among others.

These "Combination Products" pose challenges to the manufacturers and the regolatory agencies as to how to regulate the product. This includes determining what information is required during development, manufactoring and post marketing support. This talk will briefly outline some of the issue and practical solutions.