Glass has become one of the world’s leading primary packaging materials, yet still needs to be able to meet the growing requirements of the pharmaceutical industry. Sensitive new biomolecules and alternative manufacturing techniques such as lyophilization place incredibly high demands on pharmaceutical containers.

In the pharmaceutical field, lyophilization is frequently being used to extend the shelf life of highly sensitive drugs. However, if this technique means longer and more efficient medications storage; lyophilization still places mechanical and thermal stresses on the packaging, and it requires improved chemical properties of the container to ensure that the lyophilization cake has an attractive appearance.

One way to improve the packaging material is to apply extremely thin hydrophobic coatings to the inside surface of the containers with the help of a pulsed plasma technique. The coating is transparent and only about 40 nanometers thick, yet helps to produce an esthetic cake during the lyophilization process. This lowers the reject rate for pharmaceutical companies. Such coated containers can be filled, sealed and inspected as any other containers and undergo all of the normal pharmaceutical processing steps like washing, autoclaving, sterilization and depyrogenization at temperatures of up to 300° C.

A TECHNIQUE ENHANCED BY SCHOTT IMPROVED GLASS GEOMETRY

Although the coating significantly helps the vials to stand up to the lyophilization process, each step of the process poses further challenges regarding the mechanical stability of the container. For example, there is a high possibility for the glass to break due to the enormous local temperature differences.

For production reasons, the bottom of a glass vial is thinner than the walls and therefore represents the weakest point in a glass vial. It simply breaks more easily. To resolve this weakness, Schott has simulated the geometry of its glass vials using a Finite Element Method (FEM) and improved it based on the results. The new geometric design of the bottom significantly reduces glass breakage, and it also allows for better heat transfer during the lyophilization process.

This is one example how coated vials help to meet the high demands created by highly-sensitive medications and sophisticated production processes. They provide an interesting alternative where conventional packaging has reached its limits. Other coatings provide for reduced ion leaching or a low residual volume when the dosage is removed. The benefit is obvious: a more effective process that incurs lower risks inevitably means lower costs.

If you want to know more about coated vials and where to use them you can register for Schott’s webinar on 16^th January 2014 here.

As companies dive deeper into the chemical well for new, patentable, and effective therapies, the most promising candidates are less soluble, less bioavailable, and more difficult to formulate to an effective therapeutic level. As a result, many commercially potential treatments are being left at the wayside in Preclinical and early clinical development due to the high costs and risks associated with bringing these to market.

Have you already experienced this in your own company?

The expertise within a company like Catalent can provide the technology, knowledge, and commercial scale to quickly provide formulation options that optimize the therapeutic profile of one of these products that otherwise would not progress down a development pathway. For example, Catalent continues to significantly invest in R&D and created recently, the non-gelatin OptiShell™ capsule that can provide modified release profiles and semi-solid fills, expanding the range of molecules capable of being encapsulated with Softgel technology. The innovations continue with the new OptiGel Bio™ technology has enabled the oral delivery of macromolecules while the OptiGel Lock™ technology provides multi-level resistance for products requiring abuse deterrence. These new technologies combined with the legacy of 80 years of development expertise allow Catalent to provide solutions to the most difficult formulation challenges.

Want to know more about the new drug delivery technologies?

Catalent’s upcoming webinar entitled “Optimizing Drug Delivery Technologies” will provide in depth reviews of these new technologies as well as a providing insight to the advantages of a Softgel development program compared to other dosage forms. Three Catalent experts will provide insight and challenges associated with development as well as are available for questions following the presentation. Sign up today to learn how a Catalent can provide the expertise to result in a better treatment and faster to market for your most challenges therapies.

In summary, while it is always a good time to outsource a drug development challenge, it is critical to outsource to the correct partner who can rapidly provide multiple, effective solutions, and can collaborate through the entire drug development cycle.

Many gas and diesel engines as well as other in industrial applications emit exhaust gas with 350⁰ C or more into the environment. Organic Rankine Cycle (ORC) technology allows to convert this energy into electrical power with payback times as short as three years. Typical applications are biogas/anaerobic digestion, landfill gas and flares, diesel engines, mine gas, biomass burners etc.

Triogen’s ORC is a closed system with a high speed vapor turbine coupled to an electric generator; while the engineering principles are similar to large conventional steam turbines in power generation, Triogen uses an organic working fluid that allows to operate small units of 80 to 160 kW. This fits ideally to gas and diesel engines of 1.5 MW and larger. As it is an “end of pipe” solution: there is no interference with the upstream process. The standard frame size allows to offer modular, cost efficient solutions that can be combined to achieve greater power output.

As no additional energy is required, an ORC provides electricity without any fuel costs, without CO₂ or other emissions.

Founded in 2001, Triogen has successfully incorporated world class technology into a reliable and standardized product with thirty installations across Europe, over 250,000 documented running hours, availability of up to 98% and market leading efficiency. The product is certified by Lloyds according to PED and Machine-directive, and is fully mature and competitive.

Triogen’s ORC can also be operated in combined heat and power applications, allowing to generate electricity and heat from the cooling water.

Triogen works with local distributors and integrators in most countries in Europe and also engages directly with end customers when warranted by size or nature of the project. In addition to growing the European market, further growth opportunities exist in continuous operation diesel engines, industrial and process heat, biogas from biomass and direct combustion of biomass such as wood.

Triogen’s webinar entitled ‘Fuel and Emission free electricity from an advanced Organic Rankine Cycle’ will take place on 29th January at 3pm London/10am New York. Register for the webinar here.

In addition to creating market awareness for ORC technology, Triogen intends to use this webinar to engage with potential customers and distribution partners in Europe and selected regions worldwide.

What the launch* of SenseAware^SM means for business managers worldwide…

By Chris Swearingen, FedEx Global Marketing Manager- SenseAware

SenseAware^SM is a first-of-its-kind service that provides near real-time access to a package’s vital statistics whilst in transit. A multi-sensor device, deeply integrated with a powerful web-based application, SenseAware enables customers in a broad range of industries to stay connected to their high-value, critical shipments with offering them unparalleled insight into their supply chain.

How does SenseAware actually work?

The award-winning service combines unique and cutting-edge sensor technology and an information platform designed to give near-real time tracking and increased visibility to customers. SenseAware can providecustomers with information including:

• Current location of the shipments (when traveling on the ground)
• Geo-Fences around buildings and routes
• Accurate temperature, relative humidity, and barometric pressure readings
• Alerts or notifications when a shipment’s contents have been exposed to light
• Alerts for when thresholds have been reached for shock

 What could SenseAware do for your business?

With SenseAware,sensitive shipments, by which we mean fragile and requiring of tailor-made, highly specialised shipping can be monitored in greater detail.Whether you’re in the aerospace, pharmaceutical, healthcare, food and beverage, energy, supply chain industries, or simply dealing with highly sensitive information; it could be comforting to know that you can now keep track of yoursensitive shipments more closely than ever before.

With enhanced visibility and insight into your supply chain andnear real-time information on your shipment’s environmental conditions as it travels, its location, and whether or not it has been opened – you’ll have the information you need to transform your supply chain.

 What does this mean for business in general?

As well as businesses having access to information of sensitive shipments, SenseAware provides the ability to share this information across global supply chain stakeholders. Simply put, SenseAware is changing the way we ship and itschanging customers’expectationstoo.The level of sensitivity continues to grow as a top priority shipping requirement for many industries. With the opportunity to access a greater level of information about critical shipmentsin near real-time, this means we can alsohelpcustomers prepare for the unexpected.

From high-value breakable items that could be damaged if not treated with extra care, to products which need to be delivered in a precise time period, mainstream solutions simply don’t offer some shippers the level of control or visibility required.SenseAware and the insight it offers is becoming an increasinglyessential tool.

With behind-the-scenes access into your shipment’s journey, you can check your shipment is satisfactorily temperature-controlled, or on course for its estimated delivery time. And all in the safe knowledge that each supply chain division is up to date and in the loop.

Ultimately, business professionals facing the day-to-day challenge of keeping up to speed with their valuable inventory whilst it is in transit can breathe a sigh of relief. Keeping track of your sensitive shipments just got a whole lot easier.

Join Chris Swearingen, FedEx Global Marketing Manager- SenseAwareon 22^nd January at 3pm where FedEx will be addressing the shipping challenges facing business professionals within their respective industries and how FedEx shippingsolutions likeSenseAware can assist. Register here

*Where applicable.