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PUBLICATIONS

Pharmaceutical Manufacturing and Packing Sourcer

pmps
Winter 2014

   
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Industry Insight 
Industry Insight

Editor Graham Hughes highlights the importance of manufacturing and packaging to the pharma industry, before considering a selection of articles from this edition of PMPS.
 
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STERILE PACKAGING
Metal Contamination

Making a Material Difference


While plastic packaging has the edge over glass in terms of its resistance to breakage, light weight and durability, trace amounts of contaminants can drastically affect a product's quality, say Rodolfo Merola and Robert Scott at Thermo Fisher Scientific.


 
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Protein Aggregation

Under Stress


How does protein aggregation in glass vials compare to that of plastic cyclic olefin polymer containers? Lloyd Waxman, Vinod Vilivalam and Dennis Liu from West Pharmaceutical Services investigate the best packaging for therapeutic proteins.
 
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Anti-Counterfeiting
Serialisation Security

Keeping Track


With falsifi ed medicines proving a constant threat to patient safety, Ian Parsonage at Packaging Coordinators believes that implementing a global approach, alongside the use of innovative overt and covert technology, is the best way to combat counterfeiting.
 
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LOGISTICS
Environmental Waste

Total Recall

Farzad Henareh
from Stericycle ExpertSOLUTIONS talks us through the most efficient way of handling a product recall. He explains that greener methods of disposal are key to protecting the public, the environment and, ultimately, your company brand.
 
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CLEANROOMS
Rotational Cleaning

Line of Attack


The most effective way of preventing resistant strains of bacteria developing in your cleanroom is to use two or more disinfectants in rotation, thereby maximising the kill spectrum, advises Rebecca Smith at Connect 2 Cleanrooms.
 
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PACKING & PACKAGING
Polyolefin Resins

Plastic Power


Alessandro Guidicini and Alexander Woerz at LyondellBasell consider the cornerstones of service you should expect from a new plastic resin provider, which includes evaluating the right material and grade required for your healthcare packaging needs.
 
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Thermoplastic Elastomers

The Pressure is Off


Replacing traditional vulcanised rubber materials with thermoplastic elastomers could result in higher productivity and lower system costs, advises John Voyce from Polyone GLS Thermoplastic  Elastomers.
 
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Child Resistant Packaging

Defence Mechanisms

One of the biggest risks to children in the home is unintentional pharmaceutical poisoning. Marek Miszczak and Christina Desirée Holder at Gerresheimer champion the development of child-resistant packaging, while stressing that senior citizenfriendly designs must also be considered.
 
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Printing Trends

Packing a Punch


Four contemporary design trends are pushing the limits of what packaging manufacturers can deliver, but a balance between creativity and technology must be struck. Domenick Pasqualone from LPS Industries reports.
 
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NUTRACEUTICALS
Nutraceutical Manufacturing

On Top Form


Detailed design is crucial to creating a successful nutraceutical product in tablet form, but overcoming strict regulations, patient demands and manufacturing complications is no easy task, reveal Rob Blanchard and Trevor Higgins of I Holland.
 
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FLUID SYSTEM TECHNOLOGY
Thermal Fluid Maintenance

Liquid Assets


The hidden transfer of energy to the production process is often overlooked. However, Global Heat Transfer’s Clive Jones warns that an awareness of the correct methods of thermal fluid maintenance can prevent costly breakdowns and delays.
 
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MANUFACTURING & PROCESSING
Supply Chain Relationships

Linking Up

Graham Dewhurst,
Director General of the Manufacturing Technologies Association, advocates better collaboration, communication and trust between pharma companies and their outsourcing partners to achieve a stronger supply chain.
 
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Overall Equipment Effectiveness

Steps to Success


Overall equipment effectiveness is an established method for production improvement. Roland Pichler at Bosch Packaging Technology describes how it can work for pharma.
 
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API Manufacturing: India

Capacity for Growth

Pradeep Kasirajan
at Beroe predicts that by improving utilisation rates in Indian active pharmaceutical ingredient manufacturing facilities, standard operating costs will decrease. But will this result in a price drop?
 
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Manufacturing Challenges

Take Control


Growth within pharma manufacturing is predicted to be slow over the next five years. To boost this progress, Alan Johnston at Siemens Industry suggests three primary operational drivers which are currently influencing the sector.
 
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ROBOTICS & AUTOMATION
Robotic Solutions

A Helping Hand


Recent studies suggest that the long-awaited move towards robotic technology is starting to take place. Chris Sumner at FANUC outlines the many potential benefits implementation could have for the pharma industry.
 
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The End of the line
The End of the Line

Star Product

A good developer will understand the way in which product packaging is handled and perceived. Richard Harrop explains how to achieve a five-star service.
 
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Edited by
Robert Harris
Chief Technical Officer at Juniper Pharma Services
Published quarterly in
February, May,
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News and Press Releases

Vaisalas new Indigo 202: easy-to-use transmitter for smart probes


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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

ASPIRE: International EDGE Conference

28 February - 1 March 2018, The Vox Conference Centre, Birmingham

The ASPIRE international conference is taking place on the 28th February and 1st March 2018 at the Vox Conference Centre in Birmingham. The conference brings together members of the research community including research professionals from the NHS, Clinical Trial Networks and international organisations. The ASPIRE conference will allow delegates to share knowledge and best practise with the focus on enhancing the efficiency and productivity of clinical research across the UK and beyond.
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