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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Autumn 2012

   
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Manufacturing
Manufacturing Data Management

Data on a Diet

Joe Rothman at Aegis Analytical Corp applies the Lean philosophy to data and advocates data warehouse solutions that are focused on process intelligence as a way to iron out the creases in complex supply chains.
 
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Manufacturing Plant Design

Plants with Agility

When considering the design of a new manufacturing plant, it is important that one also anticipates the ‘future needs’ of the facility. Wim Spook at Matcon Ltd UK looks at some of the measures to be taken, from intelligent layout to how to handle a capacity boost.
 
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Containment Systems

Think Inside the Box

Maurice Pitcher at Powder Systems Limited discusses the importance of reliable and efficient high containment systems in pharma processing and manufacturing, and points out some essential design considerations that can make for safer and more streamlined systems.
 
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Water Purification

Pure and Simple

Pure water for the laboratory is a key ingredient in pharmaceutical production. Mark Bosley at Purite puts forward reverse osmosis water purification systems as an economical tool for developers.
 
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Cool Chain, Cargo & Logistics
Sustainable Supply Chain

Green Agenda

Supply chain management technologies are providing pharma companies with stronger green credentials – as well as improved agility and responsiveness within the supply chain – thereby leading to financial savings, as Sudeep Kumar Mandhania at Infosys explores.
 
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Temperature-Controlled Logistics  

Chain Challenge: Part 2 of 2

Robert J Hayes of Cold Chain Consultants (UK) Ltd stresses the importance of avoiding mistakes in the early phases of the cold chain process, and how temperature excursions can be minimised through effective packaging solutions and awareness of the most commonly problematic stages.
 
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Supply Chain Risk

Quality Assured

Highlighting the increasing levels of risk in today’s logistics and supply chain operations, Luc Huybreghts of Pauwels Consulting advises on how to ensure product integrity throughout the process, and which pitfalls a distributor should look out for
 
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Sustainable Packaging Design

Clean Living

Mark Church of Laminar Medica looks at how the need for businesses to comply with environmentally-friendly regulations will drive them to embrace these challenges, thus leading the way to ensure sustainable survival in the global economy.
 
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Drug Delivery 
Nanotechnology Drug Delivery

Thinking Small

With an ever increasing number of new applications, nanotechnology is becoming a key element in the drug delivery landscape of the future. Tim Harper at Cientifica Ltd considers the impact this will have on the market and where the largest gains will be seen.
 
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Formulations, Ingredients and Excipients
53 Freeze-Drying Microscopy

Freeze Frame

John G Augustine of Smithers Pharma Services shows how key data from freeze-dry microscopy can facilitate the proposal of new lyophilisation cycle parameters, improving the overall quality of the resulting product.
 
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Primary Packaging: Glass

Inner Strength

New drugs and sophisticated production processes have created extensive challenges for high-quality glass containers. Florence Buscke at SCHOTT Pharmaceutical Packaging picks out the features new glass products must possess in order to remain relevant.
 
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MANUFACTURING
Biomanufacturing

Get with the Programme

As with any manufacturing operation, biopharmaceutical production stands to benefit from adopting a Lean philosophy. Nigel J Smart at Smart Consulting Group analyses some areas for process streamlining, including training of personnel.
 
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PACKING & PACKAGING
Packaging and Labelling: Braille

Raising Information

Duncan Robinson at Pillbox Design draws out the key issues in Braille packaging design, giving a breakdown of some of the technological advances in packaging for blind and partially-sighted people that are modernising the market.
 
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Foil-Based Packaging

Selection Pack

Jez Clements at Cambridge Design Partnership discusses material choice when designing a packaging solution, pointing out the advantages of using foil, while also addressing the particular issues that come into play with this option.
 
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Blister Packaging

Pack and Blue

Blue dye testing methods for pharmaceutical blister packaging can ensure a stronger, fail-safe parameter that can elevate package integrity assurance to new levels, as Oliver Stauffer of PTI explains.
 
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the end of the line
The End of the Line

Exactly What it Says on the Tin

Richard Harrop has some interesting experiences at the 2012 PDA Pharmaceutical Cold Chain Management & Good Distribution Practice conference in Berlin.
 
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

Published quarterly in
February, May,
August, and November

News and Press Releases

CHDI Foundation extends collaboration with IRBM to accelerate development of Huntington’s disease therapeutics

IRBM, a global contract research organization (CRO), has strengthened its position in neurodegenerative disease research following an extension of its long-standing collaboration with CHDI Foundation, a nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that substantially improve the lives of those affected by Huntington’s disease (HD).
More info >>

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

Drug Delivery Partnerships 2019

28-30 January 2019, PGA National Resort & Spa in Palm Beach Gardens, FL

For 23 years, DDP has been the world’s largest drug delivery meeting place to accelerate drugs to market and lengthen lifecycles for long term profitability by finding new partners, new drug delivery technologies, and new formulation development strategies. Year after year this event brings together top scientists and business development leaders from Biotech, Pharma, Generics, Specialty Pharma and Drug Delivery companies to share, discuss, and collaborate. If you work in drug delivery, commercialization/licensing, med device, formulation, biologics, biosimilars, and similar areas, you can’t miss this event!
More info >>

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