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Pharmaceutical Manufacturing and Packing Sourcer

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Winter 2012
   
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Manufacturing
New Manufacturing Challenges

Changing Lanes

New products mean new manufacturing systems, and as more complex products are created, drug production will have to adapt to the innovations coming from the development laboratories. Matthew Chandler at Sagentia Ltd shows manufacturers the way ahead.
 
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Prefilled Syringes: Filling Systems

The Future of Processing


Several market drivers are steering the prefilled syringe industry into new territory, requiring producers to step up their filling and closure systems, as Klaus Ullherr at Robert Bosch GmbH explains.
 
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Manufacturing Environment

Taking Care of Air


Air quality, humidity and temperature need to be monitored closely to ensure a stable manufacturing environment. Chris Hansford at Hansford Sensors presents guiding principles and technologies for maintaining air within required specifications.
 
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Prefilled Syringes: Quality by Design

Designed, Sealed and Delivered


A quality by design approach can render a syringe manufacturing facility that truly lives up to its potential and ensures a superior return on investment through an optimised plant structure, as Kay Schmidt at Catalent Pharma Solutions shows.
 
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Quality Control

Total Recall

In most cases, product recalls are disastrous, so manufacturers should pull out all stops to eliminate the possibility. This process can be assisted by suitable in-line testing and checks, as Todd Blonshine at Mustard Tree Instruments explains.
 
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Cool Chain, Cargo & Logistics
Clinical Trial Logistics: IT Systems

Chain Control

The march of technology will enhance management of the R&D supply chain and enable a clearer picture of product movement through superior IT solutions, as Dirk Machert and Jens Mattuschka at PAREXEL International present.
 
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The End of the Line

Is Bigger Better?

A packaging solution needs to be the best, rather than just the biggest, points out Richard Harrop.
 
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Spotlight: Cool Chain Association

The Ultimate Aim

The current initiatives of the Cool Chain Association promise to bring safer products into the supply chain and reduce the potential for waste.
 
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Air Cargo

Jet Set


How difficult is it to transport drugs by air? Christopher Dehio at Lufthansa Cargo AG explains why this method has a history of danger, and picks out the points in the process where temperaturesensitive cargo is most at risk.
 
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Transport Media

A Safe Platform

Jim Hardisty at Goplasticpallets.com
discusses physical risk in the logistics environment, and how devices such as pallets should be chosen carefully to ensure the safety of transport personnel.
 
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Drug Delivery 
Prefilled Syringes: Device Design

Style and Substance

To ensure patient safety and adherence, as well as create brand value, the design of a prefi lled syringe must be user-focused, and should encompass several guiding principles as part of the design concept, as Dan Formosa at Smart Design points out.

 
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Packaging, Packing & Anti-Counterfeiting
Global Packaging Strategies

Location, Location, Location


Streamlining the supply chain is the obvious option for companies looking to trim the fat from their distribution budget. But as Daniel Nott at Honeywell points out, they should also consider packaging technology itself, which can now provide protection for truly international conditions.
 
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Patient Information Leaflets

On the Same Page

Neil Gleghorn at Kallik highlights how patient information leafl ets are undergoing a transformation, and points to new EU readability guidelines that will require packagers to take a more proactive approach to keeping end-users informed.
 
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Primary Packaging

The Extractable Question

Michael Creese at Smithers Rapra
reviews the current trends in extractables and leachables testing, and makes several points of comparison between approaches in the pharmaceutical, food and medical device industries.
 
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Traceability: 21 CFR Part 11

Timed to Perfection

Electronic packaging systems that track products effectively are now a central element in the supply chain. Rob Dinsmore at SolutionsPT introduces the concept of ‘availability’, which can be incorporated into tracking systems in the form of hardware and software to eliminate costly errors.
 
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Radio-Frequency Identification

Riding the New Wave

As new technology and handheld devices continue their rise to dominance, Randy Stigall at UPM identifies the ways in which tracking pharmaceutical products can be made easier by buying into these new solutions, including near fi eld communication.
 
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Formulations, Ingredients and Excipients
API Manufacturing

Novel Dispensation

Howard Biddle at 42 Technology discusses the need for effective API dispensation for oral dosage, and shows how sticky web technology provides a simple yet precise option that is starting to be commercialised on a wider scale.
 
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Edited by
Robert Harris
Chief Technical Officer at Juniper Pharma Services
Published quarterly in
February, May,
August and November

News and Press Releases

Merck Expands Excipients Portfolio, Adding Polymers for Sustained Release Injectables


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

Clinical Trial Supply Nordics 2017

7-8 June 2017, Copenhagen, Denmark

As we enter into 2017, various changes in the industry have altered the landscape for clinical trial supply businesses. With this in mind, our team has developed an extensive and informative agenda to ensure you leave with various concepts to improve your clinical trial supply chain in the ever changing environment.
More info >>

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