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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
Dr Graham Hughes
Consultant in
Pharmaceutical
Development
Published quarterly in
February, May,
August and November

News and Press Releases

Intelsius Launches Qualified Partnership Certification

Intelsius, a DGP company, a designer, manufacturer and distributor of temperature-controlled packaging solutions, based in York, UK has launched an innovative new certification process, which will help increase profit and reduce operational costs within the pharmaceutical industry.
More info >>

White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
More info >>

Industry Events

PHARM Connect Congress

25-26 February 2015, Corinthia Grand Hotel Royal, Budapest

The annual PHARM Connect Congressfor Enlarged Europe is one of the largest pharmaceutical and biotechnology manufacturing events in Central and Eastern Europe and the CIS market in 2015. The event is bringing together 500 senior decision makers from Europe’s leading pharmaceutical and biotechnology companies, giving them the opportunity to share knowledge, discuss key priorities and evaluate solution providers.
More info >>

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