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Pharmaceutical Manufacturing and Packing Sourcer |
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Industry Insight
Industry efforts to ensure the supply of effective medicines – whether it be tougher measures to combat counterfeits, better cold chain standards, or quality management priorities – are explored in this edition's PMPS. Industry Advisor Robert Harris provides an introduction.
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Temperature-Controlled Packaging
Up to Standard?
The move to large molecule medicines calls for greater reassurance of temperature-controlled packaging reliability. Richard Wood of Peli BioThermal calls for a new industry-wide standard performance measure to help bring speed and simplicity to supply across challenging shipping routes.
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Packaging TCO
At All Cost
CSafe Global's Brian Kohr argues for a total cost of ownership approach to steer temperature-controlled packaging decisions. The entire supply chain process – from packaging engineering and operations through to logistics, quality and end-use – should be assessed and wider stakeholder input sought.
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Nasal Drug Delivery
Nosing Around
Gerallt Williams from Aptar Pharma describes how the benefits of unit and bi-dose nasal and sub-lingual spray devices – notably, their wide therapeutic range and ability to improve safety and adherence – make them well-placed to tackle the problems currently surfacing within the drug delivery space.
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Auto-Injection Devices
Patients Come First
Jochen Ratjen of SHL Group identifies the key considerations for device designers of self-administered injections. While human factors engineering is a central preoccupation and source of inspiration, creative ideas must not neglect manufacturing feasibility.
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Pre-Filled Syringes
Case in Point
Pre-filled syringes contain various properties and performance requirements needed for appropriate functionality. In light of recent research and regulations, William Dierick and Hideaki Kiminami from Terumo explore changing priorities and device developments.
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Product Blinding
Behind the Mask
As rules and regulations for clinical studies pile up for packaging manufacturers, Frank Jäger at Faubel explores how, through innovative blinding and labelling techniques, guidelines can be met head on for the greater benefit of consumers, CROs and pharma companies.
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Spotlight
Tightly Sealed
Vial-based parenterals are closed with a rubber stopper before being crimped with an aluminium cap. Datwyler Sealing Solutions outlines the flip caps that are an essential feature, which
are shaped through separate manufacturing processes before being mechanically assembled to make one product.
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Tablet Tooling
Formulating a Fix
Rob Blanchard of I Holland reviews the physical variables that cause problems for tablet pressing. While persistent tooling issues do arise, a thorough review of tablet features, factoring in formulation, can go a long way to ensuring the production of robust products on a grand scale.
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Serialisation Legislation
Challenging Counterfeits
Incoming serialisation requirements will no doubt place big compliance burdens on the industry, but in the longer term will replace forgery with transparency – and open the
door to genuinely personalised medicine. Gaurav Banerjee, Rick Seibert and Jonathan Laverick at Sharp Packaging Solutions report.
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Event Review
Flying Start
Reflecting on the success of the inaugural FlyPharma Conference, co-organised by PMPS, Alan Kennedy at PartnerSave Ltd highlights the key take-home messages from September’s event, which probed the need for highly responsive, increasingly cohesive supply chains.
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Regulatory eSubmissions
Switching to Electric
eSubmissions are becoming a way of life, not only from a regulatory standpoint, but also in terms of efficiency. Darryl Clarke at Sciformix Corporation considers the new systems, processes and skillsets that come with the increased take-up of electronic Common Technical Document software.
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CMO Quality Management
Level Best
Pushing for a rethink of the industry's use of quality management, Jim Grigg, Nikhil Patel, Joely Rigby and Penny Lisney from 3M Drug Delivery Systems make the case for a Lean Six Sigma approach to achieve product and service quality – driving operational excellence and continuous improvement.
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Digital Signing
Access Denied
Those who fail to adapt to the digitalisation of the modern age do so at their own peril, warns Thales e-Security's John Grimm. Resistance to change will leave pharma and healthcare organisations sidelined, and unable to exploit the advantages to be seized through automating formerly manual processes.
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Cyber Security
Digital Warfare
Neil Oliver of Accutronics states the case for protecting hardware against the worrying threats cyber criminals pose to medical and pharmaceutical systems. Encoding efforts to ensure equipment is safe and secure is now a vital first line of defence against impending healthcare hacks.
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News and Press Releases |
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PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs
Philadelphia, USA – February 5, 2019 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation in support of increased customer demand. The new expansion will grow the robust bottling operation in Rockford by producing an extra 100 million bottles per year.
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White Papers |
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Finding the Right End-to-End Safety Solution for Your Needs
Bioclinica
With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
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Industry Events |
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9th Annual Outsourcing in Clinical Trials Europe 2019
14-15 May 2019, Milan, Italy
Now in its 9th year, the Outsourcing in Clinical Trials Europe event is firmly established as the leading platform for the biopharmaceutical industry to collaborate to improve clinical trial partnerships, accelerate development timelines and leverage new technologies.
Over 500 clinical professionals from biopharmaceutical and solution-provider companies attended the 2018 conference in Barcelona to develop new partnerships and find answers to their most pressing clinical trial challenges.
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