Videos

Kevin O’Donnell reviews the role of VVM and how it can be the answer to increase access and ensure quality of vaccine was not compromised due to unacceptable heat exposure.

Simona Zipursky reviews the cold chain challenges to demonstrate that problems are both in developing and industrialized countries and questions whether VVM should also be the answer for both.

The Controlled Temperature Chain, CTC, is an innovative approach to vaccine management allowing vaccines to be kept at temperatures outside of the traditional cold chain of +2°C to +8°C for a limited period of time under monitored and controlled conditions, as appropriate to the stability of the antigen.

The Controlled Temperature Chain, CTC, is an innovative approach to vaccine management allowing vaccines to be kept at temperatures outside of the traditional cold chain of +2°C to +8°C for a limited period of time under monitored and controlled conditions, as appropriate to the stability of the antigen.

The Controlled Temperature Chain, CTC, is an innovative approach to vaccine management allowing vaccines to be kept at temperatures outside of the traditional cold chain of +2°C to +8°C for a limited period of time under monitored and controlled conditions, as appropriate to the stability of the antigen.

James Vesper reviews the critical aspects of documents, records and record management. Documents like procedures, protocols, methods, and specifications provide instructions so people can perform tasks and make decisions safely, effectively, compliantly, and consistently. Records, such as batch manufacturing records, cleaning logs, and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were (hopefully) made in keeping with procedures and GMP expectations. Reports, another type of documentation, provide specific information on a particular topic (like an investigation or one aspect of product development) in a formal, standardized way.

Umit Kartoglu presents the critical aspect of exploitation of stability data to reach the unreached through overview of studies taking vaccines beyond the 8 deg C all published in peer-review journals as well as a new concept of cool water packs by the WHO and Vaccine Vial Monitors. As he indicates that vaccines have become more stable and there is a clear prospect of increased or even complete heat stability, and concludes that in these circumstances the dogmatic approach to the cold chain causes resources to be wasted and places unnecessary restrictions on field operations.

A movie, produced for the 10th year anniversary of the introduction of vaccine vial monitors (VVM). The movie focuses on how this simple tool expands the horizon of the immunization programme and empowers health workers serving people at the very periphery of the health system. The theme and the goal are specific but there are scenes, human conditions, and different livings for everybody to see and think about them. Shot in Niger, Vietnam and Indonesia in 2007.

Members of the pharmaceutical supply chain have various global requirements to meet during the storage, transport and handling of time and temperature-sensitive products. Changing product portfolios, requirements for good storage and distribution practices, regulatory expectations, quality management, and risk assessment factors bring many challenges to the handling of drug products. Rafik Bishara reviews the global perspectives in regulatory oversight on pharmaceutical time and temperature products.

Claude Ammann reviews the importance of understanding regulations related to the stability testing to add value to evaluate temperature excursions.

Denis Maire summarizes the technical characteristics of VVMs and explains how they work.                

Umit Kartoglu reviews temperature monitoring devices used in a typical vaccine cold chain and analyses how the readings relate to each other when there are more than one device at a particular point. This analysis is done from the VVM perspective.

Risk management involves a series of activities that are sequenced so that one step informs or shapes those that follow. James Vesper provides a high-level overview of the entire process.

Umit Kartoglu reviews the critical last mile between the service point and the end user. He further discusses the best solutions for storage and transport of products and best practices for temperature monitoring.

The video of the WHO-PDA Pharmaceutical cold chain management on wheels course conducted during 2-7 June 2008 in Istanbul, Ankara, Konya, Eskisehir and Bursa (1,400 km route) in Turkey.

Kevin O’Donnell discusses the features of nylon, EPS, PUR, airliner and VIP packaging technologies.

James Vesper goes into details of methods frequently used in risk assessments and gives first hand advice on when and how best to them: Preliminary risk assessment, failure mode effects analysis and fault tree analysis.

This is the first ever video of a full-fledged scientific article on the validity of the shake test. Shake test is the only test available to diagnose whether a freeze-sensitive vaccine has been damaged by freezing.

This is the first ever video of a full-fledged scientific article on the validity of the shake test. Shake test is the only test available to diagnose whether a freeze-sensitive vaccine has been damaged by freezing.

Andrew Garnett reviews the cold storage aspects of storage facility design and covers temperature controlled storage areas, order assembly areas and materials handling.

Andrew Garnett reviews the storage facility design with a particular emphasis on the site and buildings through analysing the reasons for storing cold chain products, different types and functions of storage facilities, location, access, security, general building design issues.

Kevin O’Donnell discusses thermodynamics, the basis of heat transfer and how we can use heat energy to our benefit in packaging.

Umit Kartoglu reviews the requirements for product arrival, storage and dispatch and analyses the role of VVM in effective stock management for each step. Special emphasis is given to the relation of VVM and expiry date in illustrating how VVM over-rules earliest expiry first out principle.

Simona Zipursky reviews the studies on taking vaccines beyond the cold chain all published in peer-review journals and comments on how VVMs could be instrumental in these operations.

Umit Kartoglu reviews the recent changes in integrity and location of VVMs and the new message VVM is giving whether a vial containing multi-dose vaccine can be kept for a subsequent session following opening the vial.

Serge Ganivet reviews the VVM use at the most periphery through different examples and brings new perspectives on how to make best decisions based on the expiry and VVM readings.