Cold-chain colleague, friend and presenter at the Berlin Conference, Richard Harrop, from the UK, has graciously provided me with highlights and his thoughts on the event. Richard has encouraged me to share his overview with visitors to the blog. Although I was not able to participate due to other commitments, I am encouraged by the level of interest, co-operation and eagerness for global harmonization from all partners to the industry.
Hello Kevin
I hope you are well.
After returning from the PDA Cold Chain Management Conference and having time to digest all of the information, I thought it would be useful for me to share with you a brief overview of some of the aspects of the two day event that I feel really stood out as moves forward (and some interesting sideways steps) in the world of temperature control.
The conference; starting at the speaker’s dinner on the eve of the opening morning and ending 48hours later, maintained a furious enthusiasm to learn, share and discuss from all involved and attending. Perhaps this group desire came from the comfort that this was not a commercial event and even though there was the chance to discuss technologies and innovations with suppliers, focus was always and unwaveringly on bringing the industry together (globally and up and down the cold chain) to enable a clearer understanding for all involved and safer products for everybody.
Passionately Chaired by Rafik Bishara who was supported by a committee of well respected industry experts, there was a real feel of industry’s coming together and wanting to move forward as a collective, something that I personally feel many of the more recent events have missed out on, due perhaps to their more commercially lead programs.
The definite sense of purpose was present in the two day agenda that broke down into seven sections with each featuring between two and four presentations from experienced people within their sectors.
Section 1: Introduction
Harmonization is the word of choice here: Three presentations worked through explaining how the PCCDG, PLF and C3 will be coming closer together and forming the Temperature-control Pharmaceutical Group (TPG).
Rafik Bishara spoke for the PCCDG and gave information regarding Technical Report No39 and how this will develop with the harmonization program
Shirley Ann Feld mapped out the PLF discussing how its 60 representatives from 23 companies enables; a Unique Net-Working Platform where attendees are free to share experiences through workshops and presentations, building on improvements as a team. On from this the TPG mission statement was released: “Define and promote good practices in the storage and transport of temperature sensitive pharmaceutical materials”.
Hugo Wegewijs Then gave us the C3 perspective with regards to harmonization and pulled together points from the previous two, creating a definite sense of global co-operation.
Section 2: Stability & Section 3: Packaging
What to monitor, what to review, how to send it, what packaging to use and how to maintain the cold chain throughout!
Stability; David Ulrich from Abbott worked through the level of temperature information his company collects for both shipments of control temperature packages and reefer trucks and how this information is used to qualify and manage their cold chain, whilst using the available stability data for products with the collected field data to ensure that the least amount of product is destroyed if excursions occur during shipment.
At last stability data is being talked about………Historically I recall it being a pretty taboo subject in many project requirement meetings or a complete mystery in others.
Also David expressed an interest in a CL document that we issue to customers asking for all of their, project criteria in an effort to speed up our development process. I believe he will call you regarding this and as a point of reference I have attached said document.
Packaging presentations from: Kodiak, Va-Q-tec, CoolPac and Cool Logistics/Thermosafe.
From my own perspective on this: Innovation in this sector is coming in the form of relationship building between customer and supplier. Now more than ever I am seeing a closer working situation as everybody strives to achieve a viable solution. For my own part it was great to present a case study that was not a simple develop, supply and exit situation but one that illustrated the value of communication between all involved parties and in some ways took a very hands on development approach that created many opportunities for all companies involved to develop their understanding.
Lyn Radnell from CoolPac Australia also presented a case study on temperature control but more importantly brought with her a matching set of cold chain values to those of her European and American friends from an up until now more quiet part of the cold chain maWith regards to new products, it seems from the more product lead presentations that Vacuum insulation is what’s “up and coming” and when combined with some of the “New PCMs” should hail in the next generation of control temperature packages, but as both of these technologies have been widely talked about for a number of years now, it does seem that rather than them being big news its more important to realize that with more people offering it and more customers demanding harder working solutions, demand will drive down the original high prices thusly making them far more commercially viable.
Section 4: Global Regulatory Requirements.
As always it’s great to hear from the regulators who are always happy to share (no names of course) all the very best examples of how bad things can get. Like most events it is often not what they give during the presentation but the value they add during the question and answer sessions. I fail to recall a single instance where either Umit Kartoglu (WHO) or Ian Holloway (MHRA) didn’t give a frank, honest and concise answer to any of the questions posed (most often by Rafik) their way.
Section 5: Quality Standards, Validation and Qualification.
What interested me most during this section was Markus Schwarz’s (Schering AG) presentation of the TKL’s (German National Working Group: Temperature Controlled Logistics) paper regarding the concept for the validation of cold chain shippers using ambient temperature data base.
The theory behind it is that by designing a control temperature package to meet specific ambient requirements it would then be possible to map the heat flow of the ambient profile and then map the heat flow of collected field data. By collating all information you would then be able to calculate whether or not the system had managed to maintain product temperature (a positive result would show the field data heat flow within that of the test ambient heat flow range). Currently the field data only comes from on line weather sources and it will be interesting to see how this new approach pans out.
Section 6: Distribution and Transportation.
Dr.-Ing. Yves Wild (Ingenieurbűro GmbH) presented on the Cold Chain Quality Indicator Standard (CCQI) in this section and mapped out how it would be possible to map out and point score the entire cold chain process to enable the selection of the appropriate cold chain supplier. A decision that could then, be backed up by certification.
Section 7: Partners in Supply Chain
Unfortunately flight times meant that this section was missed by me and my traveling colleagues.
Conclusion:
What a great start for the TPG. The level of co-operation between companies could really be seen at this event and I believe every attendee left feeling as though they had been part of an event that will help to shape the future of temperature control.
On speaking with Rafik and Georg Roessling (PDA Europe) at the end of the event the only “maybe next time” point raised was that perhaps more panel based discussion could have been included, this really came from the fact that the high volume of audience participation often caused sections to over-run their time slots.
If you would like any more specific information on the event please do not hesitate in contacting me.
Richard Harrop
