Bengt Mattson

I have today participated in the ISPE Nordic Annual Meeting and Conference on Sustainability and Green Pharmaceutical Manufacturing. I find it extremely encouraging that a well known and respected organization such as ISPE devote their entire Annual Meeting to the discussion about Pharmaceuticals and Sustainability. In the invitation to the meeting, Sakari Salla (Chairman of ISPE Nordic) writes:

"Several experts will be sharing their knowledge in the important field of sustainability in the pharmaceutical industry. The presentations will stretch from green chemistry in processes, facility design, energy savings and case stories to future perspectives and challenges for the pharmaceutical industry. This year ISPE Nordic Annual Meeting is focusing on an area of great interest for the industry and the society. It is important for the environment and for the long term sustainable growth and business for the pharmaceutical and medical industries. We are just at the very beginning of a Green Journey."

Christina Åkerman
Christina Åkerman

Presenters from a variety of backgrounds shared their expertise during the day. The introductory speech was held by Christina Åkerman, Director General at Swedish MPA. The Swedish MPA has put sustainability high on their agenda, and it felt natural that Christina laid the foundation for the seminar's discussions. Christina used the example of pharmaceutical substances discharges in India that I have discussed a numerous of times here at the blog, to make her point that "unacceptable conditions such as that have moved the pharmaceutical sector to a turning point". She sees three important things happening:

- Greater understanding from both society and industry, where the Swedish MPA's report on their governmental commision regarding stricter environmental requirements on pharmaceutical manufacturing is one important example.

- Public Awareness, with demands on actions in several areas

- The Global Challenge, where sustainable development is a new concept in large parts of the pharma world. Christina was very clear as always that Swedish MPA will work to increase awareness among medical products agencies around the globe and drive other agencies and regulators in a sustainable direction.

After Christina introductory lecture I gave a presentation where I gave the industry's general and overarching perspectives on sustainability and pharmaceuticals. Some of the pictures I used for the discussion you will be well aware of if you have followed my blog over the years:

- The Sustainable Quadrant:

- The "Walderik-Mattson-pyramid" as a general description on how sustainability is part of the business strategies in the pharma industry:

- Climate Change and Energy programs:

Pfizer Climate Goal
Pfizer Climate Goal

But I also used the comments provided by the Association of the Swedish Pharmaceutical Industry (LIF) regarding the MPA's report on stricter environmental requirements to make my point that incentives are extremely important if society wants to see a real change. Society can not expect industry to change rapidly if the "good guys" do not have any green incentives. If pricing and reimbursement systems, and related generic reforms, are built to focusing "lowest possible price" it is hard to believe that real change will really take place. You can read more on this topic on green pharmaceuticals and "the Swedish generic reform" in my blog post from yesterday (although it was written in Swedish...).

The perspectives from architects on green facilities (buildings and labs) were then provided by Johan Norén from Kanuzi Arkitekter and from Steve Agar from Devereux Architects. Some of the important take-aways from these lectures on green and  "the zero-emission" facilities were things such as general exhaust shall be cleaned and filtered, process exhaust shall be HEPA-filtered, general waste shall be sorted, and process waste treated (e.g. evaporation with heat recovery). We learned that there are a lot of good "design guides" existing, e.g. BREEAM, Labs 21 and Passivhaus.

Eva Jacobsson
Eva Jacobsson

Then Eva Jakobsson from AstraZeneca gave us a good review of Green Chemistry efforts in the industry. She presented the 12 principles of Green Chemistry for us, and gave us insights in PMI (Process Mass Intensity). PMI is the quantity of all raw materials input (kg) divided by the quantity of bulk substance produced (kg). The pharmaceutical industry has a rather poor (i.e. a high number) PMI compared to several other industry sectors. PMI-numbers in the range of 100 is not uncommon for the pharma industry, when for instance oil refinery works with PMI  around 0,1. But things can be improved by using green chemistry guidelines, available at e.g. the ACS Green Chemistry Institute. You can also read more on AstraZeneca's web page or at Pfizers web page on green chemsitry. The example below shows the improvements made on one of Pfizer's top selling products:

- From almost 2000 L solvent waste (heavily chlorinated) per kg product in the 90-ies, to less than 10 L solvent waste (non-chlorinated solvents) per kg product today:

Eva concluded her talk with some information on AstraZeneca's supplier evaluations. A strong program on environmental inspection of third party manufacturers is crucial to manage issues as the ones discussed earlier at the seminar, i.e. releases from manufacturing outsourced to e.g. India. If you are interested you can also read about Pfizer's work on External Supply through this link.

The focus then shifted to energy optimization. Niels Christian Weigelt from Lundbeck in Copenhagen gave us a long range of quick fixes how to decrease the energy consumption (and of course making money out of that). The goal for Lundbeck is to decrease the consumption with 10% per year, a tough goal but apparantly possibly to meet, even with a lot "simple quick fixes":

- Reduce number of air changes per hour and duct pressure (at least outside working hours)

- Only ventilate the animal stables and animal labs when they contain animals

- Dare to review also air changes per hour in production areas (although could be tough due to GMP-rules...)

- Only run the vacuum pumps when needed (not 24/7)

- Close down ventilation during holidays (e.g. the summer shut-down)

Seeing a list like this, really makes you scared. There are apparently still a lot of energy being wasted in the industry. Time to fix that!

Then we could listen to two presentations from Pharmadule. First from Magnus Jahnsson on "the Challenge of Going Green" and then from Robert Velén on "Green Engineering Information Management - Electronic Project data from Design through Delivery". Magnus presentation confirmed a lot of the ideas we had already seen from Lundbeck Pharma. Big contributions to "going green" is to find on ventilation. Magnus showed how energy optimization comes in  already in the design phase, e.g. through optimizing room volumes, and optimizing the pressure cascade from Grade D, through Grade C and B, into Grade A. By decreasing the pressure differences from e.g. 15 Pa to 10 Pa, or even dare to go lower (although GMP might present some problems here...) would make a tremendous energy saving. Magnus claimed that if things are done "in the best possible way" there will be GWh per year in possible savings!

Robert Velén then gave us his ideas on how IT and Engineering Information Systems really could help lowering the ecological footprint. Using modern IT solutions could save tonnes of paper (with ink...) and save transports of these piles of binders across the globe. Engineering documentation of a new pharmaceutical plant is archive safe IT soft wares, electronic signatures and systems with audit trail.

The seminar closed with a presentation by Ronni Glenn Refstrup Hansen from CMC Biologics in Denmark. He talked about reduction of waste from the next gereation of biopharmaceuticals plants. One of his examples was the difference between using ready made liquid media and powdered media. By using powdered media you save a lot of heavy transports (of water essentially) to and inside the manufacturing plants. The simple recommendation is of course to mix the your powder with water as late as possble before entering the bioreactor. But as we had heard already several times earlier during the day, also the simple solutions and quick-fixes for some reason seem to remain to be implemented...

Thanks to ISPE Nordic for a full day of very interesting presentations showing the very wide range of environmental aspects to manage within the pharmaceutical business. Just go in there and start delivering!

Bengt Mattson