RESOURCE EFFICIENCY CHALLENGES FACING THE PHARMACEUTICAL INDUSTRY

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RESOURCE EFFICIENCY CHALLENGES FACING THE
PHARMACEUTICAL INDUSTRY

• Mike Murray
• Head of Manufacturing Environment, ABPI
• Envirowise Resource Efficiency Seminar
• Wednesday 5 December 2007

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• The Pharmaceutical Regulatory Framework
• Energy in the Pharmaceutical Industry
• Packaging
• Green Chemistry
• Solvents
• Waste
• Summary

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The Pharmaceutical Regulatory Framework

• Arguably the most closely regulated manufacturing
  activity in the world
• Manufacturing and Marketing Authorisations
• Problems of variation of registered products and
  processes
• The new approach to quality
• ICH Q8,Q9, Q10
• Design space, risk management, quality systems

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Energy

• Energy in the Pharmaceutical Industry
• First steps late 1980s
• Energy Consumption Guide 33
• Good Practice Guide 87
• Climate Chang Levy and Climate Change Agrements
• The Future

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Energy in the Pharmaceutical Industry

• Traditionally a small element of the costs of
  manufacture seen as a straightforward overhead
  cost
• With the emergence of the debate on climate
  change, started appearing on the agenda in the
  late 80s discussions with ETSU
• In recent years cost of manufacturing and
  efficiency has assumed a much higher strategic
  importance rising costs have increased the
  contribution of energy to overall manufacturing
  costs
• The regulatory requirements for pharmaceutical
  manufacture have always had to be borne in mind

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Late 1980s First Steps

• Started work with the then ETSU to look at
  efficient use of energy in the pharmaceutical
  sector
• Led to the publication in 1993 of Energy
  Consumption Guide 33
• Energy Consumption Guide 33
• Survey based
• Limited number of companies
• Unit of energy performance measurement -
  GJ/m2/1000hr
• Highlighted the difficulty of benchmarking energy
  usage in the pharma industry
• Looked at six areas manufacturing, finishing,
  packaging distribution, RD/analysis,
  stores/warehousing and admin/offices
• Ranked individual activities in terms of energy
  consumption

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Energy Consumption Guide 33

• If as a minimum, those companies with above
  average consumption for pharmaceutical activities
  reduced their energy consumption to the industry
  average, it is estimated that this could result
  in annual savings of 34m across the industry as
  a whole.

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Good Practice Guide 87

• Pulled together by a distinguished author on
  pharmaceutical matters
• Use the limited learnings of ECG 33
• Pulled together some of the lessons learned in
  some best practice programmes coordinated by ETSU
  with ABPI members companies and also drew on
  other case studies and relevant best practice
  guidance in other industries
• Reviewed by ABPI Group in 2005/2006 agreed that
  the principles of the GPG still hold good

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Good Practice Guide 87 - Contents

• Strategic Approach to Energy Efficiency
• General Principles for Minimising Energy Usage
• Planning for energy efficiency
• Dont use what you dont need
• Good Housekeeping
• Specific Areas for Possible Action
• Management initiatives/techniques (awareness,
  monitoring targeting)
• Buildings (building fabric, space heating
  systems, lighting, ventilation
• Process operations (drying, evaporation, batch
  reactors, PINCH technology)
• Utilities (CHP, boilers)
• Transport

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CCL and CCAs

• Climate Change Levy introduced in 2001
• As regards Climate Change Agreements most
  eligible members (those with PPC permits) joined
  CIABATA
• Revision of CCA rules 2004
• Reviewing situation with respect to CCAs in the
  light of the rapid increase in energy prices
• Looking to see if secondary pharmaceutical
  manufacturing meets the criteria for setting up a
  pharmaceutical CCA

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The Future

• ABPIs EHS Group continues to review issues
  relating to Climate Change
• Particular areas for discussion
• Continue to investigate the possibility of a CCA
  for the pharmaceutical sector
• Will continue to review the future developments
  in respect of emissions trading and the
  challenges/opportunities that this presents to
  the sector
• Will continue to seek to facilitate exchange of
  best practices in this area between our members
• Energy efficiency now an important factor in the
  assessment of new technology

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Packaging

• Packaging Waste Directive
• Increased regulatory requirements and pressures
  for information on packaging and legibility,
  Braille, product identification codes, child
  resistance all pressures to increase pack sizes
  
• Recycled material more difficult to use in
  primary packaging but more widespread use in
  secondary and tertiary packaging
• Continued effort to design packaging with optimal
  materials usage

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Green Chemistry

• Increasing application of green chemistry
  principles and techniques
• One of the leading sectors in this approach
• Considerations
• Impacts of processes on the environment
• Minimisation of waste
• Environmental impact of products environmental
  risk assessment now part of the authorisation
  process for new products

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Solvents

• Solvent emissions directive
• Applies to pharmaceutical sites using gt50T of
  VOCs per annum
• Primary manufacture green chemistry design of
  new processes minimising use of solvents of
  concern
• Replacement of solvents of concern where feasible
• Move away from use of solvent coating in
  secondary manufacture, particularly new products

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Waste

• We produce high value products and so culturally
  have always sought to minimise waste
• Also, as with every other industry, increasing
  cost of waste disposal is an incentive
• As mentioned above, packaging minimisation in
  product design and a green approach to new
  product process design are just some of the areas
  where waste minimisation is a consideration

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Summary

• Resource efficiency is as important to the
  pharmaceutical industry as any other
  particularly in todays environment of
  rationalisation of product manufacture and asset
  utilisation.
• New approaches to product design and the
  risk-management based approach to process
  improvement will hopefully facilitate the uptake
  of improved technology developments for the
  manufacture of our products and bring with it
  enhanced resource efficiency

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• mmurray_at_abpi.org.uk
• Thanks for your attention and ..
• Any Questions?