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Slide 1 © PharmOut 2017
Quality, Sustainability and Business Efficiency Through Innovation & Good Engineering
Presented by Cameron Roberts, July 2017
Slide 2 © PharmOut 2017
Guidelines
Please contribute
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Please relax and enjoy yourself
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Slide 3 © PharmOut 2017
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Slide 4 © PharmOut 2017
What are the Priorities of Your Business?
Quality?
Safety?
Cost?
Environment?
Other?
Slide 5 © PharmOut 2017
With Respect to Reducing Utility Usage, What’s the Attitude in Your Business?
Don’t change anything
Don’t change anything that impacts GMP
There is always a trade off: cost, quality etc.
Got great ideas but change is too hard
Where do I begin?
Slide 6 © PharmOut 2017
Victorian Context
Electricity pricing increasing by 20% in next 12 months
Natural gas readily available but prices also increasing
Cost of water has double in less than 10 years
Greenhouse gas factor for electricity is worst in Australia (6 x worse than Tasmania)
GHG factor for electricity is 6 x worse than natural gas
Slide 7 © PharmOut 2017
Cost Of Pharmaceutical Water
• Purified water requires electricity and generates waste streams (RO reject, EDI rinse etc.)
• Water for Injection (WFI) requires electricity and heating (usually steam generated by natural gas boilers) and generates waste stream
• WFI can be generated by either multiple effect distillation or by vapour compression.
• Multiple effect is more common in Australia but not as energy efficient as vapour compression
Therefore, reducing water also reduces electricity, gas and waste water
Slide 8 © PharmOut 2017
Cost Of Generating Different Water Types ($/Kl)
$0 $2 $4 $6 $8 $10 $12 $14
Mains water
Highly Purified water
Hot mains water (75 °C)
Hot highly purified water
Hot WFI (Multi Effect)
Hot WFI (Vapour compression)
Cold WFI (Multi Effect)
Cold WFI (Vapour compression)
Slide 9 © PharmOut 2017
Greenhouse Gas Emissions From Generating Different Water Types (Kg CO2 Per Kl)
0 10 20 30 40 50
Mains water
Highly Purified water
Hot mains water (75 °C)
Hot highly purified water
Hot WFI (Multi Effect)
Hot WFI (Vapour compression)
Cold WFI (Multi Effect)
Cold WFI (Vapour compression)
Slide 10 © PharmOut 2017
What Does This Mean?
Every 1000 litres of cold WFI saved is equivalent to the daily emissions for the average Australian household (50 kg CO2)
For a WFI plant generating 10,000 L per hour, this equates to:
• $1.2 million in utility costs
• 4300 tonnes CO2 equivalent of Greenhouse Gas emissions
• Equivalent to 240 households
Slide 11 © PharmOut 2017
Note Of Guidance For Quality Of Water For Pharmaceutical Use (EMA) -Water Used For Cleaning / Rinsing
For sterile parenteral, minimum quality of water:
• Initial rinse: Purified water
• Final rinse: WFI
For non-sterile
• Initial rinse: Potable water
• Final rinse: Purified water
Slide 12 © PharmOut 2017
Typical CIP System
Slide 13 © PharmOut 2017
Case Study: Clean in Place
• To reduce wastage in CIP, first calculate the minimum quantity for cleaning your process equipment
• Example: small tank with dynamic spray device 100 L/min
• Table highlights “wastage” and opportunity
Cleaning Step Effective Cleaning (L)
Actual (L)
Initial rinse – 1 minute 100 1000
Detergent – 4 minutes 400 1000
Neutralisation – 1 minute 100 1000
Final rinse – 1 minute 100 1200
Total 700 4200
Slide 14 © PharmOut 2017
Static and Dynamic Spray Devices
Slide 15 © PharmOut 2017
Wastage:
Cleaning Step Supply line (L) Dump CIP tank at end (L)
Excess to rinse return line (L)
Initial rinse 200 700 0
Detergent 200 400 0
Neutralisation 200 700 0
Final rinse 200 700 200
Total 800 2500 200
Slide 16 © PharmOut 2017
Saving opportunities:
Cleaning Step
Action Saving (L) Time saving (minutes)
Initial rinse Keep water for next clean 700 2
Detergent Only make up minimum 200 4
Neutralisation Only make up minimum 500 10
Final rinse Keep water for next clean 900 2
Final rinse Sample rinse water at product tank, not end of CIP return line
200 2
Total 2500 20
Slide 17 © PharmOut 2017
Key Point: Eliminate Wastage
Only make up volume of CIP fluid required
Locate CIP system close to process equipment
Design self draining lines with minimal dead legs to optimise final rinse
Re-use final rinse as first rinse for next CIP
Slide 18 © PharmOut 2017
Water Re-use Opportunities
• Capture RO reject water to feed cooling towers
• Capture WFI still blow down to feed boilers
• Capture condenser cooling water and / or vacuum pump water from autoclaves
• Capture any other once through cooling water
By re-using “clean” waste water you are saving water and waste
Consult with water treatment service providers before implementing
Slide 19 © PharmOut 2017
Recap?
Reduce
Re-use
Recycle
Slide 20 © PharmOut 2017
Thank you. Any questions?
Cameron Roberts
Senior Engineer
Slide 21 © PharmOut 2017
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