Quality, Sustainability and Business Efficiency Through Innovation & Good Engineering. Presented by Cameron Roberts, July 2017

Transcription

1 Quality, Sustainability and Business Efficiency Through Innovation & Good Engineering Presented by Cameron Roberts, July 2017 Slide 1 PharmOut 2017

2 Guidelines Please contribute Please stop me to ask a question Please relax and enjoy yourself Please place your phone on silent mode Slide 2 PharmOut 2017

3 Using Glisser You will be able to tap the download link at the end of each presentation. This will send you an with a link to a PDF copy of the presentation slides. You cannot edit the slides, or view any presentation notes added to the original file. The live link to the presentation slides (via the glsr.it code) remains live until PharmOut deletes the presentation. Slide 3 PharmOut 2017

4 What are the Priorities of Your Business? Quality? Safety? Cost? Environment? Other? Slide 4 PharmOut 2017

5 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 5 PharmOut 2017

6 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 6 PharmOut 2017

7 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 7 PharmOut 2017

8 Cost Of Generating Different Water Types ($/Kl) 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) $0 $2 $4 $6 $8 $10 $12 $14 Slide 8 PharmOut 2017

9 Greenhouse Gas Emissions From Generating Different Water Types (Kg CO 2 Per Kl) 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

10 What Does This Mean? Every 1000 litres of cold WFI saved is equivalent to the daily emissions for the average Australian household (50 kg CO 2 ) For a WFI plant generating 10,000 L per hour, this equates to: $1.2 million in utility costs 4300 tonnes CO 2 equivalent of Greenhouse Gas emissions Equivalent to 240 households Slide 10 PharmOut 2017

11 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 11 PharmOut 2017

12 Typical CIP System Slide 12 PharmOut 2017

13 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 Detergent 4 minutes Neutralisation 1 minute Final rinse 1 minute Total Slide 13 PharmOut 2017

14 Static and Dynamic Spray Devices Slide 14 PharmOut 2017

15 Wastage: Cleaning Step Supply line (L) Dump CIP tank at end (L) Initial rinse Detergent Neutralisation Final rinse Total Excess to rinse return line (L) Slide 15 PharmOut 2017

16 Saving opportunities: Cleaning Step Action Saving (L) Time saving (minutes) Initial rinse Keep water for next clean Detergent Only make up minimum Neutralisation Only make up minimum Final rinse Keep water for next clean Final rinse Sample rinse water at product tank, not end of CIP return line Total Slide 16 PharmOut 2017

17 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 17 PharmOut 2017

18 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 18 PharmOut 2017

19 Recap? Reduce Re-use Recycle Slide 19 PharmOut 2017

20 Thank you. Any questions? Cameron Roberts Senior Engineer Slide 20 PharmOut 2017

21 PharmOut Copyright Notice All rights reserved This presentation and all associated materials are copyrighted and all rights reserved by PharmOut. No part of this presentation may be reproduced or transmitted in any form or for any purpose without the express permission of PharmOut in writing. The information contained herein may be changed without prior notice. Data contained in this presentation serves informational purposes only. PharmOut does not warrant the accuracy or completeness of the information, text, graphics, links, or other items contained within this presentation. This presentation is provided without a warranty of any kind, either express or implied, including but not limited to the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. PharmOut shall have no liability for damages of any kind including without limitation direct, special, indirect, or consequential damages that may result from the use of this presentation. Slide 21 PharmOut 2017