Changeover Creating A Unique Strategic Advantage

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Patrick Davis
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1 NRL Changeover Journey Changeover Creating A Unique Strategic Advantage John Coomey NRL Transformation Lead PMTC Knowledge Day 31 st Aug 2017

2 Novartis in Ireland Statistics provided by Novartis Ireland Ltd PMTC Technical API Operations Cleaning Workshop 2 Novartis Board Visit 24-Aug-2017 Novartis Ringaskiddy Briefing Pack

Novartis Ringaskiddy Limited Facts and Figures Operational since Feb 1994 Manufacturer of

chemistry Site Head: Dorothea Ledergerber & New Site Head from September 1 st 2017 Shane Relihan

The 855mUSD facility includes manufacturing operations, quality control laboratories, warehouse,

3 Novartis Ringaskiddy Limited Facts and Figures Operational since Feb 1994 Manufacturer of Intermediates and APIs Small, medium & large technology platforms across a wide range of chemistry Site Head: Dorothea Ledergerber & New Site Head from September 1 st 2017 Shane Relihan Employs 407 associates including 63 NBS associates Toll manufacturer for Novartis International Pharmaceutical Ltd., Branch Ireland (NIPBI) Site is situated on 532,000m 2 of which 260,000m 2 is developed. The 855mUSD facility includes manufacturing operations, quality control laboratories, warehouse, technical, IT and engineering etc. Operate 24 hour / 7 Days a week / 4 Shift Pattern PMTC Technical API Operations Cleaning Workshop 3 Nov artis Board Visit 24-Aug-2017 Nov artis Ringaskiddy Brief ing Pack

4 Novartis Ringaskiddy Campus 4

5 Multipurpose Standard Equipment 30 Head Tanks Volume 630L to 2500L 50% stainless steel, 50% glass lined 50% equipped with agitators 35 Reactors Volume 1,000L to 6,3000L 66% stainless steel, 33% glass lined 9 Crystallisers Volume 1,000L to 6,3000L 50% stainless steel, 50% glass lined 12 Separators Volume 1,000L to 10,000L 66% stainless steel, 33% glass lined 12 Centrifuges Basket Volume 800L to 1300L 66% stainless steel, 33% hastelloy 8 horizontal peeler, 4 inverting bag 7 Nutsche Filter/Dryers Filter area 0.3m2 to 4.0m2 66% stainless steel, 33% glass lined 8 Paddle Dryers Volume 800L to 2,500L 50% stainless steel, 50% hastelloy 5 PMTC Business API Use Only Cleaning Workshop

6 Multipurpose Specialised Equipment Low temperature reactors (to -120 deg C) High temperature reactors (to 150 deg C) Bus Loop hydrogenator Lyophilisers Gas dispensing stations (e.g. hydrogen chloride) Liquid dispensing stations (e.g. butyl lithium in hexane) Specialised venting systems (for hydrogen and dichloromethane) Flash evaporators De-ionised water system T4 rated equipment 6

7 Our Strategy to Compete 7

8 Campaigns & Core Module Changeovers Cent/ Dryer/ Nutsche/ Reactor/ Crystalliser Number of Campaign Starts (PB1/1A) Number of Core Module Changeovers (PB1/1A) 8

9 Changeover Process Handover Handover Production Product A Post Campaign Flush Removes gross contamination from product A contacting surfaces Changeover Changeover times reported for actual contact hrs/days of operator resource used in calendar period Resource based mainly Mon Fri 1. Set up for cleaning 2. Preliminary Clean 7. Product Train Reconfiguration 6. Preventative Maintenance/ Projects works Production Product B Blank Batch Function test of reconfigured equipment train & flush with process solvent for product B 3. Main Clean 5. Equipment disassemble & rebuild 4. Analytical Clean 9 1. Set up modules for flushing/ manual cleaning 2. Conditions often tailored for removal of raw materials 3. Conditions tailored for removal of Product A 4. Final cleaning sample submitted (if required) 5. Equipment dismantled for inspection & manual clean 6. Maintenance & Projects works completed 7. Process train reconfigured for Product B

10 Table 1 - Equipment Groups (Reactor/ Crystal, Centrifuges, Nutsche Fixed/ Mobile, Dryers) Table 2 Product Changeover combinations Table 3 - Validation limits for Production Units based on product matrix mix 10

11 Workshops - Lean Tools 11

12 Changeovers Transformation 1. People a) Dedicated NRL Site Team 2. Process a) RTF (Right First Time) b) Science based PDE c) PAT Rinse & Swab 3. Plant a) Optimise train cleaning & Reconfiguration set up 12

13 People NRL Site Changeover Organisation 2017 Transformation Lead Changeover Project Manager PU Facilitator Team Leads Maintenance Coordinator QA Specialist Operators Craft (Mech./ E/I) Process Manager Permitters Engineers (Mech./ E/I) Technical Support Engineer Planner Process Leads 13

14 Process (Last batch out to 1 st Batch In) Improvement on Post Campaign Flush (PCF) QA Oversight Optimise PCF to enable efficient start point of cleaning process Process Capability Optimise the number of circulations/ Solvent volumes/ Times Use PAT at line/ near line/ in line (No robust solution to date for cleaning) Detergent development work ongoing with ECOLAB Mill cleaning Blank Batch into 1 st Production Batch Right First Time from changeover Continuity of handover Production to Changeover to Production... 14

15 Plant Paddle Dryer (High pressure water jet & manual) DUL flush Set up investment ~ 100k/ Dryer Filters on N2 system investment ( Completed on ) ~ 100k/ Dryer Sock filter breakthrough into overheads (Engineering configuration issue identified) Spectacle spades Centrifuge (PCF, Solvent Flush & Manual) New procedure in place since Jan 17 Waste route lines to optimise cleaning set up Dedicating a flash evaporator option being assessed Spectacle spades Kitting Configurable parts, hoses, etc. Storage Suitable location Maintenance Pm s Breakdown & rebuild Reconfiguring Spares Reorder quantity & trigger Reactor/Crystalliser (PCF, Solvent Flush & Manual) Lean Modules ~ 50% completed Spray nozzles Waste routes Opportunity to improve Pumps Not on all modules Spectacle spades 15

16 Changeover Equipment Improvement Aug Paddle Dryer Condenser End Plates Upgrade for inspection Before Internal Tubes 16 After

17 Visual Boards - Changeover 17

18 Thank you

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Krauss-Maffei HD/BD helix dryers www.andritz.com 2 Krauss-Maffei HD/BD helix dryers Table of contents Krauss-Maffei helix dryer, HD 3 Process advantages 4 Krauss-Maffei helix dryer, BD 5 Process advantages