MONZA ST5 Project. Alberto Penati Patheon Monza EU Engineering Director. The world leader in serving science

Transcription

1 MONZA ST5 Project Alberto Penati Patheon Monza EU Engineering Director The world leader in serving science

2 SUMMARY 1. Monza Site Overview 2. Design Data 3. Philosophy and approach on installation 4. Challenges 5. Milestones 6. Department Location 7. Area Classification 8. Room Grade Class 9. Process Equipment 10. Flexibility 2

3 MONZA SITE OVERVIEW August 29, 2017: announcement of the completion of Thermo Fisher Scientific s acquisition of Patheon 3

4 MONZA SITE OVERVIEW Lyophilization Sterile Parenteral Liquids PFS & Cartridges Oral Solid Dosages Packaging Solids & Steriles 4

5 MONZA SITE OVERVIEW 70+ Products (30% biologics) 18 Audits by clients in TT projects managed to date 360 m2 of lyo surface (including ST5) ~50 Clients (specialty, biotech, big pharma) 10 FDA inspection (PAI and GMP ) from on going projects ~750 Current workforce Services: Manual, semiautomatic, automatic VI capability Serialization services Controlled drug/high potent drugs handling Low temperature storage options 5

6 DESIGN DATA New department for aseptic filling of lyo and liquid product Up to 250 batches/year considering 24/h lyo cycle (22M vials 6R) Freeze Dryers in pass-through configuration Maximum possible flexibility N.2 independent capping machines for lyo and for liquid Full aseptic process with crabs (equipped with VHP sterilization system) on filling line and on FD loading/unloading + grade A/B background. Grade A continuity Dedicated solution preparation area able to handle SS cooled vessels with CIP/SIP or disposable plastic bag system 6

7 DESIGN DATA BATCH SIZE = 50L L with SS tank BATCH SIZE = 20L L with disposable bag system, Dosing via rotary piston pumps with CIP/SIP and via peristaltic pumps and disposable technology Filling line with 100% IPC at full speed Vials range from 2R to 100H (50H for lyo vials), capacity to upgrade to handle pre-sterilized CZ vial Temperature control during filling via small intermediate holding tank Whole line rated for a speed of 400pz/min on 6R format Designed up to CAT3A containment 7

8 PHILOSOPHY AND APPROACH ON DESIGN ST5 suite for liquid and lyo vials will be located on the production floor (1 floor). ST5 suite is intended to be a completely separate, standalone area from other production areas with dedicated: Sterile core and supporting area Gowning (central gowning at ground floor to change from street clothes to general pharma garment) Solution preparation Filling line Clean room material preparation, with sterilization autoclaves, pass through sanitization or VHP sterilization and washing areas HVAC Dispensing where appropriate (API and excipients) and terminal sterilization operations are shared with the rest of Production on the first floor. 8

9 CHALLENGES Space available already defined (previous packaging area) Installation in the middle of the Building without interrupting the production activities New technology for Patheon, pretty new technology even for the supplier Timeline of the project (for AIFA doc submission) FAST TRACK FDs: delivery of components directly on site, assembly (mech and electrical) and testing (VIT) on site (no FAT) Short delivery time required Isolator used as CRABS into Grade A/B room 9

10 MILESTONES PO placement MAY 2015 FD delivery FAST track (chamber, condenser and cooling skid) FEB 2016 FD mechanical completion JUN 2016 Loading, unloading and filling delivery JUL 2016 Mechanical completion OCT 2017 FD qualification completion DIC 2017 Line qualification completion APR 2017 Media Fill execution JUN 2017 Documentation submitted to AIFA SEP 2017 Time from PO to delivery Time from delivery to qualification = 14 months = 9 months 10

11 MONZA ST5 DEPARTMENT LOCATION MONZA ST5 Liquid-Lyo vials dept and Production area First floor Available area 900 m 2 11

12 MONZA ST5 DETAILED ROOMS CLASSIFICATION Changing room for Sterile General corridor Vial loading and liquid unloading Filling and lyo loading Washing area and sterilization Compounding Lyo unloading and crimping Offices 12

13 ROOMS GRADE CLASS 13

14 CHALLENGES FAST TRACK and LYO ON SITE ASSEMBLY 14

15 CHALLENGES - LINE ASSEMBLY 15

16 PROCESS EQUIPMENT Vial washer, depirogenation tunnel, vial filling under crabs 16

17 PROCESS EQUIPMENT 17

18 PROCESS EQUIPMENT 3 Freeze dryers, 40m 2, automatic loading and unloading system. 18

19 PROCESS EQUIPMENT 19

20 PROCESS EQUIPMENT Crimping machine for lyo vials, external washing Crimping machine for liquid vials 20

21 FILLING IPC 100% STOPPERING AUTOMATIC LOADING UNLOADING 21

22 FLEXIBILITY DAY 1 FD 1 LOADING 24 h LYO Cycle considered 22

23 FLEXIBILITY DAY 2 FD 2 LOADING 23

24 FLEXIBILITY DAY 3 FD 3 LOADING FD 1 UNLOADING 24

25 FLEXIBILITY DAY 4 FD 1 LOADING FD 2 UNLOADING 25

26 FLEXIBILITY DAY 5 FD 2 LOADING FD 3 UNLOADING 26

27 FLEXIBILITY DAY x FD FULL LIQUID PATH 27

28 FLEXIBILITY DAY n One FD unloading LIQUID PATH 28

29 ST5 DEPARTMENT THANK YOU 29