IMA SpA. Advancements in Isolation Technology for Aseptic Filling. Marco Preus, July 2016

Transcription

1 IMA SpA Advancements in Isolation Technology for Aseptic Filling Marco Preus, July 2016

2 Agenda Isolation technology advantages Isolation technology cost saving Air flow circuits Case study: vials filling under 100% Nitrogen atmosphere

3 Isolation technologies advantages Increased product safety (that results in an increased product quality) Increased operator protection (in case of toxic product) Possibility to frequently perform cleaning and decontamination cycles Surrounding area in class C (FDA; EU-GMP) or D (EU- GMP only) Controlled atmosphere (see case study)

4 Isolation technologies cost saving The surrounding area in class C or D allows the following cost saving: Less time for personnel gowning Lower personnel gowning (material) Less ambient monitoring (viable/non-viable) Less air to be conditioned

5 Filling Line with 2 FD: different protection solutions Production Area 68 m2

6 Solution A: All production room in class A Traditional solution: production room completely in class A (68 m2 with LAF)

7 Solution B: Open Active RABS Solution with Open Active RABS: Class A: 20,6 m2; LAF 20,4 m2 (Total LAF41m2) Class B 27 m2 (Total 68 m2)

8 Solution C: Isolation Technology Solution with Isolator: Class A: 20,6 m2, Class C 47,4 m2 (Total 68 m2)

9 Clean Room vs RABS vs Isolator SOLUTION A CLEAN ROOM SOLUTION B OPEN RABS SOLUTION C ISOLATOR filling sorrounding filling sorrounding filling sorrounding CLASS A B A B A C Clean room area m ,6 47,4 Air changes per hour (considering the ceiling at 3m) Total air per hour Total air per day (24 hours) TOTAL AIR PER DAY (24 hours) in m Saving with respect to solution A -35,29% -64,54% Saving with respect to solution B -45,20%

10 Isolator Air Flow Circuits IMA Life isolators for filling lines are equipped with a sophisticated air flow circuit that can be subdivided in three main section: Re-circulated air flow to create the unidirectional air flow (LAF) Make-up air flow, to ensure an adequate amount of new air in the loop Extraction air flow, to have a fine pressure adjustment inside each isolator chamber

11 Re-circulation Air Flow It is a closed loop composed by inlet fans and inlet filters (HEPA H14) in charge of the generation of the unidirectional air flow (LAF) inside the isolator. Hepa filter with Bag-in Bag-out Recirculation Fan Air recirculation ducts At the bottom of each isolator section, all air is extracted by the fans in charge of the recirculation, and reintroduced in the isolator chamber via the filtration stage. Machine base LAF Fan LAF Filter

12 Make-up Air Flow HVAC EXTRACTION UNIT We just need to extract and makeup approx. 20% of the total amount of air, to keep the right Humidity and Temperature levels.

13 Extraction Air Flow This circuit is in charge of the fine pressure control. Large HVACs have a high response time when a modification in the air flow (pressure, speed, ) is required, due to its size and related inertia. Through this extraction pipe, the main control system is able to ensure a very fast and precise pressure control for each single section. Exhaust

14 Case study: vials filling under 100% Nitrogen atmosphere Filling Line specification: Small batches: vials per batch Filling speed: 70 VPM Single format: 5 ml Multiple filling volumes: 1.5, 3, 5 ml Extremely expensive products 100% IPC Aseptic, NON-toxic product

15 Case study: vials filling under 100% Nitrogen atmosphere Filling Line specification: Small batches: vials per batch Filling speed: 70 VPM Single format: 5 ml Multiple filling volumes: 1.5, 3, 5 ml Extremely expensive products 100% IPC Aseptic, NON-toxic product Customer requirements: Isolation technology with CLASS C background Oxygen residual inside the vials close to 0%

16 Case study: vials filling under 100% Nitrogen atmosphere 1. Nitrogen purging station 2. Nitrogen flushing of the complete isolator

17 1. Nitrogen purging 1 st step: Vials are purged with nitrogen before and after filling

18 1. Nitrogen purging 2 nd step: Filled vials are flushed with nitrogen up to the capping station Tunnel to flush the filled vials with nitrogen

19 1. Nitrogen purging 3 rd step: A concentrated nitrogen cloud is created around the capping area Nr. 2 nitrogen ejectors

20 2. Complete filling isolator is pressurized with nitrogen Accumulation table area Standard air flow Capping area Standard air flow Filling & Stoppering area 100% Nitrogen flow

21 Isolator pressure cascade Accumulation Table + 55 Pa Tunnel cooling zone + 45 Pa Filling & Stoppering + 60 Pa N2 Capping + 45 Pa Air trap + 0 Pa Room + 30 Pa Room + 15 Pa

22 Isolator pressure cascade AIR AIR N 2 AIR AIR +N 2 N 2 N 2 AIR +N 2 AIR Exhaust + 45 Pa Tunnel cooling zone Exhaust + 55 Pa Accumulation Table N2 recycling + 60 Pa Filling & Stoppering Exhaust + 45 Pa Capping + 0 Pa Air trap

23 Residual O 2 results Nitrogen vial flushing (only): Approx. 1% of residual O 2 Difficult validation procedure: O 2 analysis on samples Nitrogen vial flushing + Complete isolator nitrogen flushing: <1% forwarding to 0% of residual O 2 Easier validation approach, due to the possibility to monitor the O 2 level inside the isolator

24 IMA portfolio for aseptic filling single stop shopping..

25 ANY QUESTIONS? Marco Preus Isolation technology Product manager Shane Sipthorp Selpak