Case Study Neubau einer Parenteralia Fabrik 3. GMP-Forum, Kirchzarten 28. September 2012, Basel. Philip Schneider, F.

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1 3. GMP-Forum, Kirchzarten 28. September 2012, Basel Philip Schneider, F. Hoffmann-La Roche

2 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

3 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

4 Introduction High Rack Warehouse NPK Bldg. 235 Bldg. 231 Final Packaging Bldg. 232 Liquid vials Compounding Pre-filled Syringes Lyophilization Materials in/out 4

5 Introduction GMP compliance and quality requirements of all countries/markets Use of existing infrastructure: High rack warehouse and AGV (Automated Guided Vehicles) Service building Modular concept No complete shutdown during annual maintenance Planned Maintenance of one module without affecting remaining modules Robust aseptic processes (Isolator or RABS) Product lead times of 3 to 5 days from compounding to warehouse (liquid products). Extension of lead time for lyo.-products depending on lyo-cycle time Paperless plant, Electronic Batch Recording 5

6 Introduction Lyophilization Pre Filled Syringes Compounding Liquid Vials 6

7 Introduction 2 nd Floor Technical floor: - HVAC - Electrical Class CNC Class D 1 st Floor Production floor: 1. Vials lyophilized 2. Pre-filled syringes liquid 3. Compounding / Equipment cleaning 4. Vials liquid Class C Class A/B Support floor: Gowning, break room, offices, meeting rooms and laboratories Basement Support floor: Visual inspection, clean media generation and material in/out, cool storage stopper washing, thawing 7

8 Introduction Compounding Liquid Vials Perfilled syringes Lyophilised Vials Isolator 8

9 Introduction Liquid Vils Compounding Prefilled syringes 9

10 Introduction 10

11 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

12 Decontamination Cycle Process steps of a decontamination cycle 1. Pressure decay test of isolator 2. Dehumidification 3. VHP-cycle (Conditioning) 4. VHP-cycle (Decontamination) 5. Aeration VHP=Vaporized Hyrogen Peroxide

13 Experiences with Isolator Technology Decontamination Cycle Development Selection of materials within the isolator is important (i.e. silicone absorbs VHP, leading to long aeration times) Careful assessment of isolator loading prior decontamintation (the bigger the surface the longer the cycle) D-values of surface materials need to be known Development of cycle using bio-indicators (Geobacillus stearothermophillus)

14 Decontamination Cycle Determination of worst case areas for 6-log-reduction within the isolator (technical changes of the equipment might be necessary to enable VHPexposure)

15 Decontamination Cycle Validation/Re-validation Initial validation cycle with 3 consecutive runs Annual re-validation Re-validation in the event of changes (i.e. change in set-up loading of isolator)

16 Decontamination Cycle General aspects Decontamination Sterilisation (6-log-reduction for VHP-decontamination) A decontamination cycle takes time (change over!) Several conditions have impact to activity of VHP (i.e. temp. of surfaces) Sensitivity of materials, surfaces and product against VHP needs to be evaluated Covered surfaces during cycle need special attention

17 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

18 Set-up and change over Format change is not possible while isolator is closed (impact to line capacity in case of multi-format line) Format parts are installed prior VHP-decontamination while isolator is open (exposure to class D!) Measures to control bioburden prior VHP-decontamination is necessary (i.e. additional gowning requirements, cleaning of surfaces) Special measures necessary for equipment with product contact which is not sterilized in place (e.g. stopper bowl) Line clearance after test runs prior VHP-decontamination need special attention (i.e. in case of use of non-sterile rubber material)

19 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

20 Aseptic connections Zone C Laminar Flow SIP Dispensing & Compounding Zone D Sterilisation, Filling & Stoppering SIP Laminar Flow Zone A Filling & Stoppering Stoppers Material Transfer

21 Aseptic connections 21

22 Aseptic connections 22

23 Aseptic connections Hook-up to Isolator Hose connection 23

24 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

25 Glove handling and testing Common glove materials: Hypalon, PVC, Neopren (currently being tested at Roche s new lyo line in Kaiseraugst) Definition of frequency testing and changing of gloves required Glove testing Visual Pressure decade Definition of corrective measures in case of glove defect while filling (i.e. glove change, use of sterile tape)

26 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

27 Interventions Distinction of intervention (closed isolator) Routine intervention All intervention which are necessary during filling (i.e. collection monitoring plates) Non-Routine interventions All interventions which do no take place during filling (i.e. removing glass splinters after breakage) Limited access and space to solve all technical problems with interventions Detailed description of interventions in SOPs Training of intervention (a dummy isolator is helpful) Qualification operators by simulating interventions during media fills

28 Content Introduction Decontamination cycle Set-up and change over Aseptic connections Glove handling and testing Interventions Media Fills

29 Media Fills Initial aseptic validation of a new filling line by 3 consecutive media fills operators performing all routine interventions Annual media fills for Re-validation of filling line (typically after maintenance) Re-qualification of operator Performance of routine interventions and simulation of non-routine interventions Incubation at 25 C and 35 C for 7 days each; reading after each incubation temperature Experience so far: Approx. 15 media fills performed, no positive finding!

30 Pro & Contra Pro High level of sterility assurance during interventions Design of zone concept allows easy access to filling line w/o gowning Contra Time intense activities prior and post processing Limited flexibility in case of multi-format lines Not all technical issues can be solved via interventions at closed isolator

31 We Innovate Healthcare

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