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Welcome to my graphical Knowledge summary Dussex Jean-Charles Via pizzamiglio,9 CH-6833 Vacallo FROM IDEA TO APPLICATION.

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Presentation on theme: "Welcome to my graphical Knowledge summary Dussex Jean-Charles Via pizzamiglio,9 CH-6833 Vacallo FROM IDEA TO APPLICATION."— Presentation transcript:

1 Welcome to my graphical Knowledge summary Dussex Jean-Charles Via pizzamiglio,9 CH-6833 Vacallo FROM IDEA TO APPLICATION

2 TQMS-1 Summary of system actors

3 TQMS-1 Presentation in Work breakdown structure style

4 TQMS-2 Procedure deviation process according to deviation criticality

5 TQMS-3 Process parameter design space

6 TQMS-4 Validation workflow

7 Risk analysis Filter dryer Failure Mode Effect Analysis-01

8 Risk analysis Cause Effect Diagram: sampling sys. no powder transferred

9 Some concepts Process transfer and Equipment qualification Process transfer Equipment Qual.

10 Personnel flow, room pressure and class Example of Room layouts and symbols

11 Personnel flow Factory entrance

12 Personnel flow Class D surrounding area

13 Personnel flow Specific workplace in qualified room

14 Factory planning-P26 Water system

15 Pre-URS discussion for project definition Chromatography system pre-layout

16 Pre-URS discussion for project definition Chromatography system Project pre-layout phase 1

17 P and ID symbols Drawing symbols (CAD)

18 Filter dryer flow inversion static drying Development and test of new drying concept/components Load slurry Dry Move cake Discard In order to develop new concepts/components to be applied in filtering/drying applications, we test, using a simple PE Bucket: New discarding valve (SAV) New filter sinter plate Pneumatic conveying of dried product. New discarding cyclone In order to develop new concepts/components to be applied in filtering/drying applications, we test, using a simple PE Bucket: New discarding valve (SAV) New filter sinter plate Pneumatic conveying of dried product. New discarding cyclone Well Done. After results computing, we decide to proceed with integrations of the concept/components to the entire range of filters/dryers we are using or prototyping.

19 Filter dryer flow inversion drying tray model Filter dryer-NEW study of critical contamination points

20 Filter dryer flow inversion static drying container Filter dryer-NEW study of critical contamination points

21 Filter dryer flow inversion ancillary equipments Schematic flow of drying operations

22 Filter Dryer modules with sampling Filter 8 inch modified for integration in glove box model 2

23 Filter Dryer modules with sampling Filter 8 inch modified for integration in glove box model 3ed2

24 Filter dryer DN150 based Filter glass DN-150 with heating Layout of filter dryer with in line heater unit. Integrated mass flow controller and flash heating assembly Layout of filter dryer with in line heater unit. Integrated mass flow controller and flash heating assembly

25 Containment glove box-P13 Glass reactor units, skid mounted into glove boxes P-13

26 Containment glove box-P13 Reactor Skid and special vacuum line

27 Containment for filtering/drying Filter 10 inches in glove box, pre-layout

28 Containment area for biotech Clostridium high contamination risk lab layout ed2

29 Automated micro powder dryer-P26 Layout -1 with one outlet candle filter

30 Automated micro powder dryer-P26 Layout -4 brainstorming with customer technical staff

31 Automated micro powder dryer-P26 Final Head configuration layout (decisional to establish URS)

32 Vortex Powder management Powder management under vacuum Model integrated in glove boxes, corrected after risk analysis FMEA Basic model used to develop process

33 HELIX FLASH DISTILLATION Liquid distillation model Inert material construction No moving mechanical parts temp range RT+10 to 300°C (for Glass Model) Pressure range +0.5 to absolute vacuum Product/°C contact 5-10 seconds for water equivalent viscosity Typical use, separation of two fractions. Can be series mounted for multi-fractions distillation. Used to distillate thermo sensible products. Inert material construction No moving mechanical parts temp range RT+10 to 300°C (for Glass Model) Pressure range +0.5 to absolute vacuum Product/°C contact 5-10 seconds for water equivalent viscosity Typical use, separation of two fractions. Can be series mounted for multi-fractions distillation. Used to distillate thermo sensible products.

34 HELIX FLASH DISTILLATION Melting solids distillation model Adding the powder feeder and the in-line melting unit to the liquid distillation model; its possible to distillate melting solids wit the “Helix” A proved application is purification of DTE. Adding the powder feeder and the in-line melting unit to the liquid distillation model; its possible to distillate melting solids wit the “Helix” A proved application is purification of DTE.

35 PASS BOX Final packaging of pharmaceutical / different rooms

36 CIP VENTURI BASED RINSE STEP The separator tank (3) is filled trough one of the two separator tank waffer filling valves(1). The supply pump (2) draw the water from the tank (3) and deliver the solution to the process trough the discharge control valve (4) at the programmed flow rate. At the same time, solution is pumped trough the venturi eductor (5) and back into the separator tank (3) inlet, thereby ceating a vacuum at the CIP return connection. The high turbulence created within the circuit prevents settling of any solid and provides self cleaning of the system. The rinse step is followed ba drain step. Tipically, a serie of 3-4 rinse/drain steps are utilised for the final rinse proven by low conductivity at the Cip return connection.

37 CIP VENTURI BASED DRAIN STEP The discharge control valve (4) is closed and solution from the separator tank (3) is pumped trough the venturi eductor (5) and back into the separator tank (3) inlet, thereby ceeating a vacuum at the CIP return connection. Returning solution create a high-level condition in the separator tank (3) causing the drain control valve (6) to bleed solution to drain at the set flow rate until the process and the separator tank (3) are empty.

38 CIP VENTURI BASED WASH STEP The separator tank (3) Is filled trough one of the the two separator tank water fill valve (1). The supply pump (2) draws the water from the separator tank (3) and deliver the solution trough the process trough the discharge control valve (4) t the programmed flow rate. At the same time, solution is pumped trough the venturi eductor (5) and back into the separator tank (3) inlet, thereby creating a vacuum at the CIP return connection. he high turbulence created within the circuit prevents settling of any solid and provides self cleaning of the system. CIP solution temperatures are elevated using the a heater (7) in the recirculation loop. Chemical solutions (8) are injected into the highly turbulent separator tank (3) and controlled trough conductivity..

39 Bioreactor P&ID 30 LITER BIOREACTOR

40 Project management flows in API processing 7901 custom manufacturing, customer requirements for VMP A customer need to manufacture a new API for clinical trials Phase III. In order to fix the Validation requirements for this process, graphical representation was lay down

41 Project management flows in API processing 7901 graphical batch record test for presentation

42 Project management flows in API processing 7901 Graphical Equipment Configuration sheet After Process batch record was defined, a graphical representation of required equipment configuration was lay down

43 Project management flows in API processing 7901 Graphical micronisation external supplier control form-1 Crystalline API will be Micronised by an approved external supplier. The form on left details the Product shipment and receiving protocol page 1

44 Project management flows in API processing 7901 Graphical micronisation external supplier control form-2 Crystalline API will be Micronised by an approved external supplier. The form on left details the Product micronisation and back receiving protocol page 2

45 Project management flows in API processing 7901 Graphical example, yield sheet Process and Yield comparison between external suppliers performing micronisation


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