Systems for Pharmaceutical GMP Environments

Transcription

1 Titelmasterformat The Application of CFD in durch the Design Klicken of Building bearbeiten Services Systems for Pharmaceutical GMP Environments Mr. Kevin Lynch, Prochem Engineering Mr. Seamus Holohan, Prochem Engineering 23 rd & 24 th November Engineers Ireland, Dublin

2 Presenters Kevin Lynch Building Services Director Seamus Holohan CFD Lead

3 Outline of Presentation Prochem - Who We Are Prochem What We Do CFD Journey at Prochem How CFD is used to support design Discussion

4 Background 21 Kilkenny Engineering Design Consultancy Process and Building Services Pharmaceutical

5 Clients

6

7 GMP Good Manufacturing Practice A regulatory system which ensures Pharmaceutical manufacturing facilities maintain clean and hygienic manufacturing areas, with controlled environmental conditions to prevent cross contamination of drug product from adulterants that may render the product unsafe for human consumption.

8

9

10

11

12 CFD Journey at Prochem FUSION Programme in September 2009 with the University of Ulster Software Evaluation Steady State Simulation with basic CFD software Client requirements for Transient Simulations using ANSYS

13 Building a CFD model Room design criteria- temperature and relative humidity Types and locations of supply and return diffusers Equipment and object locations within room Heat sources Temperature of neighbouring rooms Room pressure regimes in relation to neighbouring rooms

14 Why Use CFD? Determining problematic locations within room Identifying stagnant pockets of air Identifying thermal performance of various areas of room Excellent visual presentation format to clients Ability to modify design before construction Non destructive testing of existing facilities

15 CFD Project at Biotechnology Facility Biotechnology is the controlled and deliberate exploitation of biological systems (.i.e. living cells or cell components) for the efficient manufacture or processing of useful products

16 CFD Project at Biotechnology Facility CFD was used to Help determine air change rate reduction limits Ensure ISO 8 Cleanroom cleanliness levels were maintained Calculation inputs were determined from CFD models

17 CFD Project at Biotechnology Facility

18 CFD Project Pharmaceutical Client Waterford

19 CFD Project Pharmaceutical Client Waterford - Objective Confirm room thermodynamic performance before construction Operational Conditions Temperature ± 1ºC and Relative Humidity ±3% RH Shortlisted for Innovation of the Year at Pharma Industry Awards 2015.

20 CFD Project Pharmaceutical Client Waterford Exisiting Equilibration rooms required 120 ACH to achieve room requirements with sound levels exceeding 80dBa A medium velocity induction system would allow close control of temperature and relative humidity The warehouse was able to achieve the same conditions using 15 ACH After validation was completed, 24 calibrated temperature and humidity probes were installed in the warehouse to map the operation condition

21 CFD Project Pharmaceutical Client Waterford

22 CFD Project Pharmaceutical Client Waterford - Outcome CFD helped ensure that mechanical design achieved desired outcome Significantly quieter than the existing facilities, and consequently more comfortable for operatives Reduction from 5000 kw/hr/yr per pallet space to 2800 kw/hr/yr 44% lower energy consumption requirements per pallet space than the existing facilities, reducing manufacturing cost of product Client confidence prior to construction

23 ONGOING - Transient simulation at BioPharma Facility

24 Simulation Criteria: Room temperature of 5 C ± 3 Initial product temperature of 8 C Room recovery time of 10 minutes Product pull down time of 12 hours External temperatures of 22 C Evaporator operating strategies

25 CFD Purpose - To simulate the thermal performance of rooms in the following scenarios: Product move in and temperature reduction Room recovery time following typical door opening cycles Room recovery time following door left open for extended time Changeover between run and standby systems Defrost cycle

26 Product move in and temperature reduction

27 Room temperatures above 8 C following door open for 1 minute

28 Room recovery time following typical door opening cycle of 1 minute

29 Room temperatures above 8 C following door open for 5 minutes

30 Room recovery time following extended door opening cycles

31 Changeover between run and standby systems

32 Defrost scenario

33 Discussion

34 Contact Details: Prochem Engineering Limited, 14 Danville Business Park, Kilkenny, Tel: Website: