HVAC4_0506

MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS : 

1 MCC PRESENTATION - GMP MANUFACTURING ENVIRONMENTS Presented by : Deryck Smith Consulting Engineers Module 4

GMP Manufacturing Environments : 

2 GMP Manufacturing Environments Air Handling Systems HVAC Systems Heating Ventilation Air Conditioning Module 4: Pressure Cascades & Building Layouts

GMP Manufacturing Environments : 

3 GMP Manufacturing Environments Topics for this Module: The integration of air conditioning systems and building layouts. The requirements for pressure cascades and how to achieve them. How building finishes and plant components affect facility cleanliness. Pharmaceutical Equipment

Inter-dependence of Air Handling Systems & Buildings : 

4 Inter-dependence of Air Handling Systems & Buildings Building layouts, Pressure cascades, Air handling systems and Pharmaceutical equipment are all inter-related. No one can exist without the other.

What is a Pressure Cascade? : 

5 What is a Pressure Cascade? Pressure Cascade A process whereby air flows from the cleanest area, which is maintained at the highest pressure to a less clean area at a lower pressure.

What Is the Purpose of a Pressure Cascade? : 

6 What Is the Purpose of a Pressure Cascade? Helps prevent cross-contamination between adjacent areas. Helps prevent ingress of contaminants from outside. Is used to enhance separation between areas of different cleanliness. The unit of measurement for pressure is the PASCAL (Pa)

Air Pressure Cascade : 

7 Air Pressure Cascade

Measuring the Air Pressure Cascade : 

8 Measuring the Air Pressure Cascade The pressure differential over the doorway is measured with a portable magnahelic gauge or micro manometer. Permanently installed gauges are preferred.

Room Pressure & Air Movement : 

9 Room Pressure & Air Movement A room pressure cascade system forces air to flow from clean areas to less-clean areas. Directional air movement helps carry contaminants away from a critical process.  Air movement, such as laminar flow (UDAF) over the product, protects the product. (aseptic packing / filling)

Typical OSD Plant : Cross-contamination Protection : 

10 Typical OSD Plant : Cross-contamination Protection What should the room pressures be ?

Dispensary Layout : 

11 Dispensary Layout Is this a good layout ? PIC/S PH 1/97 (Rev.3) #3.3 & 3.12

Improved Dispensary Layout : 

12 Improved Dispensary Layout What should the room pressures be ? Airflow direction

Sampling Booth Layout (1) : 

13 Sampling Booth Layout (1) SAMPLING BOOTH EXTRACT HOOD WAREHOUSE

Poor Design Extract System : 

14 Poor Design Extract System Section Through Sampling Booth

Sampling Booth Layout (2) : 

15 Sampling Booth Layout (2) SAMPLING BOOTH UDAF HOOD AIR LOCK AIR LOCK Step-over-bench CHANGE

Typical Section Through Sampling Boooth : 

16 Typical Section Through Sampling Boooth

What to Qualify in the Sampling Booth Suite : 

17 What to Qualify in the Sampling Booth Suite Cleanroom class – ISO 8 HEPA filter integrity test Airflow rates UDAF velocity Room pressures Containment – smoke tests Temperatures (< 25°C)

Ablution Layout 1 : 

18 Ablution Layout 1 Production Plant Change Room Toilets Staff Staff

Ablution Layout 2 : 

19 Ablution Layout 2 Production Plant Change Room Toilets Staff Staff

Change Room Layout : 

20 Change Room Layout

Protective Garments Outside ?? : 

21 Protective Garments Outside ?? It is pointless having a change room if it is not used properly

Slide 22: 

Sterile Suite Pressure Cascade

Product Flow Diagram : 

23 Product Flow Diagram DISPATCH SECONDARY PACKING PRIMARY PACKING DISPENSARY RAW MAT. RECEIPT PACK. MAT. RECEIPT PACK. MAT STORE MANUFACTURING GMP ZONE PRIMARY PACK MAT. CLEAN DOWN Wood free zone

Staff flow Diagram : 

24 Staff flow Diagram DISPATCH SECONDARY PACKING PRIMARY PACKING DISPENSARY RAW MAT. RECEIPT PACK. MAT. RECEIPT PACK. MAT STORE PRODUCTION STAFF ENTRY CANTEEN CHANGE GMP CHANGE GMP ZONE PRIMARY PACK MAT. CLEAN DOWN

Negative Pressure Facilities : 

25 Negative Pressure Facilities Required for facilities handling potent compounds such as penicillin & hormones. Special precautions required to prevent product contamination from the atmosphere. Exhaust air must be efficiently filtered and safe filter handling must be used.

Safe Change Filters : 

26 Safe Change Filters Used for filtering hazardous materials: Dirty filters are removed into a plastic bag The bag is automatically sealed at the filter unit housing A new filter is inserted via a plastic bag and the cover closed At no time is the operator or the atmosphere exposed to the hazardous powder.

Case Study – Penicillin Plant : 

27 Case Study – Penicillin Plant Add room pressures, Cleanroom class and comment on layout MALE ABLUT. LAUNDRY FINISH. GOODS

Case Study – Penicillin Plant : 

28 Case Study – Penicillin Plant

Building Finishes: : 

29 Building Finishes: In module 1 we discussed the need for all facility components to complement each other. Therefore a good air handling system must be complemented by a building of good design and good finishes. On the next slide we will be looking at some of the Acceptable and Un-acceptable building finishes.

Building Finishes : 

30 Building Finishes

Floors / drains : 

31 Floors / drains Tiled Floor Epoxy Floor

Poor & Good Windows : 

32 Poor & Good Windows Bacteria City !!!

Paint Finish… : 

33 Paint Finish… Not only building paintwork must be considered but also equipment Is there anything wrong with this Tablet Press?

Building & Equipment Finishes : 

34 Building & Equipment Finishes

Services Distribution : 

35 Services Distribution Impossible to clean! Easy to clean!

Keep a Balance : 

36 Keep a Balance Don’t ignore building finishes… … and then go overboard on staff dress code.

Services Distribution : 

37 Services Distribution Where ever possible services should be located behind wall panels Exposed services & pipes are very difficult to clean & sometimes impossible to clean Equipment such as Film Coaters should be enclosed so that only the front face is in the GMP area. This makes cleaning much easier. Make use of service corridors behind equipment (but must be under negative pressure)

Split Unit : 

38 Split Unit Fan liberates dust into the air Condensate drip tray Cooling Coil Poor quality Air filter

Fluid Bed Drier : 

39 Fluid Bed Drier Is the quality of the supply air to the FBD correct? What filtration is used? Is the exhaust air filtered?

Group session : 

40 Group session Airlock

Modified Layout with Cascade : 

41 Modified Layout with Cascade MAL = Material Air Lock PAL = Personnel Air Lock

Product Flow Diagram : 

42 Product Flow Diagram F/G Dispatch Secondary Packing Primary Packing Sampling A/L Raw Mat. Store Released Materials Pack Mat. Store Pharmaceutical Manufacturing Primary Pack Mat. Clean Down Work session: Connect the arrows between processes for Product Flow and Staff Flow Quarantine Sampling A/L Sampling Booth Primary Change room GMP Change Room Dispensary Pre-Staging Dispensary Post-Staging Dispensary Weiigh Booth

Product Flow Diagram : 

43 Product Flow Diagram F/G Dispatch Secondary Packing Primary Packing Sampling A/L Raw Mat. Store Released Materials Pack Mat. Store Pharmaceutical Manufacturing Primary Pack Mat. Clean Down Work session: Connect the arrows between processes for Product Flow and Staff Flow Quarantine Sampling A/L Sampling Booth Primary Change room GMP Change Room Dispensary Pre-Staging Dispensary Post-Staging Dispensary Weiigh Booth