SMF WATER SYSTEMS. (PIC/S July.2004) By Anand Kuptamatee Thai FDA Conference September 19-21, 2005

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1 SMF WATER SYSTEMS (PIC/S July.2004) By Anand Kuptamatee Thai FDA Conference September 19-21, 2005

2 DESCRIPTION OF WATER SYSTEMS CONTENT: Water Purification Process System capacity Construction materials

3 DESCRIPTION OF WATER SYSTEMS CONTENT: Filters specification Water temperature Produced water specifications

4 DESCRIPTION OF WATER SYSTEMS CONTENT: List of sampling points and frequency testing Procedure and frequency for sanitation

5 SMF, WATER SYSTEMS EXAMPLE -Potable water system -Purified water system -Water for injection system

6 1.Potable Water System Potable water is supplied to the site by metropolitan water work Authority and stored in an eighty cubic metres, concrete tank coated with epoxy paint.

7 POTABLE WATER SYSTEM It is passed through sand/gravel to metal tank, coated with epoxy paint and injected with sodium hypochlorite which stored in a twenty cubic metre reinforce fibre glass tank lined with PVC.

8 POTABLE WATER SYSTEM The water is circulated via HDPE pipings to all site for general cleaning purposes and as feed water for water purification.

9 POTABLE WATER SYSTEM The water is daily monitored and sampling for routine quality control test which include maintaining chlorine level.

10 POTABLE WATER SYSTEM The system is routine sanitized by regular backwashing of sand filter on weekly basis. In addition the piping and water reservoirs are periodic cleaned and drained for every three months.

11 2.Purified water (USP.24) Water for manufacturing purposes are treated with auto-regeneration supply plant and high quality, dead leg free stainless steel distribution system.

12 2.Purified water (USP.24) Potable water is passed through Carbon filters and organic trap filter and demineralised by passage through Cation,Anion and Polishing Cation bed resins respectively at the maximum rate of 0.5 cubic metre per hour.

13 2.Purified water (USP.24) The demineralised water is passed through series of 6 µ, 2.5 µ filters and UV-lamp before being stored in a 11,000 L 316 stainless steel storage capsule tank fitted with heated vent filter, 0.2 micron pore size.

14 2.Purified water (USP.24) The water is automatic maintained at C.Temperature, Conductivity and TOC monitors are located on the loop with alarm if their limits were exceeded. It is circulated 24 hours with UV-lamp in the circulation loop.

15 2.Purified water (USP.24) The demineralised water system is subjected to a routine maintenance program which include automatic daily backwashing of filters/ regeneration of bed resins and replacement of filters.

16 2.Purified water (USP.24) The sanitization process is performed by heating up to 80 0 c. Of the water distribution system and cool down only once a month or as necessary.

17 2.Purified water (USP.24) Input and purified water are sampled through sampling ports provided and tested daily and weekly for Chemical and Microbiological qualities respectively refer plan of Demineralized water distribution system (see Appendix)

18 3.Water For Injection System Demineralised water from the factory plant is used as feedstock for the thermocompression still with output of 350 litre per hour.

19 3.Water For Injection System The still located in an area closed to the sterile preparation area provides distilled water for all components washing and manufacture. It is also fed to the clean steam generator linked to the autoclave.

20 Water For Injection System Distilled water is collected in a 2,000L. 316 stainless steel holding tank fitted with a hydrophobic air vent filter 0.2 micron pore size and held at a minimum temperature of 80 0 c. Water is pumped from the tank and circulated continuously through a loop which services four points

21 Water For Injection System System constructed of 316 stainless steel piping and tank construction is crevice free and polished. Pipework is sloped to allow drainage and has been designed to avoid deadlegs.

22 Water For Injection System These pipes are sanitised by steam as necessary. Drains are designed and constructed to prevent back-syphonage.

23 Water For Injection System Water output quality from the still is monitored for Temperature, Conductivity and TOC. Alarms are activated if those limit are exceeded.

24 Water For Injection System Water collected from the still sampling port complies with the requirements of the USP/BP for water for Injection for Chemical, Microbial and Endotoxin qualities on weekly basis.

25 APPENDIX SYSTEM BASIC SCHEMATIC OF PURE WATER PLANT RECYCLE IN TO FEED WATER TANK HEAT EXCHANGE UNIT HEAT EXCHANGE UNIT RAW WATER INLET ORGANIC SCAVENGER CARBON FILTER RAW WATER PUMP SAMPLE TAP ST/SQW1/008 BAG FILTER 50 µ PRIMARY CONDUCTIVITY SAMPLE POINT SSP /SQW1 /084 FILTER 2.5 µ PRIMARY UV STERILIZER SAMPLE POINT SSP /SQW1 /080 FILTER 6 µ SAMPLE POINT SSP/SQW1/077 SAMPLE POINT SSP /SQW1 /073 SCION HIPOL DEINIZER FEED WATER PUMP FILTER 10 µ SAMPLE TAP ST/SQW1/058 FEED WATER TANK 1 M 3 SAMPLE TAP ST/SQW1/042 SAMPLE TAP ST/SQW1/034 SAMPLE TAP ST/SQW1/028 COOLING WATER SUPPLY RAW WATER TANK 0.5 M 3 FEED INTO PURE WATER TANK ACID AND CAUSTIC DAY TANKS LOOP RETURN SAMPLE POINT SSP /SQW1 /458 SECONDARY UV STERILIZER SAMPLE POINT SSP /SQW1 /456 COOLING HEAT EXCHANGE UNIT SECONDARY CONDUCTIVITY STERILE CEPHS STILL BOILER ROOM STERILE LIQUID PREPERATION STERILE LIQUID STILL STEM SUPPLY STERILE LIQUID LAUNDRY SINK STERILE LIQUID GARMENT WASH TABLET SYRUP PAN PACKING BOTTLE WASH HEAT EXCHANGE UNIT ORAL LIQUID SINK ORAL LIQUID SYRUP PAN CREAM MIXER CREAM SINK PURE WATER TANK 11 M 3 SAMPLE POINT SSP /SQW1 /408 PURE WATER PUMP