Wednesday, April 29, 2009

sterile area specification

Cleaning of compresses air filters. (Shavo-Norgren) Cleaning of DM water storage tank. Setting of vials washing machine. Fixing of filter of down-flow unit and to check working. Adjust manometer oil to zero. If HEPA is removed, check DOS test and air velocity. Keep SS boxes washed with DM water. Fix cleaned DM water filters in respective housings. Check all tubing, if required, changed them. Cleaning of split AC filters.
RUBBER STOPPERS TREATMENT
Get the washing machine cleaned thoroughly. Check connections of steam and DM water line. Clean SS Pall filters, GS filter and in-line. Clean SS pots and lids. Clean distilled water storage tanks and 20 Lt. capacity pressure unit. Keep in the area, plastic containers required to soak the stoppers. Clean membrane holder assembly and refill it. Fix filter of air down-flow unit and check working. If HEPA is removed check DOS test and air velocity. Set manometer oil level upto zero. Check availability of Benzalkonium Chloride & Hydrochloric Acid in washing area.
STERILZATION
Clean, dry and connect distilled water storage tank. Check working of thermostatic control. Run distilled water plant for 2-3 hours and discard the collection. Check leakages if any during run of distilled water plant. Check water conductivity. Get chemical analysis of distilled water done. Check rate of distilled water collection per hour. Check cleaned SS Pall filter is fixed to the DM water inlet before running the plant. Check working of autoclave thermograph. Check inkbottle for sufficient quantity of link. If possible, calibrate thermograph. Normal servicing of autoclave is done by vendor. Run autoclave for 30 minutes and observe any leakages through steam valves, door gasket and joint. Check working of dial thermometer. Check fixing and conditions of air in-let filter. Check working of pressure gagues. Clean the autoclave with distilled water and Benzalkonium Chloride solution before operating. Clean carriage of sterilizer chamber with vacuum cleaner and then with distilled water and sponge. Cleaning carriage of sterilizer with diluted Hydrochloric Acid and then with water. DOP test of HEPA filter module and air velocity. Run dry sterilizer empty at 300 ÂșC for 1 hour to check its heating and cooling functions. Check working of thermograph for temperature and time and working of HEPA filter after heating cycle. Checks working of inter locking system of autoclave and dry sterilizer. Check hot air leakages through door gasket. COMPOUDING ROOM Check working of homogenizer. Replace N2 25 mm filter. Connect N2 line for sparging and filtration. Remove unwanted material from tables in compounding room. Keep back material removed from sterile area. Replace all UV tubes after noting intensity. Provide new sippers for operators. Check working of conveyer & filling machine. Check grease in filing machine. Check all nitrogen, oxygen and LPG gas lines for working and leakages. Check all gas liners are correctly identified. Check the pressure of room and change rooms. Check temperature of filling room. Replace old sponge used for wiping foot soles change room. Calculate air change per hour from velocity of air through each terminal HEPA filters. Open all return air riser dampers. Check working of fumigation switch and plate. Get area cleaned with 0.5 % Aarshol again before starting fumigation. Check working of down-flow unit, portable laminar including DOP test and air velocity. Check working of ampoules filling machine if required. SEALING ROOM
Run machine without vials for few minutes. Observe any abnormal sound. Take trial of 2 ml vials sealing. Lubricate the machine and keep ready for use. Thoroughly wipe and clean vibrator with 70 % IPA.
INSPECTION ROOM
Keep batch ready in inspection room. Remove labels of the product other than those that are under inspection. Take trial of machine without vials. LABELLING ROOM Keep batch and labels ready for labeling on the first day of the start up. Keep about 3.0 kg. Gum Acacia in container. Remove previously labelled products from area. Check al accessories required for labeling. PACKING ROOM Keep packing materials, batch ready for packing. Check all accessories required for packing. Confirm line clearance before packing start up.
DM WATER PLANT
Formaldehyde treatment and double regeneration of DM water plant. Formaldehyde treatment should be given only if viable counts are high. Check DM water free from acid, alkali, formaldehyde traces for pH. Clean SS storage tank used for multicolumn distillation still.

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