QUALITY UPDATE Paul Newell Quality & Systems Manager WINNERSH NOV 2011 WINNERSH JULY 2012 8 SEALED STAINLESS STEEL MIXING VESSELS MIXING VESSELS & RAW MATERIALS WITHIN BUND TO CONTAIN ANY SPILLAGE PUMPS, MOTORS, LIGHTING, FORK LIFT TRUCKS ALL EXD RATED MIXING VESSELS LIQUIDS PUMPED INTO VESSEL FROM FLOOR LEVEL FEED PIPE INSIDE VESSEL GIVES BOTTOM FILL SOLID RAW MATERIALS ADDED VIA MANWEIGH HATCH FIRE TRIANGLE ALL 3 ELEMENTS NEED TO BE PRESENT FOR A FIRE TO OCCUR NITROGEN IS USED TO REMOVE OXYGEN FROM MIXING VESSEL & FEED PIPES GROUNDING & BONDING ARE USED TO MINIMISE SPARK GENERATION NO FREE-FALL OF SOLVENTS OR RAPID PUMPING SAFETY FEATURES NITROGEN GAS USED TO PURGE PIPES & MIXING VESSEL NITROGEN GENERATOR IN SEPARATE UNIT WITH COMPRESSORS GROUNDING & BONDING SAFETY FEATURES EARTHING STRAPS CONNECTED TO RAW MATERIAL CONTAINERS NITROGEN GAS ADDED TO RAW MATERIAL CONTAINERS SAFETY FEATURE S OVERFILL PROTECTION FITTED TO ALL VESSELS AUDIBLE & VISIBLE ALARM IF NITROGEN PRESSURE IS TOO LOW ENVIRONMENT PROTECTION EXTRACTED AIR FROM FACTORY & LABS IS PASSED THROUGH CARBON FILTERS COMPLIES WITH ENVIRONMENTAL LEGISLATION ENVIRONMENT MONITORING DAILY CHECKS ON VOC LEVELS INSIDE FACTORY CRITICAL SERVICES MONITORING COMPRESSORS, NITROGEN GENERATOR & EXTRACTION CONTROLLERS LOCATED IN PURPOSE BUILT UNIT ALL EQUIPMENT CHECKED X2 EACH DAY & RESULTS RECORDED SAFETY FEATURES EMERGENCY SHOWER LOCATED ADJACENT TO MIXING AREA SEPARATE EYEWASH STATION CHECKED MONTHLY FOR OPERATION FINISHED GOODS & PACKING EXTERNAL STORAGE QC LABORATORY MAINTENANCE ROOM STORAGE FOR EQUIPMENT SPARES & TOOLS BENCHES FOR LIMITED AMOUNT OF REPAIR WORK STORAGE AREA FOR RETAINED SAMPLES 1 LITRE SAMPLE OF ALL BATCHES RETAINED FOR SHELF LIFE OF PRODUCT GROUPED BY PRODUCT TYPE FINISHED GOODS STORAGE ORDER PICKER USED TO REACH TOP OF RACKS ORDER PICKER FITTED WITH VOC MONITOR ELECTRONIC GUIDE LINES IN FLOOR TO MAINTAIN CENTRAL POSITION PALLET WRAPPING AUTOMATIC STRETCH WRAPPING WE CAN ALSO WEIGH FINISHED PALLETS ON THIS MACHINE RAW MATERIAL TESTING WATER CONTENT OF RESINS & SOLVENTS RAW MATERIAL TESTING FTIR ON LIQUIDS & SOLIDS VS APPROVED REFERENCE SAMPLE RAW MATERIAL TESTING SOLIDS CONTENT OF LIQUID RESINS RAW MATERIAL TESTING - VISCOSITY RAW MATERIAL GOODS-IN LABELLING AWAITING INSPECTIONCLEARED FOR PRODUCTION USE MANUFACTURING CONTROLS TANK 1 MISCELLANEOUS TANK 2 1B51 FAMILY TANK 3 1B73 FAMILY TANK 4 1A33 FAMILY TANK 5 THINNERS & STRIPPERS TANK 6 UV40 FAMILY TANK 7 - 1B31 FAMILY TANK 8 1R32A-2 FAMILY MIXING VESSELS DEDICATED TO PRODUCT TYPES MANUFACTURING CONTROLS MIXING VESSELS DEDICATED TO PRODUCT TYPES DEDICATED MIXER FOR WATER BASED GRADES DEDICATED MIXER FOR GELS LOW VOLUME PRE-BLEND PRODUCTS MIXED IN DRUMS FLUSHING REGIME USED FOR ALL MIXING VESSELS & DISPENSING PUMPS TO ELIMINATE POSSIBILITY OF CROSS CONTAMINATION DEDICATED AREA FOR FILLING OF SYRINGES & CARTRIDGES MANUFACTURING CONTROLS BATCH RECIPE SYSTEM UNIQUE TO HUMISEAL RAW MATERIALS ADDED BY WEIGHT MIXING VESSELS FITTED WITH LOAD CELLS ALARM IF RM WEIGHT TARGET EXCEEDED COMPREHENSIVE BATCH REPORT FINAL INSPECTION VISCOSITY 25C centipoises) SOLIDS (% of non-volatiles by weight) DENSITY OR SPECIFIC GRAVITY (grms/cc) FINAL INSPECTION TACK FREE TIME (minutes before coating is touch dry) APPEARANCE (clear of bits) FLUORESCENCE (UV tracer is present - or absent if 1B73 LED) FINAL INSPECTION PYMS (NEW) - PY ROLOSIS M ASS S PECTROSCOPY SAMPLE IS HEATED TO RELEASE VOLATILE CONSTITUENTS VOLATILES PASS THROUGH A COLUMN RETENTION TIME IN COLUMN DEPENDS ON CHEMICAL TYPE MASS SPECTROMETER ANALYSES CHEMICAL STRUCTURE OF EACH INGREDIENT AFTER IT LEAVES COLUMN DETECTS IF CORRECT INGREDIENTS ARE PRESENT DETECTS IF ROGUE INGREDIENTS ARE PRESENT KEY EVENTS 2012 EXIT FROM CAMBERLEY -JAN COMPLETION OF EQUIPMENT INSTALLATION JAN CREATION OF SOPs FOR MANUFACTURE, DISPENSING, LABELLING & DESPATCH JAN /FEB OPERATOR TRAINING JAN/FEB CLEANING & VALIDATION OF MANUFACTURING VESSELS - FEB FIRST PRODN. BATCH FEB. 1B31 HE8000 US DOD MIL SPEC AUDIT - MAY TRIAL BATCH UV40 - JULY TRIAL BATCH UV AUG WORLD CLASS PERFORMANCE MAXIMUM OF 3.4 DEFECTS PER MILLION (3.4 PPM) WORLD CLASS PERFORMANCE SIGMA LEVELPPM ,500 66,800 46, IF MANUFACTURE 40,000 LITRES PER MONTH, 6 SIGMA MEANS NO MORE THAN 3.4 LITRES REJECTED IN 25 MONTHS SUMMARY SAFETY IS TOP PRIORITY STATE OF THE ART FACILITY & EQUIPMENT MODERN MANUFACTURING CONTROLS INCREASED LEVELS OF RAW MATERIAL TESTING ADDITIONAL PYMS TESTING AT FINAL INSPECTION CONTINUE TO MONITOR KEY PERFORMANCE INDICATORS AIM TO CONTINUALLY IMPROVE OUR BUSINESS PROCESSES SETTING AMBITIOUS 6 SIGMA TARGETS