本模塊作為審核指南，完成模塊中內(nèi)審的考核以確定被審公司是否符合可樂(lè)要求YesDivNo341) Questionnaire: pDoes the plant follow the Company requirements on Auxiliary Materials? 2 原材料方面工廠符合公司要求1. Is the plant only buying Activated Carbon and/or Liquid Nitrogen fromDivision authorized suppliers and supply points?2工廠所購(gòu)活性碳和液氮是來(lái)自于認(rèn)可供應(yīng)商的嗎Does the plant use Company Specifications for the Activated Carbon?工廠用的活性碳標(biāo)準(zhǔn)是來(lái)自公司的嗎Are Company requirements on Activated Carbon and its receipt followed?符合公司的活性碳和接收要求Does the plant follow Company Specifications and Requirements on LiquidNitrogen? 5工廠的液氮都符合公司的標(biāo)準(zhǔn)和要求Does the plant follow Company Specifications and Requirements on Nitrogen EnrichedAir? 6工廠液氮的收集都符合公司的要求嗎Are the recommendedcompositions used for specific auxiliary materials used in the Water Treatment? 7用于水處理輔材中所用的推薦成份嗎Are the recommendedcompositions used for specific auxiliary materials used in sweetener treatment and bottle washers? 15用于糖料和洗瓶機(jī)的輔材中用的推薦成份嗎Are all GMP issues covered for the storage of auxiliary materials? 16GMP函蓋了輔材一塊嗎2) Reference Standards List:Beverage OperationsManualBO-SP- 280BO-SP- 285General Specifications for Auxiliary Materials Activated Carbon for Water TreatmentBO-SP- 335BO-SP- 350Lime (Calcium Hydroxide)SandBO-SP- 286Activated Carbon for CO2 TreatmentBO-SP-355Soda AshBO-SP- 287Activated Carbon for Sugar TreatmentBO-SP-360Sodium AluminateBO-SP- 340Liquid NitrogenBO-SP-365Sodium ChlorideBO-SP- 345Nitrogen Enriched AirBO-SP- 300Caustic Soda (Sodium Hydroxide)BO-SP- 290Aluminum SulfateBO-SP- 320Filter AidBO-SP- 295Calcium ChlorideBO-SP- 325Filter SheetBO-SP- 305BO-SP- 310BO-SP-315BO-SP- 316BO-SP-307BO-SP- 306ChlorineFerric ChlorideFerrous SulfateFerric SulfateCalcium HypochloriteSodium HypochloriteBO-SP- 370BO-SP- 311BO-RQ- 910Sodium GluconatePolyaluminum ChloridePurchasingBO-RQ- Good Manufacturing Practices200BO-SP- 308-Design CriteriaChlorine DioxideBO-SP- 305Gaseous ChlorineTCCQS updates are captured till December 15, 2005 3) Specifications and Requirements Summary:Specifications / RequirementsAuxiliary Materials:1Does the plant follow the Company requirements on Auxiliary Materials? 原材料方向工J符合公司要求The plant must have an approval system in place for aux. materials suppliers. Lists of approved suppliers / materials must be available.公司對(duì)輔料有一個(gè)認(rèn)可機(jī)制，并要有供應(yīng) 商清單和材料清單BO-SP-280 Purchase contracts for auxiliary material require for each shipment輔材采購(gòu)合同要涵蓋以下內(nèi)容：- letter stating that the material meets legal specifications- 符合地方法規(guī)的書(shū)向聲明- a supplier s certificate of analysis- 供應(yīng)商COA All auxiliary materials to be legal in country of use (suppl.certificate) 所有輔材都符合所在國(guó)的要求嗎(供應(yīng)商 證書(shū)) Aux. materials do not contain asbestos (e.g. mats. for filtering sugar) 石棉/、屬于輔材仃列 Incoming batches to be checked for integrity, appearance, quantity. 對(duì)來(lái)料的完整性、外觀、數(shù)量檢查2Is the plant only buying Activated Carbon and/or Liquid Nitrogen from Division authorized suppliers and supply points?BO-RQ-910 Plant only purchases Activated Carbon and / or Liquid Nitrogen from Division authorized suppliers and工廠所購(gòu)活性碳和液氮是來(lái)自于認(rèn)可供應(yīng) 商的嗎supply points. 只從認(rèn)可的供應(yīng)商處采購(gòu)活性碳/液氮 Up to date list of Div. authorized suppliers and supply points available on site. 要有供應(yīng)商認(rèn)可清單3Does the plant use Company Specifications for the Activated Carbon?工廠用的活性碳標(biāo)準(zhǔn)是來(lái)自公司的嗎Zinc: only when activated carbon is activated by ZnCl.鋅：僅當(dāng)活性碳是用ZnCl.水活化Recommended parameters can be verified as part of the acceptance criteria.BO-SP-285 / BO-SP-286 / BO-SP- 287 Only “virgin " and food -gradeActivated Carbon is purchased & used.采購(gòu)和使用無(wú)污染或是食品級(jí)的活性碳 Required parameters:參數(shù)要求：- Butane activity:> 20 g /100 g ( CO treatment only ) 丁烷僅用于CO處理- Hardness:> 95% ( COtreatment only ) 硬度僅用于CO處理- Polycyclic Aromatic Hydrocarbons (PAHs):0.02 a g/l (in water extra ctables)-Ignition temp.:> 450 0 C(CQ treatment only) 燃點(diǎn)溫度- Moisture:< 5%( COtreatment only ) 濕度- Heavy metals (as Pb):< 10mg/kg in water extractables 重金屬- Water extract. substance:< 3%w/w 水中提取物- pH:4.0 - 7.0(Sugar treatment only)- Zinc:<20 mg / kg ( Sugar &H2O treatments) 鋅- Abrasion number:> 70%(water treatment only)- Iodine number:> 600mg/g ( water treatment only ) 碘量 Additional Recommended Composition:- Arsenic (As):< 3 mg/kg神- Copper (Cu):<25 ppm銅- Cyanogen compounds:PassFCC test氟化合物- Lead (Pb):< 10 mg/kg鉛- Sulfated ash:<5%determined on 1.0 g 硫化灰份- Total ash:< 15% w/w總灰份- Total sulfides:< 10 mg/kgin water extractables 總硫- Apparent density:0.25 -0.50 g/cm3(water and sugar)密度- Chloride (Cl):<0.53 %(water and sugar) 氯- Iodine number:> 850mg/g (sugar treatment only) 碘量- Iron:<0.1%(sugartreatment only) 鐵- Moisture:< 8% w/w (water andsugar) 濕度4Are Company requirements on Activated Carbon and its receipt followed?符合公司的活性碳和接收要求BO-SP-285 / BO-SP-286 / BO-SP-287 Activated Carbon to be delivered in dry, undamaged packages with labels that properly show the producer and package content. 活性碳的運(yùn)輸要干燥、包裝完好、包裝要 后商標(biāo)、生產(chǎn)冏和凈含量 For sugar treatment, Powdered Active Carbon (PAC) to be used5Does the plant follow Company Specifications and Requirements on Liquid Nitrogen?工廠的液氮都符合公司的標(biāo)準(zhǔn)和要求 糖處理要用粉劑活性碳 Upon re-charge, take a retention sample of the Granulated Activated Carbon (enough for 3 full analyses). Store sample till next recharge. Certificate of Analysis (for all required parameters) for every batch. 每批的COA Full CoA (required and recommended parameters) 全分析報(bào)告 The CoA analyses must be performed by a Division accredited lab.CO激是公司認(rèn)可的化驗(yàn)室得出的BO-SP-340 Comply with US Food Chemicals Codex (FCC) and JECFA 匕美國(guó)國(guó)食品化學(xué)品和JECF紳目符 Comply with local food regulations 與地方法規(guī)相符 Odor:odorless 氣味 無(wú)味 Assay:> 99.99 % v/v 純度 Carbon monoxide (CO):< 10ppm v/v 一氧化碳 Oxygen:< 20 ppm v/v 氧 Liquid Nitrogen to be manufactured from cryogenic distillation 低溫蒸儲(chǔ)制液氮 Nitrogen to be delivered in containers approved for its use 用認(rèn)可功用的車罐運(yùn)輸 Certificate of Analysis for each batch supplied: 每批提供COA- Assay純度- Carbon Monoxide- 一氧化碳- Oxygen- 氧- CoC for all other parameters(e.g. JECFA compliance)-COB所宿其他參數(shù)6Does the plant follow Company Specifications and Requirements on Nitrogen Enriched Air?工廠液氮的收集都符合公司的要求嗎 Nitrogen enriched air can be used for:從空氣中提煉氮?dú)饪捎糜? pressurizing filler system during sanitation,- 消毒過(guò)程中對(duì)FILLER機(jī)的力口壓 系統(tǒng)- undercover gassing- 除潛在氣體，- filler bowl counter pressure,- 劃、形缸氣壓- push gas for syrups- 推糖.BO-SP-345 To be produced from hollow-membranes or pressure swing adsorption generators Compressed air specifications (for process to produce N-enriched air): 壓縮空氣標(biāo)準(zhǔn)：(氮富集空氣工藝)- Odor:no strong off-odors- 氣味 無(wú)強(qiáng)烈異味- Carbon monoxide:< 10 ppmv/v- 一氧化碳- NQ< 2.5 ppmv/v- 氮氧化物- Oil:< 2 ppmw/w- 油- SO:< 5 ppmv/v- 二氧化硫- Total hydrocarbons:< 5 ppmv/v- 總姓 Nitrogen Enriched Air to meet US FCC specs and TCCC specs.空氣富集的氮?dú)庖厦绹?guó)標(biāo)準(zhǔn)- Odor:odorless- 氣味- Assay:between 90 and99 % v/v、- 純度- Carbon Dioxide (CO 2): <0.03% v/v- 二氧化碳- Carbon Monoxide:< 10 ppmv/v- 一氧化碳- Oxygen:< 10% v/v- 氧- Nitric Oxide / Nitrogen7Are the recommendedcompositions used for specific auxiliary materials used in the Water Treatment?用于水處理輔材中所用的推薦成份嗎Dioxide: <2.5 ppm v/v- 一氧化氮/二氧化氮- Sulfur Dioxide (SO2)： <5 ppmv/v- 二氧化硫 Use restrictions:- Not to be used in carbonators or proportioners during production- 生產(chǎn)時(shí)不用調(diào)配器- Not to be used for de-aerating (sparging) product, syrup or water- 不用于除氣產(chǎn)品、糖漿或水中BO-SP-290 Aluminum Sulfate (Al 2SO.14H2O):- HO soluble alu in solid (as Al 2C3):>17,0 %- 水中可溶鋁(固體)以 ALQ計(jì)- in liquid:>8,0 %- 液態(tài)- water soluble iron in solid (as Fe2C3): <0,75 %- 水中可溶鋁(固體)以Fe2CM- in liquid:<0,35 %- 液態(tài)- insoluble matter in solid: <0.5 %- 不溶物(固態(tài))- in liquid:<0.2 %-液態(tài)BC-SP-295 Calcium Chloride (CaCl2):- Flake form is preferred over liquid, solid and palletized-Assay: 77-80% w/w (flake)-含量93-97 % w/w (pellet)-Alkali chlorides:<2.0 % (as NaCl)- 堿性氯化物- Other impurities: <1.0 %- 其他雜質(zhì)BO-SP-305 Gaseous Chlorine:-Available chlorine:95 % purity by volume有效氯- Appearance:Amber liquid of greenish- 外觀yellow gas- Odor:pungent, irritating odor氣味- Moisture:1.41< 50 ppm 濕度-Specific Gravity: (liquid)特定引力-Vapor Density:2.49 (dry gas) 蒸氣密度Impurities by weight:-Chloroform:< 50 ppm氯仿-Total THMs< 300 ppm-Total Heavy Metals< 30ppm (as Pb)總重金屬-Arsenic< 3 ppm神-Mercury < 1 ppm 汞-Lead< 10 ppm-Carbon Tetrachloride< 100 ppm 四氯化碳-Non Volatile Residue< 50 ppm 非揮發(fā)性殘留BO-SP-306 Sodium Hypochlorite - Ca(OC l 2)- Appearance:Clear greenish-yellow liquidwith a faint chlorinous odor 外觀黃綠色液體，有氯味- % Available Chlorine: 10-16% w/v 后效氯- Insolubles < 0.15% w/w 不溶物- Excess Caustic Soda 0.1-0.4 % w/w 額外苛性鈉- Specific Gravity>1.14- pH > 11- Transition Metal Ions-Iron< 0.5 mg/l w/v 鐵-Copper< 0.05 mg/l w/v 銅-Nickel< 0.05 mg/l w/v 鍥BO-SP-307 Calcium Hypochlorite Ca(OC l 2)-Appearance:White powder, granule orTablet 外觀 白色粉末、晶體或片狀-Appearance of solution:Clear溶液外觀 透明- Odor: Chlorine-like odor氣味 似氯味- Chlorine Content: to 70% w/w-Stability-available 35% minimum chlorine after 2 hoursat 100oC: 穩(wěn)定性- 下2小時(shí)有效氯- Moisture : 10% maximum 濕度- By-products: 副產(chǎn)品-Bromate Ion (BrO 50 mg/l w/v maximum-Chlorate Ion (ClO 1.5 gr/l maximum-Metals:-Iron300 mg/kg maximum 鐵-Manganese 40 mg/kg maximum鎂-Loss on Drying 5% w/w maximum601000c條件3 )3 )-pH at 5% w/v solution 10.5 minimum5% w/v 溶液 pH-Free Alkali< 1.5% w/w (as NaOH) 自由堿-Insolubles in water5% maximum水中不溶物BO-SP-308 Chlorine Dioxide - (ClO 2)- Appearance:Yellow to reddish-yellow gas外觀黃色或是黃中顯紅氣體- Odor:Pungent. Distinctive fromchlorine bleach氣味刺激性氣味，類似于含氯的漂白粉氣味- Solubility3.01 g/L溶解性- Density1.6 g/ml密度-Impurities (by weight, in80%sodium chlorite solution)雜質(zhì)(重量法，于80%R化鈉溶液 計(jì))- Arsenic< 0,0003%神- Sodium chloride 17%氯化鈉- Sodium Hydroxide< 3.0%氫氧化鈉-Sodium Carbonate< 2.0%碳酸鈉-Sodium Nitrate< 0.1%硝酸鈉-Sodium Chlorate< 1.0%氯酸鈉-Sodium Sulfate< 3.0 %硫酸鈉BO-SP-310 Ferric Chloride (FeCl3):-Assay:> 28 %(09 HSE) 9寸 V -UE-nuEo) POE t(施警)+tf率wu還 % 93 V 一(p,5b=) uo 上 snohLL-qn-os -Eol (顯c) +tf率 wu還 % 0.0 VognuEo) uo 上 snohLL-qn-os -Eol (施警)+tf率wu還 % 0.0 A 一(p,5b=) uo.!=OELL-qn-os -Eol (顯c) +tf率 wu還 %oodLAognuEo) uo.!=OELL-qn-os -Eol 一(oxe(os)z LL) 24_ns OE0.9oisOG %90vognuEo) JOJ)1u6e 6UPPEOQUE s%90.0M歷-qn-osu 二 Eol c#c)w母田皿 5sz hse) cxio.om 一(p-5b=) POEoJm-ns tc#c)w母田皿 5sEs E) xyov -UE-nuEo) POEoJm-ns t(施警)貓>m還 % 9。+I0.8 一(p-5b=) uo 上 -qn-os -Eol (顯c) ss%96L A-UE-nuEo) uo 上 -qn-os -Eol 一(OIZW OS LL) l_ns snoLLgoisOGWM脾 (OH SE) 9LM-POEOJO-LPOJPAH s%03v歷-qn-osu 二 Eol %90v puo-lp snohLL 至(eoLLSE)自由酸(晶體)-Free acid (liquid): approxim. 0.5 % (as H2S。自由酸(晶體)-Water insoluble matter:<6.5 % of the ferric sulfate 水不溶物-Total insolubles (liquid form): <0.1 %總不溶物(液態(tài)形式)BO-SP-335 Lime (Calcium Hydroxide; Ca(OH) 2):- No use of quicklime 不用生石灰- Assay:> 95 %w/w (as Ca(OH) 2) 含量- Magnesium:< 1.5 %鎂- Sulfate:<1.0 %硫BO-SP-350 Sand:-Sand to be inert quartz 石英中沙 粒-Coefficient of uniformity:1.60-1.75 均勻系數(shù)-Organic matter:<0.5 % 有機(jī)物-Foreign matter:<4.0 %異物BO-SP-355 Soda Ash (anhydrous sodium carbonateNaCO):- Dry white powder; not to contain large lumps or crystals 干燥白色粉末，沒(méi)有大塊結(jié)晶塊> 98 %2Al2。):- Assay:化驗(yàn)- Insoluble matter:<0.05 %不溶物BO-SP-360 Sodium Aluminate (N(- Purity (solid):>75 % 純度(固態(tài))- Purity (liquid):>32 % 純度(液態(tài))- Insoluble matter (solid): <10 %不溶物(固態(tài))- Insoluble matter (liquid): <0.5 %不溶物(液態(tài))BO-SP-365 Sodium Chloride (NaCl):- Purity:> 97 %w/w 純度- Moisture:<2.0 %濕度- Sulfate:<1.5 %硫- Calcium and Magnesium: <0.6 %鈣、鐵- Insolubles:<2.0 %不溶物- Total impurities: <4.0 %總雜質(zhì)BO-SP-311 Polyaluminum Chloride (PACl):-PACl content as Al 2Q: 2.0 to25.0 % by weightPACl含量(以Al 2。計(jì))as Al:2.5 to13.0 % by weight(以Al計(jì))- Basicity:10 to 83%堿度- Turbidity:< 50 NTU濁度- Specific gravity:1.1to 1.4 特定引力- Bromide Residual: < 50 mg/kg 澳化物殘留8Are the recommendedcompositions used for specific auxiliary materials used in sweetener treatment and bottle washers?用于糖料和洗瓶機(jī)的輔材中用的推薦成份 嗎-Combined Alumina< 23%鋁化合物BO-SP-300 Caustic Soda (Sodium Hydroxide;NaOH used for bottle washing):,苛性鈉(NaOHg于洗瓶)- Not to come from electrolytic process using mercury cells 用汞電池電解所得- Purity (solid):> 95 %(as NaOH)純度- Total heavy metals:< 30mg/kg總重屬- Mercury:<0.1mg/kg汞BO-SP-320 Filter Aid (for simple syrup filtering):輔助過(guò)濾器(用于單糖漿)- Particle size:min 90% < 40 m / 20% < 5粒子直徑- pH of a 10% slurry in water:5.0 - 10.010%!漿水- Water soluble:<0. 5 %水溶液- Hydrochloric aid (soluble):<2.5 %鹽酸-Lead:< 10 mg/kg鉛-Arsenic:< 10 mg/kg神BO-SP-325 Filter Sheets:過(guò)濾器- Material:cellulose /free of asbestos and glass fibres 用料- Pore size:10- 15 p. m9Are all GMP issues covered for the storage of auxiliary materials? GMP 涵蓋了輔材一塊嗎These are approved conditions in order to fulfill the general requirement of “Prevent Contamination " from or via auxiliary materials.認(rèn)可條件目的在于實(shí)現(xiàn)通過(guò)輔料防止污染 的總要求孔徑-Extractables:< 0.25 %w/w 可溶出物-Heavy metals:< 1 mg/kg重金屬BO-SP-370 Sodium Gluconate (C eHnNaO bottle washer additive):糖酸鈉- Purity:> 98.0 %w/w 純度- Moisture:< 1.0 %w/w 濕度- Heavy metals:< 20 mg/kg重金屬BO-RQ-200 Three separate areas are provided for the storage of:三個(gè)單獨(dú)區(qū)域用于貯存- water treatment chemicals- 水處理化學(xué)品- cleaning and sanitizing compounds- 消毒和清潔劑- lubricants and solvents- 潤(rùn)滑劑 All areas are restricted 所有區(qū)域所受控 Storage areas for liquid acids and/or caustics have containment dikes 液酸液堿貯放區(qū)后二次防護(hù)。 Storage areas for liquid acids and/or caustics have adequate draining (drains with containment) 液酸液堿貯放區(qū)后足夠的排水道 Easily accessible safety showers and eye wash stations are installed 安裝了便捷式安全淋浴和眼睛沖洗站 Each storage area has a ventilation system (at least 3 changes / hour) 每個(gè)貯存區(qū)都有換風(fēng)系統(tǒng)(至少1小時(shí)3 次)Note