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1、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要求 Yes Div No 3 4 1) 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 from Division a

2、uthorized suppliers and supply points?2 工廠所購活性碳和液氮是來自于認(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

3、on Liquid Nitrogen? 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 Enriched Air? 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 recommendedcompo

4、sitions used for specific auxiliary materials used in sweetener treatment and bottle washers? 15 用于糖料和洗瓶機的輔材中用的推薦成份嗎 Are all GMP issues covered for the storage of auxiliary materials? 16 GMP函蓋了輔材一塊嗎 2) Reference Standards List: Beverage Operations Manual BO-SP- 280 BO-SP- 285 General Sp

5、ecifications for Auxiliary Materials Activated Carbon for Water Treatment BO-SP- 335 BO-SP- 350 Lime (Calcium Hydroxide) Sand BO-SP- 286 Activated Carbon for CO2 Treatment BO-SP- 355 Soda Ash BO-SP- 287 Activated Carbon for Sugar Treatment BO-SP- 360 Sodium Aluminate BO-SP- 340 Liqui

6、d Nitrogen BO-SP- 365 Sodium Chloride BO-SP- 345 Nitrogen Enriched Air BO-SP- 300 Caustic Soda (Sodium Hydroxide) BO-SP- 290 Aluminum Sulfate BO-SP- 320 Filter Aid BO-SP- 295 Calcium Chloride BO-SP- 325 Filter Sheet BO-SP- 305 BO-SP- 310 BO-SP- 315 BO-SP- 316 BO-SP- 307 BO-S

7、P- 306 Chlorine Ferric Chloride Ferrous Sulfate Ferric Sulfate Calcium Hypochlorite Sodium Hypochlorite BO-SP- 370 BO-SP- 311 BO-RQ- 910 Sodium Gluconate Polyaluminum Chloride Purchasing BO-RQ- Good Manufacturing Practices 200 BO-SP- 308 -Design Criteria Chlorine Dioxide BO-SP- 305

8、 Gaseous Chlorine TCCQS updates are captured till December 15, 2005 3) Specifications and Requirements Summary: Specifications / Requirements Auxiliary Materials: 1 Does the plant follow the Company requirements on Auxiliary Materials? 原材料方向工J符合公司要求 The

9、 plant must have an approval system in place for aux. materials suppliers. Lists of approved suppliers / materials must be available. 公司對輔料有一個認(rèn)可機制，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 ?輔材采購合同要涵蓋以下內(nèi)容： - letter stating that the material me

10、ets legal specifications - 符合地方法規(guī)的書向聲明 - 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的要求嗎(供應(yīng)商 證書) ? Aux. materials do not contain asbestos (e.g. mats. for filtering sugar) ? 石棉/、屬于輔材仃列 ? Incoming bat

11、ches to be checked for integrity, appearance, quantity. ? 對來料的完整性、外觀、數(shù)量檢查 2 Is 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 authorize

12、d suppliers and  工廠所購活性碳和液氮是來自于認(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 3 Does the plant use Company Specifications for the Activated Carbon? 工廠用的活性碳標(biāo)準(zhǔn)是來自公司的嗎 Zinc: only when activated

13、 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 -grade Activated Carbon is purchased & used. ?采購和使用無污染或是食品級的活性碳 ? Required parameters:參數(shù)要求： - Butane activity

14、: > 20 g / 100 g ( CO treatment only ) 丁烷 僅用于CO處理 - Hardness: > 95% ( CO treatment 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) 燃點溫度 - Moisture: < 5% ( CO treatment only ) 濕度 - Heavy metals

15、 (as Pb): < 10 mg/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: > 600  mg/g ( water treatment only ) 碘量

16、 ? Additional Recommended Composition: - Arsenic (As): < 3 mg/kg 神 - Copper (Cu): <25 ppm 銅 - Cyanogen compounds: Pass FCC 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/kg in water extractables 總硫

17、 - Apparent density: 0.25 - 0.50 g/cm3 (water and sugar) 密度 - Chloride (Cl): <0.53 % (water and sugar) 氯 - Iodine number: > 850 mg/g (sugar treatment only) 碘量 - Iron: <0.1% (sugar treatment only) 鐵 - Moisture: < 8% w/w (water and sugar) 濕度 4 Are Company requirements on Activated Carbo

18、n 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 b

19、e used 5 Does 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 Analy

20、sis (for all required parameters) for every batch. ? 每批的COA ? Full CoA (required and recommended parameters) ? 全分析報告 ? The CoA analyses must be performed by a Division accredited lab. CO激是公司認(rèn)可的化驗室得出的 BO-SP-340 ? Comply with US Food Chemicals Codex (FCC) and JECFA ? 匕美國國食品化學(xué)品和JECF紳目符 ? Com

21、ply with local food regulations ? 與地方法規(guī)相符 ? Odor: odorless ? 氣味 無味 ? Assay: > 99.99 % v/v ? 純度 ? Carbon monoxide (CO): < 10 ppm v/v ? 一氧化碳 ? Oxygen: < 20 ppm v/v ? 氧 ? Liquid Nitrogen to be manufactured from cryogenic distillation ? 低溫蒸儲制液氮 ? Nitrogen to be delivered in containers appro

22、ved for its use ? 用認(rèn)可功用的車罐運輸 ? 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

23、 (e.g. JECFA compliance) -COB所宿其他參數(shù) 6 Does 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: 從空氣中提煉氮氣可用于 - pressurizing filler system during sanitation, - 消毒過程中對FILLER機的力口壓 系統(tǒng) - undercover

24、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-

25、 odors - 氣味 無強烈異味 - Carbon monoxide: < 10 ppm v/v - 一氧化碳 - NQ < 2.5 ppm v/v - 氮氧化物 - Oil: < 2 ppm w/w - 油 - SO: < 5 ppm v/v - 二氧化硫 - Total hydrocarbons: < 5 ppm v/v - 總姓 ? Nitrogen Enriched Air to meet US FCC specs and TCCC specs. 空氣富集的氮氣要符合美國標(biāo)準(zhǔn) - Odor: odorless - 氣味 - Assay: be

26、tween 90 and 99 % v/v、 - 純度 - Carbon Dioxide (CO 2): <0.03% v/v - 二氧化碳 - Carbon Monoxide: < 10 ppm v/v - 一氧化碳 - Oxygen: < 10% v/v - 氧 - Nitric Oxide / Nitrogen 7 Are 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

27、 Dioxide: <2.5 ppm v/v - 一氧化氮/二氧化氮 - Sulfur Dioxide (SO 2)： <5 ppm v/v - 二氧化硫 ? Use restrictions: - Not to be used in carbonators or proportioners during production - 生產(chǎn)時不用調(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 Sulfat

28、e (Al 2SO.14H2O): - HO soluble alu in solid (as Al 2C3): >17,0 % - 水中可溶鋁(固體)以 ALQ計 - 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-S

29、P-295 ? Calcium Chloride (CaCl 2): - Flake form is preferred over liquid, solid and palletized - -Assay: 77-80% w/w (flake) -含量 93-97 % w/w (pellet) -Alkali chlo

30、rides: <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:

31、(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 <

32、 50 ppm 非揮發(fā)性殘留 BO-SP-306 ? Sodium Hypochlorite - Ca(OC l 2) - Appearance: Clear greenish-yellow liquid with 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 >

33、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 or Tablet 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

34、味 - Chlorine Content: to 70% w/w -Stability-available 35% minimum chlorine after 2 hours at 100oC: 穩(wěn)定性-- 下2小時有效氯 - 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: -Iron 300 mg/kg maximum 鐵 -Manganese 40 mg/kg

35、maximum 鎂 -Loss on Drying 5% w/w maximum 60 1000c條件 3 ) 3 ) -pH at 5% w/v solution 10.5 minimum 5% w/v 溶液 pH -Free Alkali < 1.5% w/w (as NaOH) 自由堿 -Insolubles in water 5% 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

36、黃中顯紅氣體 - Odor: Pungent. Distinctive from chlorine bleach 氣味 刺激性氣 味，類似于含氯的漂白粉氣味 - Solubility 3.01 g/L 溶解性 - Density 1.6 g/ml 密度 -Impurities (by weight, in 80%sodium chlorite solution) 雜質(zhì)(重量法，于80%R化鈉溶液 計) - Arsenic < 0,0003% 神 - Sodium chloride 《 17% 氯化鈉 - Sodium Hydroxide < 3.0%

37、 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 (FeCl 3): -Assay: > 28 % (09 HSE) ％9寸 V -UE-nuEo)) POE ①①t— (施警)+tf率wu還 % 93 V 一(p,5b=) uo 上 snoh①LL①-qn-os -Eol — (顯c) +tf率 wu還 % 0

38、.0 VognuEo)) uo 上 snoh①LL①-qn-os -Eol — (施警)+tf率wu還 % 0.0 A 一(p,5b=) uo.!=OE①LL①-qn-os -Eol — (顯c) +tf率 wu還 %oodLAognuEo)) uo.!=OE①LL①-qn-os -Eol — 一(o^xe(os)z ①LL) 24_ns OE①0.? 9ois—OG %90vognuEo) JOJ)1u①6e 6UPPEO—QUE — s %90.0M 歷①-qn-osu 二 Eol — c#c)w母田皿 5sz hse) ％cxio.om 一(p-5b=) POEoJm-ns ①①

39、t— c#c)w母田皿 5sEs E) ％xyov -UE-nuEo)) POEoJm-ns ①①t— (施警)貓>m還 % 9。+I0.8 一(p-5b=) uo 上 ①-qn-os -Eol — (顯c) ss %96L A -UE-nuEo)) uo 上 ①-qn-os -Eol — 一(OIZW OS ①LL)① l@_ns sno」」①LL? gois—OG WM脾 (OH SE) ％9LM -POEOJO-LPOJPAH — s %03v 歷①-qn-osu 二 Eol — %90v ④ puo-lp snoh①LL— 至 (eo①LLSE)

40、 自由酸(晶體) -Free acid (liquid): approxim. 0.5 % (as H 2S。 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 - Assa

41、y: > 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 % 有機物 -Foreign matter: <4.0 % 異物 BO-SP-355 ? Soda Ash (anhydrous sodium carbonate NaCO): - Dr

42、y white powder; not to contain large lumps or crystals 干燥白色粉末，沒有大塊結(jié)晶塊 > 98 % 2Al2。): - Assay: 化驗 - 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 mat

43、ter (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

44、Al 2Q: 2.0 to 25.0 % by weight PACl含量(以Al 2。計) as Al: 2.5 to 13.0 % by weight (以Al計) - Basicity: 10 to 83% 堿度 - Turbidity: < 50 NTU 濁度 - Specific gravity: 1.1 to 1.4 特定引力 - Bromide Residual: < 50 mg/kg 澳化物殘留 8 Are the recommendedcompositions used for specific auxiliary materials us

45、ed in sweetener treatment and bottle washers? 用于糖料和洗瓶機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 N

46、aOH) 純度 - Total heavy metals: < 30 mg/kg 總重屬 - Mercury: <0.1 mg/kg 汞 BO-SP-320 ? Filter Aid (for simple syrup filtering): ?輔助過濾器(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 - 10.0 10%!漿水 - Water soluble: <0. 5 % 水溶液 - Hydrochloric aid (

47、soluble): <2.5 % 鹽酸 -Lead: < 10 mg/kg 鉛 -Arsenic: < 10 mg/kg 神 BO-SP-325 ? Filter Sheets: ?過濾器 - Material: cellulose / free of asbestos and glass fibres 用料 - Pore size: 10 - 15 p. m

48、 9 Are 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)可條件目的在于實現(xiàn)通過輔料防止污染 的總要求 孔徑 -Extractables: <

49、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: ?三個單獨區(qū)域用于貯存 - wate

50、r treatment chemicals - 水處理化學(xué)品 - cleaning and sanitizing compounds - 消毒和清潔劑 - lubricants and solvents - 潤滑劑 ? 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。 ? Storage areas for liquid acids and/or caustics have ade

51、quate 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) ? 每個貯存區(qū)都有換風(fēng)系統(tǒng)(至少1小時3 次) Note