la-1993-0064-a - als technichem (s) pte ltd technichem (s) pte ltd certificate no. : la-1993-0064-a...
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ALS Technichem (S) Pte Ltd Certificate No. : LA-1993-0064-A
121 Genting Lane, #04-01
ALS Building Issue No. : 17
Singapore 349572 1 3
Date : 07 June 2013
FIELD OF TESTING : Chemical and Biological Testing
MATERIALS/ PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
A. OILS & FATS
1. Acid value/F.F.A AOCS Ca 5a-40 (2009) / ISO 660 (1996)
2. Anisidine value AOCS Cd 18-90 (2009)
FOSFA (1991)
3. Ash AOCS Ca 11-55 (2009)
4. Cloud point AOCS Cc 6-25 (2009)
BS 684 Section 1.1.5 : 1987 (1993)
5. Cold test AOCS Cc 11-53 (2009)
6. Colour ISO 15305 (1998)
-F.A.C AOCS Cc 13a-43 (2009)
-Lovibond AOCS Cc 13e-92 (2009)
7. Fatty Acid Composition by QWIFD OF09, QWIFD OF25
GLC, cls, cis-trans isomers AOCS Ce 2-66 (2009) (Preparation)
AOCS Ce 1h-05 (2009) Capillary GLC
QWIFD OF10
AOCS Ce 2-66 (2009) (Preparation)
AOCS Ce 1f-96 (2009)
8. Insoluble impurities AOCS Ca 3a-46 (2009), ISO 663 (2000)
9. Iodine value AOCS Cd 1d-92 (2009), ISO 3961 (1996)
Certificate No. : LA-1993-0064-A Issue No. : 17 Date : 07 June 2013 Page : 2 of 17
MATERIALS/ PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
10. Litre-Weight in Air/S.G. Cc 10c-95 (2009), ISO 6883 (2000) 11. Melting point AOCS Cc 3-25 (2009)
(slip point)
12. Moisture AOCS Ca 2a-45 (2009)
(Distillation Method)
13. Moisture & volatile matter AOCS Ca 2c-25 (2009) (Air Oven Method), ISO 662 (1998)
AOCS Ca 2b-38 (2009)
(Hot Plate Method)
14. Peroxide value AOCS Cd 8-53 (2003)
ISO 3960 (2001)
15. Refractive index AOCS Cc 7-25 (2009)
16. Rancidity index BS 684 : Section 2.32 : 1979 (1991)
17. Saponification value AOCS Cd 3-25 (2009)
ISO 3657 (2002)
18. Titer AOCS Cc 12-59 (2009)
Tr 1a-64
19. Total fatty matter BS 684 : Section 2.4 : 1976 (1992)
20. Trace metals for Cu, QWIFD /OF08 /Ashing /Acid
Fe, Pb,Ni digestion/ ICP-OES
21. Unsaponifiable matter AOCS Ca 6a-40 (2009)
22. Cholesterol QWI FD /OF26 / HPLC
B. SAUCES 1. Benzoic Acid QWIFD /FC 01 AOAC 979.08
Section 29.1.14 (2010) / HPLC
2. Nitrogen (soy sauce) QWI FD /FC 21 AOAC 955.4
Section 2.4.03 (2010) / Tecator
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MATERIALS/ PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS /
TECHNIQUES / EQUIPMENT
C. BEVEARGES & 1. Benzoic acid QWIFD /FC02, AOAC 979.08 CORDIALS Section 29.1.14 (2010) / HPLC
D. BREADS & BAKERY 1. Propionic acid QWIFD /FC03, AOAC 950.35 PRODUCTS Section 32.3.05 (2010) / HPLC
E. FOOD I. General Foods: Microbiology 1. Total Colony Count QWI MIC08 FDA-BAM Online Chapter 3 : 2001
Beverages &
Cordials 2. Total Coliform Count QWI MIC11 FDA-BAM Online Chapter 4 : 2002
Milk & Milk
Products 3. Total E.Coli Count QWI MIC11 FDA-BAM Online Chapter 4 : 2002
Chilled & Frozen
Foods 4. Yeast and Mould Count QWI MIC15
FDA-BAM Online Chapter 18 : 2001
5. Salmonella spp. QWI MIC20 FDA-BAM Online Chapter 5 : Dec 2007
6. Staphylococcus aureus QWI MIC19 FDA-BAM Online Chapter 12 : 2001
7. Shigella spp QWI MIC21 / Compendium of Methods for the Microbiological Examination of Food 4th Edition, 2001, Chapter 38
8. Listeria QWIMIC 23 monocytogenes FDA-BAM Online Chapter 10 : 2003,
9. Total Acid Producing QWI MIC65, Compendium of Micro Bacteria Methods, 4
th Edn, Chapter 19
10. Thermophilic Bacteria QWI MIC64, FDA-BAM Online: 2001 Chapter 3 : 2001 (modified)
11. Vibrio cholera } QWI MIC22 } FDA-BAM Online, May 2004, Chapter 9 12. Vibrio parahaemolyticus }
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MATERIALS/ PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS/
TECHNIQUES/ EQUIPMENT
13. Bacillus cereus QWI MIC 24 FDA-BAM Online, Jan 2001, Chapter 14 14. Clostridium perfringens QWI MIC 25/ FDA-BAM Online, January 2001, Chapter 16 15. Campylobacter. Spp QWI MIC77/ FDA-BAM Online Chapter 7, January 2001 16. Yersina Enterocilitica QWI MIC78/ FDA-BAM Online Chapter 8, January 2001 17. Enterbacter Sakazakii QWI MIC78/ ISO/ TS 22964 IDF/RM210 1
st Edition 2006-02-01
18. Enterbacteriaceae QWIMIC57 19. Staphylococcal Enterotoxin QWI MIC82/ FDAS-BAM Online ELISA-based method Chapter 13A:Jan 2001 20. Bacillus Diarrhoeal QWI MIC 83 TECRA Bacillus Diarrhoeal Enterotoxin (ELISA- Enterotocin Visual Immunoassay based method) 21. Gluten Test QWI MIC 85/ Enzyme Immunoassay by Veratox Gliadin Test Kits 22. E-coli 0157: H7 QWI MIC86/ Neogen Reveal Microbial Screening Test AOAC Method No. 2000.13 23. Tempo Enumeration of Micro ATS QWIMIC-92 A-E organism in Food A. Tempo TVC Enumeration of AOAC official Method 2008.10 aerobic mesophilic total flora (2010 Ed) in 40-48 hours B. Tempo CC Enumeration of
Coliforms according to the AOAC R1 Performance Tested
SM
Method-Certificate No 060702 FDA-BAM definition in 24 hours C. Tempo EC Enumeration of AOAC 2009.02 (2010 Ed) Escherichia coli in 24 hours
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MATERIALS/ PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS/
TECHNIQUES/ EQUIPMENT
D. Tempo STA Enumeration of AOAC R1 Performance Tested
SM
Staph in 24 hours Method-Certificate No 120901 E. Tempo YM Enumeration of AOAC R1 Performance Tested
SM
yeast and moulds in 72-76 Method-Certificate No 041001 hours 24. PCR for Salmonella.spp & ATS QWIMIC 93A-B Listeria monocytogenes in AOAC-RI 010802, AOAC-RI 010803 Food II. General Foods: Nutritional Labelling
1. Ash Content QWI FD/FC 05 Bread AOAC 930.22 Section 32.3.08 (2010)
Canned Vegetables AOAC 925.51 Section 42.1.12A (2010)
Cereal Products/ AOAC 923.03 Section 32.1.05 (2010)
Flour
Cocoa Products AOAC 972.15 Section 31.1.04 (2010)
Confectionery AOAC 925.49 Section 44.3.01C (2010)
Dairy and Dairy AOAC 920.117 Section 33.6.05 (2010)
Products-Butter
Dairy and Dairy AOAC 935.42 Section 33.7.07 (2010)
Products-Cheese
Dried Milk AOAC 930.30 Section 33.5.05 (2010)
Evaporated Milk AOAC 945.48 Section 33.4.01E (2010)
Fruits and Fruit AOAC 940.26 Section 37.1.18A (2010)
Products Meat and Meat AOAC 920.153 Section 39.1.09 (2010)
Products Milk AOAC 945.46 Section 33.2.10 (2010)
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MATERIALS/ PRODUCTS TESTED
TESTS / PROPERTIES
STANDARD METHODS /
TECHNIQUES / EQUIPMENT
Non-Alcoholic Beverages AOAC 950.14 Section 29.1.03A (2010)
Nuts and Nut Products AOAC 950.49 Section 40.1.08 (2010)
Seafood AOAC 938.08 Section 35.1.14 (2010)
Spices AOAC 941.12 Section 43.1.05A (2010)
ISO 928 / ASTA Method 3.0
Sweetened Condensed Milk AOAC 920.115 Section 33.4.02E (2010)
Tea AOAC 920.100 Section 30.1.25A (2010)
2. Moisture QWIFD /FC20 Spices AOAC 986.21 Section 43.1.04 ( 2010)/
Distillation Method
Flour AOAC 925.10 Section 32.1.03 (2010)/
Air Oven Drying
Meat and Poultry AOAC 950.46 Section 39.1.02B (2010)/
Air Oven Drying Sugar AOAC 925.45 Section 44.1.03B (2010) /
Air Oven Drying 3. Fat Content QWI FD / FC 22 Nuts & Nut Products AOAC 948.22 Section 40.1.05 (2010)/
Gravimetric Method / Ether Extract Meat and Poultry AOAC 960.39 Section 39.1.05 (2010)/
Ether Extract
Flour/Bread AOAC 922.06 Section 32.1.14 (2010)/
Acid Hydrolysis / Solvent Extraction Method Coffee AOAC 920.97 Section 30.1.17 (2010)/
Petroleum Ether Extract
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MATERIALS / PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS / TECHNIQUES / EQUIPMENT
Seafood AOAC 948.15 Section 35.1.23 (2010)/
Acid Hydrolysis / Solvent Extraction Method Milk Products AOAC 905.02 Section 33.2.25 (2010)/
Alkaline Hydrolysis (Roese-Gottlieb Method)
Dried Milk Products AOAC 932.06 Section 33.5.08 (2010)/
Alkaline Hydrolysis (Roese-Gottlieb Method)
4. Protein QWIFD /FC 21 Meat Products Tecator application note ASN 3106
Cereal Products Tecator application note ASN 3100
Butter Tecator application note ASN 3137
Food & 5. Total Carbohydrate and QWIFD /FC 23
Food Ingredients Energy Value (by calculation)
6. Determination of 22 Metals QWIFD /FC25/ Acid Digest /ICP-OES in Liquid and Solid Food Products: AOAC 990.08 Section 9.2.39 (2010) (Al, As, B, Ca, Cd, Cr, Cu, Fe, K, Mg, Mn, Mo, Na, Ni, P, Pb, Sb, Se,Si, Sn, Tl and Zn) 7. Determination of Trace QWIFD/ FC74/ Hydride AAS
Element for As AOAC 986.15 Section 9.1.01 (2010)
8. Fatty acid composition – QWIFD/ OF25 / GC Capillary cis,cis-trans isomers AOCS (2009) Ce 1h-05 9. Cholesterol QWIFD/ FC28 / HPLC
10. Dietary Fibre QWIFD/ FC35 / AOAC 985.29
Section 45.4.07 (2010)
11. Saturated Fat/mono- QWI FD / FC 49
unsaturated fat/poly- by calculation from Fatty Acid Profile
unsaturated fat/trans fat by GC Capillary
Certificate No. : LA-1993-0064-A Issue No. : 17 Date : 07 June 2013 Page : 8 of 17
MATERIALS / PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS / TECHNIQUES / EQUIPMENT
Food & 12. Vitamin A – Retinol QWIFD/ FC33/HPLC
Food Ingredients
13. Vitamin A - -Carotene QWIFD/ FC34/HPLC
14. Vitamin B1 QWIFD/ FC31, AOAC 942.23 Section
45.1.05 (2010)/Fluorometry
15. Vitamin B2 QWIFD/ FC32, AOAC 970.65 Section
45.1.08 (2010)/Fluorometry
16. Vitamin B6 by HPLC-FLD ATS QWIFD FC 116 AOAC.2004.07, GB 5413.13.2010
17. Vitamin C QWIFD/ FC30, AOAC 967.22 Section
45.1.15 (2010)/Fluorometry
18. Vitamin D3 by HPLC-DAD ATS QWIFD FC117
(using Vitamin D2 as Internal AOAC 995.05, AOAC 2002.05
Standard)
19. Vitamin E – Alpha QWIFD/ FC52, AOAC 992.03 Section
Tocopherol 50.1.04 (2010) / HPLC
20. Niacin (Vit B3) by HPLC QWIFD/ FC109
Ref: Global Agriculture Information
Network
21. Taurine by HPLC QWIFD/ FC108
Ref: Journal of AOAC International
Vol. 83, No. 4,2000
22. Total Sugar QWIFD / FC36, AOAC 923.09 Section
(as Invert Sugar) 44.1.05 (2010)
23. Sugar Profile in Food by QWIFD /FC91
HPLC- Glucose, Fructose, Ref: Dionex Tech Note 40
Sucrose, lactose and Maltose
24. Nitrogen/Protein in Solid Food ATS QWIFD FC 118
by Thermo Flash 4000 Thermo App. Note
42121/42122/42125
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MATERIALS / PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS / TECHNIQUES / EQUIPMENT
III. General Foods: 1. Nitrate and Nitrite QWIFD/ FC24 / Cd Reduction / Preservatives UV Spectrophotometer 2. Salt Content QWIFD / FC47 / AOAC 937.09 Section 35.1.18, 935.47 (2010) Section 39.1.10 (2010) & AOAC 935.43 Section 33.7.10 (2010) 3. Benzoic acid QWIFD / FC01, AOAC 979.08 Section 29.1.14 (2010)/Steam Distillation/HPLC 4. Sorbic acid QWIFD / FC04/Steam Distillation/HPLC 5. Sulphur Dioxide QWIFD/ FC48/ Idometric Titration 6. Sulphur Dioxide QWIFD/ FC79 By Optimised Monier Williams Method AOAC 990.28 Section 47.3.43 (2010)
Beverages 7. Caffeine QWIFD/ FC57 / HPLC
Carbonated Drinks & Reference : AOAC 979.08 Section
Decaffeinated 29.1.14 (2005)
Sauces & Foodstuffs 8. Methyl and Propyl Parabens QWIFD/ FC71 / HPLC
IV. General Foods: Mycotoxins Food and 1. Aflatoxins QWIFD/ FC29 /TLC, Ref : NATA
Food Ingredients (B1, B2, G1, G2) Proficiency Testing Program with ref. JAOAC Vol 61, Pg 793-800, 1978 2. Aflatoxins QWIFD / FC51 / HPLC (B1, B2, G1, G2) Ref: AOAC 991.31-Section 49.2.18 (2010), & AOAC 994.08 Section 49.2.19A (2010) 3. Determination of QWIFD/ FC94 /HPLC Zearalenone Ref: AOAC 985.18 4. Patulin in Apple Products QWIFD/ FC97 By HPLC Ref: AOAC 200.02
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MATERIALS / PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS / TECHNIQUES / EQUIPMENT
Cocoa/ Coffee 5. Ochratoxin A QWIFD/ FC54 / HPLC AOAC 2000.09 Section 49.6.02A (2010) & AOAC 2004.10 Milk and 6. Aflatoxin M1 QWI/FD FC70/ By HPLC Milk Products 7. Determination of Aflatoxin QWI FD FC 98 M1 & M2 Ref: AOAC 2000.08
V. General Foods:
Food Safety &
Others Foods and Fish 1. Mercury QWIFD/ FC 26
AOAC 971.21 Section 9.2.22 (2010) / Acid Digestion / Flow Injection Mercury Analyser Food and Food 2. Determination of 3- QWIFD/ FC27 / GCMS
Ingredients monochloropropanediol AOAC 2000.1 Section 48.1.06 (3-MCPD) 3. Determination of 1-3 QWIFD/ FC56 / GCMS Dichloropropanediol (1, 3-DCP) 4. Sudan, I, II, III and IV QWIFD/ FC55/ HPLC 5. Melamine by Dilution QWIFD/ FC80/ USFDA LIB No. 4421/ dilution/ LCMSMS 6. Melamine and Cyanuric QWIFD/ FC85/ USFDA LIB No. 4421 / Acid by Dilution dilution/ LCMSMS 7. Melamine by SPE QWIFD/ FC82/ USFDA LIB No. 4422 / SPE/ LCMSMS 8. Chloramphenicol in Milk QWIFD/ FC90/ by LCMSMS 9. Chloramphenicol in QWIFD/ FC83/ by LCMSMS Honey 10. Chloramphenicol in Seafood QWI FD/ FC89/ by LCMSMS
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MATERIALS / PRODUCTS TESTED
TESTS / PROPERTIES STANDARD METHODS / TECHNIQUES / EQUIPMENT
11. Malachite and QWI FD/ FC92/ by LCMSMS Leucomalachite Green 12. Nitrofuran in animal QWI FD/ FC84/ by LCMSMS derived foods, seafood, seafood based sauces, milk and milk based products, essence products, honey and egg powder 13. Determination of Acrylamide QWIFD/ FC93 /by LCMSMS 14. Cyclamate (Cyclamic Acid) QWIFD/ FC99 in Food by HPLC Ref: BS EN 12857:1999 15. Artificial sweetener QWIFD/ FC88/ HPLC (Acesulfame-K , Aspartame , Saccharin) in drinks by HPLC Liquid / Semi-solid 16. pH determination QWI FD/FC 45
foods SS 288: 1998, SS 340: 1999 Spices and 17. Volatile and non volatile QWI FD/FC 66, AOAC 30.012 (1984)
Condiments 18. Volatile oils QWI FD/FC 67 AOAC 962.17 Section 43.1.14 (2010) / ASTA method 5.0 / Steam Distillation 19. Acid Insoluble Ash QWIFD /FC46 / AOAC 941.12 Section 43.1.05B (2010) ISO 930 / ASTA Method 4.0
VI. Cream Crackers 1. Peroxide value QWIFD/ FC07 ) 2. F.F.A QWIFD/ FC08 ) SS 287:1987 3. pH QWIFD/ FC10 )
VII. Dried Noodles and 1. F.F.A QWIFD/ FC15 ) SS 219:1979 Pasta Products 2. Peroxide value QWIFD/ FC16 )
VIII. Peanut Butter 1. F.F.A QWIFD/ FC17 / SS 179:1978
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MATERIALS/
PRODUCTS TESTED TESTS / PROPERTIES
STANDARD METHODS/ TECHNIQUES/ EQUIPMENT
F. CHINESE 1. Trace Elements : Cu, Pb, As, QWI PP02 / PROPRIETARY Cd, Sn Acid digestion/ ICP- OES
MEDICINES, COSMETICS, 2. Mercury QWI PP01 / FIMS PHARMACEUTICAL AND HEALTH 3. Staphylococcus aureus QWI MIC26 PRODUCTS USP 35 (2012), Sections 61 & 62 4. Total Plate Count QWI MIC27
USP 35 (2012), Sections 61 & 62
5. Total Yeast and Mould QWI MIC28 Count USP 35 (2012), Sections 61 & 62
6. Salmonella QWI MIC29
USP 35 (2012), Sections 61 & 62
7. E. Coli QWI MIC29
USP 35 (2012), Sections 61 & 62
8. Pseudomonas aeruginosa QWI MIC26
USP 35 (2012), Sections 61 & 62
9. Candida Albicans in ATS-QWIMIC-87
Pharmaceutical Products USP 35 (2012), Section 61 and 62
G. PETROLEUM 1. Water Content by distillation ASTM D95-05 (2010) PRODUCTS
(KEROSENE, GAS OIL, DIESEL,
2. Total Sediment in Residual Fuels
ASTM D4870-09
FUEL OIL
3. Ash from Petroleum Products ASTM D482-07
4. Flash Point by PMCC Tester ASTM D93-10
5. Kinematic Viscosity of ASTM D445-11 Transparent & Opaque Liquids 6. Density / Specific Gravity / API ASTM D1298-99
Gravity of Liquid Petroleum by (Reapproved 2005) Hydrometer Method
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MATERIALS/
PRODUCTS TESTED TESTS / PROPERTIES
STANDARD METHODS/ TECHNIQUES/ EQUIPMENT
7. Determination of Aluminium and ASTM D5184-01 Silicon in Fuel Oils by Ashing (Reapproved 2006) Fusion, ICP, Atomic Emission Spectrometry
8. Determination of Additive ASTM D5185-09 Elements, Wear Metal and Contaminants in used Lubricating
Oils by ICP-AES
9. Sediment in Crude Oils / Fuel ASTM D473-07
Oils by Extraction 10. Carbon Residue – Micro Method ASTM D4530-11 11. Sulphur by Energy Dispersive ASTM D4294-10 X-Ray Fluorescence Spectrometry 12. Pour Point ASTM D97-11 13. Distillation at Atmospheric ASTM D86-11a Pressure 14. Determination of Water by ASTM D6304-07 Coulometric Karl Fischer Titration 15. Calculated Cetane Index of ASTM D976-06 Distillate Fuels 16. Determination of V, Ca, P, Zn, ATS QWI PET/ F13 Na in Fuel Oils by ICP-AES 17. Density, Relative Density and API ASTM D4052-09 Gravity of liquids by Digital Density Meter 18. Calculated Carbon Aromaticity ISO 8217 (2010) Index 19. Hydrogen Sulphide in Fuel Oils ASTM D7621-10/ IP570 by Rapid Liquid Phase Extraction 20. ASTM Colour of Petroleum ASTM D1500-07 Products (ASTM Colour Scale)
Certificate No. : LA-1993-0064-A Issue No. : 17 Date : 07 June 2013 Page : 14 of 17
MATERIALS/
PRODUCTS TESTED TESTS / PROPERTIES
STANDARD METHODS/ TECHNIQUES/ EQUIPMENT
21. Acid Number by Colour-Indicator ASTM D974-11 Titration 22. Acid Number Petroleum Products ASTM D664-11 by Potentiometric Titration 23. Detection of Copper Corrosion ASTM D130-10 from Petroleum Products by the Copper Strip Tarnish Test 24. Cloud Point of Petroleum Products ASTM D2500-11
H. ROHS (IEC 62321) ELECTRONIC/ ELECTRICAL COMPONENTS Plastics 1. Determination of Cadmium Sample Preparation
and Lead EPA 3052 / Acid digestion / Microwave oven Analysis EPA 6010 / ICP – OES
Metals 2. Determination of Cadmium Sample Preparation
and Lead EN 13346 (Method B) / Acid Digestion Analysis EPA 6010 / ICP – OES
Plastics 3. Determination of Mercury Sample Preparation
EPA 3052 / Acid digestion /
Microwave oven
Analysis
USEPA 7471B / Cold Vapour
technique / FIMS
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MATERIALS/
PRODUCTS TESTED TESTS / PROPERTIES
STANDARD METHODS/ TECHNIQUES/ EQUIPMENT
Metals 4. Determination of Mercury Sample Preparation
EN 13346 (Method B) / Acid digestion Analysis USEPA 7471B / Cold Vapour
technique / FIMS Plastics & Metals 5. Determination of Trace Elements Sample Preparation
Chromium (VI) EPA 3060A / Alkaline Extraction Analysis USEPA 7196A / Colorimetric method / UV-VIS Spectrometer Plastics / Rubber / 6. Determination of Polybromodiethyl Sample Preparation
Polymer Ether’s (PBDE) and EPA 3540 / Soxhlet Extraction Polybromobiphenyl’s (PBB) Analysis GCMS Coated Metals 7. Test for Presence of Hexavalent IEC 62321/Ed 1.0
Chromium (Cr VI)
I. POLYMERS 1. Halogen (Chlorine and Bromine) by EN 14582 (Oxygen Bomb) Ion Chromatography EN 14582 Annex A, (Combustion Flask)
J. CONSUMABLES 1. Total Lead (Pb) in Metal Children’s CPSC-CH-E1001-08.1 AND TOYS Products 2. Total Lead (Pb) in Non-Metal CPSC-CH-E1002-08 Children’s Products 3. Total Lead (Pb) in Paint and Other CPSC-CH-E1003-09.1 Similar Surface Coatings
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MATERIALS/
PRODUCTS TESTED TESTS / PROPERTIES
STANDARD METHODS/ TECHNIQUES/ EQUIPMENT
K. PHARMACEUTICAL PRODUCTS I. Pharmaceutical and 1. Sterility Test } biological products, } medical devices, 2. Method Suitability / Validation }
ophthalmic products Test (Bacteriostasis and } EP 7.1 2.6.1 Fungistasis) of sterility test }
} 3. Growth Promotion Test }
II. Pharmaceutical and 1. Bacterial Endotoxins Test by USP 35 2012 <85> biological parenteral Chromogenic Kinetic Assay products, medical Method devices, purified water, process water, dialysate solutions
III. Antibiotic drug 1. Microbiological Assay of EP 7.3 2.7.2 products Antibiotic
IV. Monitor plates and 1. Microbiological Identification ATS QWI PMIC 03
broths (settle plates, Tests contact plates, air sampler strips, broths)
from microbiological
monitoring of manufacture
environment
Certificate No. : LA-1993-0064-A Issue No. : 17 Date : 07 June 2013 Page : 17 of 17
Approved Signatories
Mrs Wong Mei Hong - for all accredited tests (except Section H)
Ms Pansy Teo - for Section H and J
Ms Amy Sol - for Section G
Mr Yao Kai Wen - Section A (except cholesterol), Section G, H, I and J
Mr Tan Teong Huat - for Section J
Mr Jasper Tan Boon Hwa - for microbiological tests in Section E1-22 & F3-8
Ms Regina Lim - for Section A to F (except microbiological tests)
Ms Jinny Quek - for microbiological tests in Section E & F, all tests in Section K
Mr Kent Tan - for Section I
Ms Leong Suet Ping - for Section I
Ms Joanne Chia - for Section EII.: 16, 18, 20, 21, 23, EIV. 3, 4 & EV. 5-15
Mr Yat Nai Teck - for Section G
Ms Sandra Sng - for Section K
Ms Sheena Lim - for microbiological tests in Section E & F; all tests in Section K
Ms Lee Geok Cheng - for Sections H & J
Note : This laboratory is accredited in accordance with the recognised International Standard ISO/IEC 17025:2005. A laboratory's fulfilment of the requirements of ISO/IEC 17025:2005 means the laboratory meets both the technical competence requirements and management system requirements that are necessary for it to consistently deliver technically valid test results. The management system requirements In ISO/IEC 17025:2005 (Section 4) are written in language relevant to laboratory operations and meet the principles of ISO 9001:2008 Quality Management Systems — Requirements and are aligned with its pertinent requirements.