Public Analyst's Laboratory - Galway

Transcription

1 Seamus Quirke Road, University College Hospital, Galway Testing Laboratory Registration number: 009T is accredited by the Irish National Board (INAB) to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO/IEC 17025: nd Edition General Requirements for the Competence of Testing and Calibration Laboratories (This Certificate must be read in conjunction with the Annexed Schedule of ) Date of award of accreditation: 05:05:2002 Date of last renewal of accreditation: 06:12:2016 Expiry date of this certificate of accreditation: 06:12:2021 This shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Chairperson: Dr Adrienne Duff Issued on 06 December 2016 Ms Ita Kinahan Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Board. The INAB is a signatory of the European co-operation for (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement. Edition 59, 06/12/ T Page 1 of 23

2 Schedule of (Annex to Certificate) PUBLIC ANALYST'S LABORATORY - GALWAY Initial Registration Date : 12-December-1989 Postal Address: (Address of other locations as they apply) Seamus Quirke Road University College Hospital Galway Telephone: +353 (91) Fax: +353 (91) Helena.mcgrath@hse.ie Contact Name: Dr Helena McGrath Facilities: Conditionally available for Public testing Edition 59, 06/12/ T Page 2 of 23

3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD (INAB) is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO/IEC or ISO (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : Permanent laboratory calibration and testing where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Category C: Category D: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and testing that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Board. Site calibration and testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing laboratory. Testing may be performed using (a) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/testing service: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. Unavailable for public calibration/testing more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. INAB will, on request, verify the status and scope. Edition 59, 06/12/ T Page 3 of 23

4 766 Waters Water for potable and domestic purposes Drinking waters Chemical tests:- Colour Pt/Co mg/l Documented In-house Methods based on:- 400nm Pt/Co scale (Method 2/6).99 Other waters Turbidity N.T.U.s S.M. 22 nd Ed. (2012) 2130B, Bottled waters Nephelometry - Formazin (Method 2/7) Conductivity µs/cm S.M. 22 nd Ed. (2012) 2510A, at 20 C Electrometry (Method 2/8) ph S.M. 22 nd Ed. (2012) 4500-H + B Electrometry (Method 2/9) Free and total Chlorine mg/l S.M. 22 nd Ed. (2012) 4500-CL G, Colourimetry (Method 2/10) Note: S.M. denotes "Standard Methods for the examination of Waters and Waste Waters" Edition 59, 06/12/ T Page 4 of 23

5 766 Waters Water for potable and domestic purposes Drinking waters Chemical tests:- Fluoride 100-5,000 µg/i F Documented In-house Methods based on:- S.M. 22 nd Ed. (2012) 4100 B Ion Chromotography (Method 2/25).99 Other waters Ammonium Automated salicylate Bottled waters 1.6 mg/l method Total Oxidised Nitrogen 2.0- S.M. 22 nd Ed. (2012) mg/L NO2 B Nitrite S.M. 22 nd Ed. (2012) 1.0 mg/l 4500-N03 H Aquakem (Method 2/37) 766 Waters.99 Other waters Total and free Chlorine S.M. 22 nd Ed. (2012) Swimming pool and mg/ I Cl 4500-CL G, Colourimetry Jacuzzi (Method 2/10) Edition 59, 06/12/ T Page 5 of 23

6 766 Waters Trace Metals: In house method 2/46 based Cadmium µg/l on US EPA Method Waters for potable Lead μg/l ICP-MS and domestic purposes Nickel μg/l Chromium μg/l.07 Bore waters Selenium μg/l Arsenic μg/l.99 Other waters Aluminium μg/l Dialysis waters Boron μg/l Bottled waters Copper μg/l Zinc μg/l Iron μg/l Manganese μg/l 766 Waters Volatile Organic Compounds: In house method 2/80 Based Water for potable and domestic purposes Bore waters Other waters Bottled water not including carbonated bottled water 1,2- Dichloroethane μg/l Benzene μg/l Bromodichloromethane μg/l Bromoform μg/l Chloroform μg/l Dibromochloromethane 2-125μg/L Tetrachloroethene μg/l on S.M. 22 nd Ed (2012). 6200B GC-MS Trichloroethene μg/l Edition 59, 06/12/ T Page 6 of 23

7 756 Drugs and Pharmaceuticals Drugs Uniformity of Mass of single dose preparation Uniformity of Mass of delivered doses from multi dose containers [British Pharmacopoeia] [European Pharmacopoeia] (Method 3/2) Subdivisions of Tablets 10mg to 100g Disintegration (Tablets/Capsules/Granules) [British Pharmacopoeia] [European Pharmacopoeia] [United States Pharmacopoeia] (Method 3/4) Assay and Identification:- % of labelled content (i) HPLC (ii) Absorption Spectrophotometry HPLC (Method 3/5) UV/VIS Spectrometry (Method 3/6) (Based on monographs in the above Pharmacopoeia or customer supplied methods where the active ingredient is isolated by solution or extraction) *Flexible scope: Drug and pharmaceuticals may be added and ranges extended in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 7 of 23

8 756 Drugs and Pharmaceuticals Drugs Uniformity of content of single dose preparation % of labelled content Uniformity of dosage units Documented In-house Methods based on:- [British Pharmacopoeia] [European Pharmacopoeia] [United States Pharmacopoeia] (Method 3/7) UV or HPLC ph measurement 1-13 Electrometry ( Method 3/8) Dissolution-Solid Oral Dosage Forms % of labelled content [British Pharmacopoeia] [European Pharmacopoeia] [United States Pharmacopoeia] (Method 3/9) * Flexible scope: Drugs and pharmaceuticals may be added and ranges extended in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 8 of 23

9 * Dairy products Potassium % Flame photometry.03 Meat & meat products, game & poultry Sodium % In house method 1/40.05 Fats and oils.06 Soups broths & sauces.07 Cereals & bakery products.16 Nut and nut products, snacks (Snack foods only).17 Prepared meals.18 tuffs intended for special nutritional uses * Flexible scope: Additional food matrices may be added in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 9 of 23

10 Dairy products Total solids 1-15% m/m In-house method 1/1 Milk & cream Milk Delvo test SP < or > IU Penicillin G K+/ml In-house method 1/10A Freezing Point Depression -422 to -621 m o H Extranous water: 0.5% to16% In-house method 1/6A based on IS EN ISO 5764:2009 Cyroscope Titratable Acidity ml of 0.1M NaOH/10mL In-house method 1/7 based on BS 1741:1989 Section 10.1 and ISO 6091:1980 Edition 59, 06/12/ T Page 10 of 23

11 Public Analyst's Laboratory -Galway.12 Alcoholic beverages (Other than wine), Spirits, Distillates, Ethanol and Water Mixtures Apparent Alcoholic Strength by Direct Measurement 0-100% v/v DA-510 Instruction Manual, Density Meter (Method 1/13) Edition 59, 06/12/ T Page 11 of 23

12 Public Analyst's Laboratory -Galway Dairy Products Egg and egg products Meat & meat products, game&poultry Fish, shellfish&molluscs Fats & Oils Soups,broths&sauces Cereals&bakery products Ices & desserts Cocoa&cocoa preparations,coffee& tea *(except those containing sugars or starchy products with low fat levels) Confectionery Nuts&nut products,snack Prepared dishes *(except those containing high sugars or starchy products with low fat levels) tuffs intended for special nutritional uses. Fat % m/m Documented In-house method 1/5 using Werner Schmid procedure Acid Hydroloysis / Extraction Edition 59, 06/12/ T Page 12 of 23

13 Public Analyst's Laboratory -Galway Meat& meat products, game & poultry Fish,shellfish&molluscs Soups,broths&sauces Fruit&vegetables Non-alcoholic beverages Wine Alcoholic beverages (other than wine) Confectionery tuffs intended for special nutritional uses Additives Sulphur Dioxide mg/kg (or L) Documented in-house Tanner method 1/50 by distillation. Edition 59, 06/12/ T Page 13 of 23

14 Dairy products Egg & egg products Fish, shellfish & molluscs Soups, broths & sauces Cereals & bakery products Fruit & vegetables Non-alcoholic beverages Wine Alcoholic beverages (other than wine) Ices & deserts Confectionery Prepared dishes Food stuffs intended for special nutritional uses Additives Sorbic Acid and Benzoic Acid mg/ L (Liquids) mg/kg (Solids) Annex K-2 & K-3 of Laboratory QAP Manual Documented in-house HPLC method 1/55 * Flexible scope: Additional food matrixes may be added and ranges extended for the above additives and contaminants, in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 14 of 23

15 *Allergens in foods using the ELISA Technique to include In-house method based on quality assurance procedures manual annex K- 6 - ELISA Protocol.15 Confectionery Gluten Method 1/31A procedure.07 Cereals and bakery Range mg/kg using (Gliadin Elisa Kit) products ELISA technique and Annex K-6 of QAP Manual.18 tuffs intended for special nutritional uses Including Baby food.15 Confectionary Peanut In House method 1/41 (Chocolate) Range ppm R-Biopharm FAST Peanut.07 Cereals and Bakery (Part No. R6202) ELISA test Products (Biscuits) kit. * Flexible scope: Additional allergens or food matrices may be added and range extended for the detection of allergens using the ELISA technique, and flexibility concerning the performance of the test method, in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Additionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 15 of 23

16 Dairy products Egg &egg products Meat &meat products, game & poultry Fish, shellfish & molluscs Fats & oils Soups, broths&sauces Cereals & bakery products Fruit & vegetables Herbs & spices Non-alcoholic beverages Wine Alcoholic beverages (other than wine) Ices & desserts Cocoa &cocoa preparations, coffee & tea Confectionery Nuts &nut products,snack Prepared dishes tuffs intended for special nutritional uses Additives Others Including high protein foodstuffs Chemical Tests Ash Nitrogen % m/m 0-37% m/m Protein % (Calculation from Nitrogen result) Documented In-house Methods based on:- In-house method 1/12 In-house method 1/14 In-house method 1/14 Edition 59, 06/12/ T Page 16 of 23

17 Dairy products Egg & egg products Meat &meat products, game & poultry excludes sausages + high fats Fish, shellfish & molluscs Fats & oils Includes only butter and fats Soups, broths&sauces Cereals & bakery products Fruit & vegetables Ices & desserts Cocoa &cocoa preparations, coffee & tea Confectionery Excludes syrups and sugars Nuts &nut products,snack Prepared dishes tuffs intended for special nutritional uses Additives Chemical Tests Moisture % m/m Documented In-house Methods based on:- In-house method 1/18 Edition 59, 06/12/ T Page 17 of 23

18 Dairy products Egg & egg products Meat & meat products, game & poultry Fish,shellfish&molluscs Fats & oils Soups, broths & sauces Cereals & bakery products Fruit & vegetables Herbs & spices Non-alcoholic beverages Wine Alcoholic beverages (other than wine) Ices & desserts Cocoa & cocoa preparations, coffee & tea Confectionery Nuts & nut products, snack Prepared dishes tuffs intended for special nutritional uses Additives Others Foreign Objects CCFRA Guidelines for the identification of foreign bodies reported in food, 2 nd Ed. No.4, General Classification based on: Microscopy (Method 1/80) Physical/Chemical/ Microscopical examination (Method 1/81) Edition 59, 06/12/ T Page 18 of 23

19 * Dairy products Milk Dairy spreads Folic acid *2-160µg/100g * µg/100g Liquid Chromatography- Mass Spectroscopy(LC-MS) In House method 1/42.05 Fats and oils Spreads * µg/100g.07 Cereals & bakery products *6-1000µg/100g.10 Non-alcoholic beverages *2-160µg/100ml.18 tuffs intended for special nutritional uses Baby Food * µg/100g *Flexible scope: Additional food matrixes may be added and ranges extended in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 19 of 23

20 .05 Dairy products -cheese Fish, crustaceans & molluscs Biogenic Amines*: Putrescine Cadaverine Histamine Tyramine mg/kg JAOAC Vol. 78, No HPLC (method 1/36) Annex K-2 & K-3 of Laboratory QAP Manual.05 Fats & oils Documented In-house.06 Soups, broths & sauces Methods based on:-.10 Non-alcoholic Refractive Index Refractrometer (Method beverages Sol.Solids as sucrose 0-85% w/w 1/17).15 Confectionery Preserves * Flexible scope: Additional food matrixes may be added and ranges extended for the above additives and contaminants, in accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 20 of 23

21 Dairy products Fruit & vegetables Non-alcoholoc Beverages Wine Alcoholic beverages (other than wine) Confectionery ph 2-12 Electrometry (Method 1/19) 752* Residues in and Analytes* *Documented In-house Agricultural Materials - Arsenic mg/kg method 1/24 Inductively - Cadmium mg/kg Coupled Plasma - Mass - Chromium mg/kg Spectrometry (ICP - MS) Elements - Lead mg/kg with microwave digestion. Food & Drink - Nickel mg/kg - Selenium mg/kg * Flexible scope: Additional food matrixes may be added, analytes and ranges extended. In accordance with the laboratory's approved and documented procedures. For details refer to the laboratory's list of Aditionally Accredited Tests, available from the laboratory. Edition 59, 06/12/ T Page 21 of 23

22 757 Cosmetics, perfumes & essential oils Cosmetics Arsenic mg/kg Cadmium mg/kg Chromium mg/kg Lead mg/kg Nickel mg/kg In house method 4/1 based on ISEN 15763:2009 ICP - MS with microwave digestion Edition 59, 06/12/ T Page 22 of 23

23 Constituents of the Environment Waters other than saline Bathing waters Chemical Tests Colour mg/L Pt/Co Documented In-house Methods based on:- 400nm Pt/Co Scale (Method 2/6).12 Saline waters ph S.M. 22 nd Ed. (2012) 450- Bathing waters HB, Electrometry (Method 2/9) Edition 59, 06/12/ T Page 23 of 23