Professional Documents
Culture Documents
Portfolio of Services
March 2012
CONTENTS
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Nutritional Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
A. Product Safety Risk Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carbohydrates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lipids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Minerals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Proteins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Proximates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vitamins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4 4 4 4 4 4
Probiotics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Quantitative Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Microbiology Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Qualitative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Quantitative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 What is a stability study? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What are the advantages of stability study? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Objectives: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . History:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Study duration: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other studies to determine shelf life: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 9 9 9 9 9
Stability Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Nutritional Clinical Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Services Performed Outside North America Genetically Modified Organisms (GMO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Mixed Bacterial Species by dHPLC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Diversity of Complex Flora Analysed by dHPLC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Target Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Advantages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 11 11 11
The entire content of this Catalog is subject to copyright protection. Copyright 2011 Silliker, Inc. All rights reserved. The contents of this Catalog may not be copied other than for use by non-for-profit organization, and appropriate reference with all copyright notices stated. The Catalog may not be copied, reproduced or otherwise redistributed. Except as expressly provided above, copying, displaying, downloading, distributing, modifying, reproducing, republishing or retransmitting any information, text or documents contained in this Catalog or any portion thereof in any electronic medium or in hard copy, or creating any derivative work based on such documents, is prohibited without the express written consent of Silliker, Inc. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any copyright of Silliker, Inc., or any party affiliated with Silliker, Inc.
About Silliker
For over 40 years, Silliker has championed quality systems and results that are documentable and reproducible. Our commitment to operational excellence helps our valued clients protect brand image, ensure timely delivery of products that match customer requirements, and meet exacting specifications for quality and safety. As a pioneer in the analysis of dietary supplements, Silliker is a trusted and innovative partner of dietary supplement companies around the globe. This booklet provides an overview of our expert services, which we are continously expanding to meet the needs of our customers. Employing the latest methodologies and cutting-edge technologies, our extensive analytical services meet recognized standards, such as United States Pharmacopeia (USP) and Food Chemical Codex (FCC). Throughout our operations, we utilize validated and official methods of AOAC INTERNATIONAL, AOCS, USDA, AACC, and other recognized bodies to ensure the delivery of accurate, reliable and acceptable data. Our operations are highly skilled in the detection and identification of microbial, chemical, and physical contaminants. As part of our services, Silliker method development specialists can modify existing client proprietary assays to corroborate product label claims or stated specifications. Globally, dietary supplement companies are charged with integrating science-based strategies and programs into a comprehensive safety program to assure product safety and quality. Silliker professionals understand your challenges and can help you implement an integrated program to maximize safety and safeguard your brand. Whether youre launching a new product or conducting a clinical trial, Silliker professionals can assist you. Accredited to ISO 17025, an internationally recognized benchmark of technical and managerial excellence, our laboratories are reinforced by an extensive quality system that incorporates internal control samples, external control matrices, and reputable proficiency programs. We dedicate ourselves to meeting and exceeding the expectations of our valued clients. The success of your quality assurance program largely depends on your continuous commitment to quality. Leading companies worldwide recognize Silliker as a trusted partner due to our ability to deliver accurate information in a timely manner, our reputation as a scientific leader, and our local and international presence.
www.silliker.com Silliker delivers uniform and precise testing results that are recognized worldwide. At our dedicated dietary supplement centers in North America and Europe, our scope of services include:
In addition to our extensive microbiology and chemistry expertise, we offer human clinical trials and stability studies to support your product development needs. We also provide label claim support with full testing documentation and nutritional labeling. Our application expertise includes dietary supplements, functional foods, nutraceuticals and nutritional beverages.
Microbiological
Pathogens Probiotics
info@silliker.com
Identity Testing Assay / Potency Testing Stability Studies / Shelf-life Nutritional Analyses Clinical Trials cGMP Consulting
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Nutritional Analyses
Carbohydrates
Beta-glucan D3-D10 Dextrose Easily assimilated carbohydrates Fructooligosaccharides Fructose Galactose Glucose Non-soluble fibres Inulin Lactose Malto-dextrin Maltose Maltotriose Raffinose Rhamnose Saccrose Soluble fiber Starch Total carbohydrates Total fiber Total sugars Monounsatured fatty acids Omega-3 and -6 fatty acids Peroxide value Phytosterol + / - Polarized compound Polyunsatured fatty acid Saponification value Saturated fatty acid Smoke point Total sterol Trans fatty acid Unsaponifiable matter Wax Collagen (l-hydroxyproline) Creatinine Free amino acid Gamma-aminobutyric acid N-acetylcysteine N-acetyltyrosine Nitrate Nitrite Protein Soluble proteins Taurine Total amino acid Total nitrogen Total nitrogen matter Total protein Total volatile basic nitrogen Tryptophan Urea Whey protein nitrogen Vitamin B2 Vitamin B3 or PP Vitamin B5 Vitamin B6 (Pyridoxine) Vitamin B9 Vitamin C Vitamin H or B8 Vitamin K1 Vitamin K3 Vitamin P Vitamin A Zinc
Minerals
Ashes Cadmium Calcium Chorids Chromium Cobalt Copper Iodine Iron Lead Magnesium Manganese Mercury Phosphorus Potassium Sodium Total sulphur Zinc
Vitamins
Ascorbyl palmitate Beta-carotene Para-amino benzoic acid Vitamin A Vitamin B1 (thiamin) Vitamin B12 Vitamin B2 (riboflavin) Vitamin B3 or PP (nicotinamide and niacin) Vitamin B4 (choline) Vitamin B5 (pantothenic acid) Vitamin B6 (pyridoxine hydrochloride) Vitamin B9 (folic acid) Vitamin C (L-ascorbic acid) Vitamin D2 (calciferol) Vitamin D3 (cholecalciferol) Vitamin E Vitamin H or B8 (biotin) Vitamin K1 Vitamin K2-7 Vitamin K3 Vitamin P (rutin)
Proximates
Ash Calcium Dry matter Easily assimilated carbohydrates Fat Magnesium Moisture Nutritional value Phosphorus Potassium Protein Sodium Total carbohydrates Total fiber Vitamin B1 (Thiamin) Vitamin B12 (Riboflavin)
Lipids
Acid value Cholesterol CLA EPA/DHA Fat acidity Fatty acids Free fatty acids Insoluble impurities in hexane Iodine value Melting point
Proteins
5-hydroxytryptophan Ammonia Ammonia nitrogen
Probiotics
Quantitative Testing
As your R&D partner, the Silliker Food Science Center can help you identify potential quality and safety issues prior to product launch. Silliker can provide independent third party validation of probiotic viability and stability through the products expiration date. Common enumeration tests include total viable count, Bifidobacterium count, and Lactobacillus count. The total viable count reports all live bacteria regardless of genus. The Bifidobacterium and Lactobacillus results are reported at the genus level regardless of species. 4
Identification Technologies
Through its Microbial Identification Program, the Silliker Food Science Center can provide you with accurate and reliable source tracking services utilizing state-of-the-art technologies. These services offer a reliable tool for strain differentiation and comparison. uuGene Sequencing Gene sequencing is considered the gold standard for microbial identification. The main benefit of this technology over traditional phenotypic methods is the ability to quickly generate accurate and reproducible results at the genus and species level. This saves time and money during product development when rapid definitive results are needed. uuRep-PCR by DiversiLab Repetitive sequence based Polymerase Chain Reaction (Rep-PCR) allows verification of the probiotic strain integrity over time, which provides scientific substantiation for any strain associated label claims. An initial probiotic sample is analyzed via Rep-PCR to get a DNA fingerprint master, which is stored in a database. Fingerprints of subsequent samples are compared against the master sample to determine production lot acceptance or rejection. uudHPLC The denatured High Performance Liquid Chromatography (dHPLC) is a new tool for DNA fragment analysis of mixed bacterial species in various environments. This high speed, high resolution, and automated technology can detect polymorphism in DNA, allowing differentiation between similar probiotic strains. The dHPLC method offers the ability to determine the population dynamics of microbial communities without a culture step. In yogurt, for example, this application allows users to track the probiotic population dynamics throughout the products shelf life.
Coloring Agent
Allura red AC Amaranth Anthocyanin Astaxanthin Azorubine Beta-carotene Betanin Bixin Brilliant blue FCF Canthaxanthin Capsanthine Carminic acid Erythrosin Indigo carmine Licopene Lutein Patente blue V Ponceau 4R Quinoline yellow Red 2G Riboflavin Sunset yellow FCF Tartrazine Total carotenoid Total Xantophyll
Sweetners
Acesulfame K Aspartamine Cyclamate Isomalt Lactitol Maltitol Manitol Neohesperidin DC Saccharin Sorbitol Sucralase Sugar alcohol Xylitol
Flavors
Vanillin
(continued)
W Water Determination, Method 1, Karl Fischer Weight variation - fill weight Weight variation - USP Wild yam Diosgenin X Xanthan gum Z Zeaxanthin
T Taurine (pure) Tea Tree Oil: terpinen-4-ol and 1,8-cineole content Theobromine Thiamin Total Bioflavonoid (Citrus) Turmeric - ID Turmeric: curcuminoids Tyrosine V Valerian: Valerenic acids Valine Vanilla Vinpocetine Vitamin A Vitamin A palmitate Vitamin B1 - assay Vitamin B12 Vitamin B2 Vitamin B3 Vitamin B5 Vitamin B6 Vitamin C Vitamin D Vitamin E Vitamin H1 Volatile Oil Content - (USP) Volatile Oil Content - (AOAC)
Contaminant Analyses
Allergens (Detection)
AlmondQualitative CeleryQualitative EggQuantitative (Ovalbumine) FishQualitative GlutenQuantitative (Gliadin) HazelnutQualitative Milk ( lacto )Quantitative de .lactoglobuline Milk ( caseine )Quantitative (casine) Milk ( lactose )Detection and Dosage MustardQualitative Nut packageQualitative: Almond, hazelnut, pistachio, walnut, pecan nut, cashew, macadamia nut, Brazil nut PeanutQualitative PistachioQualitative SesameQuantitative SesameQualitative Shellfish MolluskQuantitative SoybeanQualitative SulfitesDetection Limit 3 mg/kg LupinQuantitative WalnutQualitative WheatQualitative
Heavy Metals
Antimony Arsenic Cadmium Chromium Lead Mercury Selenium
Mycotoxins
Aflatoxin B1 Aflatoxin M1 Aflatoxin M2 Aflatoxins B1-B2-G1-G2 Citrinin Deoxynivalenol Ergosterol Fumonisin B1 Ochratoxin A Patulin T2 toxin Trichotecenes Zearalenone
Pesticides
Insecticides Aldrin Amitraz Carbamates Disulfoton Fluvalinate Malathion
Metidathion Organochlorine compound Organophosphate Pentachlorophenol Phosphide Pyrethroid Tetradifon Triazophos Herbicides Dicamba Glyphosate Isoxaben Mecoprop Pentachlorophenol Triazines and metabolites Trifluralin Fungicides Benomyl Captan Carbendazim Dinocap Fluazinam Folpet Imazalil Iprodione Myclobutanil Propamocarb Quintozene Tecnazene Thiabendazole Total dithiocarbamate
Other Contaminants
Rotencide - Coumafene (warfarine) - Coumarine Polycyclic Aromatic Hydrocarbons - Benzo-apyrene Acrylamide Rotencide - Coumafene (warfarine) - Coumarine Dioxins - Polychlorobiphenyl type dioxins Radioactivity - Radioactivity (Radionucleids research)
Microbiology Analyses
Qualitative Pathogens
Given the proper environmental conditions, hazardous pathogens can grow, proliferate, and take harborage in your processing plant. With an exceptional knowledge of food matrices and regulatory requirements, Silliker microbiologists employ approved analytical methods to isolate and identify foodborne pathogens. Bacillus cereus Campylobacter Clostridium botulinum Clostridium perfringens Hemorraghic Escherichia coli Enteropathogenic E. coli E. sakazaki Listeria monocytogenes Salmonella Shigella Staphylococcus aureus Vibrio species Yersinia enterocolitica 8
Quantitative Pathogens
Spoilage organisms are a leading and annual cause of product waste and lost revenues in the global food industry. Protecting your product, bottom line, and valued customers against costly spoilage organisms requires accurate analytical data from a reputable resource. Our services include, but are not limited to: Aerobic / Anaerobic plate counts Coliforms Escherichia coli Enterococci Yeast and mold counts Acidophiles Anaerobes Psychrotrophs Spore counts Thermophiles
uuTo establish the best-by, sell-by, or expiration date. uuReport of the minimum temperature during storage, transport and handling which must be respected. uuTo reduce costs due to the quality deterioration of a product on the market. uuTo identify product weaknesses and introduce the necessary changes in order to prolong shelf-life.
Objectives:
The stability study can control the qualitative and quantitative evolution of the packaging, active ingredients and product microbial stability (raw materials, finished products). It aims to validate or determine the shelf-life before product selling.
History:
The samples are stored in an environmental chamber where temperature and humidity are defined and controlled.
Study duration:
Study Long-term Medium Accelerated
Example of planning under the specified guidance on the ICHQ1A standard: Storage conditions 25C 2C / 60% RH 5% 30C 2C / 65% RH 5% 40C 2C / 75% RH 5% Recommended Testing Frequency 0, 3, 6, 9, 12, 18, 24 and 36 months 0, 3, 6, 9 and 12 months 0, 3 and 6 months
Depending on the individual product stability, tests are conducted at frequencies defined in advance. In addition, light condition studies following the ICHQ1B (photostability testing) can also be performed.
Study types
uuWeight management satiety uuGastroenterology, gut microbiota uuMetabolism, cardiovascular health uuCognition, aging uuGlycemic and insulinemic index uuImmune defense
Central Lab
uuBone the measurement of hormones related to the mineralization through radiography (DEXA method) uuOxidative stress uuInflammation markers [not inflammatory] uuSatiety hormones and mediators uuLipids and lipoproteins uuMarkers of metabolic disorders uuBioavailability of vitamins and minerals uuIntestinal flora analysis
A Quality Approach
Biofortis is certified to the ICH E9 and ISO 9001:2008 standard, applying this quality-centric approach to the design, set-up and management of clinical studies. Applying Good Clinical Practices including detailed Standard Operating Procedures is another way
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(performed in Nantes,FR)
Analyses
uuEndogenous target:corn, soybean, canola seed, wheat, tomato, rice uuScreening test: P35s, Tnos, Pnos, BAR, PAT, RR uuIdentification test : soja RRS, mas Bt11, Bt176, Mon810, T25, GA21, Starlink, Herculex, NK603, Mon863, DAS 55122, riz LL601 and 62, canola seed... uuRegulatory analyses: package analysis evolving with European legislation uuVirus specific test: CAMV
(performed in Nantes,FR)
The Denaturing High Performance Liquid Chromatography (dHPLC) is a tool for the analysis of mixed bacterial species in various environments. This high speed and automated technology can analyze DNA fragments derived from human, animal, plant and microbial origins. Due to its speed and high resolution, this method is particularly useful for detecting polymorphisms in DNA. The dHPLC method can follow the evolution of microbial communities without a culture step. Diversity of Complex Flora Analyzed by dHPLC uuFood pathogen flora uuClinic disease flora uuIntestinal flora uuMouth flora uuSkin flora uuTechnology flora (ferments, probiotics) uuBeverages flora (bottled water, beer) Applications The dHPLC offers a wide range of applications regarding quality control, authenticity control and clinical studies: uuReal time evolution follow-up of specific flora (ex: impact of probiotic on target bacteria from intestinal flora) uuIdentification of bacterial species cultivable and noncultivable uuBacterial species differentiation in complex flora uuBacterial composition purity checking of manufacturing batches uuShelf life studies uuClinical studies uuTechnological flora studies uuFerments characterization uuAnalysis of antibiotics impact on flora Target Products uuRaw food uuManufactured goods or finished products uuFermented food products (cheese, fresh dairy products)
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Silliker, Inc. 111 E. Wacker Drive, Ste. 2300 Chicago, IL 60601 / USA Tel. +1 312 938 5151 email. info@silliker.com www.silliker.com 12