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Testing Process

The design of any test program begins with listening and understanding your unique challenges and capabilities.

Through open dialog we help you understand compliance and assess the risks in your processes or environment.

You’ll receive a tailored, problem-solving compliant solution whether it is data for an FDA submission for a medical device,
on-going monitoring for a pharmaceutical process or utility, or compliance for food distribution.

If you would like to discuss how we can help you please email or call us.

info@ultimatelabsinc.com
Phone (858) 677-9297

USP Water Testing Kits

Order USP Water Kits through our Amazon store.

This kit is complete for meeting the USP Purifed Water requirements at an ISO and EPA certified laboratory. Test kit includes certified sampling containers for TOC, bioburden and conductivity.

Click Here To Order Yours.

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Ultimate Labs performs testing according to methods listed in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur. or EP) and Japanese Pharmacopoeia (JP). In addition, we perform testing according to AOAC Official Methods of Analysis, ASTM testing standards, AAMI and other standard testing compendia. The control of the microbiological quality of water systems is an important consideration for most pharmaceutical and consumer product manufacturing sites. In addition, chemical purity (often represented by Total Organic Carbon or TOC and Conductivity) is another important constituent in establishing control of purified water systems. Whether testing USP or EP Purified Water or Sterile Water for Injection, using a lab that understands the differences between the compendial water monographs is critical for the quality control of the water system and ultimately the quality and safety of your product. Testing of water systems should begin with development or review of installation, operational and performance qualification methodology through the implementation of the IQ/OQ/PQ and routine monitoring Whether testing to meet United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur. or EP), Japanese Pharmacopoeia (JP) or other compendial requirements, our full-service, cGMP, ISO 9001 accredited microbiological testing services can provide you with timely test results that you require, backed by a staff of dedicated professionals.

Click Here To Order Yours.

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Environmental Monitoring

Clean rooms are where medicines, medical devices, biologics and therapeutics are manufactured.

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Ensure your products’ safety with efficient and precise contaminant monitoring from Ultimate Labs.

We support utility qualifications and provide on-going monitoring to establish a baseline and trends during your manufacturing process.

Contact us for Scheduling

Test Code Test Description Test Conditions Sample Size
NC001 Negative Control (TSA Plate) Incubation 30-35C for 3-5 days,  20-25C for 2-5 days 1 plate
NC002 Negative Control (SDA Plate) Incubation 20-25C for 5-7 days 1 plate
NC003 Negative Control (Other Plate) Incubation per Media Specifications 1 plate
NV001 Non-Viable Air Performed per ISO or Client Specifications 1 location
VA001 Viable Air (TSA SAS) Incubation 30-35C for 3-5 days, 20-25C for 2-5 days 1 plate
VA002 Viable Air (SDA SAS) Incubation 20-25C for 5-7 days 1 plate
VA003 Viable Air (Other SAS) Incubation per media specifications 1 plate
SP001 Viable Air (TSA Settling Plate) Incubation 30-35C for 3-5 days, 20-25C for 2-5 days 1 plate
SP002 Viable Air (SDA Settling Plate) Incubation 20-25C for 5-7 days 1 plate
SP003 Viable Air (Other Settling Plate) Incubation per media specifications 1 plate
VS001 Viable Surface (TSA Plate) Incubation 30-35C for 3-5 days, 20-25C for 2-5 days 1 plate
VS002 Viable Surface (SDA Plate) Incubation 20-25C for 5-7 days 1 plate
VS003 Viable Surface (Other Plate) Incubation per media specifications 1 plate
VS004 Viable Surface (Swab) Streak onto TSA & Incubation 30-35C for
3-5 days, 20-25C for 2-5 days
1 swab

Water Testing

Water is used for manufacturing pharmaceuticals and injectable medicines.  Drinking water is monitored for public safety and food manufacturing.

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Ensure water quality with timely bioburden and coliform testing from Ultimate Labs.

We can also apply various chemical analyses to determine the attributes of your water.

Contact us for Scheduling

Test Code Test Description
USP1231BIO USP 1231 Bioburden MF
HACH10250 HACH 10250 Chlorine Total
SM4500CIG SM 4500-CI G Total Chlorine
EPA9221CT EPA 9221 Total Coliform – Colitag P/A
EPA9221MF EPA 9221 Total Coliform – MF m-Endo
EPA1622 EPA 1622 Cryptosporidum
SM9223 SM 9223 Total Coliforms and E.coli P/A
SM9213D SM 9213 Pseudomonas P/A
SM9213 SM 9213 S. Aureus
HDYBYCE Legionella P/A
HACH8014 HACH 8014 Barium
HACH10251 HACH 10251 Barium
HACH8013 HACH 8013 Arsenic
HACH8311 HACH 8311 Ozone
HACH8012 HACH 8012 Aluminum
USP1231NC USP 1231 Bioburden MF – Negative Control
USP788W USP 788 Particulates
USP643TOC USP 643 Total Organic Carbon
USP645 USP 645 Conductivity
SM2510B SM 2510 B Conductivity
CLSIC3A4R CLSI C3-A4 Resistivity
CLSIC3A4BIO CLSI C3-A4 Bioburden MF
CLSIC3A4E CLSI C3-A4 Endotoxin
CLSIC3A4TOC CLSI C3-A4 Total Organic Carbon
USP85 USP 85 Endotoxin
USP643TC USP 643 Total Carbon
USP643IC USP 643 Inorganic Carbon
HACH8030 HACH 8030 Hardness, Ca & Mg
40CFR141N 40 CFR 141 Nitrate
USP791 USP 791 pH
SM4500HB SM 4500-H+B pH
WSDW Water Safe Drinking Water
SM2520 SM 2520 Salinity
HACH8186 HACH 8186 Silica, LR
SM2540CD SM 2540 C Solids, Dissolved
SM2540CF SM 2540 C Solids, Filterable
SM2540F SM 2540 F Solids, Settleable
SM2540B SM 2540 B Solids, Total
SM2540D SM 2540 D Total, Non-Filterable
HACH8006 HACH 8006 Suspended Solids
HACH8113 HACH 8113 Chloride
HACH10050 HACH 10050 TPH Water and Soil
HACH10229 HACH 10229 Iron
HACH10227LR HACH 10227 Sulfate LR
HACH10227HR HACH 10227 Sulfate HR
HACH10205 HACH 10205 Ammonia
40CFR141T 40 CFR 141 Tubidity
HACH10171 HACH 10171 Chloramine, Mono, LR
USP231 USP 231 Heavy Metals
HACH10050 HACH 10050 Atrazine
HACH10238 HACH 10238 Copper
HACHEDTA EDTA HAC-DT Total&Calcium (hardness)
HAC10206 HACH 10206 Nitrate
HACH10237 HACH 10237 Nitrite
HACH10240 HACH 10240 Volatile Acids
HACH10239 HACH 10239 Alkalinity
HACH8185 HACH 8185 Silica
HACH10216 HACH 10216 Lead
HACH 10200 HACH 10200 Free Ammonia
HACH 8317 HACH 8317 Lead
HACH 8017 HACH 8017 Cadmium
EPA353.2 EPA 353.2 Nitrite
HACH8160 HACH 8160 TDS
HACH10242 HACH 10242 TKN
HACH8000 HACH 8000 COD
HACH10230 HACH 10230 BOD
HACH10253 HACH 10253 Sulfide / Hydrogen Sulfide
HACH10248 HACH 10248 Sulfate
SM4500S2 SM 4500 S2 Sulfide
HACH8034 Manganese
HACH 10065 Mercury
HACH10225 Fluoride
SM9213 SM 9213 Pseudomonas P/A
HACH10220 HACH 10220 Nickel
HACH8037 HACH 8037 Nickel

Microbiology

Identifying contaminants assures the safety and efficacy of consumer products such as medicines and disinfectants.

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Make informed decisions about your product throughout manufacturing, development, and clinical trials, to patient use.

Rely on Ultimate Labs to conduct rapid microbiology testing for the timely results you require.

Contact us for Scheduling

Test Code Test Description
MICRO:USP51 USP 51 AntiMicrobial Effectiveness Test
MICRO:USP1227 USP 1227 Validation of Microbial Recovery
MICRO:USP55BI USP 55 Biological Indicator No/Growth
MICRO:USP55TC USP 55 Total Viable Spore Count
MICRO:USP61GPP USP 61 Media Growth Promotion – Plate
MICRO:USP61GPL USP 61 Media Growth Promotion – Liquid
USP61MF USP 61 Product Microbial Enumeration Membrane Filtration
USP61MPN USP 61 Product Microbial Enumeration Most Probable Number
MICRO:USP61SD USP 61 Product Microbial Enumeration Serial Dilution
USP61TAMC USP 61 Product Microbial Enumeration Total Aerobic Plate Count
USP61TYMC USP 61 Product Microbial Enumeration Total Yeast Mold Count
USP61SUIT USP 61 Product Suitability Test
USP61MFSP USP 61 Product Microbial Enumeration MF Spread Plate w serial dilutions
USP62NC USP 62 Product Microbial – Negative Control
USP62GN USP 62 Product Microbial – Bile Tolerant Gram Negative
USP62EC USP 62 Product Microbial – E. Coli
USP62S USP 62 Product Microbial – Salmonella
USP62PA USP 62 Product Microbial – Pseudomonas Aeruginosa
USP62SA USP 62 Product Microbial – Staphylococcus Aureus
USP62C USP 62 Product Microbial – Clostridia
USP62CA USP 62 Product Microbial – Candida Albicans
USP71RPC USP 71 Reagent Sterility Test Membrane Filtration – Positive Control
USP71RNC USP 71 Reagent Sterility Test Membrane Filtration – Negative Control
USP71RMF USP 71 Reagent Sterility Test Membrane Filtration
USP71RMS USP 71 Reagent Sterility Test Method Suitability
USP71PPC USP 71 Product Sterility Test Membrane Filtration – Positive Control
USP71PNC USP 71 Product Sterility Test Membrane Filtration – Negative Control
USP71PMF USP 71 Product Sterility Test Membrane Filtration
USP71PMS USP 71 Product Sterility Test Method Suitability
MICRO:USP71INC USP 71 Media Fill Incubation
MICRO:USP71NG USP 71 Media Fill No/Growth
USP71PDI USP 71 Product Sterlity Test Direct Inoculation
MICRO:USP71DICM USP71 Product Sterility Direct Inoculation of the Culture Medium
MICRO:USP71BFMF Bacteriostasis/Fungistasis Validation for Product Sterility Membrane Filtration
MICRO:USP71BFSTD Bacteriostasis/Fungistasis Validation for Product Sterility Standard
USP85P USP85 Bacterial Endotoxin – Product
USP85IE USP85 Bacterial Endotoxin – Inhibition/Enhancement
USP85VAL USP85 Bacterial Endotoxin – Validation
USP1113C USP 1113 Bacterial Characterization
USP1113GS USP 1113 Bacterial Gram Stain
USP1113ID USP 1113 Bacterial Identification (Vitek 2)
USP1113P USP 1113 Bacterial Enumeration with Photo
USP1113M USP 1113 Mold Characterization
ISO11137NC ISO11137 Medical Device Bioburden Membrane Filtration – Negative Control
ISO11137PMF ISO11137 Medical Device Bioburden Membrane Filtration
ISO11137PSW ISO11137 Medical Device Bioburden Swab
CLSIM100S20 CLSI M100-S20 AntiMicrobial Susceptability Testing
MICSTUDY Customize MIC study
ECVDIL Endotoxin Challenge Vials Serial Dilutions
ECV Endotoxin Challenge Vials Population Verification

Food Testing

Food moves from harvest, production, and distribution through broad supply chains.

Specializing in hazardous food testing verification and cottage food Class A and Class B testing.

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Count on Ultimate Labs when you need speedy food screening in adherence to government regulations or distributor requirements.

Located border-close, we are an ideal resource for testing imported produce from Mexico.

Contact us for Scheduling

Test Code Test Description
BAM001 BAM CH 1 – Food Sampling & Prep of Sample Homogonate
FSIS001 FSIS/USDA Method 1 – Sample Prep for Meat, Poultry & Egg
BAM002 BAM CH 2 – Microscopic Exam of Foods
FSIS002 FSIS/USDA Method 2 – Physical Exam of Meat & Poultry
BAM003 BAM CH 3 – Aerobic Plate Count
FSIS00301 FSIS/USDA Method 3.01 – Quantitative Analysis of Bacteria in Foods
AOAC970301M BioControl SimPlate® – Total Plate Count (Meat)
AOAC970301V BioControl SimPlate® – Total Plate Count (Vegetable)
AOAC 992.330 BioControl ColiComplete® Total Coliforms/E. Coli
BAM004A BAM CH 4A – Diarrheagenic E. Coli
FSIS00506 FSIS/USDA Method 5.06 – ID E. Coli O157:H7
BAM004 BAM CH 4 – Enumeration of E. Coli & Coliforms
AOAC070801GB25 SDIX RapidChek® E. coli 0157 (including H7) Lateral Flow Assay – Ground Beef 25g
AOAC070801GB375 SDIX RapidChek® E. coli 0157 (including H7) Lateral Flow Assay – Ground Beef 375g
AOAC070801BT SDIX RapidChek® E. coli 0157 (including H7) Lateral Flow Assay – Beef Trim
FSIS/USDA005A02 FSIS/USDA Method 5A.02 – E. Coli O157:H7 Screen Test
AOAC010401GB BAX® System PCR Assay for Screening E. coli O157:H7 – Ground Beef
AOAC010401AC BAX® System PCR Assay for Screening E. coli O157:H7 – Apple Cider
AOAC010401OJ BAX® System PCR Assay for Screening E. coli O157:H7 – Orange Juice
AOAC050501GB BAX® System PCR Assay for Screening E. coli O157:H7 MP – Ground Beef
AOAC050501BT BAX® System PCR Assay for Screening E. coli O157:H7 MP – Beef Trim
AOAC050501S BAX® System PCR Assay for Screening E. coli O157:H7 MP – Spinach
AOAC050501L BAX® System PCR Assay for Screening E. coli O157:H7 MP – Lettuce
BAXSTEC BAX® System PCR Assay for Screening E. coli STEC
AOAC031002L BAX® System Real-Time PCR Assay for E. coli O157:H7 – Lettuce
AOAC031002S BAX® System Real-Time PCR Assay for E. coli O157:H7 – Spinach
AOAC031002BT BAX® System Real-Time PCR Assay for E. coli O157:H7 – Beef Trim 375g
AOAC031002GB BAX® System Real-Time PCR Assay for E. coli O157:H7 – Ground Beef 25g
FSIS005B02 FSIS/USDA Method 5B.02 – E. Coli STEC Screen Test
BAM005 BAM CH 5 – Salmonella
FSIS00405 FSIS/USDA Method 4.05 – ID Salmonella
AOAC080601 SDIX RapidChek® SELECT™ Salmonella
FSIS004C03 FSIS/USDA Method 4.05 – PCR Salmonella Screen
AOAC100201M BAX® System PCR Assay for Screening Salmonella – Meat & Poultry
AOAC100201C BAX® System PCR Assay for Screening Salmonella – Mozerella Cheese
AOAC100201EGG BAX® System PCR Assay for Screening Salmonella – Liquid Egg
AOAC100201PB BAX® System PCR Assay for Screening Salmonella – Peanut Butter
AOAC100201AS BAX® System PCR Assay for Screening Salmonella – Alfalfa Sprouts
AOAC100201F BAX® System PCR Assay for Screening Salmonella – Raw Frozen Fish
AOAC100201OJ BAX® System PCR Assay for Screening Salmonella – Orange Juice
AOAC100201MC BAX® System PCR Assay for Screening Salmonella – Milk Chocolate
AOAC100201DM BAX® System PCR Assay for Screening Salmonella – Nonfate Dry Milk
AOAC100201BP BAX® System PCR Assay for Screening Salmonella – Black Pepper
AOAC100201P BAX® System PCR Assay for Screening Salmonella – Pasta
AOAC100201SP BAX® System PCR Assay for Screening Salmonella – Soy Protein Powder
AOAC100201SW BAX® System PCR Assay for Screening Salmonella – EM Swabs
BAM006 BAM CH 6 – Shigella
BAM007 BAM CH 7 – Campylobacter
BAM008 BAM CH 8 – Yersinia
FSIS/USDA009 FSIS/USDA Method 9 – ID Yersinia
BAM009 BAM CH 9 – Vibrio
BAM010 BAM CH 10 – Listeria Monocytogenes
BAM011 BAM CH 11 – Serodiagnosis of Listeria Monocytogenes
FSIS00807 FSIS/USDA Method 8.07 – ID Listeria Monocytogenes
AOAC020401F SDIX RapidChek® Listeria – Shellfish
AOAC020401D SDIX RapidChek® Listeria – Dairy
AOAC020401M SDIX RapidChek® Listeria – Meat
AOAC020401SW SDIX RapidChek® Listeria – EM Swabs
FSIS008A04 FSIS/USDA Method 8A.04 – PCR Listeria Monocytogenes Screen
AOAC030901SW BAX® System PCR Assay for Screening L. monocytogenes – EM Swabs – Stainless Steel
AOAC070202 BAX® System PCR Assay for Screening L. monocytogenes
AOAC080901S BAX® System PCR Assay for Screening L. monocytogenes 24E – Spinach
AOAC080901C BAX® System PCR Assay for Screening L. monocytogenes 24E – Cheese
AOAC080901F BAX® System PCR Assay for Screening L. monocytogenes 24E – Frankfurter
AOAC080901SH BAX® System PCR Assay for Screening L. monocytogenes 24E – Cooked Shrimp
AOAC080901SW BAX® System PCR Assay for Screening L. monocytogenes 24E – EM Swabs – Stainless Steel
AOAC030502F BAX® System PCR Assay for Screening Genus Listeria – Frankfurters
AOAC030502S BAX® System PCR Assay for Screening Genus Listeria – Smoked Salmon
AOAC030502V BAX® System PCR Assay for Screening Genus Listeria – Vegetable
AOAC030502C BAX® System PCR Assay for Screening Genus Listeria – Cheese
AOAC030502SW BAX® System PCR Assay for Screening Genus Listeria – EM Swabs
AOAC050903S BAX® System PCR Assay for Screening Genus Listeria 24E – Spinach
AOAC050903C BAX® System PCR Assay for Screening Genus Listeria 24E – Cheese
AOAC050903F BAX® System PCR Assay for Screening Genus Listeria 24E – Frankfurters
AOAC050903SH BAX® System PCR Assay for Screening Genus Listeria 24E – Cooked Shrimp
AOAC050903SW BAX® System PCR Assay for Screening Genus Listeria 24E – EM Swabs Stainless Steel
BAM012 BAM CH 12 – Staph Aureus
AOAC120701GB BAX® System Real-Time PCR Assay for Staphylococcus aureus – Ground Beef
AOAC120701S BAX® System Real-Time PCR Assay for Staphylococcus aureus – Soy
AOAC120701IF BAX® System Real-Time PCR Assay for Staphylococcus aureus – Infant Formula
BAM014 BAM CH 14 – Bacillus Cereus
CMMEF32 CMMEF 14 – Bacillus Cereus
FSIS/USDA012 FSIS/USDA Method 12 – Examine Bacillus Cereus
BAM016 BAM CH 16 – Clostridium Perfringens
FSIS/USDA013 FSIS/USDA Method 13 – Examine Clostridium Perfringes
BAM017 BAM CH 17 – Clostridium Botulinum
CMMEF33 CMMEF 33 – Clostridium Botulinum
BAM018 BAM CH 18 – Yeast, Molds & Mycotoxins
AOAC2002.11M BioControl SimPlate® – Yeast and Mold (Meat)
AOAC2002.11V BioControl SimPlate® – Yeast and Mold (Vegetable)
BAM028 BAM CH 28 – Vibrio Cholerae
CMMEF64WA CMMEF 64 Water Activity
CMMEF64WA CMMEF 64 Titrable Acidity
EC1935/2004 EC 1935/2004 Organoleptic Test
CMMEF19 CMMEF 19 – Lactobacillus
AACC4415A AACC 44-15A Moisture Content – Oven Dry
CMMEF64PH CMMEF 64 pH
NUDB Nutritional Analysis Database
SHELFLIFECQS1 Shelf Life CQS 1
SHELFLIFE Shelf Life
AOACRI101102EM Romer RapidChek® Listeria: EM Swab
AOACRl051101FD Gluten Testing

Custom Tests

Every question has an answer and every problem has a solution.

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Find personalized solutions for your unique problem by tapping into the technical expertise at Ultimate Labs.

Contact us to learn more.

Routine Tests

Let us do the mundane so you can focus on what’s important to grow your business.

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Environmental Monitoring

  • Non-Viable Air
  • Viable Air
  • Viable Surface
  •  Clean Room Qualification

Microbiology

  • Gram Stain
  • Identification
  • Growth Promotion
  • Endotoxin

Water Testing

  • USP Purified
  • USP WFI
  • Bioburden
  • Coliforms

Food

  • Salmonella
  • Listeria
  • E. coli
  • Environmental Monitoring