MAS - Sure-Biochem Laboratories LLC - 47QSWA21D004C

GENERAL SERVICES ADMINISTRATION

Federal Supply Service

Authorized Federal Supply Schedule Price List

On-line access to contract ordering information, terms and conditions, up-to-date pricing, and the option to create an electronic delivery order are available through GSA

Advantage!®, a menu-driven database system. The INTERNET address GSA

Advantage!® is: GSAAdvantage.gov.

Multiple Award Schedule

FSC Group: Scientific Management and Solutions FSC Class: Leave Blank

Contract number: 47QSWA21D004C

Contract period: April 23, 2021 to April 22, 2026

SURE-BIOCHEM LABORATORIES, LLC

1000 Atlantic Ave

Camden, NJ 08104-1132

Phone: 888-398-7247, Ext.108

Fax: 888-603-5064

Contractor’s internet address/web site where schedule information can be found:

www.surebiochem.com

Contract administration source (if different from preceding entry).

Rafiq Heigler, 888-398-7247, Ext.108, rheigler@surebiochem.com

Business size: Small Business List Socioeconomic status: Woman Owned business, Women Owned (WOSB), Women Owned

(EDWOSB), SBA Certified Small Disadvantaged business, SBA Certified 8(a) Firm, SBA

Certified HUBZone Firm

For more information on ordering from Federal Supply Schedules visit the following website:

https://www.gsa.gov/schedules

Price list current as of Modification #PS-0007 effective Nov 27, 2024

Prices Shown Herein are Net (discount deducted)

TABLE OF CONTENTS

General Contract Details p.1

Customer Information p.3

Appendix A – Testing Description p.5

Appendix B – GSA Price List p.16

Keywords p.36

CUSTOMER INFORMATION

1a. Table of awarded special item number(s) with appropriate cross-reference to item descriptions and awarded price(s).

SINs Recovery SIN Title

541380 541380RC Testing Laboratory Services

1b. Identification of the lowest priced model number and lowest unit price for that model for each special item number awarded in the contract. This price is the Government price based on a unit of one, exclusive of any quantity/dollar volume, prompt payment, or any other concession affecting price. Those contracts that have unit prices based on the geographic location of the customer, should show the range of the lowest price, and cite the areas to which the prices apply.

See Page 6

1c. If the Contractor is proposing hourly rates, a description of all corresponding commercial job titles, experience, functional responsibility and education for those types of employees or subcontractors who will perform services shall be provided. If hourly rates are not applicable, indicate “Not applicable” for this item. See Page 6

2. Maximum order: SIN 541380: $250,000.00

3. Minimum order: $100

4. Geographic coverage (delivery area). Domestic

5. Point(s) of production (city, county, and State or foreign country). ,

6. Discount from list prices or statement of net price. Government Net Prices (discounts already deducted.)

7. Quantity discounts. None

8. Prompt payment terms. Information for Ordering Offices: Prompt payment terms cannot be negotiated out of the contractual agreement in exchange for other concessions. Net 30 days.

9. Foreign items (list items by country of origin). Not Applicable

10a. Time of delivery. (Contractor insert number of days.) To Be Determined at the Task Order level

10b. Expedited Delivery. Items available for expedited delivery are noted in this price list.

Contact Contractor

10c. Overnight and 2-day delivery. Contact Contractor

10d. Urgent Requirements. Contact Contractor

11. F.O.B. point(s). Destination

12a. Ordering address(es). 1000 Atlantic Ave., Camden, NJ 08104-1132

12b. Ordering procedures: For supplies and services, the ordering procedures, information on

Blanket Purchase Agreements (BPA’s) are found in Federal Acquisition Regulation (FAR)

8.405-3.

13. Payment address(es). Ordering Address

14. Warranty provision. Standard Commercial Warranty Terms & Conditions

15. Export packing charges, if applicable. Not Applicable

16. Terms and conditions of rental, maintenance, and repair (if applicable). Not Applicable

17. Terms and conditions of installation (if applicable). Not Applicable

18a. Terms and conditions of repair parts indicating date of parts price lists and any discounts from list prices (if applicable). Not Applicable

18b. Terms and conditions for any other services (if applicable). Not Applicable

19. List of service and distribution points (if applicable). Not Applicable

20. List of participating dealers (if applicable). Not Applicable

21. Preventive maintenance (if applicable). Not Applicable

22a. Special attributes such as environmental attributes (e.g., recycled content, energy efficiency, and/or reduced pollutants). Not Applicable

22b. If applicable, indicate that Section 508 compliance information is available on Electronic and Information Technology (EIT) supplies and services and show where full details can be found (e.g. contractor’s website or other location.) The EIT standards can be found at:

www.Section508.gov/.

Not Applicable

23. Unique Entity Identifier (UEI) number. E3C2X74KTN38

24. Notification regarding registration in System for Award Management (SAM) database.

Contractor registered and active in SAM http://www.section508.gov/

APPENDIX A

TESTING DESCRIPTION

CLEANROOM VALIDATION & ENVIRONMENTAL MONITORING

Testing and certification of all classifications of ISO cleanrooms and anterooms including particle counting, HEPA filter integrity testing, airflow volume/velocity, room pressurization, temperature and humidity monitoring. Environmental monitoring of air and surface microbes including the development of sampling plans, sample collection, incubation, analysis, microbial identification, reporting and data trending. Compressed air testing for non-viable and viable particles, hydrocarbons and dew point. Competency training, both initials and continued education, for cleanroom best practices, aseptic technique, deviations and gowning. Consultation on contamination investigations and quality system documentation.

• Viable Particulates - Active Air Sampling

Includes active air sampling using the RCS Biotest impaction device to sample a defined volume of air, embedding viable particulates onto sterile media strips.

• Viable Particulates - Surface Sampling

Includes surface sampling using contact plates to detect inadequate disinfection procedures

• Viable Particulates - Passive Air Sampling

Includes passive air sampling using settling plates exposed to an environment for a specified period of time.

• Viable Particulates - Gloved Finger Sampling

Includes gloved finger sampling in which personnel touch agar with fingertips of both hands in a manner to create slight impression in agar

• Non-viable Particulates

Includes the use of a discrete particle counter to sample a defined volume of air, measuring particle sizes of 0.5, 1.0, and 5.0 μm particles

• Microbiological Identifications

Includes sub-culturing Microbial identification using MALDI-TOF technique Report

Generation

• Water Analysis

Includes total coliforms Total aerobic microbial count

• Compressed Air Monitoring - Non-viable Particulates

Includes analysis for non-viable particulates, dew point and compressed hydrocarbons/oil mist per ISO 8573-1

• Compressed Air Monitoring - Viable Air Particulates

Viable air particulates per ISO 8573-7

USP TESTING – STANDARD TESTING

U.S. Pharmacopeial Convention (USP) Testing - USP establishes primary standards for ensuring quality in pharmaceutical development & manufacturing. USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility. The USP provides a foundation of principles for uniform and reliable quality which consumers expect when they buy and use these products. USP’s principles are enforceable in the United States by the FDA, and these guidelines are utilized throughout more than 140 nations.

• <51> Antimicrobial Effectiveness Testing

Antimicrobial Effectiveness Testing (AET) also known as Preservative Efficacy Testing (PET) is microbial challenge methodology performed to assure the preservative in a product, or the antimicrobial action created by the properties of a product, is sufficient to combat the introduction of microorganisms.

• <61> Suitability of the Counting Methods in the Presence of Product

The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery.

• <62> Suitability of the Test Methods in the Presence of Product

The Aerobic Plate Count (APC) is used as an indicator of bacterial populations on a sample.

... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F.

• <61> Total Aerobic Microbial Count

... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F)

• <61> Total Yeasts and Molds Count

The total yeast and mold count (TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products.

• <62> Bile Tolerant Gram Negative Bacteria

They include, Gram negative bacteria that grow in the presence of bile salts, non-lactose fermenting but able to utilize glucose, e.g., some Bile Tolerant Gram Negative Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas.

• <62> Escherichia coli (E.coli)

Escherichia coli (abbreviated as E. coli) are bacteria found in the environment, foods, and intestines of people and animals. E. coli are a large and diverse group

• <62> Salmonella

Salmonella is a genus of rod-shaped Gram-negative bacteria of the family Enterobacteriaceae.

The two species of Salmonella are Salmonella enterica and Salmonella bongori. S. enterica is the type species and is further divided into six subspecies that include over 2,600 serotypes

• <62> Pseudomonas aeruginosa

Pseudomonas aeruginosa is a common encapsulated, Gram-negative, rod-shaped bacterium that can cause disease in plants and animals, including humans

• <62> Staphylococcus aureus

Staphylococcus aureus is a Gram-positive, round-shaped bacterium that is a member of the

Firmicutes, and it is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin.

• <62> Clostridia

The Clostridia are a highly polyphyletic class of Firmicutes, including Clostridium and other similar genera. They are distinguished from the Bacilli by lacking aerobic respiration. They are obligate anaerobes and oxygen is toxic to them.

• <62> Candida albicans

Candida albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora. It can also survive outside the human body. It is detected in the gastrointestinal tract and mouth in 40–60% of healthy adults

• <2021> Heterotrophic Plate Count on Process Water

Heterotrophic plate count (HPC) is a method that measures colony formation on culture media of heterotrophic bacteria in drinking water. Thus, the HPC test (also known as Standard Plate

Count) can be used to measure the overall bacteriological quality of drinking water in public, semi-public and private water systems.

• <2021> Total Yeasts and Molds Count

Featured snippet from the web. The total yeast and mold count (TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products.

• <2021> Bile Tolerant Gram Negative Bacteria fermenting but able to utilize glucose, e.g., some Bile Tolerant Gram Negative Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas.

• <2022> Escherichia coli (E.coli)

Escherichia coli, also known as E. coli, is a Gram-negative, facultative anaerobic, rod-shaped, coliform bacterium of the genus Escherichia that is commonly found in the lower intestine of warm-blooded organisms.

• <2022> Salmonella

A bacterium that occurs mainly in the intestine, especially a serotype causing food poisoning.

• <2022> Pseudomonas aeruginosa that can cause disease in plants and animals, including humans.

• <2022> Staphylococcus aureus

Staphylococcus aureus is the most dangerous of all of the many common staphylococcal bacteria

• <2022> Clostridia are obligate anaerobes and oxygen is toxic to them

USP TESTING – EXPEDITED TESTING

U.S. Pharmacopeial Convention (USP) Testing - USP establishes primary standards for ensuring quality in pharmaceutical development & manufacturing. USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility. The USP provides a foundation of principles for uniform and reliable quality which consumers expect when they buy and use these products. USP’s principles are enforceable in the United States by the FDA, and these guidelines are utilized throughout more than 140 nations.

• <51> Antimicrobial Effectiveness Testing

Antimicrobial Effectiveness Testing (AET) also known as Preservative Efficacy Testing (PET) is microbial challenge methodology performed to assure the preservative in a product, or the antimicrobial action created by the properties of a product, is sufficient to combat the

• <61> Suitability of the Counting Methods in the Presence of Product

The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery. 20 grams or mL per sample.

• <62> Suitability of the Test Methods in the Presence of Product

... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F 20 grams or mL per sample.

• <61> Total Aerobic Microbial Count

... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F) 20 grams or mL per sample

• <61> Total Yeasts and Molds Count

The total yeast and mold count (TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products. 20 grams or mL per sample.

• <62> Bile Tolerant Gram Negative Bacteria fermenting but able to utilize glucose, e.g., some Bile Tolerant Gram Negative Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas. 20 grams or mL per Sample.

• <62> Escherichia coli (E.coli)

Escherichia coli (abbreviated as E. coli) are bacteria found in the environment, foods, and intestines of people and animals. E. coli are a large and diverse group 20 grams or mL per

• <62> Salmonella

The two species of Salmonella are Salmonella enterica and Salmonella bongori. S. enterica is the type species and is further divided into six subspecies that include over 2,600 serotypes 20 grams or mL per sample.

• <62> Pseudomonas aeruginosa that can cause disease in plants and animals, including humans 20 grams or mL per sample.

• <62> Staphylococcus aureus

Staphylococcus aureus is a Gram-positive, round-shaped bacterium that is a member of the

Firmicutes, and it is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin. 20 grams or mL per sample.

• <62> Clostridia are obligate anaerobes and oxygen is toxic to them 20 grams or mL per sample.

• <62> Candida albicans

Candida albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora. It can also survive outside the human body. It is detected in the gastrointestinal tract and mouth in 40–60% of healthy adults 20 grams or mL per sample

• <2021> Heterotrophic Plate Count on Process Water

Heterotrophic plate count (HPC) is a method that measures colony formation on culture media of heterotrophic bacteria in drinking water. Thus the HPC test (also known as Standard Plate

Count) can be used to measure the overall bacteriological quality of drinking water in public, semi-public and private water systems 20 grams or mL per sample.

• <2021> Total Yeasts and Molds Count

Featured snippet from the web. The total yeast and mold count (TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products 20 grams or mL per sample.

• <2021> Bile Tolerant Gram Negative Bacteria fermenting but able to utilize glucose, e.g., some Bile Tolerant Gram Negative Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas. 20 grams or mL per sample.

• <2022> Escherichia coli (E.coli)

Escherichia coli, also known as E. coli, is a Gram-negative, facultative anaerobic, rod-shaped, coliform bacterium of the genus Escherichia that is commonly found in the lower intestine of warm-blooded organisms 20 grams or mL per sample.

• <2022> Salmonella

A bacterium that occurs mainly in the intestine, especially a serotype causing food poisoning.

20 grams or mL per sample.

• <2022> Pseudomonas aeruginosa that can cause disease in plants and animals, including humans 20 grams or mL per sample.

• <2022> Staphylococcus aureus

Staphylococcus aureus is the most dangerous of all of the many common staphylococcal bacteria 20 grams or mL per sample.

• <2022> Clostridia are obligate anaerobes and oxygen is toxic to them 20 grams or mL per.

FOOD TESTING

Food Processing Validation tests, Shelf-Life studies, and Environmental monitoring. We also provide microbiology testing for support of HACCP and GMP plans. We work closely with our clients to develop the best food microbiology testing procedures needed for their products taking into account the ingredients, pH, water activity, processing and storage conditions (time and temperature). Our facilities are Biosafety Level 2 so we can work with a wide variety of pathogenic bacteria and viruses. Our lab has trained Food Microbiologists with over 15 years of experience who can handle not only your routine testing needs, but also your special projects, research projects, and product development analytical support.

• Aerobic (Standard) Plate Count (Petrifilm)

... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F) 100 ML or grams of sample required.

• Anaerobic Plate Count

This assay is used to determine the number of anaerobic (growth without oxygen) mesophilic

(growth at body temperatures i.e. 35 C) bacteria contained in a food product or ingredient. No information about potential food borne pathogens can be inferred from anaerobic plate counts.

100 ML or grams of sample required.

• Bacillus cereus

Bacillus cereus is a Gram-positive, rod-shaped, facultative anaerobic bacterium that can produce toxins which cause food poisoning. It belongs to the Bacillus genus and shares similar characteristics, such as forming protective endospores, with other Bacillus members including

B. 100 ML or grams of sample required.

• Campylobacter

A bacterium that typically infects the bowels. Now a leading cause of bacterial food poisoning, Campylobacter jejuni is most often spread by contact with raw or undercooked poultry. A single drop of juice from a contaminated chicken is enough to make someone sick. 100 ML or grams of sample required.

• Clostridium perfringens

C. perfringens is a gram-positive spore-forming anaerobic (meaning it can grow without oxygen) bacteria that is normally found in the intestines of humans and animals. It is also a common cause of food poisoning when ingested in sufficient numbers. 100 ML or grams of

• E. coli - 3 Tube MPN

Most Probable Number (MPN) is a method used to estimate the concentration of viable microorganisms in a sample by means of replicate liquid broth growth in ten-fold dilutions

MPN is most commonly applied for quality testing of water i.e to ensure whether the water is safe or not in terms of bacteria present in it 100 ML or grams of sample required.

• E. coli - VRB plate (Petrifilm)

Petrifilm E. coli/Coliform Count Plate is a sample-ready-culture-medium system which contains Violet Red Bile (VRB) nutrients, a cold-water-soluble gelling agent, an indicator of glucuronidase activity (BCIG), and a tetrazolium indicator that facilitates colony enumeration in food and beverage samples. 100 ML or grams of sample required.

• E. coli H7:O157

A dangerous form of Escherichia coli, the colon bacillus, a bacterium that normally lives in the human colon. ... Hemorrhagic colitis -- E coli O157:H7 causes about 20,000 cases of hemorrhagic colitis (bloody inflammation of the colon) a year in the US. 100 ML or grams of

• E. coli in water (membrane filtration) coli in ambient water or wastewater based on the development of colonies that grow on the surface of a membrane filter. A sample is filtered through the membrane, which retains the bacteria. ... The target colonies on modified mTEC agar are red or magenta in color after the incubation period 100 ML or grams of sample required.

• Enterobacteriaceae

Enterobacteriaceae is a family of Gram-negative, facultatively anaerobic, non-spore-forming rods. Characteristics of this family include being motile, catalase positive, and oxidase negative; reduction of nitrate to nitrite; and acid production from glucose fermentation. 100

ML or grams of sample required.

• Flat Sour Spores he spores are ubiquitous in nature, being isolated in areas from the arctic to the deserts as well as from foods. ... The flat-sour aerobes are two in number, one Bacillus stearothermophilus, typical of flat-sour spoilage of low acid foods and the other Bacillus coagulans, typical of flat-sour spoilage of acid foods. 100 ML or grams of sample required

• Lactobacillus

Lactobacillus is a genus of Gram-positive, facultative anaerobic or microaerophilic, rod-shaped, non-spore-forming bacteria. They are a major part of the lactic acid bacteria group.

100 ML or grams of sample required

• Listeria monocytogenes

Listeria monocytogenes is the species of pathogenic bacteria that causes the infection listeriosis. It is a facultative anaerobic bacterium, capable of surviving in the presence or absence of oxygen 100 ML or grams of sample reqired

• Listeria spp. (environmental)

Characteristics of L. monocytogenes. L. monocytogenes is an environmental pathogen that can contaminate foods and cause a mild, non-invasive illness (called listerial gastroenteritis) or a severe, invasive illness (called listeriosis) 100 ML or grams of sample reqired

• Osmophilic Yeast

A simple presence-absence test for detection of small numbers of osmotolerant yeasts in highsugar foods is useful for enumeration. Osmophilic Agar (MY 40 Agar) is generally used for this purpose. Osmophilic yeasts usually are the cause of spoilage of high-sugar foods, including jams, honey, concentrated fruit juices, chocolate candy with soft centres etc.

• Pathogen Testing

Pathogen testing in food mainly involves looking for likely or suspected forms of bacterial contamination by pathogens such as E. coli, Salmonella, Listeria, Campylobacter and

Staphylococcus. ... One is plating food samples on agar plates and watching for the growth of bacterial colonies, which may take several days. 100 ML or grams of sample required

• Pseudomonas aeruginosa that can cause disease in plants and animals, including humans. 100 ML or grams of sample required

• Psychotropic/Psychrophilic Plate Count

Fifty-four. (49.5%) plate count applications employed incubation temperatures of 308C and below. From the 26 reports that employed psychrotrophic counts. 100 ML or grams of sample required

• Salmonella

The two species of Salmonella are Salmonella enterica and Salmonella bongori. S. enterica is the type species and is further divided into six subspecies that include over 2,600 serotypes.

• Shigella

Shigella is a genus of bacteria that is Gram-negative, facultative anaerobic, non-spore-forming, nonmotile, rod-shaped and genetically closely related to E. coli. 100 ML or grams of sample required

• Standard Panel (APC, Y&M, E. coli/coliforms, S. aureus)

... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F). 100 ML or grams of

• Staphylococcus aureus – MPN

The most probable number (MPN) method (2) is recommended for routine surveillance of products in which small numbers of S. aureus are expected and in foods expected to contain a large population of competing species. 100 ML or grams of sample required

• Staphylococcus Aureus - Plate (Petrifilm)

Staph Express Count Plate is a sample-ready-culture medium system which contains a cold-watersoluble gelling agent. The chromogenic, modified Baird-Parker medium in the plate is selective and differential for Staphylococcus aureus (S. aureus) but may also indicate

Staphylococcus hyicu. 100 ML or grams of sample required

• Streptococcus spp.

Streptococcus is a genus of gram-positive coccus or spherical bacteria that belongs to the family Streptococcaceae, within the order Lactobacillales, in the phylum Firmicutes. Cell division in streptococci occurs along a single axis, so as they grow, they tend to form pairs or chains that may appear bent or twisted. 100 ML or grams of sample required

• Sulfide Spoilage Bacteria

Is a genus of Gram-positive, obligately anaerobic soil bacteria. A type of sulfate-reducing bacteria, Desulfotomaculum can cause food spoilage in poorly processed canned foods.[citation needed] Their presence can be identified by the release of hydrogen sulfide gas with its rotten egg smell when the can is first opened. They are endospore-forming bacteria.

• Sulfide Spoilage Bacteria (Canners)

He bacteria Clostridium botulinum releases the toxin that causes botulism as part of its natural anaerobic process, meaning it multiplies in an oxygen-free environment. 100 ML or grams of

• Thermophilic Anaerobic Spores

Anaerobic thermophilic sporeformers are among the principal causes of spoilage. of canned foods sincenot only are their vegetative cells adapted to life at elevated. temperatures, but also their spores are unusually heat resistant, some surviving. even half an hour of autoclaving. 100

ML or grams of sample reqired

• Total Coliforms - MPN

The number of total coliforms is determined by counting the number of tubes giving positive reaction (i.e both color change and gas production) and comparing the pattern of positive results (the number of tubes showing growth at each dilution) with standard statistical tables.

MPN test is performed in 3 steps. 100 ML or grams of sample required

• Total Coliforms - Petrifilm Plate

The number of total coliforms is determined by counting the number of tubes giving positive reaction (i.e both color change and gas production) and comparing the pattern of positive results (the number of tubes showing growth at each dilution) with standard statistical tables.

MPN test is performed in 3 steps. 100 ML or grams of sample required

• Validation process, shelf life studies

Shelf-life studies are primarily conducted to determine and validate the length of time a food will retain its quality under a given set of storage conditions from the time the food is prepared or manufactured. 100 ML or grams of sample required

• Vibrio spp.

Vibrio is a genus of Gram-negative bacteria, possessing a curved-rod (comma) shape, several species of which can cause foodborne infection, usually associated with eating undercooked seafood. Typically found in salt water, Vibrio species are facultative anaerobes that test positive for oxidase and do not form spores. 100 ML or grams of sample required

• Vibrio parahaemoliyticus

Vibrio parahaemolyticus is a curved, rod-shaped, Gram-negative bacterium found in brackish, saltwater, which, when ingested, causes gastrointestinal illness in humans. V.

parahaemolyticus is oxidase positive, facultatively aerobic, and does not form spores. 100 ML or grams of sample required

• Yeast and Mold Count (Petrifilm)

Yeast and Mold Count Plate is a sample-ready culture medium system which contains nutrients supplemented with antibiotics, a cold-water-soluble gelling agent, and an indicator that facilitates yeast and mold enumeration. 100 ML or grams of sample required

• Yersinia enterocolitica

Yersinia enterocolitica is a Gram-negative, bacillus-shaped bacterium, belonging to the family

Yersiniaceae. It is motile at temperatures of 22–29° C, but becomes nonmotile at normal human body temperature. 100 ML or grams of sample required

• pH

In chemistry, pH is a scale used to specify how acidic or basic a water-based solution is. Acidic solutions have a lower pH, while basic solutions have a higher pH. At room temperature, pure water is neither acidic nor basic and has a pH of 7. 100 ML or grams of sample required

• Water activity (Aw)

Water activity is the partial vapor pressure of water in a substance divided by the standard state partial vapor pressure of water. In the field of food science, the standard state is most often defined as the partial vapor pressure of pure water at the same temperature. 100 ML or grams of sample required

SURFACE TESTING

Although transmission from surfaces is not currently thought to be the main mode of virus transmission, the world’s health agencies are still learning about how this disease spreads the severity of illness it causes. The best way to prevent or slow down transmission is to be well-informed about the COVID-19 virus, how it spreads and what you can do to ensure your environments are as safe as possible.

• Covid-19 Surface Testing

SBL employs a RT-qPCR test that targets the SARS-CoV-2-nucleocapsid N gene. This method is specified by the Centers for Disease Control (CDC) and authorized by the U.S. Food and

Drug Administration (FDA) for clinical COVID-19 diagnostics. Since the human RNAse P gene is not analyzed in our test, SBL’s RT-qPCR test can only be used for environmental testing on surfaces; not for processing patient SARS-CoV-2 specimens. In addition, since environmental samples frequently contain qPCR inhibiting substances found in dirt, soil, and dust that can affect the qPCR reaction performance, SBL will be applying a proprietary nucleic acid (NA) extraction method to every sample. This will ensure the removal of any qPCR inhibitors, as well as ensure the accurate detection of the target viral RNA.

• Covid-19 Surface Testing - Single Swab

Single Swab used for Covid-19 Test

• Covid-19 Surface Testing - Sample Cooler

A sample cooler is needed for each sampling event, we will include a cooler. If you are utilizing your own cooler to return samples, please let us know and we will not include this fee.

• A.T.P Analysis

Adenosine Triphosphate (ATP) analysis, monitoring, collection, and report data for multiple quality indicators. The testing and analysis from surface and liquid samples, high sensitivity

ATP/Allergen Prevention, Total Viable count, Enterobacteriaceae, Coliform, E. coli, Listeria spp, Listeria monocytogenes, Alkaline Phosphates and Acid Phosphates, with a sensitivity that can detect down to 0.1 femtomoles of ATP

APPENDIX B – GSA PRICE LIST

MULTIBLE AWARD SCHEDULE

SIN/SIN(s

Propose d

Labor

Category/Serv ice Title

Labor Category/Service

Description (250 words)

Unit of Issue

(e.g. Hour, Daily Rate, Task, Sq Ft)

Price

Offered to

GSA

(including

IFF)

CLEANROO

M

VALIDATIO

N &

ENVIRONM

ENTAL

MONITORIN

G

Testing and certification of all classifications of ISO cleanrooms and anterooms including particle counting, HEPA filter integrity testing, airflow volume/velocity, room pressurization, temperature and humidity monitoring.

Environmental monitoring of air and surface microbes including the development of sampling plans, sample collection, incubation, analysis, microbial identification, reporting and data trending.

Compressed air testing for non-viable and viable particles, hydrocarbons and dew point.

Competency training, both initials and continued education, for cleanroom best practices, aseptic technique, deviations and gowning.

Consultation on contamination investigations and quality system documentation.

541380

Viable Particulates - Active Air Sampling

Includes active air sampling using the RCS Biotest impaction device to sample a defined volume of air, embedding viable particulates onto sterile media strips

Agar Strip

$48.87

Viable Particulates -

Surface Sampling

Includes surface sampling using contact plates to detect inadequate disinfection procedures

Rodac Plate $48.87

Particulates - Passive Air Sampling

Includes passive air sampling using settling plates exposed to an environment for a specified period of time

Rodac Plate

$24.43

Particulates -

Gloved Finger Sampling

Includes gloved finger sampling in which personnel touch agar with fingertips of both hands in a manner to create slight impression in agar

Rodac Plate $34.21

541380 Non-viable Particulates

Includes the use of a discrete particle counter to sample a defined volume of air, measuring particle sizes of 0.5, 1.0, and 5.0 μm particles

N/A $24.43

Microbiological Identifications

• Includes sub-culturing Microbial identification using MALDI-

TOF

technique Report Generation

Rodac Plate

$63.53

Water Analysis

Includes total coliforms Total

100 ML

$34.21 aerobic microbial count

Compressed Air

Monitoring - Non-viable Particulates

Includes analysis for non-viable particulates, dew point and compressed hydrocarbons/oil mist per ISO 8573-1

N/A

$674.36

Compressed Air

Monitoring - Viable Air Particulates

Viable air particulates per ISO

8573-7

N/A

$547.30

USP TESTING

- STANDARD

TESTING

U.S. Pharmacopeial Convention

(USP) Testing - USP establishes primary standards for ensuring quality in pharmaceutical development & manufacturing.

USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility.

The USP provides a foundation of principles for uniform and reliable quality which consumers expect when they buy and use these products. USP’s principles are enforceable in the United

States by the FDA, and these guidelines are utilized throughout more than 140 nations.

<51>

Antimicrobial

Effectiveness

Testing

Antimicrobial Effectiveness

Testing (AET) also known as

Preservative Efficacy Testing

(PET) is microbial challenge methodology performed to assure the preservative in a product, or the antimicrobial action created by the properties

Per Sample

$806.30 of a product, is sufficient to combat the

<61> Suitability of the Counting

Methods in the

Presence of

Product

The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery

<62> Suitability of the Test

Methods in the

Presence of

Product

The Aerobic Plate Count (APC) is used as an indicator of bacterial populations on a sample It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to

40°C; 77 to 104°F

<61> Total

Aerobic

Microbial

Count

The Aerobic Plate Count (APC) is used as an indicator of bacterial populations on a sample ......................... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to

40°C; 77 to 104°F)

Yeasts and

Molds Count

The total yeast and mold count

(TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products.

<62> Bile

Tolerant Gram

Negative

Bacteria

They include, Gram negative bacteria that grow in the presence of bile salts, non-lactose fermenting but able to utilize glucose, e.g., some Bile

Tolerant Gram Negative

Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas.

<62>

Escherichia coli

(E.coli)

Escherichia coli (abbreviated as

E. coli) are bacteria found in the environment, foods, and intestines of people and animals. E. coli are a large and diverse group

Salmonella

Salmonella is a genus of rod-shaped Gram-negative bacteria of the family

Enterobacteriaceae. The two species of Salmonella are

Salmonella enterica and

Salmonella bongori. S.

enterica is the type species and is further divided into six subspecies that include over

2,600 serotypes

Pseudomonas aeruginosa

Pseudomonas aeruginosa is a common encapsulated, Gram-negative, rod-shaped bacterium that can cause disease in plants and animals, including humans

Staphylococcus aureus

Staphylococcus aureus is a

Gram-positive, round-shaped bacterium that is a member of the Firmicutes, and it is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin.

<62> Clostridia

The Clostridia are a highly polyphyletic class of Firmicutes, including Clostridium and other similar genera. They are distinguished from the Bacilli by lacking aerobic respiration. They are obligate anaerobes and oxygen is toxic to them

<62> Candida albicans

Candida albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora. It can also survive outside the human body.

It is detected in the gastrointestinal tract and mouth in 40–60% of healthy adults

<2021>

Heterotrophic

Plate Count on

Process Water

Heterotrophic plate count

(HPC) is a method that measures colony formation on culture media of heterotrophic bacteria in drinking water.

Thus the HPC test (also known as Standard Plate Count) can be used to measure the overall bacteriological quality of drinking water in public, semi-public and private water systems

$58.64

<2021> Total

Molds Count

Featured snippet from the web The total yeast and mold count

(TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products

<2021> Bile

Negative

Bacteria

They include, Gram negative bacteria that grow in the presence of bile salts, non-lactose fermenting but able to utilize glucose, e.g., some Bile

Tolerant Gram Negative

Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas.

<2022>

(E.coli)

Escherichia coli, also known as

E. coli, is a Gram-negative, facultative anaerobic, rod-shaped, coliform bacterium of the genus Escherichia that is commonly found in the lower intestine of warm-blooded organisms

$29.32 a bacterium that occurs mainly in the intestine, especially a serotype causing food poisoning.

aeruginosa

Pseudomonas aeruginosa is a common encapsulated, Gram-negative, rod-shaped bacterium that can cause disease in plants and animals, including humans aureus

Staphylococcus aureus is the most dangerous of all of the many common staphylococcal bacteria

Clostridia

The Clostridia are a highly polyphyletic class of Firmicutes, including Clostridium and other similar genera. They are distinguished from the Bacilli by lacking aerobic respiration. They are obligate anaerobes and oxygen is toxic to them

USP TESTING

- EXPEDITED

TESTING

U.S. Pharmacopeial Convention

(USP) Testing - USP establishes primary standards for ensuring quality in pharmaceutical development & manufacturing.

USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility.

The USP provides a foundation of principles for uniform and reliable quality which consumers expect when they buy and use these products. USP’s principles are enforceable in the United

States by the FDA, and these guidelines are utilized throughout more than 140 nations.

<51>

Antimicrobial

Effectiveness

Testing

Antimicrobial Effectiveness

Testing (AET) also known as

Preservative Efficacy Testing

(PET) is microbial challenge methodology performed to assure the preservative in a product, or the antimicrobial action created by the properties of a product, is sufficient to combat the

$1,209.45

<61> Suitability of the Counting

Methods in the

Presence of

Product

The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery. 20 grams or mL per sample

$73.30

<62> Suitability of the Test

Methods in the

Presence of

Product

The Aerobic Plate Count (APC) is used as an indicator of bacterial populations on a sample It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to

104°F 20 grams or mL per sample

Aerobic

The Aerobic Plate Count (APC) is used as an indicator of bacterial populations on a sample ......................... It is not a measure of the entire bacterial population; it is a generic test for

Microbial

Count organisms that grow aerobically at mesophilic temperatures (25 to

40°C; 77 to 104°F) 20 grams or mL

Molds Count

The total yeast and mold count

(TYMC) is a test to detect mesophilic fungi in pharmaceutical ingredients that range from raw materials and water to the finished products.

20 grams or mL per sample

<62> Bile

Negative

Bacteria

They include, Gram negative bacteria that grow in the presence of bile salts, non-lactose fermenting but able to utilize glucose, e.g., some Bile

Tolerant Gram Negative

Bacteria includes members of the family Enterobacteriaceae, Pseudomonads and Aeromonas.

(E.coli)

Escherichia coli (abbreviated as

E. coli) are bacteria found in the environment, foods, and intestines of people and animals.

E. coli are a large and diverse group 20 grams or mL per

Salmonella is a genus of rod-shaped Gram-negative bacteria of the family

Enterobacteriaceae. The two species of Salmonella are

Salmonella enterica and

Salmonella bongori. S.

enterica is the type species and is further divided into six subspecies that include over

2,600 serotypes 20 grams or mL per sample aeruginosa

Pseudomonas aeruginosa is a common encapsulated, Gram- negative, rod-shaped bacterium that can cause disease in plants and animals, including humans 20 grams or mL per sample aureus

Staphylococcus aureus is a Gram-positive, round-shaped bacterium that is a member of the Firmicutes, and it is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin. 20 grams or mL

<62> Clostridia

The Clostridia are a highly polyphyletic class of Firmicutes, including Clostridium and other similar genera. They are distinguished from the Bacilli by lacking aerobic respiration. They are obligate anaerobes and oxygen is toxic to them 20 grams or mL per sample

<62> Candida albicans

Candida albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora. It can also survive outside the human body. It is detected in the gastrointestinal tract and mouth in 40–60% of healthy adults 20

<2021>

Heterotrophic Plate

Count on Process

Water

Heterotrophic plate count (HPC) is a method that measures colony formation on culture media of heterotrophic bacteria in drinking water. Thus the

HPC test (also known as Standard

Plate Count) can be used to measure the overall bacteriological quality of drinking water in public, semi-public and private water systems 20 grams or mL per

$87.96

Featured snippet from the web

The total yeast and mold count (TYMC) is a test to detect mesophilic fungi in

541380 <2021> Total

Yeasts and Molds

Count pharmaceutical ingredients that range from raw materials and water to the finished products 20

Per Sample $87.96

<2021> Bile

Negative Bacteria

They include, Gram negative bacteria that grow in the presence of bile salts, non-lactose fermenting but able to utilize glucose, e.g., some Bile

Tolerant Gram Negative Bacteria includes members of the family

Enterobacteriaceae, Pseudomonads and Aeromonas. 20

(E.coli)

Escherichia coli, also known as E. coli, is a Gram-negative, facultative anaerobic, rod-shaped, coliform bacterium of the genus Escherichia that is commonly found in the lower intestine of warm-blooded organisms 20 grams or mL per sample

$43.98

<2022> Salmonella a bacterium that occurs mainly in the intestine, especially a serotype causing food poisoning. 20 grams or mL per aeruginosa

Pseudomonas aeruginosa is a common encapsulated, Gram-negative, rod-shaped bacterium that can cause disease in plants and animals, including humans 20 grams or mL per aureus

Staphylococcus aureus is the most dangerous of all of the many common staphylococcal bacteria 20 grams or mL

<2022> Clostridia

The Clostridia are a highly polyphyletic class of Firmicutes, including Clostridium and other similar genera.

They are distinguished from the Bacilli by lacking aerobic respiration. They are obligate anaerobes and oxygen is toxic to them 20 grams or mL per

Food Processing Validation tests, Shelf- Life studies, and Environmental monitoring. We also provide microbiology testing for support of HACCP and GMP plans. We work closely with our clients to develop the best food

FOOD TESTING

microbiology testing procedures needed for their products taking into account the ingredients, pH, water activity, processing and storage conditions (time and temperature). Our facilities are Biosafety Level 2 so we can work with a wide variety of pathogenic bacteria and viruses. Our lab has trained Food Microbiologists with over 15 years of experience who can handle not only your routine testing needs, but also your special projects, research projects, and product development analytical support.

Aerobic (Standard) Plate Count (Petrifilm)

The Aerobic Plate Count (APC) is used as an indicator of bacterial populations on a sample ..... It is not a measure of the entire bacterial population; it is a generic test for organisms that grow aerobically at mesophilic temperatures (25 to 40°C; 77 to 104°F) 100 ML or grams of sample reqired

100 ML or grams

$19.55

Anaerobic Plate

This assay is used to determine the number of anaerobic (growth without oxygen) mesophilic (growth at body temperatures i.e. 35 C) bacteria contained in a food product or ingredient. No information about potential food borne pathogens can be inferred from anaerobic plate counts. 100 ML or grams

Bacillus cereus

Bacillus cereus is a Gram-positive, rod-shaped, facultative anaerobic bacterium that can produce toxins which cause food poisoning. It belongs to the Bacillus genus and shares similar characteristics, such as forming protective endospores, with other Bacillus members including B. 100 ML or grams of sample reqired

Campylobacter

A bacterium that typically infects the bowels. Now a leading cause of bacterial food poisoning, Campylobacter jejuni is most often spread by contact with raw or undercooked poultry. A single drop of juice from a contaminated chicken is enough to make someone sick. 100

Clostridium perfringens

C. perfringens is a gram-positive spore-forming anaerobic (meaning it can grow without oxygen) bacteria that is normally found in the intestines of humans and animals. It is also a common cause of food poisoning when ingested in sufficient numbers. 100 ML or grams of sample reqired

E. coli - 3 Tube

MPN

Most Probable Number (MPN) is a method used to estimate the concentration of viable microorganisms in a sample by means of replicate liquid broth growth in ten-fold dilutions MPN is most commonly applied for quality testing of water i.e to ensure whether the water is safe or not in terms of bacteria present in it 100 ML or grams of

E. coli - VRB plate (Petrifilm)

Petrifilm E. coli/Coliform Count Plate is a sample-ready-culture-medium system which contains Violet Red Bile (VRB) nutrients, a cold-water-soluble gelling agent, an indicator of glucuronidase activity (BCIG), and a tetrazolium indicator that facilitates colony enumeration in food and beverage samples. 100 ML or grams of

E. coli H7:O157

A dangerous form of Escherichia coli, the colon bacillus, a bacterium that normally lives in the human colon Hemorrhagic colitis -- E coli O157:H7 causes about 20,000 cases of hemorrhagic colitis (bloody inflammation of the colon) a year in the US. 100 ML or grams of

$53.75

E. coli in water coli in ambient water or wastewater based on the development of colonies that grow on the surface of a membrane filter. A sample is

$39.09

(membrane filtration) filtered through the membrane, which retains the bacteria.

The target colonies on modified mTEC agar are red or magenta in color after the incubation period 100 ML or grams of sample reqired

Enterobacteriacea e

Enterobacteriaceae is a family of Gram-negative, facultatively anaerobic, non-spore-forming rods.

Characteristics of this family include being motile, catalase positive, and oxidase negative; reduction of nitrate to nitrite; and acid production from glucose fermentation. 100 ML or grams of

Flat Sour Spores he spores are ubiquitous in nature, being isolated in areas from the arctic to the deserts as well as from foods The flat-sour aerobes are two in number, one Bacillus stearothermophilus, typical of flat- sour spoilage of low acid foods and the other Bacillus coagulans, typical of flat-sour spoilage of acid foods. 100 ML or grams of sample

$53.75

Lactobacillus

Lactobacillus is a genus of Gram-positive, facultative anaerobic or microaerophilic, rod-shaped, non-spore-forming bacteria. They are a major part of the lactic acid bacteria group. 100 ML or grams of

Listeria monocytogenes

Listeria monocytogenes is the species of pathogenic bacteria that causes the infection listeriosis. It is a facultative anaerobic bacterium, capable of surviving in the presence or absence of oxygen

100 ML or grams of sample reqired

$68.41

Characteristics of L. monocytogenes.

L. monocytogenes is an environmental pathogen that can

541380 Listeria spp.

(environmental) contaminate foods and cause a mild, non-invasive illness (called listerial gastroenteritis) or a severe, invasive illness (called listeriosis) 100 grams $58.64

Osmophilic Yeast

A simple presence-absence test for detection of small numbers of osmotolerant yeasts in high-sugar foods is useful for enumeration.

Osmophilic Agar (MY 40 Agar) is generally used for this purpose.

Osmophilic yeasts usually are the cause of spoilage of high-sugar foods, including jams, honey, concentrated fruit juices, chocolate candy with soft centres etc.

Pathogen Testing

Pathogen testing in food mainly involves looking for likely or suspected forms of bacterial contamination by pathogens such as E.