Microbac Laboratories Inc.
9.4/10 Overall Rating
100% Positive
7 Orders Completed
Pittsburgh, Pennsylvania, US
Microbac is a premier testing company that partners with clients to help them understand the quality, safety and performance of their products and operations. Through a network of 30 laboratories running numerous tests for the food, environmental, life science and specialty markets each day, Microbac creates time-sensitive data and insights to support its clients' informed decision-making.
We have a wide spectrum of scientific testing capabilities and expertise. From food to consumer products, industrial materials to drinking water, soil and air to drug development and discovery - we touch many industries within the economy and can simplify the purchase of testing services across a broad universe of needs.
At Microbac, we endeavor to deliver value that reaches beyond the walls of our laboratories. We collaborate with our clients to understand their performance objectives and offer tools, services and solutions to help meet those objectives.
If you're looking for top tier laboratory services, or are interested in joining a premier laboratory group, we want to hear from you.
Microbac routinely performs antimicrobial efficacy tests that meet or exceed industry and governmental standards, both in the U.S. and abroad. However, gaining final regulatory approval is a multi-faceted process, and we are trusted to provide essential services along the way. Clients have relied upon our professional staff to furnish total solutions, from new product research and development capabilities, to final testing for safety and efficacy, or for modification or enhancement of existing label claims.
Since each client has unique needs, the proposed course of action will be decided based upon collaboration between the client's in-house science team and our expert staff. Microbac's expertise includes, but is not limited to, the following areas:
USP 51 - Antimicrobial Effectiveness Testing
The objective is to assess the effectiveness of inherent or added antimicrobial preservatives in a product. The sample is spiked with a known amount of microbial load and depending on product type is analyzed on day 7, 14 and 28.
Method Suitability
An initial method suitability is performed to demonstrate at least a 70% recovery of spiked organisms. Method suitability includes determination of an appropriate dilution factor and which in activators are required for the particular product under test. Method suitability is performed concurrently with the AET test and is generally completed by day 5. The information obtained from method suitability is applied to sample analysis on days 7, 14 and 28.
Sample Quantity Required
A 75 mL quantity for a liquid or 75 g of a cream is recommended and is sufficient for both method suitability and AET testing.
Turn Around Time
The test itself requires a minimum of 33 days from initiation and reports are generally issued within 40 days from sample receipt.
The objective is to determine the quantity of mesophilic bacteria and fungi that may grow under aerobic conditions. Mesophilic bacteria grow best at moderate temperatures, typically between 20 and 45°C.
Method Suitability
The ability of the test to detect microorganisms in the presence of product must be established. Suitability is generally a onetime test but must be confirmed if a change in the product may affect the outcome of the test is introduced. Method suitability is performed by inoculating the sample with a quantity of a microbial load with individual bacteria and fungi or as a suspension. A control is similarly prepared and analyzed. The responses of the sample and control are compared for acceptance. The acceptance criteria for the plate count method is 50-200% recovery.
Minimum Sample Quantity Required
Unless otherwise directed in the monograph, 10 mL or 10g of material is to be tested. For fluids in aerosol form, 10 containers are sampled. For transdermal patches, 10 units are sampled. Generally it is recommended to submit twice the minimum quantity needed for testing.
Turn Around Time
The turnaround time for regularly submitted samples 10 business days. Expedited testing less than 5 days is not available due to the incubation time required to complete the test. Turn-around time for method suitability generally can be completed in 10 business days but may be extended if the acceptance criteria are not met on the first pass. Expedited testing must be pre-arranged.
USP 62 - Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
The objective is to determine the presence or absence of the aerobic microorganisms Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella, Candida albicans, the anaerobic microorganism Clostridium or bile tolerant gram negative bacteria.
Method Suitability
The ability of the test to detect the specified microorganisms in the presence of product must be established. Suitability is generally a onetime test but must be confirmed if a change in the product may affect the outcome of the test is introduced. Method suitability is performed by inoculating the sample with a quantity of each specified microorganism of interest individually. The acceptance criteria requires detection of the specified organism. If the acceptance criterion is not met, it may be due to inherent antimicrobial properties of the sample that needs to be neutralized.
Requested Sample Quantity
A submission of 15 mL or g is sufficient for all pathogens except as listed below.
Salmonella: 50 mL or g
Turn Around Time
Ten business days.
A five day expedited TAT is available for all pathogens with prior arrangement. Depending on incubation time, sample may be faster.
The objective is to detect or quantify endotoxins from Gram negative bacteria using amoebocyte lysate from the horseshoe crab. There are three techniques for this test: The gel-clot technique, which is based on gel formulation; the turbidometric technique, based on the turbidity after cleavage of an endogenous substrate; and the chromogenic technique, based on the development of color after cleavage of a synthetic peptide–chromogen complex. Microbac offers the turbidometric technique.
Preparatory Testing
The USP requires that preparatory testing be performed for each product to verify the solution does not interfere with the test. This is a one-time evaluation where the sample is spiked at least in duplicate with endotoxin and a recovery of 50 – 200% must be observed.
Turn Around Time
The turnaround time for regularly submitted samples 10 business days. Expedited testing is available. Turn-around time for Preparatory Testing can be completed in 10 business days but may be extended if the acceptance criteria are not met on the first pass. Expedited testing must be pre-arranged.
Sample Quantity
Unless otherwise directed in the monograph, 10 mL or 10g of material is to be tested.
Microbac monitors the security and quality of conditions of your samples 24 hours/day, 7 days/week.
Whether your drug substance is investigational, your key product is already on the market, or your article is still in the approval process, Microbac offers a variety of stability storage and testing services.
We offer a range of controlled-temperature and humidity environmental conditions, as well as a comprehensive selection of analytical capabilities to meet your needs.
Microbac can assist with protocol design, ongoing sample testing, and trends analysis during, and at the conclusion, of testing.
Whether your storage condition needs are long-term, intermediate, or accelerated, Microbac’s automated systems work for you.
Stability Storage per ICH Guidelines
Stability Testing
Microbac understands the new challenges facing biomedical companies as the industry undergoes rapid change and the introduction of radical new device designs, biomaterials, and testing techniques. Our staff focuses on working with you to develop a medic device testing regime that will assist in turning your prototype products into the innovations of tomorrow.
Mechanical medical device testing is a critical step in turning innovative concepts into reliable products. Microbac staff can customize your testing plan from test feasibility and design, protocol development, test implementation and results interpretation and final reporting.
Your Device Testing Partner
Microbac Laboratories medical device testing lab can provide innovative technical consulting expertise in the areas of medical hardware testing, analyzing medical components, formulating medical products, and comprehensive failure analysis. Our diverse background enables Microbac to assist manufacturers in the medical device industry, providing the results you need and the tests your industry demands.
Let our experience problem solvers and materials specialists go to work for you. Our analysts have strong backgrounds in materials applications, uses, and environmental effects on materials. In accordance with 21 CFR 820.50, Microbac is capable of assisting GMP medical device manufacturers by operating as an extension of their quality system.
Your laboratory partner in developing, transferring, or validating methods must have significant experience with relevant analytical technologies, as well as a thorough understanding of the regulatory environment. Microbac has that expertise.
Microbac can assist your company, whether your needs include start-from-scratch method development, improvement of a problematic method, or validation of a tried-and-true method.
Microbac can provide support through the technical and regulatory issues associated with the development, optimization, or validation of analytical methods, including methods that are part of an NDA or ANDA submission, or are to be used for a ready-to-sell product.
Method Development
Microbac’s scientists have developed and validated multiple chromatographic and spectroscopic assays and dissolution methods for clients. These include methods for API and finished products.
Method Transfer
Microbac provides on-site assistance in transferring our methods to clients, and have demonstrated proficiency in transferring methods from our clients. We assist with typical and novel drug delivery systems, including immediate and extended-release formulations.
Method Validation
Microbac will assist with or execute Validation Protocol per USP, FDA, and ICH Guidelines. We can verify the stability-indicating nature of methods through forced degradation and confirmation or identification of degradation products. For chromatographic methods, our stability-indicating detection capabilities include diode array and mass spectrometry.
he Agrochemical Sciences Department at Microbac Laboratories offers research and testing services related to pesticide residues for the agrochemical, agricultural, and food industries.
Quality
Microbac’s Wilson Division is an FDA registered facility operating under an ISO 17025:2005 accredited (A2LA) scope of work specific to pesticide residues analysis.
Screening - USDA “List”
The USDA no longer maintains an active pesticide screening requirement. Microbac performs the list as contained in an USDA memoranda and in direct correspondence. Customization of the list to meet customer requirements is available.
CORESTA GRL
The Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) maintains Agrochemical Guidance Residues Levels Agrochemical Guidance Residue Levels (GRLs, CORESTA Guide N° 1) and conducts regular proficiency studies across independent and manufacturers’ laboratories. Microbac participates in each of the studies and offers the complete list of pesticide residues per the CORESTA Guide.
Instrumentation
The following are Chemical Analysis tests which can be performed:
Food testing and analysis play a crucial part in our everyday lives. Food safety testing ensures the food we eat is safe for consumption, nutritional analysis provides details on the ingredients of food, and food chemistry testing provides the levels of additives and contaminants in food we would otherwise not know about.
Microbac has operated full-service food testing laboratories for over 30 years and this experience enables our microbiology and food testing labs to handle all manners of food analysis. We offer time and money-saving counsel on testing programs, ensuring the most accurate food safety testing and food nutritional analysis available.
In addition to complying with its strict, internal Quality Assurance program’s procedures, Microbac’s team of chemists follows official AOAC methods, where applicable, to assure the accuracy of your food chemistry testing data.
Microbac offers food chemistry testing, nutrition analysis, food safety testing, and food microbiology testing for a variety of applications. Other specialized services include:
Microbac provides technical expertise and knowledge to assure your food product receives proper nutritional labeling according to the strict requirements of the United States FDA. In order to assist the food industry in faster placement of products into the marketplace, Microbac is offering 5-day turnaround time for nutritional label analysis.
NLEA Mandatory Package
An ISO 17025 accredited laboratory and quality system, Microbac offers a Standard NLEA Label to be produced in 5 business days. NLEA Labels are also available in longer negotiable time frames to suit the needs of businesses. Microbac tests the actual food product according to AOAC-approved analytical chemistry methods. A properly formatted Nutrition Facts Panel is created from laboratory analysis, which is used to develop a camera-ready copy.
Database Analysis
Microbac reviews food product formulations and food ingredient statements and inputs them into a modified computer database to generate a camera ready, FDA-approved Nutrition Facts Panel.
Consulting
Microbac provides consulting services for FDA regulations for the labeling of food, nutraceuticals, and dietary supplements.
Import and Export Relations
Each country has unique requirements to meet for legal marketing of food products. Microbac will assist you in identifying and meeting those food safety and food testing requirements.
Elite scientists at Microbac Laboratories provide their expertise to meet the continual demand for Genetically Modified Organisms (GMO) analysis and detection. GMOs are organisms, usually plants, that have had a portion of their genome modified and are created when foreign genetic material (DNA) is introduced into the host’s DNA. GMOs are typically some type of commercial crop such as tomatoes, soybeans or corn. Microbac’s team utilizes PCR-based analysis of the DNA from these crops to deliver a quick and definitive answer as to whether a sample contains any GMO material.
The introduction of the foreign DNA is usually done to infer resistance in these crop plants to either a naturally occurring disease such as a virus, or to herbicides such as Round Up, but some can be introduced to enhance or reduce other factors in the plants such as flavors or freshness. Specific genetic markers are used in creating these GMO events. It is these markers that are being detected when samples are tested for GMO material.
The experienced team at Microbac has the capability to screen for many common markers used for GMO events such as the 35S promoter and the NOS terminator. Additionally, Microbac has the ability to go further and analyze for specific events themselves such as vector 21-41 found in tobacco or Round Up Ready products found in crops such as corn and soybeans.
Exporters and wholesalers dealing with foreign entities are directly affected by GMO contaminated materials since most governments around the world have either banned or severely limited the importation of GMO materials into their countries. This is especially true of wheat products which are to be GMO free even in the United States. Having a certificate of analysis that guarantees the absence of GMO material in a product makes it less likely that a manufacturer’s product will be held up by customs and ensures that the product is distributed into the marketplace in an acceptable time.
Product Testing Services
"This lab was efficient, fast, and a breeze to work with! Thank you to the entire team! I can't wait for our next set of experiments!"
"Responsive and fast turnaround at a reasonable price"
"We used Microbac for a development of an in vitro viral sustainability test for one of our projects. They did a fantastic job, delivering high quality data within the agreed timeliness. They communicated with us through out the process and answered all of our questions. I highly recommend Microbac. Regards,"
Microbac Laboratories Inc. has not received any endorsements.