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News and articles about laboratory testing for medical devices. Find here all the information you need to know about EtO residuals and microbiology testing, bioburden testing, sterilization validation, accelerated aging, and more!
We help you understand how we work, costs and turnaround times for medical device testing. Stay up to date and learn more about why is laboratory testing important.
How Comprehensive Product Testing Expertise Reduces Risk for Medtech Manufacturers
When the lifesaving and lifechanging products you make are going into patients’ bodies, there is no room for error. Every medical device manufacturer knows this…
Accelerating Time to Market By Streamlining Medical Device Testing
One of the biggest challenges in medical device manufacturing is simply getting the product to market quickly. Speed to launch isn’t just about competitive advantage;…
The Benefits of Outsourcing Medical Device Product Testing
As a medical device manufacturer, you know that every product you bring to market must meet rigorous testing standards to ensure patient safety.
How To Calculate Allowable Limits For Ethylene Oxide Sterilization
Learn what ethylene oxide residuals are and how to calculate allowable limits for EtO-sterilization of medical devices and products.
Tolerable Exposure Limits For Ethylene Oxide Sterilized Medical Devices
Learn about ethylene oxide residuals and how to calculate tolerable exposure limits for EtO-sterilized medical devices and products.
Key Differences Between USP 1115, USP 1116 and USP 1211
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
How To Calculate Tolerable Contact Limits For Ethylene Oxide
Learn what ethylene oxide residuals are and how to calculate tolerable contact limits for EtO-sterilized medical devices and products.
Isolators Vs. Restricted Access Barrier Systems
Learn what isolators and RABS are, and if they can be useful in the manufacturing, filling, testing, or packaging processes for medical devices.
What Are Restricted Access Barrier Systems (RABS)?
Learn what restricted access barrier systems (RABS) are and how are they useful in manufacturing or packaging processes for medical products.
Electron Beam vs. Gamma Radiation Sterilization
Learn the differences between electron beam (e-beam) and gamma radiation sterilization processes and which to use for medical device sterilizations.
What is electron beam sterilization?
Learn about electron beam (e-beam) processes and when to use it to sterilize medical devices and products.
Microbial Aerosol Challenge Testing vs. Microbiology Testing
Learn the differences between microbial aerosol challenge testing and microbiology testing for parenteral products and combination products.
Microbial Aerosol Challenge Testing vs. Bioburden Testing
Learn the differences between microbial aerosol challenge testing and bioburden testing for combination products as well as parenteral products.
How is EtO residuals testing performed?
Learn what ethylene oxide residuals are and how EtO residuals testing for medical devices and other products is performed.
Which Is The Best Sterilization Method For Your Medical Device?
Learn about medical device sterilization options and which one is the best to sterilize your medical devices following regulatory requirements.
USP 88 In-Vivo Cytotoxicity Testing
Learn what USP 88 cytotoxicity tests are available and which ones you will need to meet the regulatory requirements for your medical devices.
USP 87 In-Vitro Cytotoxicity Testing
Learn what USP 87 cytotoxicity tests are available and which ones you will need to meet the regulatory requirements for medical products.
How Do You Perform Endotoxin Tests And Pyrogen Tests?
Learn how to perform endotoxin and pyrogen tests for your medical device, and identify which tests will be needed for your device.
How Much Does Medical Device Development Cost?
Learn how the FDA defines medical devices, 510(k) submission types, and the approximate cost for developing new medical devices.
How Do You Select Biocompatibility Tests For Medical Devices & Implants?
Learn about biocompatibility tests for medical device and implant regulatory requirements, USP guidance, and medical devices categorizations.
How To Prepare Your Samples For Ethylene Oxide Residuals Testing
Learn about what product samples will need to be sent and when for Ethylene Oxide (EtO) residuals testing of sterilized medical devices.
In-Vitro USP 87 Vs. In-Vivo USP 88 Cytotoxicity Testing
Learn about in-vitro vs. in-vivo medical device cytotoxicity assessments, and requirements of USP 87 and USP 88.
Ethylene Oxide Residuals Exhaustive Extraction Measuring Methods
Learn about the methods used to measure ethylene oxide (EtO) residuals via exhaustive extraction for medical devices and products.
Ethylene Oxide Residuals Simulated-Use Extraction Measuring Methods
Learn about the methods used to measure ethylene oxide (EtO) residuals via simulated-use extraction for medical devices and products.
Is Sensitization Testing Needed For Regulatory Approval Of Medical Devices?
Learn what sensitization testing is and what sensitization tests are needed to meet regulatory requirements for medical devices.
Cytotoxicity Testing Vs. Physiochemical Testing For Medical-Grade Plastics
Learn about cytotoxicity and physiochemical testing requirements for medical-grade plastics used in injectable products.
Elution Vs. Agar Diffusion Cytotoxicity Testing
Learn about agar diffusion and elution tests for medical device cytotoxicity assessments and how to perform these kinds of tests.
Agar Diffusion Vs. Direct Contact Cytotoxicity Testing
Learn about agar diffusion and direct contact tests for medical device cytotoxicity assessments and how to perform these tests.
Direct Contact Vs. Elution Cytotoxicity Testing
Learn about direct contact and elution tests for medical device cytotoxicity assessments and how to perform these tests.
How to validate isolators used for medical device testing?
Learn about isolators and isolator validations and how to validate ISO Class-5 isolator systems used for medical device testing and sterile products.
USP Guidelines On Isolator Systems
Learn what isolators are, USP guidelines on isolator systems, and if they are useful in the manufacturing or packaging processes for your medical devices.
Microbiology Sampling For Regulatory Testing Of Inhalable Devices
Learn techniques for obtaining enough product from inhalant medical device packaging to perform microbiology sampling for regulatory testing.
Depyrogenation And Sterilization For Medical Devices
Learn about depyrogenation, steam sterilization, and if steam should be used to sterilize your medical device or product.
What Are Sterilization Indicators & Sterilization Integrators?
Learn what sterilization indicators and integrators are, how they are used, and which medical device sterilization processes use them.
Depyrogenation By Radiation Vs. Sterilization By Radiation
Learn the differences between sterilization and depyrogenation processes that use radiation and when to use each process to sterilize medical devices
Liquid Vs. Vapor Phase Sterilization
Learn about vapor phase sterilization, liquid phase sterilization, and if either method should be used for your sterile medical device or product.
Liquid vs. Radiation Sterilization For Medical Devices
Learn about liquid phase sterilization, radiation sterilization, and if either method should be used for your sterile medical device or product.
Liquid Phase vs. Steam Sterilization
Learn about liquid phase sterilization, steam sterilization, and if either method should be used for your sterile medical devices or products.
What Is Liquid Phase Sterilization?
Learn about liquid phase sterilization, what include specific liquid sterilants, and if this method should be used to sterilize your medical devices.
Radiation Sterilization Vs. Vapor Sterilization
Learn about sterilization by radiation and vaporization processes and when to use them to sterilize your medical devices and products.
Ethylene Oxide Vs. Vapor Phase Sterilization
Learn about vapor phase sterilization, ethylene oxide sterilization, and if either method should be used for your sterile medical device or product.
Vapor Phase Vs. Steam Sterilization
Learn about vapor phase sterilization, steam sterilization, and if either method should be used for your sterile medical devices or products.
What Is Vapor Phase Sterilization?
Learn about vapor phase sterilization, some difficulties and practices required, and if it should be used for your sterile medical device or product.
Top 3 Water Sanitization Methods For Sterile Product Processing
Learn what the top water sanitization methods are for monitoring and controlling microbial contamination during sterile product manufacturing.
Dry Heat Depyrogenation vs. Sterilization For Sterile Products
Learn about dry heat depyrogenation, dry heat sterilization, and how to create a dry heat process for your sterile product needs.
Ethylene Oxide Depyrogenation Vs. Sterilization For Medical Devices
Learn about ethylene oxide (EO) depyrogenation, ethylene oxide sterilization, and how to create a dry heat process for your sterile products.
Depyrogenation Vs. Sterilization For Medical Devices
Learn about depyrogenation, sterilization, and which processes to use for your medical devices and sterile products.
When To Use Dry Heat Vs. Rinsing For Medical Device Depyrogenation
Learn what depyrogenation is and when to use dry heat vs. rinsing for endotoxin removal from a medical device or product.
Depyrogenation Of Sterile Products By Dry Heat Vs. Filtration
Learn what depyrogenation is and when to use dry heat vs. filtration for endotoxin removal from a medical device or parenteral product.
Endotoxin Removal From Sterile Products By Rinsing Vs. Filtration
Learn what depyrogenation is and when to use filtration vs. rinsing for endotoxin removal from a medical device or parenteral product.
How to depyrogenate parenteral products by filtration
Learn what depyrogenation by filtration is and which filtration types to use for endotoxin removal from parenteral products.
How to depyrogenate sterile products by rinsing
Learn what depyrogenation by rinsing is, why is depyrogenation needed and how to use rinsing for a medical device’s or product’s endotoxin removal.
Guideline To Create Your Own Endotoxin Indicator For Regulatory Testing
Learn how to select and create endotoxin indicators for depyrogenation validation processes and regulatory testing.
What Is Mycoplasma Sterilization?
Learn what mycoplasma is and how to sterilize your medical device, parenteral product, or medical product against them.
Top 6 Ways To Measure Humidity For Medical Device Sterilization
Learn USP-approved ways to measure and track humidity for medical device sterilization, and relative humidity measurement devices.
Top Ways To Measure Temperature For Product Sterilization
Learn the top USP-approved ways to measure temperature for product sterilization and other regulatory tests, and the top measurement devices.
What Is The Difference Between Biological Indicators And Endotoxin Indicators?
Learn about biological indicators used in sterilization validations and endotoxin indicators for depyrogenation validations.
Are Endotoxins And Lipopolysaccharides The Same?
Learn about the relationship between endotoxins and lipopolysaccharides (LPS), and their similarities and differences.
Contract Testing Vs. Contract Manufacturing Organizations For Medical Device Outsourcing
Learn the differences between contract testing and contract manufacturing and how they can both ease medical device manufacturing and regulatory testing.
How Do Autoclaves Sterilize Medical Devices?
Learn about sterilization testing and validations and how autoclaves use steam to sterilize medical devices or other medical products.
How To Validate Steam Sterilization Processes For Medical Devices?
Learn what sterilization validations are and how to validate steam sterilization processes for your medical device or medical product.
Save Start-up Time And Money Using Contract Testing Services
Learn what contract testing is and the benefits of using contract testing organizations to support you with medical device regulatory testing.
How To Validate Sterility In Autoclaves Vs. Radiation Sterilized Medical Products
Learn what sterilization validations are and how to perform sterilization validations for radiation sterilized medical devices or medical products.
What Medical Devices Aren’t Regulated By The FDA?
Learn what medical devices are and aren’t regulated by the United States Food and Drug Administration (FDA) and how the FDA classifies medical devices.
Importance Of Medical Devices In Healthcare
Learn about the importance of medical devices in healthcare, and their current benefits as well as facility and patient-related risks regarding its usage.
What Medical Devices Can Be Sterilized With Ethylene Oxide?
Learn about the problems and benefits with sterilization by Ethylene Oxide, and which medical devices can be sterilized with ethylene oxide.
Top 3 ISO-Approved Methods For Radiation Sterilization Dose Setting
Learn what radiation sterilization is and how to determine the appropriate radiation dose for your medical devices or medical products.
How To Perform Sterilization Validations For Radiation Sterilized Products
Learn what sterilization validations are and how to perform sterilization validations for radiation sterilized medical devices or medical products.
How does the FDA classify medical devices?
Learn how the FDA classifies medical devices, what means each classification, and how to determine the classification of your medical device or product.
Top 9 Sterilization Process Controls You Need Before Your Next Audit
Learn what sterilization validations are, and nine process controls to maintain the validity of your medical device’s sterilization processes.
How To Use Dry Heat Sterilization For Depyrogenation Of Medical Devices
Learn about sterilization by dry heat, how it is performed, and how it can be used to depyrogenate medical devices and products.
Top 3 Sterilization Validation Methods For Medical Devices
Learn what sterilization validations are and the top three methods to meet sterility regulatory requirements for your medical device or product.
Water Sampling Vs. Air Sampling Methods For Environmental Monitoring
Learn about water sampling, air sampling, and when to use these methods for environmental monitoring of your manufactured products.
Sterilization By Radiation Vs. Ethylene Oxide For Medical Devices
Learn about sterilization by radiation vs. ethylene oxide and when to use these methods to sterilize medical devices and products.
Top Biological Indicators For Each Sterilization Validation Process
Learn about biological indicators used in sterilization validations and which to use to verify the sterility of your medical devices and products.
Top 7 Sources Of Microbial Contamination
Learn about sterilization and the top seven sources for microbial contamination of medical devices and products.
Cytotoxicity Testing Vs. Microbiology Testing
Learn about the differences between cytotoxicity and microbiology testing, and when your medical device needs cytotoxicity and microbiology testing.
Environmental Monitoring Vs. Ethylene Oxide (EO) Residual Testing
Learn how EO residual testing compares to environmental monitoring and how these tests relate to regulatory testing for medical devices or products.
Bacterial Endotoxin Testing Vs. Environmental Monitoring
Learn about the differences between bacterial endotoxin testing and environmental monitoring for your medical device or medical product.
Steam Sterilization Vs. Dry Heat Sterilization For Medical Devices & Products
Learn about steam sterilization, dry heat sterilization, and which method to use to sterilize various medical devices and products.
Why Are Bacterial Spores Hard To Sterilize?
Learn about sterilizing bacterial spores, why they are hard to kill, and how to create sterilization processes to fully sterilize your medical devices.
Sterilization By Ethylene Oxide (EO) For Medical Devices
Learn about sterilization by ethylene oxide (EO), when to use it to sterilize your medical devices and products, and other alternatives to it.
Sterilization By Moist Heat
Learn about sterilization cycle steps, sterilization by moist heat and when to use it to sterilize correctly your medical devices and products.
Sterilization By Radiation
Learn about sterilization by radiation, how it is performed and when to use it to sterilize your medical devices and products.
Sterilization Of Bacteria, Fungi And Virus For Medical Devices
Learn about sterilization methods, microbial death kinetics, and the three types of microorganisms medical devices and products must sterilize against.
Microbiology Testing Vs. Environmental Monitoring
Learn how microbiology testing compares to environmental monitoring and how they relate to regulatory testing for your medical device or medical product.
Sterilization By Filtration For Parenteral & Biologic Products
Learn about sterile filtration, when to use it to sterilize parenteral and biologic products and product-filter compatibility considerations.
Sterilization By Dry Heat For Medical Devices & Products
Learn about sterilization by dry heat, how is it performed, and when to use it for sterilization of your medical devices and products.
F Value Calculations For Medical Device And Product Sterilization
Learn about microbial death kinetic, calculations for F values, and how F values are used for medical device and product sterilization.
D Value Vs. Z Value Calculations For Medical Devices & Product Sterilization
Learn about microbial death kinetics and calculations for bioburden, D values and Z values, and what these values mean when it comes to sterilization.
USP 1111 Guidelines & Limits For Bioburden
Learn about bioburden testing , different methods of sterilization, and what are bioburden limits based on USP 1111 guidelines considerations.
Bioburden Vs. Biofilms For Medical Device Testing
Learn about how bioburden and biofilms relate, and how bioburden and biofilms relate to biocompatibility requirements for medical devices.
Sterilization Vs. Pasteurization For Parenteral Products
Learn the differences between pasteurization and sterilization, the benefits of pasteurization and the requirements for sterilization validation.
Sterilization Validations vs. Sterility Testing
Learn how sterilization validations compare to sterility testing and how these tests relate to regulatory testing for your medical device or product.
How To Test For Subvisible Particles In Therapeutic Protein Injections
Learn how particular matter testing is performed and how this relates to regulatory requirements for therapeutic protein injections.
Subvisible Particle Detection Within Traditional Parenteral Products Vs. Therapeutic Protein Biologics
Learn the differences between traditional particulate matter testing and particulate matter testing for biologics for therapeutic protein products.
Environmental Monitoring Of Non-Sterile Processes
Learn what are non-sterile products and how to monitor environments for non-sterile production and testing processes of your medical devices and products.
How To Perform Environmental Monitoring For Sterility Assurance
Learn how to monitor environments for sterility assurance and what are aseptic process simulations for your medical devices and medical products.
Sterilization Validations vs. EO Residual Testing
Learn how EO residual testing compares to sterilization validations and how these tests relate to regulatory testing for your medical devices or products.
Sampling For Sterility Testing
Learn how sterility testing sampling is performed and how many product units for your injectable or medical product will need to be tested per batch.
How To Control Endotoxins In Medical Products
Learn techniques for controlling endotoxins in parenteral products so that medical devices, products, and injectables meet FDA limits for pyrogenicity.
USP 788 Particulate Matter Testing Methods
Learn how particular matter testing is performed, which method to use, and how this relates to regulatory requirements for injectable parenteral products.
How To Perform Particulate Matter Testing For Ophthalmic Solutions
Learn how particulate matter testing is performed and how this microbiology test relates to regulatory requirements for ophthalmic solutions.
How Are Microbial Characterizations For Microbiology Testing
Learn what microbial characterization is, how is microbial characterization performed, and how it relates to testing your medical devices or products.
What Are The Current Issues With Electronic Particle Counters?
Learn about the issues with electronic particle counters and what to watch out for with light obscuration particle count testing for parenteral products.
EO Residual Testing Vs. Sterilization Validations Vs. Sterility Testing
Learn the differences between ethylene oxide (EO) residual testing, sterilization validations, regarding regulatory testing for medical devices or products.
How To Perform Microbiology Testing For Nutritional & Dietary Supplements
Learn how microbiology testing is performed and how it relates to testing your nutritional and dietary supplements.
Cytotoxicity Testing Vs. EO Residual Testing
Learn about the differences between cytotoxicity and ethylene oxide (EO) residual testing for your medical devices or medical products.
Pyrogens vs. Bacterial Endotoxins For Regulatory Testing
Learn about bacterial endotoxins, other pyrogens, and bacterial endotoxin pyrogenicity testing for your medical device or medical product.
How To Measure Endotoxins In Medical Products
Learn techniques for measuring endotoxins during manufacturing to ensure your medical devices, products, and injectables meet FDA limits for pyrogenicity.
Alternatives To LAL Pyrogen Testing
Learn how USP 151 pyrogen testing using rabbits is performed and how this relates to regulatory requirements for your medical devices and products.
Bioburden Testing vs. Environmental Monitoring
Learn how bioburden testing compares to environmental monitoring and how these tests relate to regulatory testing for your medical device or product.
Bioburden Testing vs. Sterility Testing
Learn how bioburden compares to sterilization validations and how these tests relate to regulatory testing for your medical device or medical product.
What Types Of Pyrogens Should You Evaluate For Your Medical Device Or Medical Product?
Learn about endogenous and exogenous pyrogens and how they relate to regulatory requirements for your medical devices and products.
Sterility Testing Methods For Regulatory Testing
Learn about the methods used after initial manufacturing and after stability testing to test for the sterility of your medical device or product.
Environmental Monitoring vs. Sterilization Validation
Learn how environmental monitoring compares to sterilization validations and how these tests relate to regulatory testing for your medical device or medical product.
How To Perform A Microscopic Particle Count Test For Particulate Matter Within Injectables
Learn one of two methods for particulate matter testing and how this test relates to regulatory requirements for your injectable parenteral products.
How To Perform Light-obscuration Particle Matter Testing For Injectables
Learn how particular matter testing is performed and how this test relates to regulatory requirements for your injectable parenteral products.
Bacterial Endotoxin vs. Microbiology Testing
Learn about the differences between bacterial endotoxin testing and microbiology testing for your medical devices or medical products.
How To Control Equipment And Protocols That Laboratory Technicians Use For Microbiology Testing
Learn how to control equipment and protocols that laboratory technicians use for microbial testing of medical devices and aseptic processing environments.
How To Record And Evaluate Data For Regulatory Microbiology Testing
Learn tools for accurately recording and evaluating microbiology testing data to support FDA approval of your medical devices and medical products.
How To Control Media And Test Strains For Medical Device Testing
Learn how to control and monitor media and testing strains for microbiological testing of medical devices, and aseptic processing environments.
Bioburden Testing vs. Microbiology Testing
Learn how bioburden testing compares to microbiology testing and how these tests relate to regulatory testing for medical devices.
Bioburden vs. Cytotoxicity Testing
Learn how bioburden testing compares to microbiology testing and how these tests relate to regulatory testing for medical devices.
Environmental Monitoring of Aseptic Processes
Learn how to monitor environments for aseptic production and testing processes of your medical devices and your medical products.
Bacterial Endotoxin vs. Cytotoxicity Testing
Learn the differences between bacterial endotoxin and cytotoxicity testing and how they relate to the regulatory testing of medical devices or products.
What Is In-vivo Implantation Cytotoxicity Testing For Medical Devices And Drugs?
Learn more about in-vivo implantation testing and whether or not you will need it for cytotoxicity testing of your medical device, drug, or product.
How Is Intracutaneous Cytotoxicity Testing Performed?
Learn more about in-vivo intracutaneous testing and whether or not you will need it for cytotoxicity testing of your medical device, drug, or product.
What Is Systemic Injection Cytotoxicity Testing For Medical Devices And Drugs?
Learn more about in-vivo system injection testing and whether or not you will need it for cytotoxicity testing of your medical device, drug, or product.
What Is An Elution Test For Cytotoxicity?
Learn more about elution testing and cytotoxicity for your medical devices and products.
What Is Agar Diffusion Test For Cytotoxicity?
Learn more about agar diffusion testing for cytotoxicity and why is it essential for your medical devices and products.
What Is Direct Contact Cytotoxicity Testing?
Learn more about direct contact testing, cytotoxicity and how contact tests are performed for your medical devices and products.
Endotoxin Limits And Calculations For Medical Devices And Combination Products
Learn the endotoxin limits for medical devices and combination products, differences between them and how each one is calculated.
Bacterial Endotoxin Limits And Calculations For Drugs And Biologics
Learn the endotoxin limits for drugs and biological products and how they are calculated to ensure control of microbial and endotoxin contamination.
10 Things You Need to Know About Ethylene Oxide Sterilized Medical Devices
Learn 10 things you need to know about ethylene oxide (EO) sterilized medical devices and EO residual testing.
Special Considerations For Bacterial Endotoxin Tests For Medical Devices
Learn about the endotoxin limits for medical devices, how medical device product families are handled for bacterial endotoxin testing, and more.
Bacterial Endotoxin vs. Bioburden Testing
Learn about the differences between bioburden, bacterial endotoxins, and their medical device testing methods.
Neutralization of Antimicrobial Activity
What is antimicrobial activity for medical products and why it is important for bioburden testing. Learn how to neutralize it for regulatory testing.
Recovery of Microorganisms For Bioburden Testing
Microorganism recovery efficiency is essential for bioburden test validity. Learn more about product sample preparation and microorganism recovery.
What Are USP 61 Microbiological And Bioburden Testing Methods
Learn about the examination methods and techniques covered in USP 61 and how these relate to bioburden testing.
Bacterial Endotoxin Testing For Medical Devices
What is bacterial endotoxin testing? Why are endotoxins harmful? Learn about it and how bacterial endotoxin testing is performed.
Comparison Between USP 60, USP 61, And USP 62
Learn about the U.S. Pharmacopeia and the differences between USP 60, USP 61, and USP 62 standards.
Bioburden and USP 60
Learn all about the methods covered in USP 60 and how these relate to bioburden testing.
Bioburden Testing For Medical Devices
What is bioburden testing? Why is bioburden testing necessary? Learn more about these questions, about bioburden testing methods and more.
Bioburden and USP 62
USP 62 covers tests for specific microorganisms. Learn about the procedures, tests and methods covered in USP 62 and how these relate to bioburden testing.
6 Key Soil Markers For Testing Device Cleanliness
Looking to determine if your reusable device’s cleaning protocol is robust enough? Use these 6 soil markers to test the cleanliness of your devices.
Medical Device Packaging Materials And Considerations For Sterilization Processes
Learn more about packaging options, packaging material types, and additional packaging considerations for your device.
5 Calculations You Need To Know To Determine EO Residuals For Your Device
These are the five calculations you should know related to EO and ECH toxicity limits your product needs to meet.
Overkill Method For Sterilization Validation
Learn all about the overkill method and why it is better for you to use it for sterilization validation process of your products.
Top 5 Of Things You Need To Know About Extraction Techniques For EO Residuals
If you are in need of EO Residual Testing, these are five things you should know about extraction techniques for EO residuals testing.
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