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Contract manufacturing news and regulatory testing updates about cleaning validations, preservative efficacy testing, research and development activities, EtO residuals and microbiology testing, and more!
Stay up to date on the challenges and regulations in biopharmaceutical, contract manufacturing, laboratory testing and R&D process development.
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. Product and…
USP 81 Turbidimetric Testing For Antimicrobial Medical Products
Learn about turbidimetric testing and zone of inhibition testing for agents, materials, and coatings on or within medical devices or products.
Top 4 Cleaning Validation Challenges In 2022 For Reusable Devices
Learn about the top challenges medical device companies face when performing cleaning validations for reusable medical devices.
How To Perform Cleaning Validations For Reusable Devices
Learn calculations and most probable number equations for alternative method equivalency testing for microbiological testing and medical product testing.
Qualitative Equivalency Methods For Microbiological Testing
Learn calculations and most probable number equations for alternative method equivalency testing for microbiological testing and medical product testing.
Cleaning Validations Vs. Sterilization Validations For Medical Devices
Learn the differences between cleaning validations and sterilization validations for regulatory testing of your medical devices.
Medical Device Corrosion Resistance
Learn about corrosion resistance for reusable medical devices exposed to gamma radiation and ethylene oxide sterilization processes.
Spaulding Classification Guidelines For Reusable Devices
Find here Spaulding classification guidelines for reusable medical devices regarding cleaning validations and sterilization validations.
USP 81 Zone of Inhibition Testing For Antimicrobial Medical Products
Learn about the USP 81 zone of inhibition test for antimicrobial agents, materials, and coatings on or within medical products and cylinder-plate assays.
What Are Method Suitability Testing & Method Equivalency Testing?
Learn about method suitability and equivalency testing requirements for new medical devices, products, and alternative test methods.
Save Money With A Combined Microbial Aerosol Challenge With Bioburden Test
Learn how to combine microbial aerosol challenge with bioburden testing for parenteral products, combination products, and medical devices.
Top Nonsterile Manufacturing Processes
Learn about environmental controls, pharmaceutical products, and the top nonsterile manufacturing processes for medical devices and products.
Preservative Efficacy and Preservative Challenge Testing Are The Same?
Learn about preservative efficacy testing, its’ many names, and its’ uses for medical devices, cosmetics, and parenteral products.
Microbial Aerosol Challenge Testing Vs. Bacterial Endotoxin Testing
Learn the differences between microbial aerosol challenge testing and bacterial endotoxin testing for combination and parenteral products.
Preservative Challenge Testing Vs. Bacterial Endotoxin Testing
Learn the differences between preservative challenge testing and bacterial endotoxin testing for combination products, cosmetics, and parenteral products.
What are the top challenges with aseptic filling and finishing?
Learn the challenges that must be overcome to fill your medical devices or products safely, accurately and ensuring regulatory compliance.
What is aseptic fill-finish manufacturing?
Learn what aseptic filling and finishing manufacturing processes are and how to contribute to aseptic filling success.
Why is sterile fill and finish outsourcing so popular?
Learn why more cosmetic, medical device, and pharmaceutical companies are outsourcing the fill and finish aspect of their products.
Secret Ways To Save Money On Preclinical Animal Studies
Learn about substance administration for preclinical animal studies and how to save money on aseptic parenteral product filling for these studies.
Does the FDA Regulate Cosmetic Products?
Learn what is considered a cosmetic product, the extent to which the FDA regulates cosmetics, and who is responsible for their safety.
What Are The Minimum Fill Requirements For Cosmetic Products?
Learn about the minimum filling requirements for creams, gels, lotions, ointments, pastes, powders, aerosols, foams, and sprays.
What is the Magnusson & Kligman Test For Sensitization?
Learn about the Magnusson & Kligman guinea pig maximization test used as FDA’s gold standard for regulatory sensitization assessments.
Sensitization Vs. Irritation Vs. Cytotoxicity Testing
Learn all about the differences between sensitization, irritation, and cytotoxicity testing for medical devices and implants.
Sensitivities Testing Alternatives In Mice For Medical Devices & Implants
Learn about the sensitization test alternatives in mice for your medical device or implant’s regulatory requirements.
Sensitivities Testing Alternatives In Guinea Pigs For Medical Devices & Implants
Learn about the sensitization test alternatives in guinea pigs for your medical device or implant’s regulatory requirements.
Preservative Efficacy Testing Vs. Stability Testing
Learn about the differences between preservative efficacy and stability testing for medical devices, cosmetics, and parenteral products.
Functionality Testing Vs. Cytotoxicity Testing For Injectables
Learn about functionality and physiochemical testing, and both testing requirements for medical-grade plastics used in injectables.
Functionality Testing Vs. Physiochemical Testing For Medical-Grade Plastics
Learn about functionality and physiochemical, and both testing requirements for medical-grade plastics used in injectables.
Excipient Cytotoxicity Testing For Cosmetic Or Parenteral Products
Learn about medical-grade excipients, toxicity data, and cytotoxicity testing regulatory requirements for your cosmetic and parenteral products.
Cytotoxicity Testing For Plastics Used In Injectables
Learn about the types of plastic used in injectable product-packaging systems and the cytotoxicity requirements for packaging components.
Physiochemical Testing For Plastics Used In Injectables
Learn about the types of plastic components used in injectable products and the physiochemical requirements for packaging components.
Functionality Testing For Plastics Used In Injectable & Implantable Devices
Learn about the types of plastic used in injectable products and functionality testing requirements for these packaging components.
Preservative Efficacy Testing And Cytotoxicity Testing Principles And Differences
Learn principles and differences between preservative efficacy and cytotoxicity testing for medical devices, cosmetics, and parenteral products.
Preservative Efficacy Testing Vs. Ethylene Oxide Residuals Testing
Learn about the differences between preservative efficacy and ethylene oxide residuals testing for medical devices and cosmetics or parenteral products.
Preservative Efficacy Testing And Package Integrity Testing Principles And Differences
Learn principles and differences between preservative efficacy and package integrity testing for medical devices, cosmetics, and parenteral products.
Preservative Efficacy Testing Vs. Sterility Testing
Learn about the differences between preservative efficacy and sterility testing for medical devices, cosmetics, and parenteral products.
How To Select Water For Use In Cosmetic & Pharmaceutical Products
Learn about the types of water for use in cosmetic and pharmaceutical products, what is water for injection, hemodialysis and sterile water.
Microbiology Testing Vs. Microbial Immersion Challenge Testing
Learn about the differences between microbiology testing and microbial immersion challenge testing for medical devices and parenteral products.
Preservative Efficacy Testing Vs. Microbiology Testing
Learn about the differences between preservative efficacy and microbiology testing for medical devices, cosmetics, and parenteral products.
Preservative Efficacy Testing Vs. Bioburden Testing
Learn about the differences between preservative efficacy and bioburden testing for medical devices, cosmetics, and parenteral products.
What Is Sterilization In Place?
Learn about sterilization in place and if these techniques are needed to manufacture your medical devices or sterile medical products.
Top 5 Seal Quality Tests For Sterile Packaging
Learn which are the best tests to perform to prove your sterile product packaging seals meet regulatory standards.
Preservative Challenge Testing Vs. Disinfectant Challenge Testing
Learn about the differences between preservative and disinfectant challenge testing for medical devices, cosmetics, and parenteral products.
Preservative Challenge Testing Vs. Microbial Immersion Challenge Testing
Learn the differences between preservative challenge testing and microbial immersion challenge testing for cosmetics, and parenteral products.
Preservative Challenge Testing Vs. Microbial Aerosol Challenge
Learn about the differences between preservative challenge testing and microbial aerosol challenge for cosmetics and parenteral products.
Sterile Product Storage & Transportation Mistakes To Avoid For Start-ups
Learn the top storage and transportation mistakes to avoid for start-ups to keep your medical devices and products safe for patient use.
Microbial Aerosol Challenge Vs. Disinfectant Challenge Testing
Learn about the differences between microbial aerosol challenge and disinfectant challenge testing for parenteral product packaging and manufacturing.
Sterilization By Filtration Vs. Depyrogenation By Filtration For Parenteral Products
Learn about sterile filtration, depyrogenation, and the appropriate filters to use to remove endotoxins from parenteral and biologic products.
How To Perform USP 51 Antimicrobial Testing
Learn how to perform USP 51 antimicrobial testing, what types of product need it, and how it relates to FDA testing for parenteral products.
Top FDA-Approved Sterile Product Formulation And Filling Environments
Learn the top FDA-approved sterile product formulation and filling environments used for parenteral product and cosmetic filling processes.
How To Perform Microbial Enumeration Testing For Dietary Supplements
Learn what USP 2021 microbiological tests quantify microbes and ensure that your dietary or nutritional supplements meet regulatory requirements.
How To Determine Parenteral Product Viscosities For Newtonian Fluids
Learn how to calculate parenteral product viscosity for a Newtonian fluid in preparation for pre-filled syringe and vial packaging options.
How To Determine Parenteral Product Viscosities For Non-Newtonian Fluids
Learn how to calculate parenteral product viscosity for a non-Newtonian fluid in preparation for pre-filled syringe and vial packaging options.
Calculating Apparent Viscosity Vs. Absolute Viscosity For Parenteral Products
Learn how to calculate apparent viscosity for a non-Newtonian fluid and absolute viscosity for Newtonian fluids for parenteral cosmetic products.
Contract Manufacturing For Outsourcing Pharmaceutical Production
Learn about pharmaceutical manufacturing and the benefits and risks of using contract manufacturing for producing your pharmaceutical products.
Contract Manufacturing For Outsourcing Cosmetics & Beauty Products
Learn about outsourcing manufacturing the benefits and risks in using contract manufacturing for producing your cosmetic or beauty products.
Contract Manufacturing For Pharmaceutical Vs. Cosmetic Production
Learn what contract manufacturing is and the differences between using a cmo for pharmaceuticals and cosmetics product production.
Top 10 Contract Manufacturing Mistakes Medical Device Startups Should Avoid
Learn the benefits of contract manufacturing and how to avoid mistakes when outsourcing your medical device manufacturing.
Differences Between Rolling Ball Viscometers And Rotational Rheology
Learn the differences between capillary viscometers and rotational rheology, and the benefits of each other for parenteral product viscosity calculations.
Benefits Of Rotational Rheology Vs. Capillary Viscometers
Learn the differences between capillary viscometers and rotational rheology, and the benefits of each other for parenteral product viscosity calculations.
Microbiological Testing For Nonsterile Dietary Supplements
Learn what USP 2023 microbiological tests are needed to meet your dietary or nutritional supplement’s regulatory requirements.
What Is The Microbiology Of Air In Regulatory Manufacturing Environments?
Learn about the microbiology of the air, its importance and which airborne microbes can contaminate GMP manufacturing environments.
Differences Between Capillary And Rolling Ball Viscometers
Learn about capillary and rolling ball viscometers methods, and the differences between them for parenteral product viscosity calculations.
Top 3 Delivery Options For Viscous Parenteral Products
Learn about auto-injectors technology, large-volume injectors and needle-free delivery, the top delivery options for viscous parenteral products.
Top Five Microorganism Contaminants
Learn about the microbiology of water and the top microbial contaminants that can contaminate your medical devices and products during manufacturing.
How To Perform Disinfectant Challenge Testing For Cleaning Validations
Learn how to perform USP 1072 disinfectant challenge testing for cleaning validations to ensure your medical device or product meets FDA guidelines.
How To Perform Cleaning Validations For Glassware
Learn how to perform glassware cleaning validations in order to meet USP 1051 regulatory requirements for your parenteral or cosmetic product.
How To Test For Parenteral Product Viscosity Using The Rolling Ball Method
Learn about newtonian viscosity and the rolling ball method, and how to calculate parenteral product viscosity using USP 913 rolling ball method.
How To Calculate Parenteral Product Viscosity Using The Rotational Rheometer Method
Learn how to calculate parenteral product viscosity using the rotational rheometer methods from USP 912, and the differences between one and another.
How To Calculate Parenteral Product Viscosity Using The Capillary Viscometer Method
Learn how to calculate parenteral product viscosity using the USP 911 capillary viscometer methods: suspended-level method and simple u-tube method.
How To Determine A Disinfectant’s Activity For Cleaning Validations
Learn how to determine the activity of a disinfectant and select an appropriate disinfectant for cleaning validations of manufacturing environments.
Top Three Cleaning Processes That Must Be Validated
Learn what cleaning validation is and the top three cleaning processes that must be validated to keep your medical device or medical product sterile.
Water Sampling Methods For Environmental Monitoring Of Parenteral Products
Learn about water sampling and when to use these methods for environmental monitoring of your parenteral products.
Sterilization Vs. Sanitization Vs. Disinfection
Learn the differences between sterilization, sanitization and disinfection, and how they relate to your medical devices and products.
Top 4 Filters For Parenteral Product Sterilization
Learn about sterilization by filtration, which filters to use and what are the primary filter types used to sterilize your parenteral products.
Parametric Release Programs vs. Sterility Testing For Medical Devices And Products
Learn how parametric release programs compare to sterility testing and which option is best to meet regulatory requirements for medical devices or products.
Top 25 Aseptic Processes For Your Parenteral Product
Learn about aseptic processes and the top 25 protocols to validate to keep aseptic processes from microbial contamination for your parenteral products.
Aseptic vs. Non-Sterile Processes For Medical Devices & Products
Learn the differences between aseptic and non-aseptic processes and which is the best one to use for your medical device or product.
Bubble Emission Vs. Dye Penetration Package Leak Testing
Learn about bubble emission testing and dye penetration test methods and their importance in ensuring your medical device’s packaging integrity.
Dye Penetration Testing Methods For Porous Vs. Nonporous Packaging Materials
Learn about dye penetration testing methods, what are they useful for, and how they differ for porous and nonporous packaging materials.
Dye Penetration Testing Methods For Nonporous Packaging Materials
Learn about dye penetration testing for nonporous packaging materials, and its importance in ensuring your medical device’s packaging integrity.
Bioburden Vs. Pyrogens In Biocompatibility Testing For Cosmetics
Learn about the differences between bioburden and pyrogenicity testing, and how they relate to biocompatibility testing for your cosmetic products.
How To Overcome Filling Challenges With Viscous Parenteral Products
Learn about the challenges that companies face when manufacturing viscous medical and cosmetic products and how to overcome filling them.
8 Factors To Consider When Designing A Microbial Challenge Test
Learn how to design microbial challenge testing and how these tests are used to verify your medical device or product package integrity.
How To Choose The Best Sterile Fill Method For Parenteral Products
Learn about sterile filling and its importance, and how to choose the best method to fill vials and syringes with your parenteral or cosmetic products.
Requirements You Must Meet For FDA-Approved Medical Face Masks
Learn about the ASTM F2100 standards for medical face mask materials and what requirements you must meet for materials in facial mask manufacturing.
How To Perform Aseptic Media Fill Simulations
Learn how to set up and run media fill simulations for aseptic process validations, when should it be performed and its importance for aseptic products.
Stability Testing vs. Package Integrity Testing
Learn the differences between stability and package integrity testing and how these regulatory tests relate to your medical devices and products.
Are you looking for better medical device contract testing and manufacturing services?
We specialize in regulatory tests for medical, injectable, topical, & cosmetic products.
We also provide syringe & vial filling, and solve regulatory testing challenges for unique products that meet FDA requirements.
Our regulatory tests include:
- Preservative efficacy testing
- Microbial aerosol challenge testing
- Particulate matter testing
- Accelerated aging testing
- Bioburden, endotoxin, and cytotoxicity testing
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