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Pharmaceutical & Biologics Packaging Testing

Pharmaceutical & Biologics Packaging Testing

When a compound is complete and ready for packaging and shipping, the processes of compliance and due diligence are still extremely relevant. Testing using a range of methods is necessary to ensure that products are not contaminated or compromised. A few primary forms of testing are necessary when packaging, processing, and transporting pharmaceuticals or biologics. These include E&L testing, container closure integrity, and shipping distribution testing. What Is E&L Testing? Extractables and leachables (E&L) are types of materials that can migrate from a packaging system component (i.e., container or closure system) and can contaminate a final product. Comprehensive testing is...

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E-Beam Sterilization Technology: Key Facts | Advanced Sterilization

E-Beam Sterilization Technology: Key Facts | Advanced Sterilization

E-Beam Sterilization Technology: Key Facts As technology and science progress, sterilization is advancing along with it. Electron beam (or e-beam) processing has evolved significantly since first developed in the 1950s. Many improvements have been made in this time, but one thing remains the same - e-beam sterilization is undeniably the most advanced sterilization method on the market, and MediZap is proud to offer this technology to our clients.  But, what exactly is it, and why is it the most advanced method? Let's take a closer look.  What is E-Beam Sterilization? E-beam processing is the most progressive technologies on the market....

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SiO2 Scales Manufacturing Of COVID-19 Vaccine Vials | MediZap

SiO2 Scales Manufacturing Of COVID-19 Vaccine Vials | MediZap

We are proud to be a partner of SiO2, a materials science company that is continuously introducing breakthrough disruptive technology. SiO2 has deep partnerships with leading research universities such as the University of California, the University of Chicago, MIT, and CalTech. With COVID-19 still prevalent worldwide, and the need for a vaccine and effective distribution more critical than ever, SiO2 found themselves ahead of schedule on their manufacturing of hybrid vials to use for the COVID-19 vaccine. Why Hybrid Vials? Leaders in the scientific community around the world have flagged concerns about the distribution of possible COVID-19 vaccines. The primary...

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483 Observations and Warnings - What’s The Difference? | MediZap

483 Observations and Warnings - What’s The Difference? | MediZap

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of pharmaceuticals, biologics, and much more. It is one of the leading regulatory and compliance agencies that a compounding pharmacy will work alongside while developing products. The FDA is responsible for routine inspections, which many manufacturers know all too well! But, three little numbers - 483 - can come from the inspections, and they mean serious business. But there are two different types of terms associated with these numbers: "Observations" and "Warning Letters." Today, we'll look at the difference between...

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