Articles

Aseptic Fill vs. Terminal Sterilization | Newsletter | Issue 06 | 2021

Aseptic Fill vs. Terminal Sterilization | Newsletter | Issue 06 | 2021

Aseptic pharmaceutical manufacturing requires that all sterile drug products be filled into clean and hygienic containers, then sealed using primary and secondary packaging. However, this practice, though widely used, cannot obtain the Sterility Assurance Level, or SAL of 10-6. This has required new methods of sterilization to be brought to the market. Why Terminal Sterilization Terminal sterilization can provide this proper Sterility Assurance Level. This sterilization process has products sterilized in their final container or packaging, which permits the measurement and evaluation of quantifiable microbial lethality. It is an essential process as it ensures the parenteral/injectable drug products remain sterile and without the...

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Partnership with Industry Leader, SIO2: Innovator Of COVID-19 Vaccine Vials | Newsletter | Issue 05 | 2021

Partnership with Industry Leader, SIO2: Innovator Of COVID-19 Vaccine Vials | Newsletter | Issue 05 | 2021

From manufacturing a better vial to carry COVID-19 vaccines in, to devising a biodegradable packaging, SIO2 is creating a better world by rethinking the ways products are created. SIO2 provides pre-validated, electronic-beam (E-beam) capable solutions that allows compounding pharmacies to reduce research and development time and deliver the safest product on the market.  With the global pandemic and the corresponding release of vaccines worldwide, the shortage of glass vials has threatened to be a major problem. SIO2 Materials Science uses plasma technology, creating a tiny, minuscule layer of medical-grade glass inside plastic vials. An incredible, and needed, innovation as vaccine roll-out has progressed...

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Quality by Design - Regulatory Compliance in Pharmaceuticals | Newsletter | Issue 05 | 2021

Quality by Design - Regulatory Compliance in Pharmaceuticals | Newsletter | Issue 05 | 2021

In the pharmaceutical industry, there has always been significant intent to produce drug products with enhanced quality that meets all regulatory standards and requirements. The consistent production of drug products that maintain their desired quality traits has always been a challenge.  Time and again, regulations have been put in place for pharmaceutical products in order to accomplish the desired therapeutic benefits to the patient community. Yet, in spite of all the massive efforts, news of recalls, rejects, and failures ostensibly due to their quality and manufacturing standards not meeting the criteria that were set. The main factor behind such recurrent...

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Packaging Closures for Pharmaceutical Products | Newsletter | Issue 05 | 2021

Packaging Closures for Pharmaceutical Products | Newsletter | Issue 05 | 2021

Closures on a container-closure system are a critical part of the packaging for a sterile product. These closures maintain the sterility of the pharmaceuticals and prevent any contamination.  What Are Container-Closure Systems?  Parenteral products are formulated and packaged to both be sterile and maintain their sterility during terminal sterilization processes. A crucial part of package design lies in their container-closure mechanism, which functions to keep the contents sterile and prevent any contamination after a needle is inserted. An example of this is enabling resealing of the vial once the needle is withdrawn. Manufacturers of these products must have confidence in...

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