Articles

SteriTek Dallas Grand Opening and MediZap Exclusive Partnership | Newsletter | Issue 06 | 2021

SteriTek Dallas Grand Opening and MediZap Exclusive Partnership | Newsletter | Issue 06 | 2021

We partner exclusively with SteriTek to create the first and only e-beam terminal sterilization solution with unique value-driving benefits of dedicated line capacity, 48-hour / 24-hour turnaround, complete validation services, and cold chain processing. SteriTek is the San Francisco Bay Area and Silicon Valley’s leader in E-beam sterilization and X-ray irradiation for complex products and sensitive materials. With a name that has a proven track record, SteriTek is also ISO 11137 and ISO 13485 certified, FDA registered, DEA registered. SteriTek Is Growing Because of SteriTek’s expansive track record in the industry and its leadership in the field, SteriTek is growing...

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cGMP Controlled Raw Materials Best Practices | Newsletter | Issue 06 | 2021

cGMP Controlled Raw Materials Best Practices | Newsletter | Issue 06 | 2021

Recently, the FDA has been providing much heavier guidance - and more Form 483s for objectionable conditions - with respect to the regulatory requirements of cGMP controlled raw materials. As a result, they are also providing more information on overall best practices for these materials. It is critical for those working in the pharmaceutical industry to understand the ever-changing requirements and best practices pertaining to cGMP. Regulations Guiding cGMP Controlled Raw Material are in FDA regulations 21 CFR 211.84 Subpart E: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures Overview of the Regulation Section D of the FDA...

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Form Meets Function In Pharmaceutical Packaging | Newsletter | Issue 06 | 2021

Form Meets Function In Pharmaceutical Packaging | Newsletter | Issue 06 | 2021

The pharmaceutical packaging market experiences annual growth and advancement of products by at least 5% per year with a market value of over $20 billion a year. Constant innovations in the pharmaceuticals themselves have a direct impact on the packaging. These include features such as blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap-off ampoules, unit note two-in-one pre filled vial design, prefilled syringes and child-resistant packs. There are specific packaging functions and categories of packaging that are critical to development, which we’ll outline in this article. Functions of Pharmaceutical Packaging Packaging functions...

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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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