Posts by Derek Prince
Call for Collaboration: Terminal Sterilization for Aseptic Manufactured Products Based on Bioburden, Sterilization Temperature F0 to accomplish a PNSU ≥ 10-6
Liquid filled products manufactured aseptically are usually assumed to be inappropriate for steam sterilization due to possible heat liability of the finished product. However, these products must be sterile. Data is needed to verify that new approaches in the current USP <1229.2> can provide due diligence to justify standard practices or to supplement aseptic manufacturing…
Read MoreThe Importance of Clean Glass Containers and Stoppers for Pharmaceutical Applications
by Daniel Prince FDA has published guidance for industry to assure patient safety public that glass containers such as vials, beakers and rubber stoppers be clean. Gibraltar provides vials that meet these requirements and is an outsourcing destination for the washing of containers and closures with USP/EP Water for Injection (WFI) as well as being…
Read MoreUnderstanding how the sterilization temperature and sterilization exposure time are developed
By Daniel Prince Commercially prepared bacterial spores known as biological indicators (BI) are the preeminent tools used to verify and validate that items subjected to steam or dry heat sterilization are sterile to a very high level of probability. This is because they are used as standards to allow measurements of multiple replicates that are…
Read MorePrince Sterilization Services LLC Spins Off From Gibraltar Laboratories
FAIRFIELD, N.J. — Operating under Gibraltar Laboratories since 2015, the sterilization services division has successfully spun-off into its own entity named Prince Sterilization Services, LLC. The decision to formally separate the companies comes from the early success and plans to scale the sterilization business. Since its inception in 2015, Prince has entered into business contracts…
Read MoreSome of the Different Types of Sterilization Methods and Their Advantages
In our industry companies it’s important to have a variety of sterilization methods in order to accommodate a broad range of products and equipment including different devices, media, medical instruments and products.
In the medical and health care industries, there are few things more important than proper sterilization. There is a proper way to sterilize for each element of the pharmaceutical and health care industries. This is true for medical equipment, medical devices and pharmaceutical drugs, implants and injectable vaccinations.
Read MoreDifference Between Moist Heat Sterilization & Dry Heat Sterilization
There are different processes available through which you can sterilize different materials. To be able to choose the right sterilization process, one must know what method suits the material in question more. You can’t sterilize materials that are heat sensitive with autoclaves. Similarly, you can’t use filter sterilization with chemicals having a greater microbe size when compared with the membrane pores of the filter.
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