Kurt McCauley

May 29, 2024 | bioprocessonline.com | Kurt McCauley

By Kurt McCauley, R & D Lab Manager The objective of a sterilization process is to kill the naturally occurring microbial contamination (bioburden) present in the product. Two common sterilization methods used are the Bioburden Based Sterilization (BBS) method and the Overkill Sterilization (OS) method. Here we will explore Product D-Value Studies, which are critical to your company developing a Sterilization Process.

Mar 15, 2024 | pharmaceuticalonline.com | Kamil Shaik |Guriqbal Singh |Kurt McCauley

Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world. Quality Control In Medical Writing: What It Means And Why It MattersIn effective organizations completing projects smoothly, learn why quality control is not an “I email you a document and you review it” task meant to be completed quickly.

Jun 6, 2023 | meddeviceonline.com | Kurt McCauley

By Kurt McCauley Steam sterilization of liquid products, especially large volumes, can take significantly longer than sterilizing dry or porous materials. This additional thermal insult, much of which occurs during the come-down phase, can chemically alter the product. Many companies have moved away from these excessive cycles due to this. However, many liquid products, including water, are not compromised by longer sterilization cycles, and as such, longer cycles are still in use.