"How do I know if I have AMC?" Hopefully, you are not suspicious of airborne molecular contamination because of poor yield or customer complaints
Sterilizing and disinfection are not the same as cleaning. A device may be sterile. A sterile device may be left in an airtight container and remain sterile for years, perhaps decades. However, if the device is not clean, it can still negatively impact the host.
Specifically, the VDmax methods are for selected sterilization doses of 25 kGy and 15 kGy. The method for 25 kGy is applicable to products having an average bioburden less than or equal to 1,000 CFUs (colony forming units) per device. The method for 15 kGy is applicable to products having an average bioburden less than or equal to 1.5 CFUs per device.
Most managers have achieved their positions because their supervisors recognized them for their high energy, their ability to solve problems, and their “can-do” attitudes. Unfortunately, none of those qualities are guarantees that they will be very good at supervising other people.
Do you get the little, unimportant things completed first because they are easy and their completion makes you feel good? Or, do you focus your efforts on the things that will really make a difference for your organization and your life?
I've developed a mantra of sorts over the years that talks about what people want from work. I've added and subtracted items from the list, and I've explained them in different ways over the years, but fundamentally, people want:
While microbial-induced corrosion (MIC) does not produce a unique type of corrosion, understanding the dynamics of microbes is a key to avoiding a problem. Microbes thrive under the same conditions as present in many aqueous cleaning systems.
Airborne Molecular Contamination (AMC) can be a "silent poisoner" of your process and product. AMC is any unwanted organic or inorganic molecule that is carried by the air to the surface of the product.
We often take measurements. We want to know how much of something we have or donâ€™t have. Itâ€™s what we technologists do.
There can be no mistaking that we are entering a new era in the pharmaceutical and biotech marketplace.
Cost reduction is no longer just a part of the overall continuous program; it is the critical requirement for survival.
An environmental sampling process that employs technology, ensures cleanroom efficiency and security.
Perhaps the most commonly used metrics to compare consumables are sorbency and cleanliness. Sorbency, or the ability of a textile product to wick and hold liquid, can be a useful metric for cleanroom applications that may involve large liquid spills.