Handling, Storage, Distribution

Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product.  21 CFR 820 breaks down the requirements for each of these processes.  A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product.  These…

Friday Facts – Deviations

A deviation is described as a departure from an approved procedure or specification.  It represents a failure to meet requirements in the manufacture of product, in-process specifications or production requirements.  There is a difference between a planned or unplanned deviation.  Planned deviations have been approved before execution, whereas unplanned deviations (also called incidents) are technically…

Friday Facts – Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

Chemical Indicators Benefits

Biological Indicators have proven themselves to be extremely valuable tools for verifying sterilization conditions within sterilization cycles over the several decades in which they have been utilized. As many would say, “The bugs don’t lie”.  And, what better way to test for the destruction of microorganisms that to test the cycle with highly resistant biological…

Positive BI in your VHP Process? Now what?

A customer recently contacted us detailing how positive biological indicators (BIs) were popping up in their Vapor Hydrogen Peroxide (VHP) process. The customer explained that they had no trouble with a square shaped room but when the configuration of the room changed (to an L-shaped room for example), they would experience unexpected positives. The positive…