Japanese method for workplace organization. The five S’s are seiri, seiton, seiso, seiketsu, and shitsuke or sorting, straightening, shining, standardizing, and sustaining. The picture shows a 5s organized tool system. Every tool has it’s place and if it is not there it is obvious.
A controlled document that contains validated instructions on how to perform and document the manufacture of a product.
Can also be referenced as Microbial Limit Testing. Most often it is referring to the number of bacteria living on a surface or in a substance. Photo Credit
Corrective Action Preventative Action – This is a process for correcting and preventing errors during a procedure. A corrective action may be implemented as the result of a non conformance or deviation. The corrective action may be a document change, training, or any documented activity that is designed to stop the re-occurrence of the deviation. … Read more
A technique using various sized columns and substrates to perform purification by Size Exclusion Chromatography (SEC), Cation Exchange or Affinity Chromatography. The photo shows a Protein A 5ml column that is showing signs of channeling. The darker brown colored sample can be seen seeping unevenly through the resin. When you have a channeling column you … Read more
Clean in Place – Cleaning of equipment that may be too large to move and is cleaned with a CIP skid that pipes in the required cleaning solutions and water.
Special membrane filters with a determined molecular cutoff are used to separate out unwanted water and larger molecules while retaining the desired smaller molecules to create a more concentrated and pure solution.
Computer System Validation
Enzyme-linked immunosorbent assay An example of an analytic assay that demonstrates a color change to identify an antibody reaction to a substance. Referred to as a wet lab technique.
Equipment Qualification – Validation procedure for qualifying equipment used for GMP production.