Recent cases of the super-bugs in Australia, the US, UK and Asia have caused major issues for food processing companies; including public recalls and lawsuits.
What makes the difference in wiper products is the amount of surface contamination they leave behind after use.
SEMI Document E78-0998 describes the elements of a static control program: these include grounding, static dissipative materials and air ionization. These elements are supported by personnel training and regular program audits.
As recently pointed out in this magazine, it only takes about 25 V of static electricity to functionally destroy an MR head.
In many instances, it is no longer adequate to show that a pharmaceutical or medical device is sterile, but one also must demonstrate that it is “pyrogen free.”
The manner in which pharmaceutical isolators, compounding aseptic isolators and bio-safety cabinets are used dictate the somewhat varied approach to cleaning and where applicable, disinfection practices.
Searching for nothing would seem to be an absolute waste of time — unless you are responsible for cleaning validation. In that case, success is deliciously ironic since you can say, “I found nothing and that’s good news”.
During the manufacture of pharmaceutical and biotechnology products, care must be taken to ensure that these products are not contaminated either by the previous manufacturing run or by the cleaning process itself.
Books, Articles and Monographs
Compounding Aseptic Isolators and Class II biological safety cabinets are used in hospital pharmacies and other dispensing facilities to formulate (i.e. “compound”) individual prescriptions for patient care.