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.
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”.
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.
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.
Books, Articles and Monographs
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.
For pharmaceuticals that cannot be given terminal sterilization at the end of production, the alternative of aseptic fill is available, requiring sterile materials placed in sterile containers in a cleanroom.
Thorough cleaning is crucial to aseptic fill operations, but it must be validated as well as monitored. This article has presented some sampling, extraction and analysis options that have proved successful in their application.
What makes the difference in wiper products is the amount of surface contamination they leave behind after use.
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.
As recently pointed out in this magazine, it only takes about 25 V of static electricity to functionally destroy an MR head.
Electrostatic charge build-up in cleanrooms can produce higher levels of surface contamination, electrostatic discharges that damage integrated circuits, MR and GMR heads, and electromagnetic pulses that can disrupt robotics.
Using mechanical energy and a surfactant solution to remove wiper particles can approximate actual conditions of use.