Follow relevant site protocol (procedures for safety, contamination, etc.) and wear cleanroom gloves...
Clean Manufacturing Tutorial: "Abrasion Basics for Contamination Control". To minimize particles, understand abrasion.
If you had to describe the overriding characteristic of sterile environments in one word, that word might be “uncompromising”. This word conveys the sense that sterility requirements in these
Using mechanical energy and a surfactant solution to remove wiper particles can approximate actual conditions of use.
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
As recently pointed out in this magazine, it only takes about 25 V of static electricity to functionally destroy an MR head.
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 c
What makes the difference in wiper products is the amount of surface contamination they leave behind after use.
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 pro
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 container
Cleaning validation for production equipment at pharmaceutical facilities is an evaluation examination that is conducted to prevent cross-contamination from previously processed products and
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
Excess electrical charge plays a significant role in contamination. It can cause an energetic discharge (“electrostatic discharge” or “ESD”) that causes damage, and it can attract particles,
Compounding Aseptic Isolators and Class II biological safety cabinets are used in hospital pharmacies and other ...
Swabbing Guide. Swab Requirements: • Minimal background interference. • High recovery rate. • Low particle generation. Where to..
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, disinfectio
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.” This article provides practic
Who knew that there was so much technology associated with such a small piece of cloth?
Sistema de mopping modular, con componentes intercambiables y compatibles, permite la adaptación para limpieza desinfección en cualquier tipo de zonas estériles o no estériles. Sistema de pre
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.
From wiping residues on hard surfaces to applying cleaning solutions, wipers perform a variety of tasks that help maintain the cleanliness levels desired in a given cleanroom environment. Thi
Searching for nothing would seem to be an absolute waste of time — unless you are responsible for cleaning validation.
Pharma and Biotech manufacturing facilities face ever more demanding regulatory and productivity challenges. These challenges are made more acute as products come off patent protection.