Paperwork, raw materials for manufacturing the product, tools, and equipment must be successfully transferred to the cleanroom. The goal of a materials transfer program is to keep contamination from the outside world from entering the cleanroom. Benefits of investing effort in a materials transfer program include higher quality product, lower costs, and an enhanced competitive position.
Some materials are double bagged, some single bagged, and may be stored for long periods of time in cardboard boxes in warehouse environments. Other materials such as tools may not be bagged at all and are likely to have come from an uncontrolled environment.
Contamination control protocols for material transfer are vital. Materials brought into the cleanroom that have not been cleaned effectively during the transfer process are an immense source of particulate and thin film contamination. Inadequately cleaned materials can be a huge source of spore forming bacteria, extremely resistant bugs that are very difficult to eradicate from a cleanroom environment. Manufacturers of all critical product should be concerned about the impact of biological contamination, not just those producing medical devices and pharmaceuticals. Many people are not aware that biological contamination will dramatically affect particulate counts which are required in every cleanroom industry. At the same time, sterility is not enough; “dead dirt” can wreck havoc with critical devices. Water soluble lubricants and near-neutral pH processes can provide water, warmth, and nutrients, a favourable environment for biological contamination.
From: Keeping Product Clean In and Out of the Cleanroom — (Part 1) The Interface
