Are you aware that incorrect materials transfer could pose one of the biggest potential sources of contamination within a clean room ? How many of you can say that while performing the transfer of materials into the clean room environment you are fully aware of your actions ,practices , and methods?
KEEPTHE PRODUCT CLEAN
Paper work ,raw materials for manufacturing the product, tools ,and equipment must be successfully transferred to the clean room. The goal of a materials transfer program is to keep contamination fromthe outside world from entering the clean room. 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 maybe stored for long periods of time in cardboard boxes in warehouse environments. Other materials such as tools may not be bagged a tall and are likely to have come from an uncontrolled environment.
Contamination control protocols for material transfer are vital .Materials brought into the clean room that have not been cleaned effectively during the transfer process are an immense source of particulate and thin film contamination. In adequately cleaned materials can be a huge source of spore forming bacteria ,extremely resistant bugs that are very difficult to eradicate from a clean room environment. Manufacturers of all critical product shouldbe 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 clean room 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 .
ROOM DESIGN
Materials transfer maybe through a hatch leading directly from an unmonitored manufacturing area to a clean room or a transfer hatch between two clean rooms . Is this an optimal arrangementyou’re your process ? With a hatch ,employees are tempted to stand on either side ,engaging in lively conversation, even enjoying their morning coffee .Such behaviour increases the likelihood of contamination .For new construction, consider a material transfer room.
Material transfer rooms should function like gowning rooms with a ‘clean’ side and a‘ dirty’ side .Very often a line of tape separates the seareas .In practice , a “line in the sand,” does not keep personnel from crossing over to the ‘clean’ side inadequately gowned or in street clothes. Too often we see issues with high levels of contamination on the ‘clean’ side of the material transfer room where the root cause is the ‘dirty’ side .
Rather than as trip of tape , consider an “étagère,” a physical barrier such as rack in gorcabinets that allows expedited transfer of materials while discouraging personnel movement to the clean side. If rack in gor cabinets are on wheels, it is simple to move them to allow access of large equipment or bulky materials. Of course, because such barriers are not physically distinct rooms, the dirty side of the transfer room should also be fairly clean.
CONVENIENCE
Cleaning materials within the transfer area must be convenient. A wipe down station should always be visible in the material transfer room with allow-residue cleaning agent such as isopropyl alcohol (IPA)and low-lint wipes readily accessible. If there is a hatch rather than a room, consider wipe down stations immediately before and immediately after transfer. If no wipe down station is present ,there is the temptation for personnel to pass material in without cleaning it.
TRANSFERVERSUSGOWNING
The changing/gowning areas should not be used for wiping down and transferring materials to a void potential contamination of personnel and clean room clothing. Good practice within a clean room should generally allow clean materials to come in one way and used materials to exit by another area.
Keeping Product Clean In and Out of the Clean room