Things to Consider When Transferring Objects to a Cleanroom
There are important rules to remember when transferring raw materials into a cleanroom. Products, equipment, and even operators can introduce contaminants which could be extremely dangerous for the controlled environment. In most cases, new items might be wiped down, cleaned, repackaged, or prepared a proper way to enter a cleanroom safely. There are three most used transfer methods.
Multiple Cleanroom Bag Method
Personnel uses cleanroom bags to protect any materials being transitioned into the cleanroom. The number of clean bags per item varies depending on the manufacturing process. When multiple level classification areas are involved, the outside clean bag is removed at each new level entered. Once it reaches the final level, the last bag is removed. When using this method, the contaminants from lower classification areas are not being tracked into the controlled environment. Some manufacturing materials are supplied in several clean bags making the outside bag potentially very contaminated, so it serves to exercise caution when removing it.
This method calls for wiping or spraying products or materials with a suitable disinfection solution before entering the clean area in airlock. This process supplies greater control of preventing contamination because it regulates the amount and types of disinfectants used. The critical thing to remember is that materials should be wiped down using a traditional wiping technique – wiping from the cleanest to the least clean area using overlapping strokes in one direction. This method can be used by itself or implemented in addition to the clean bag method. Most of the companies creates their own SOP (Standard Operating Procedure) for disinfection materials, cleaning locations, technics so that identical results can be achieved every time.
Direct Sterilization Method
The direct sterilization method is probably the most effective, but it has a price. The facility would need special equipment such as a pass-through autoclave. Once the materials are placed in one side of the autoclave, the sterilization cycle begins. The process usually includes a vacuum, steam, HEPA air supply and cooling sequence depending on the material.
Certain materials are not allowed in a cleanroom at all. For example, cardboard and wood cannot enter a cleanroom because such materials can shed contaminant fibers or even bring mold into the controlled environment. Certain products packaged in cardboard must be removed from the box before they enter the room.
Another dangerous contamination element is the operators. People working in the cleanroom should go through the disinfection process before entering a cleanroom. There should be a specific gowning room to avoid contaminants from the personnel’s everyday clothing. Every person’s hygiene plays a significant role in contamination control as well. Operators should maintain personal hygiene – taking showers, washing hands, wearing clean clothes. It is essential to educate the staff about the appropriate hygiene habits. Controlled Environment like Biopharmaceutical applications required more controlled procedure – double gowning, air showers etc. for operators to enter cleanroom area.
The transfer process in a cleanroom is an essential element in contamination control. Unfortunately, the material process training is usually not given enough time, which results in employees and operators missing significant steps. It is crucial that personnel understand the importance and responsibility of their actions and how they might affect the production. It is advised that the management provides vital support and understanding when training the material transfer processes.
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