How to Make your cleanroom meet FDA standards?

What is FDA?

FDA is the abbreviation of the Food and Drug Administration, and is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment, and radioactive products produced or imported in the United States.

In the food and medical and biological industries, clean rooms are very sensitive environments. Good cleanroom enclosure materials and strict construction requirements are required to meet FDA (United States Food and Drug Administration) and USDA (United States Department of Agriculture) and other governments Relevant standards and regulations formulated by the organization. After years of production and construction experience, Wiskind concluded that one of the most important elements to achieve these standards is to optimize access to cleanroom doors and isolate the surrounding environment.

1.Tightness

A clean room with good sealing has two major advantages:

It helps prevent particulate matter from the external environment from slowly penetrating through the gap during door closure.

It helps maintain proper pressure between the two rooms. In this way, when the door is opened, the air tends to flow out rather than flow in. According to the US Food and Drug Administration specifications, we know that "it is important to obtain proper airflow-it should flow from the area with higher cleanliness to the adjacent area with lower cleanliness." The criterion for achieving this requirement is "maintain a positive pressure difference of at least 10-15 Pa between adjacent rooms of different cleanliness levels."

In order to effectively seal, Wiskind cleanroom door adopts double-layer density. The door leaf and the door frame are each provided with a sealing strip, and the double-layer seal is more reliable. After being tested by the National Construction Engineering Quality Supervision and Inspection Center, the positive and negative wind resistance levels reach level 6, which is more suitable for some stricter door requirements.

2.Easy to clean/rinse

The clean room must be free (or as close to free as possible) of microbial contaminants. In terms of the concentration of pollutants in the house, the allowable range of error may vary according to the specific level of the clean room, but basically all clean rooms should be very easy to clean. Wiskind considered the corners and corners that may be more difficult to clean when designing and constructing cleanroom doors. For example, there are no exposed fasteners on the door frame. This completely smooth surface means fewer gaps to hide dust and contaminants. In addition, the types of doors are divided into clean steel doors and aluminum alloy doors-all of which are easy to wash and fully comply with FDA standards.

3.Durability

Durability means that the possibility of a failure that causes an unexpected shutdown is lower. We can imagine that if a mechanical failure occurs in the clean door, it will cause a few minutes of uncontrolled airflow between the two environments. In view of the sag problem of the door body after a period of opening and closing, the wiskind cleanroom door first uses special reinforced hinge fixing parts and lock body fixing parts, changing the traditional point connection to multi-contact, surface connection, and the door body connection is stressed It is more uniform and more powerful. Secondly, it adopts a special reinforced structure around the door leaf, and forms a whole with hinge reinforced fixing parts and lock body fixing parts. The overall force is applied, so you don’t have to worry about the shutdown.

Secondly, Wiskind cleanroom door adopts a full life cycle service. The quality of the door hardware will directly affect the use of the door. The lock is made of a customized German GEZE lock. After 500,000 opening and closing experiments, the whole door is guaranteed for 2 years and free maintenance service for life.

Wiskind group has a 41-year history and is involved in the mental facade, mental roof, cold room system, steel building system, modular building system, and cleanroom system. Wiskind clean tech focuses on the cleanroom area for more than 11 years and it has become the biggest manufacturer of the cleanroom panels, doors, and windows in China.

Also, we are the market-leader supplier for the pharmaceutical industry and hospital in domestic.

For the overseas market, we have exported our products to USA, Russia, Iraq, UAE, Israel, Thailand, Myanmar, Vietnam, Egypt, etc.

We are committed to the most influential enterprise in the cleanroom enclosure. If you have a project now, you are so welcomed to send an inquiry. We promise you the best quality at the best price.