The basic definition of a “clean room” is an area that has a controlled environment so that specific products can be manufactured and assembled. Within this room, the number of airborne particles must be controlled within specific guidelines and limits. That means all laboratory supply products used for the clean room must be able to comply with those limits, otherwise the products being manufactured and assembled will not be up to certain standards.
You can reference what the current clean room standards for airborne particles through ISO 14644-1 and ISO 14644-2. Sometimes you may still see references to Federal Standard 209E, but this standard was discontinued in November 2001. Strict rules are then followed to make sure the environment stays in compliance.
This is why specific clean room products are required when operating within this environment. Only laboratory supply products that comply with the specific regulations put forward by the International Organization for Standardization.
Within a clean room environment, contamination is either an act or a process which causes the airborne particle limits to be exceeded for some reason. There are two basic types of contamination that clean room products work to prevent: particulates and film-type contamination. Either can cause a tremendous amount of damage within the manufacturing cycle because it interferes with the quality of product being used.
“It is useful to assume that the operator is always contaminated while operating in the aseptic area. If the procedures are viewed from this perspective, those practices which are exposing the product to contamination are more easily identified.” – Hank Avallone
The sources of contamination must be specifically controlled by your clean room products and internal procedures in order to stay within current ISO standards. Most contaminants that interfere with a clean room environment come from 5 basic sources.
#1. Facility Sources. This would include particulates which come from the walls, wall paint, construction materials, or HVAC debris. Certain vapors, room odors, leaks, and spills may also qualify as a facility source of contamination for a clean room.
#2. Human Sources. This includes any skin flakes, oils, or similar biological debris that commonly sheds off of the human body. Saliva and hair are also common contamination sources. Certain clothing debris, cosmetic debris, and cologne/perfume would also cause contamination.
#3. Tool Sources. The tools that are used in a clean room environment can also contribute to high levels of airborne particulate contamination. Oils, emissions, wear particles, and even vibration also contribute to clean room contamination.
#4. Fluid Sources. Certain chemicals, outgasses, and even floor finishes or coatings are common sources of contamination for a clean room. One overlooked contaminate in this category happens to be deionized water.
#5. Manufacturing Sources. The products being created or assembled in a clean room environment also contribute to its contamination when not properly controlled. This may include aluminum particles, flakes of quartz, silicon debris, or stainless steel shavings.
Whether you’re looking to improve the effectiveness of your cleaning personnel or you want to implement an improved set of procedures to limit contamination, here are some procedures that can help create the environment you need.
Then only approved gloves, clothing protectants, finger cots, and tools should be used within the clean room. This is because fingerprints can immediately damage the manufacturing or assembly process. Tools, when not in use, should be placed on an approved wiper or similar product and must be approved for the clean room class that must be maintained.
You may also need to implement specific behavioral guidelines for the clean room. Believe it or not, one of the most common reasons for clean room contamination is horseplay between co-workers. You may also need to remind workers not to write on their equipment or garments, limit the speed of walking, and not remove items from beneath a garment.
When you are utilizing the best clean room work platforms and products as part of the manufacturing and assembly process, you are naturally limiting common sources of contamination. These platforms are specifically built to meet ISO standards, with custom sizing in dimension and size available. Purpose-specific options are also available for today’s best clean room work platforms.
Stainless steel ladders and stands, made from either 304 or 316 grade are both suitable from use in a clean room. Look for flat-perforated treads to further minimize other sources of contamination for the best possible results. Plate-mounted casters, diamond-plate trading, along with electropolish and passivation, are also available with the best clean room work platforms.
Clean room supplies are affordable, durable, and often custom-made to make sure you receive a great product at a great price. This one simple investment is the best way that you can control airborne particulates from a variety of contaminants, including from your ladders, platforms, and similar materials.
Even with high quality stainless steel ladders and platforms approved for clean room use, there are certain actions which must be limited. This includes prohibiting tools to rest on these platforms as that can still contribute to an inappropriate level of particulates in the atmosphere.
If you have further questions about clean room products or wish to know how our platforms can stand up to your stringent requirements for a specific classification, then contact us today at your convenience. With a durability beyond question, you’ll be able to create the safe and clean work environment your manufacturing and assembly requires.