Updating Your Knowledge of Standards and Recommended Practices

Harold D. Fitch

Learning about the contamination control industry is easy if you take the time to read the standards and recommended practices (RPs) that affect your industry. Standards and RPs are an important part of many technologies–contamination control is no exception. Standards and RPs provide a basis for:

establishing a “stake in the ground” for measurements and conditions

measurement techniques

educating industry participants

establishing common goals

improving communication

individual and company participation

preventing or establishing competitive advantages

advancing the technology

We`ll discuss this list in more detail later in the column. But first, let`s examine the differences between standards and RPs.

Standards vs. Recommended Practices

Standards specify requirements that must be met; they can be product-related, i.e., measurements, color or performance criteria. They can also be more remote, such as the manufacturing conditions that must be adhered to during product manufacturing. The latter case is very important to the contamination control field, because it led to the establishment of clean manufacturing space and cleanrooms. Standards are generally issued by some ruling body–such as the federal government–for both commercial and military applications.

Technical societies originally issued standards. However, when court cases established a legal and financial responsibility for damages caused by these standards, it became apparent that technical societies must use an alternate vehicle; hence the establishment of recommended practices.

In the contamination control field, there are two major standards: Federal Standard 209, pertaining to air cleanliness–latest release 209E, 1992–and Military Standard 1246C, pertaining to product cleanliness–recent release, 1993.

RPs are industry-recognized good manufacturing practices (GMP), but are not mandatory. They may be utilized by agreeing parties to establish mandatory requirements, but they are only current thinking on good industry approaches.

There are a number of recommended practices issued by The Institute of Environmental Sciences (see chart).

The Impact

Let`s take a slightly more detailed look at the impact of standards and RPs on contamination control.

Both standards and RPs establish a “stake in the ground” for measurements and conditions. Standards and RPs provide the current industry thinking on measurements and conditions practiced by the participants. For example, Federal Specification 209 provides both the room classification (Class 100, Class 10, Class 1, etc.) and particle size that must be measured in establishing the class of the cleanroom. Federal Specification 209 has evolved with yearly updates. Minimum particle-size has decreased from 0.5 micron to 0.1 micron or less. In the specification`s latest version–209E, class and particle-size requirements are left up to the user, who has to negotiate with suppliers.

Standards and RPs provide key measurement techniques and conditions. They must also provide acceptable methods for making the measurements. Federal Specification 209, for instance, provides acceptable methods and equipment for taking particle counts and goes into sampling techniques and statistics for attaining meaningful and repeatable results. In addition, standards and RPs educate industry participants. Good industry standards and recommended practices provide information about the industry itself. A newcomer to contamination control can learn a lot by reading about appropriate standards and practices.

Standards and RPs affect the industry when common goals are established by manufacturers, users, suppliers, R&D teams, and the academic community working together. In Federal Specification 209, for example, flexible classes and particle-size requirements were developed to meet the needs of the electronics and pharmaceutical industries. Working on standards and RPs also provides key input to people, such as the measurement equipment manufacturers, by letting them know how well their equipment is meeting industry requirements and where to go in the future.

This “working together” also provides a vehicle for communication. Everyone benefits by sharing and discussing their own views and learning the concerns of others. Cross-fertilization is an important result of the standards and RPs work.

Standards and RPs activities allow individuals and companies to participate in activities that directly affect them. It is important not to have rules established for you by others without your own interests being represented. Again, the work on Federal Specification 209 and the establishment of classes and sizes for particles to meet the needs of particular industries is very important. It would cost billions of dollars to upgrade pharmaceutical manufacturing facilities to meet cleanliness requirements of 0.1 micron when 0.5 micron may be adequate for that industry at this time.

Proper standards and RP activities should be used to establish realistic goals for technologies and industries, but should not be used solely to establish a competitive edge by one group or country over others.

Standards and RP activities should also advance technology by sharing current levels of accomplishment and setting goals for future requirements. In addition to measurement equipment, this applies equally to enhanced cleanliness classes, smaller particle-size requirements, improved cleanroom garments and commodities, etc., across the board. Open, worldwide participation in standards and RP activities is what drives technology forward.

The Institute of Environmental Sciences (IES) is in charge of “recommended practices and acts” as the caretaker for the federal government on Federal Specification 209 and Military Standard 1246. In addition, the IES has been designated as the caretaker on contamination control issues in the United States by the American National Standards Institute (ANSI) and also holds the chair on international contamination control standards through the International Standards Organization (ISO) for ANSI.

Participation in all of this standard and RP activity is open to anyone who wants to get involved. You do not have to be a member of the IES. The main requirement is to maintain active participation, attend working group sessions, complete work assignments on time, and treat information confidentially until release. All the documents mentioned above are initially issued temporarily with a review period (usually one year) for addressing concerns and making changes.

There are certainly other groups–such as Sematech, SEMI, MITI, and JESSI–involved in contamination control standards and RPs. Fortunately, most of these activities are coordinated with and channeled through the IES.

For contamination control professionals, getting involved in these areas is an excellent way to make contacts throughout the industry, improve one`s perspective, and make a real contribution to our field. n

Harold D. Fitch is president of Future Resource Development (Burlington, VT), a consulting firm specializing in cleanroom education and problem-solving. He conducts international training seminars for CleanRooms` shows and seminars.