Cleanroom and Critical Environment

Cleanrooms handle very precise and important testing procedures that require the highest degree of diligence to sanitary procedures and quality lab practices. Cleanrooms are designed to control the number of airborne particulates that are in the area. They use filters to collect the contaminants from the air and they do not recycle air back into the room. Analysts that work in cleanrooms must take numerous precautions to prevent bringing in harmful pollutants, which includes dressing in protective gear.

What is a Cleanroom?

Cleanrooms are highly controlled laboratory environments that provide a work space with a limited number of harmful contaminants. A work environment with control over airborne pollutants is essential for many laboratory practices. Air particulates could contaminate and affects data results or the quality of sensitive manufactured products. When working with these sensitive methods, it is important to take all protective precautions to ensure data and product integrity.

Different Types of Cleanrooms

There are different classifications of cleanrooms. Those classifications are differentiated by the number and size of airborne particulates that are in the room per cubic meter. Some classifications can operate with more lax requirements and others must be strict in their control policies.

Cleanrooms can operate on a scale of ISO 1 through ISO 9. ISO 1 marks an extremely clean room while, the other end of the spectrum, ISO 9 is considered satisfactorily clean. ISO 1 has the strictest requirements on the particulate size and concentration. No particulates can be greater than 5.0µm in an ISO 1 cleanroom and particulates are measured down to 0.2µm. An ISO 9 cleanroom does still have some regulation requirements but it is listed as normal room air.

The type of manufacturing a product requires determines what level of cleanliness is required.

• ISO 8 is the base cleanroom requirement
• ISO 5 is the minimum needed for the pharmaceutical industry
• ISO 1-4 are the highest and most strictest classifications 

ISO, the International Organization of Standards, lists all procedures, methods and requirements for each level of cleanroom. Make sure to review your ISO standards for compliance.

Shoe Covers

Shoe covers are vitally important when keeping a cleanroom clean. Employees can contribute a large number of particulates to the room if they are not properly geared. Fabric and debris particulate could move from their shoes to the air or they may be carrying bacteria that could negatively impact the testing occurring in the laboratory.

Shoe covers are required for all different classifications of cleanrooms!

Basic shoe covers are required in certain classes of cleanroom including ISO 6, ISO 7 and ISO 8. The higher grades of cleanrooms require you to use boot covers, which have a much higher range of coverage than a standard shoe cover. Check your ISO classification as each class has different PPE requirements to make sure you are meeting the requirements.

Shoe covers fit right over the shoes that you are wearing. Elastic along the top ensures that they will stay in place over your shoe. They are made from durable materials like polyurethane, plastic, latex, or a combination of those constituents, which makes them durable and tear resistant. They are waterproof and hold all dust and debris inside so it doesn’t contaminate your workspace.

Disposable Shoe Covers are Essential

Disposable shoe covers play an important role in running a cost effective, sanitary, and safe cleanroom.

Sanitary

By keeping disposable shoe covers, employees can maintain a standard procedure on applying a new pair of shoe covers before entering the clean space. Then they can dispose of those shoe covers when they are leaving the cleanroom. This is an easy procedure to implement that will ensure that no contamination occurs from employee shoes as they enter the laboratory.

Cost Effective

Disposable shoe covers are cost effective as they can be purchased in large quantities. Also, no time or materials must be spent in order to ensure the proper sanitization that would come with using reusable shoe covers. Higher class cleanrooms require clothing to be disposable for its reduced risk of contamination.

Safety

Shoe covers can be purchased with or without skid resistant tread. Skid resistant tread can be an important safety item for laboratory employees because it help can prevent dangerous falls.

Where Can I Purchase Shoe Covers to Meet My Laboratory Needs?

Shoe covers can be obtained from your laboratory inventory supplier. Lab Pro Inc can provide shoe covers in a variety of sizes, to ensure that your personnel can be outfitted with equipment that fits. They also have varying volumes of disposable shoe covers to offer, to meet your individual needs whether you need a little or a lot. Buy as few as a single pair or as many as 1700 in a single order! Boot covers are also available for those laboratories that require extra protection.

For over 40 years, Lab Pro Inc. has been committed to delivering the highest quality chemicals, PPE such as Shoe covers, lab supplies, laboratory equipment and cleanroom apparel to medical device and electronic manufacturing laboratories worldwide. To learn more, visit the biggest Lab Supply showroom in California, or contact us online or at 888-452-2776.

References

Editors, RS. “People Are Using These Shoe Covers to Avoid Tracking Germs Indoors.” Rolling Stone, Rolling Stone, 20 Apr. 2020, www.rollingstone.com/product-recommendations/lifestyle/best-shoe-covers-disposable-booties-986653/

PharmOut, et al. “Cleanrooms in Simple Terms a Practical Guide.” PharmOut, 25 Feb. 2018, www.pharmout.net/cleanrooms-in-simple-terms/

www.smpmedia.net, SMP media GmbH |. “Recommended Cleanroom Clothing per Cleanroom Classes.” Berner, 29 Sept. 2016, www.berner-safety.de/recommended_cleanroom_clothing_per_cleanroom_classes_en_1415.html