Guide to the Cleanroom Industry
Disposable Cleanroom Suit and Apparel
From clean garment manufacturing, to packaging and overall performance, there are many quality factors to consider as you select the right disposable cleanroom suit, smock, hood, coverall, and general apparel for your cleanroom and/or controlled environment.
All cleanrooms are controlled environments, but not all controlled environments are clean.
It’s important to you to not only protect your people, but also, protect your controlled environment and your product from contamination and excursions.
At Lakeland, we have a reputation for creating industry-leading personal protective equipment and apparel. We’ve created a free comprehensive guide intended to be your go-to educational resource when it comes to choosing the best cleanroom apparel for your application.
Follow the links below or download the guide now.
Cleanroom Quick Links
- Clean vs Sterile Cleanroom Manufacturing
- Cleanroom Suit Manufacturing & Sterility Data Support
- Why Packaging Matters for Your Controlled Environment
- Lakeland CleanMax® Apparel Features & Benefits
- Why Choose Lakeland for Your Cleanroom Garments?
- Cleanroom Garment Quick Selection Guide
- CleanMax® Versus Reusables
Clean Vs. Sterile Cleanroom Manufacturing
Your cleanroom classification requires you to meet ISO14644 standard and Institute of Environmental Sciences and Technology (IEST) recommended practices, but have you thought about the particle counts on your cleanroom apparel as a result of the manufacturing process?
The primary objective of cleanroom gowning is to eliminate contamination risks. Are you positive your cleanroom garments are not introducing more contaminants?
Just because something is sterile, doesn’t mean it’s particle free.
What is a Sterile Garment?
A ‘sterile’ garment can be manufactured in any type of facility; it simply undergoes a sterilization process once the garment is complete. In many cases, sterile cleanroom suits, disposable coveralls, and general apparel are not clean-processed and therefore, the garments have a heavy particle load and can introduce foreign particles into your cleanroom and/or controlled environment.
What is a ‘Clean and Sterile’ Garment?
A ‘clean and sterile’ garment is both sterile and clean manufactured. This means the garment is sewn and constructed in a controlled clean manufacturing environment. A clean manufacturing facility ensures that operators are not shedding any particles onto the garments during the construction and manufacturing process.
Cleanroom garments that are manufactured to be ‘clean and sterile’ offer significantly less excursions and lower surface particle counts in contrast to garments that are not clean manufactured.
Cleanroom Suit Manufacturing & Sterility Data Support
You only want the best for your cleanroom and/or controlled environment, so don’t be afraid to ask for the data. Not only should you insist on clean-manufactured garments for your cleanroom and/or controlled environment, it should be easy for you to see the data supporting the sterility of your garments.
At Lakeland, we make it easy for you to see and access the chain of custody for garment sterility.
In fact, it’s as easy as 1-2-3.
- Locate the QR code for you garment (it can be found on the garment tag, the individual package and on the box used for shipping.)
- Scan the QR code to access the Lakeland website database.
- View and print your sterility certificate as needed.
When you choose Lakeland CleanMax® apparel, we make it easy for you to access and print sterility certification.
Look for the Red Indicator Dot
Quickly assess the sterility of your garments with a gamma indicator dot, which acts as a visual indication that the product has been exposed to gamma radiation. Lakeland CleanMax® Sterile offers individually wrapped cleanroom garments with an expiration date and a self-adhesive, nontoxic indicator sticker that changes from yellow to red upon exposure to a validated dose of gamma radiation.
Moreover, each case is also equipped with a date of irradiation and a sterility indicator to ensure that upon arrival, your garments meet the necessary sterility requirements for your cleanroom classification.
Why Packaging Matters for Your Controlled Environment
How a cleanroom garment is packaged is critical to reduce cleanroom contamination and for the safety of your employees. The packaging process must be designed to:
- Reduce excursions
- Decrease doffing and donning time
- Prevent cleanroom contamination
Lakeland CleanMax® products are packaged to ensure maximum garment protection.
- Each package includes an easy open strip allowing for less handling when removing the garment from packaging during the donning process.
- Garments are folded and left unzipped to allow for easier donning.
- Garments are individually packaged without excessive wrinkling and to maintain cleanliness.
- The packaging can be wiped down with IPA without the fear of the print smearing or creating cross contamination.
- Individually packaged garments are placed in a sealed heavy-duty outer bag to protect the integrity of the garment and to facilitate staged entry into the gown room cleanroom.
- The cleanroom coveralls and frocks are positioned so wearers can only grab the inside of the garment, right below the collar area. This eliminates any contamination on the exterior surface.
- As the garment is pulled out of the packaging, the folded garment will fall easily, ready for the next step in the donning process.
- The bib on the hood is folded over so wearers can remove the hood from the package and don by touching only the inside of the garment.
- Boots are packaged in pairs with the upper of the boot folded over so the wearer can grab the boot by the inside of the upper to easily slide over shoes and up the calf.
Protect your cleanroom and/or controlled environment, your product and your people with packaging designed to minimize excursions and contamination. Learn more about Why Packaging Matters for Cleanroom Apparel and Safe Donning.
Lakeland CleanMax® Apparel Features and Benefits
CleanMax® is a high quality microporous laminate material that is lightweight and impervious to liquids, harsh chemicals and microorganisms. Available products range from disposable coveralls, to smocks, frocks, hoods, boots and more.
Benefits of Choosing Lakeland CleanMax®:
- PPE Cat 3 Type 5 & 6
- All garments are sterilized to a level of 10-6 SAL
- IEST-RP-CC003 Category I Cleanliness
CleanMax® Clean Manufactured and CleanMax® Sterile are both clean-processed garments, ready for use in ISO Class 4 – 8 Cleanrooms.
Clean manufactured and clean manufactured sterile garments are beneficial in meeting the strict cleanroom requirements of high-tech manufacturing, compound pharmacy, biotech, life sciences, medical device, food industry, microelectronics and industries utilizing controlled environments.
Cleanroom disposables are not created equal -- here are just some of the details that you can expect when you choose Lakeland CleanMax®:
- IEST-RP-CC003 Category I Particle Cleanliness
- Latex-free and silicone-free
- Resistant to blood and body fluid penetration, viral penetration, and BBP’s
- Chemical penetration resistance to oils, bleach and 50% Sodium Hydroxide
- Have 99.999% bacterial filtration efficiency
- All bound seams
- No pre-washing required
Lakeland Non-Sterile Disposables
At Lakeland, we understand that not all manufacturing facilities require sterilized garments. As such, we are proud to offer Lakeland CleanMax® Clean Manufactured garments without sterilization. These garments are identical to our sterile garments, but they forgo the sterilization process. Lakeland CleanMax® Clean Manufactured offers the same clean garments as our sterile garments for your cleanroom and/or controlled environment without the added cost of sterilization.
Choosing clean-manufactured garments for your cleanroom and/or controlled environment means maximum protection from unnecessary excursions during donning and doffing and foreign particle contamination.
Why Choose Lakeland For Your Cleanroom Garments?
Lakeland CleanMax® cleanroom garments provide the comfort, quality and protection you expect, all backed by our 30+ years as a manufacturer of disposable protective apparel.
Availability is Essential
Product availability is critical for your controlled environment. Losing valuable production hours because you lack cleanroom apparel is not an option. Our team at Lakeland and our network of exceptional distributors will help you find the right garment for your cleanroom application and ensure you get your order when you need it with our inventory management program.
Customer Service is Our Strength
At Lakeland, superior customer service is one of our biggest strengths. With a small, highly trained team dedicated to customer satisfaction, we are always ready to assist. Whether it is pairing the right customer with the right distributors, obtaining technical data for audits, or securing sterility certificates, our team at Lakeland will work directly with you to meet your needs. Moreover, we are ready to help you protect your people and your environment if your product or cleanroom garment needs change over time.
At Lakeland, we are here to support your team and to help you feel secure in your investment to protect your people, your cleanroom and/or controlled environment and your product.
Cleanroom Garment Quick Selection Guide: Who Should Use CleanMax®?
Confidence in your cleanroom starts with understanding how to select the right disposable coveralls, frocks, or general cleanroom apparel for your unique needs. Part of the benefit of working with Lakeland is ongoing access to our team of cleanroom industry experts. In just a few minutes, we will work with you to determine the type of garment required for your application and environment, and discuss how we can help you protect your team effectively with clean-manufactured garments.
Applications for CleanMax® Cleanroom Apparel
CleanMax® Clean Sterile
• Aseptic or Terminally Sterile Cleanroom Environments
• ISO Class 4-8 Cleanroom
• Sterility assurance level of 10-6 SAL
CleanMax® Clean Manufactured
• ISO Class 4-8 or Below Non-Aseptic Cleanrooms or Controlled Environments
CleanMax® vs Reusables: Which is Better?
Each time a cleanroom garment is handled, a chance for contamination occurs. A reusable garment goes through multiple steps in the laundering process leading to greater risk of contamination.
Choose Lakeland CleanMax® and feel secure in your investment in your most critical assets: your people, your controlled environment and your product.
Take the first step toward proven protection with Lakeland CleanMax® clean manufactured garments for controlled environments.
Contact us now for a free consultation and vendor list provided by a Lakeland representative.