In Part 1, we discussed different kinds of fabrics used to make disposable cleanroom garments. Depending on the application, each has its own unique place in cleanrooms. As discussed, an electronics manufacturer will have different garment needs than a pharmaceutical manufacturer. Manufacturers would need to make decisions based on particulate control, sterility, and cross-contamination concerns. An interesting point that surfaced through research, however, is that comfort is one of the most important considerations when choosing the right garment.
Solid State Technology (SST) posted a thorough article on cleanroom garments called, “Disposable cleanroom garment use and markets.” Here we will outline garment suppliers and their products.
- Cardinal Health – The authors dedicated a significant amount of space to this company, citing them as a market leader in sterile, disposable cleanroom garments. Manufacturing garments for use in Class 100 (ISO Class 5) to Class 100,000 (ISO Class 8), Cardinal Health offers the highest sterility assurance level available – .000001. The company’s sterile and nonsterile garments are made with Tyvek. The sterile Micro-Clean line is laundered and sterilized with gamma radiation. They are individually bagged and packaged in a Class 10 cleanroom. The three lines of nonsterile garments include the Micro-Clean 2-1-2 Opti-Soft. It’s coated to eliminate loose fibers and can be recycled.
- DuPont – Offering four different lines of disposable garments, DuPont’s sterile garments come with a “Certificate of Irradiation and Sterility.” The IsoClean is a durable garment that offers excellent barrier properties. ProClean garments are exceptional liquid and particulate barriers. The Suprel LS line offers good liquid and particulate barriers along with exceptional comfort. Summus, with good barrier and breathability, is the most economical line.
- Kimberly-Clark (KC) – These SMS fabric garments offer strength and cloth-like comfort. The Kleenguard brand products have a patented microforce barrier fabric that not only provides “outstanding particulate holdout,” but also “claim to be 25 times more breathable than Tyvek.” According to SST, “The fabric has a clothlike, abrasion-resistant, spunbond polypropylene outer layer and includes a middle layer comprising an intricate web of microfibers that filter out many water-based liquids and dry particulates.”
These were the three companies with the best product descriptions, though the article also mentions Alpha Pro Tech, Lakeland Industries, Cellucap/Melco Manufacturing, and Shenzen Selen Static Scientific. For a link to the full article, click here. Most of these manufacturers’ lines can be purchased through distributors like WWR Scientific Products. Global Recovery Systems is mentioned as a company that recycles disposable cleanroom garments.
Today’s technology for cleanroom garments is quite impressive, but it can overwhelm the person who has to decide what kind of garment to use. Disposable garments, as described in the SST article, are often more cost-effective than reusable garments. Manufacturers who use cleanrooms need to know what kind of protection they are looking for and go from there. The right garment not only protects the products, but also keeps employees happy.
There are many considerations cleanroom operators must make when deciding on a garment for the cleanroom. Different uses and requirements will dictate whether disposable or reusable is more appropriate as well as what material is needed for the application. For medium to high-risk environments, disposable garments tend to be more cost-effective. We will focus on qualities of disposable garments here.
Different industries have separate needs when it comes to their cleanroom garments. For example, pharmaceutical manufacturing looks at particulate control and sterility. Electronics manufacturers would be most concerned with particulate. Biotech companies are concerned about cross-contamination. Each manufacturer will be interested in different qualities of fabric and suppliers.
Here are some of the fabrics used for the garments:
- Tyvek, made by DuPont, is probably the most well known fabric in the cleanroom industry. It performs well in Class 100 (ISO Class 5) to Class 100,000 (ISO Class 8). The material is breathable and offers light splash protection against non-hazardous liquids. Most organic and inorganic chemicals will not affect the physical properties of the material. Tyvek remains strong and flexible wet or dry, and down to -100 degrees Fahrenheit. While the garments can be treated to be static-dissipative, they are not static shielding. There is free-fiber generation at wear points, and if exposed to a flame, Tyvek will melt away.
- Spunbonded-meltblown-spunbonded (SMS) – The spunbonded polypropylene outer layers offer extra strength and comfort. The microfiber matrix middle layers filter out fine particulates and water-based liquids. This is a breathable fabric but does not block particle and microbes as well as Tyvek.
- Spunbonded Polypropylene (SBPP) – This nonwoven material offers minimal barrier properties. It is used for low-cost commodity applications like shoe covers, coveralls, lab coats, and bouffants.
- Compressed Polythylene – 65% low-density polyethylene and 35% light low-density polyethylene make up this lightweight film that is practically impervious. Best used when physical properties must be unaffected by either chemicals or solvents.
- High Moisture Vapor Transmission (HMVT) Fabric – This film by BF Goodrich lets moisture escape while keeping liquids from penetrating. Solid State Technology’s article, “Disposable cleanroom garment use and markets” says the film: “incorporates monolithic film technology to provide textile producers with waterproofing qualities, selective permeability, tear and puncture resistance, and barrier protection.”
You can see that each material caters to a slightly different set of needs. Cleanroom garment technology has come a long way since Tyvek came out in the early 1960s. Comfort has proven to be a highly significant consideration in these garments; this is obvious when we see adjectives like, “lightweight” and “breathable.” These are other factors that garment suppliers consider with their products. Next week we will outline some garment suppliers and what they offer.
Gerbig Engineering has encountered many unique manufacturing scenarios over the years and the flexibility of the AireCell system in conjunction with our engineering experience makes for high performing low cost solutions. When a GEC customer needed to get some clean air over an exposed process but without space to add any walls or vertical supports AireCell modular extrusions were used to create a structural ceiling section that was hung from the existing building structure housing a FFU and allowing clean air to flow over the process without interference. AireCell extrusions were able to provide a quick and cost effective solution.
“Of the many potential sources of contamination in cleanrooms…, none is more persistent, pervasive, or pernicious than the human beings who occupy them” (Jan Eudy, “Clean Manufacturing Cleanrooms: Human Contamination.”)
Cleanroom operators have a colossal responsibility. Contamination in a clean room can threaten the health of the public and destroy the reputation of a company. While equipment, surfaces, and structures produce harmful particles, humans are what most jeopardize cleanroom integrity. Eudy wrote in her article: “Just as humans are the greatest potential contamination risk, they are also the greatest resource for contamination control. A thorough, comprehensive training program detailing all aspects of cleanroom management will empower the cleanroom operators to control the degree of contamination during the production process.”
Whether or not to train cleanroom operators is not the issue, however. Attending even the most thorough training does not guarantee that the operator will understand or retain all of the information. Elaine Kopis Sartain, of the STERIS corporation, wrote an article detailing her expert advice on cleanroom operator training: “Designing A Results-Oriented Training Program for Cleanroom Operators.” She says, “One of the challenges that trainers face is how to take information and convey it to people in a manner that permanently modifies their behavior.”
Sartain outlines some simple and effective steps to train cleanroom operators in the most effective, behavior-modifying way:
- Clarify the message. Training shouldn’t just include the “how” and “what,” but also the “why.” Information will stick when consequences are explained in plain language. Be very clear about what can happen in each step if protocol is not followed. When available, offer real-world examples. Don’t just list what is prohibited; state why. For example, one could explain as Eudy wrote, “Cosmetics are prohibited because in addition to their gross particle generation, cosmetics release iron, aluminum, silicone, carbon, titanium, magnesium, potassium, sulfur, and calcium.”
- Engage the trainee. As much as an employee may want to pay attention, his mind will wander if he is bored. Sartain suggests personalizing the message and presenting it in a captivating or entertaining format. Listing the “whys,” as stated above, can help personalize the message. Sartain also suggests having the trainees create their own training videos. This is a phenomenal idea, as not only do people learn by doing, they learn best by teaching others. Any opportunity to have attendees take and research information and present it to one another will help seal it into their memories. The more fun the activity, the more engaged the audience will be.
- Reinforce the behavior. Sartain states, “reinforcement can be accomplished through additional training, audits, and supervision, including performance reviews.”
Even the most responsible and reputable companies need to proactively ensure that cleanroom operators receive effective training. It is the most assured way to avoid devastating consequences.