Cleanroom Garment IIoW Decision Loops

TABLE OF CONTENTS

·         OVERVIEW

·         BACKGROUND

o   Reusable

o   Disposable

o   Combination

·         DISPUTED COST OF OWNERSHIP FACTORS

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OVERVIEW

McIlvaine is initiating a number of IIoW Decision Loops to help cleanroom operators make the lowest total cost of ownership (LTCO) choices. The Industrial Internet of Wisdom (IIoW) connects all the knowledge to provide validation of the choice. This can be labeled Lowest Total Cost of Ownership Validation (LTCOV).

Validation is defined as successful communication of a superior choice. This communication requires a loop connecting the media, events, niche experts, associations, purchasers, and suppliers. It requires accurate classification and easy access to support documents.

McIlvaine is supplying the proposed structure and encouraging the industry to provide the details. Part of the effort needs to be identification and debate of disputable issues.

Cleanroom Garment IIoW Decision Loops

·         Reusable vs Disposable

·         Reusable

o   fabric selection

o   garment selection

o   processing selection

o   vendor selection

·         Disposable

o   fabric selection

o   garment selection

o   vendor selection

These decision loops need to be unique depending on the industry, cleanroom class and process. The criteria for cytotoxic drugs need to prioritize worker protection. 2nm chip production requires  conditions better than ISO 3. A hospital operating room, Covid isolation room, and compounding pharmacy all have different cost factors.

BACKGROUND

Here is background information for the loops.

The Case for Reusable Garments

Prudential Makes the Case for Reusable Garments

Environmental Impacts

Most companies that use cleanroom products do not consider the environmental impacts. It entails more than just solid wastes being dumped in a landfill. The materials used to make disposables can be broken down into two basic components: fabrics and contaminates. Fabrics are inert and will biodegrade over time without any impact to the environment. Contaminates, on the other hand, are those materials that biodegrade and, in the process, release CO2 (carbon dioxide) and CH4 (methane) from chemical reactions. Reusable garments are made from polyethylene terephthalate (PET), which is the same plastic used to manufacturer plastic drinking bottles. PET is fully recyclable and able to be reused numerous times, with minimal impacts to the environment.

Lifecycle Comparison

The lifecycle of reusable and disposable garments includes several different factors, such as the cost for the garments, the company’s CO2 footprint, energy use, and solid waste. Disposables go through the following stages during their lifecycle:

·                     Manufacturing

·                     Cleanroom Use

·                     End of Life

Reusables go through the following stages during their lifecycle:

·                     Manufacturing

·                     Cleanroom Use

·                     Laundry Transport

·                     End of Life

With reusables, after each cleanroom use, they are transported to a laundry facility where they are washed and, if needed, sterilized, before being returned to the company to be used again. The cycle continues until the end of life of the garment.

Twenty reusables are able to be reused 50 times on average, compared to using 1,000 disposables. The costs for purchasing the reusables and paying a laundry service to wash them is much less than the cost paid for the disposables. In addition, the total amount of energy and resources used over the entire lifecycle in megajoules (MJ) for reusables is about 8,380 MJ, compared to 10,900 to 19,200 for disposables, depending upon the materials used to make the disposables.

Businesses which choose a disposable cleanroom garment solution incur the following (per 520,000 units):

·                     30-129% increase in natural resource usage

·                     52-143% increase in energy use (throughout lifecycle)

·                     38-135% increase in the business’s CO2 footprint

·                     17 times more solid waste contribution in landfills

·                     4 times more water usage (throughout lifecycle)

Alternatively, using 10,400 units of reusables helps save approximately 3.5 million MJ of energy, with a 210,000 kg reduction in CO2 emissions. In the end, using reusables is better for the environment, saves com

Source: Overcash, Michael, Eric Vozzola, and Evan Griffing. “Implications of Reusable Versus Disposable Garments – Environmental Dimensions of Cleanroom Coveralls.” 8 October 2015. PDF File.panies money, and reduces overall waste

The American Reusable Textile Association (ARTA) Study

A study  was conducted on the environmental and economic impacts of using reusable and disposable cleanroom garments. The ARTA-supported study was conducted by Environmental Clarity  and based, in part, on a previous life cycle analysis on cleanroom coveralls published in the PDA Journal.

In cleanroom facilities, both disposable and reusable textile garments meet the particulate standards from most rigorous to the most basic levels. However, the reusables offer two additional benefits, lower cost and reduced environmental impact. The environmental and economic benefits when cleanrooms select reusable textile garments are now clearly defined in detail (based on estimates from detailed life cycle data on reusable and disposable products) and can be used by both suppliers and customers to add to their own environmental sustainability scorecards.

Environmental and economic savings

The study found that when US cleanroom operations choose reusable coveralls over disposable ones:

• More than 141 million megajoules (MJ) non-renewable energy (nre) (38 million kWh) is saved each year. Over a decade, 1.4 billion MJ nre is saved.
  • Annually, this environmental savings is equivalent to offsetting the carbon emissions from 1,650 cars annually, substituting for the diet impact of 4,100 persons, or displacing 89,000 iPads (design life).
• Costs are reduced by 58% over disposables and provide an economic savings estimated at $120 million each year, which is $1.2 billion over a decade.
  • The financial savings of a full-market use of reusables would be about $210 million/year (nearly $2.1 billion in a decade). In order to capture the full benefit of reusables for a future market, 87.5% reusables was analysed (12.5% are mandatory disposables).

These new US data quantify and reinforce the economic and environmental benefits of cleanroom decisions for selecting reusables. This information can be used by policy makers, sustainability program directors, purchasing organizations, and others.

From this study, the reusable cost savings did not appear to depend on the size of the cleanroom operation nor the region of the country located. These benefits are directly accrued to the cleanroom organizations in their financial reporting and increasingly to their sustainability scorecards. In addition, the manufacturers and the laundry organizations can share the sustainability credits with all their customers. The study concludes that providing this information can help cleanroom firms' decision-making and guide a path toward greater cost savings and environmental improvements.

The environmental analysis was from cradle-to-end-of-life (CTEOL) for each disposable cleanroom package.

The current reusable cleanroom market (14.1 million packages) was assessed to be 60% nonsterile and 40% sterilized and the total market is 50% reusable and 50% disposable

https://pubmed.ncbi.nlm.nih.gov/29444994/

Dastex Case for Reusables

In various publications on the subject of "Disposable garments for cleanroom use", the impression has been – and still is – conveyed that there are many technical arguments in favor of using disposable garments from well-known manufacturers without restrictions even in cleanroom class ISO 5 (in accordance with ISO 14644-1). However, anyone who examines this statement, application in classes ISO 5 or 6 more closely, will quickly come across an essential detail that calls into question the unconditional use of disposable garments. In most cases, disposable garments are not decontaminated after production. All impurities from the manufacturing process thus enter the respective cleanrooms 1: to 1 without hindrance. We took this as an opportunity to check in our own test cleanroom "Body-Box" to what extent disposable garments are generally suitable for cleanroom use, especially with regard to particle emission.

Certainly there are special areas of application where the use of cleanroom suitable disposable garments are still useful. It is important, however, that in critical areas (starting with class ISO 6 or better, or ISO 4) care should be taken to ensure that disposable garments have been appropriately decontaminated before packing. Only pre-cleaned disposable garments (material 2) are qualitatively, in terms of particle emission, comparable to decontaminated reusable garments (material 7).

There are considerable qualitative differences between the various disposable garment systems on the market with regard to their particle emission, which a user should definitely examine more closely and adjust to his requirements before using them in his cleanroom

https://www.dastex.de/fileadmin/2_Media/3_Veroeffentlichungen/en/Einwegbekleidung_vs._Mehrwegbekleidung_2020__03-2006__E_01.pdf

The Case for Single Use Garments

Here are results of a study by Kimberly Clark.

The Case for a Reusable/Disposable Combination

The analysis of Cleanroom World

Cleanroom apparel can be one of the most significant costs in a cleanroom, and people often ask whether it’s better to buy disposable cleanroom clothing or launderable cleanroom garments that can be washed and reused multiple times.

The answer: It depends.

Pros and Cons of Disposable Cleanroom Apparel

The beauty of disposable cleanroom apparel is that it’s easy to use. No need to launder anything, just wear it and toss it out. Particularly with the stricter classes of cleanrooms (e.g. Class 1 or Class 2 cleanrooms), disposable garments tend to be the most effective.

However, the costs for using something just once (or several times, depending on the manufacturers’ specifications) can add up, as you constantly have to replace the protective garments. Some of the less expensive types of disposable cleanroom garments tend to rip more easily, which means that they might not even make it through a single work shift. Also, reusable cleanroom clothes might need to be disposed of differently than ordinary waste, so those costs and protocol need to be considered.

Pros and Cons of Washable Cleanroom Apparel

The primary benefit of washable cleanroom apparel is that this type of cleanroom clothing and accessories can cost less, over the long haul. While reusable clothing and garments typically cost more to purchase, the fact that you can get multiple uses out of them dramatically reduces the cost per use. Washable cleanroom apparel also tends to be made out of fabrics that are more “breathable,” which makes them more comfortable to wear.

The downside of using launderable cleanroom apparel is that you need to find a safe, consistent, and effective way to wash the clothing between uses. If you’re using an outside company to launder your cleanroom garments, you need to ensure that their transportation and cleaning processes conform to your cleanroom class requirements.

The Best of Both Worlds: Disposable and Reusable Apparel

Often, when setting up a cleanroom environment and protocols, people will choose to use a combination of reusable and disposable garments. For example, they might choose washable cleanroom coveralls, but opt for disposable bouffant caps. To make a good decision about what to do for your cleanroom, you might consider setting up a spreadsheet and listing each individual item of clothing you need and whether it would be better to use a disposable or reusable version of the item (weighing in cost, comfort, convenience, and cleanroom conformance requirements).

Common Types of Cleanroom Apparel

The most common types of cleanroom apparel that are available in disposable and washable options include:

•cleanroom suits
•cleanroom coveralls
•cleanroom coats
•cleanroom gowns
•cleanroom frocks
•cleanroom sleeves
•bouffant caps
•hoods
•gloves
•masks
•shoe and boot covers

DISPUTABLE COST OF OWNERSHIP FACTORS

Discussions and webinars need to be conducted to obtain the conflicting views and provide purchasers with a better basis for decision making. Environmental Impact-disposal is used as an example

·         Comfort

·         Contamination

o   material properties

o   filtration efficiency

·         Total cost of ownership

·         Environmental Impact

o   garment production

o   processing

o   disposal

Environmental Contamination from Garment Disposal

·         garment properties

o   life in a landfill

o   contaminants emitted e.g. methane, harmful chemicals metals

·         garment fate

o   landfill

o   waste to energy facility

o   product from recycled plastic

o   ocean contamination

·         TCO Criteria

o   likelihood of a given fate

o   impact quantification

o   impact assessment

§  regulations present and future

§  measurement criteria

·         life quality

·         discounted future value

·         Tribal Values (do cleanroom owners in Montreal  prioritize reducing annual temperatures or preventing sea rise as do operators in Los Angeles)

Product from Recycled Waste

Input needs to be provided by the suppliers and consultants  relative to the Product from Recycled Waste option we need to learn more about the KC program in terms of the cost versus virgin plastic and the availability of this option for a given location

The RightCycle Program by Kimberly-Clark™ Professional turns hard-to-recycle PPE into new consumer goods.

Items to recycle include:

• Gloves
• Disposable cleanroom and lab apparel
• Safety eyewear

With The RightCycle Program, these everyday items get a second life when they are turned into:

• Patio furniture
• Flower pots and planters
• Plastic shelving
• Recycling bins

Measurement Criteria

Cardinal Health engaged McIlvaine in an extensive study which included the measurement criteria for waste disposal harm. One important output was a new metric to measure harm and good based on life quality of the customers. This includes discounted future values.  Global warming has a long term impact whereas many impacts such as comfort are felt immediately

Reducing world CO2 levels by purchasing reusable gowns may help people on the equator 50 years from now but if inefficient wastewater treatment at the local laundry creates virus risks for the hospital clients you have to consider what is labeled tribal values. Life quality can be measured in a unique way which makes comfort and possibly even appearance important.

This factor cuts both ways. It can be argued that comfortable and more attractive reusable garments have a benefit measured in Quality Enhanced Life Days (QELD). This is the new metric to replace  QALY or quality adjusted life years. This widely used metric does not consider comfort or other life quality issues and emphasizes just life quantity.

http://www.mcilvainecompany.com/SURS/subscriber/Text/White_Paper_8-17-09.pdf